2 Animal health law
| (34913)
9468/13
COM(13) 260
+ ADDs 1-2
| Draft Regulation on animal health
Commission Staff Working Document — Executive Summary of the Impact Assessment
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| Legal base | Articles 43(2), 114(3) and 168(4)(b); co-decision QMV
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| Document originated | 6 May 2013
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| Deposited in Parliament | 13 May 2013
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| Department | Environment, Food and Rural Affairs
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| Basis of consideration | EM of 22 May 2013 and Minister's letter of 1 July 2013
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| Previous Committee Report | None, but see footnote
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| To be discussed in Council | See para 2.17 below
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| Committee's assessment | Politically important
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| Committee's decision | Not cleared; further information awaited
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Background
2.1 European animal health law is currently focused on preventing
and controlling transmissible diseases which may have significant
health and economic impacts, as well as effects on international
trade in animals and animal products, and the Commission points
out that the current framework comprises around 50 basic Directives
and Regulations, some of which were adopted in the early 1960s,
since when new challenges have emerged in the form of diseases
which were previously unknown, whilst trading conditions have
changed radically.
2.2 It also notes that an independent review in 2004 concluded
that, although the system was functioning properly, there was
a need to address issues such as the complexity of the framework,
the lack of an overall strategy, insufficient focus on disease
prevention, and possible improvements to intra-EU trade, and that
this led to the adoption in 2007 of the EU Animal Health Strategy
2007-2013.[10] It has
now proposed this new Regulation, which would provide legal support
for that Strategy, and establish a single, simplified framework
which sets out the objectives, scope and principles of regulatory
intervention, based on good governance and international standards,
enabling a quick reaction in case of emerging diseases, ensuring
consistency across the field of animal health, reducing the impact
of animal diseases on animal and public health, animal welfare,
economy and society, and ensuring the smooth functioning of the
internal market for animals and animal products.
The current document
2.3 Current European legislation currently governs disease
preparedness, notification, control, surveillance and eradication
on a disease basis, with rules governing intra-EU trade, movements,
identification and traceability having been developed on a species-by-species
basis, and rules around trade with third countries on a product
basis. This Regulation would replace the various individual Regulations,
Directives and Decisions in question, and would be underpinned
by more detailed delegated and implementing acts, with the existing
measures being repealed at dates to be determined by the Commission
over a 36-month transitional period, when those new acts have
been adopted.
2.4 The Regulation would be divided into the
following main parts.
PART I: GENERAL RULES
2.5 This sets out the general principles for
good animal health in EU legislation, and brings together measures
for terrestrial and aquatic animals (including farmed animals,
pets, animals in zoos, aquaria and scientific establishments,
wild animals, and bees). It also provides for the prioritisation
and listing of diseases which are likely to have a significant
impact, and will, for the first time, enable EU resources to be
systematically prioritised on a scientific and evidential basis.
The responsibilities of all those with a key role in the safeguarding
of animal health (such as operators, veterinarians, and pet keepers)
are also explicitly laid down for the first time, with operators
and animal professionals being required to acquire a basic knowledge
of animal health and related matters.
PART II: NOTIFICATION, SURVEILLANCE, ERADICATION
AND DISEASE FREEDOM
2.6 The responsibilities for notification and
surveillance, including animal health visits, are clarified, as
are the roles of operators, competent authorities and others regarding
the surveillance of the animal health situation in the EU, and
the new system allows for better use of the synergies between
the surveillance undertaken by those concerned in order to ensure
the most effective and cost efficient use of resources. In addition,
compartments,[11] currently
permitted only for Avian Influenza related measures and in aquaculture,
could be used more widely, thus introducing more flexibility into
disease control measures, and the possibility of continuing movements
and trade under certain circumstances, considered from a risk-based
perspective.
PART III: DISEASE PREPAREDNESS, AWARENESS AND CONTROL
2.7 There would be a continuing requirement on
Member States to draw up and implement contingency plans for dealing
with certain diseases; the regulatory framework for vaccination
would now be explicitly and coherently provided for; and rules
for the use of antigen, vaccine and reagent banks would be laid
down, as would rules on control measures to be taken in the case
of suspected or confirmed outbreaks of certain diseases. There
would, however, be little change to the existing system, which
is considered to work well.
PART IV: REGISTRATION, APPROVAL, TRACEABILITY AND
MOVEMENTS
2.8 This part is split into three titles, with
distinct rules for terrestrial, aquatic, and other animals, reflecting
their different production methods and epidemiology. The titles
dealing with aquatic and terrestrial animals lay down measures
which help to identify and trace animals and establishments, the
traceability of animals being of crucial importance during a disease
outbreak so that the epidemiology of the disease is understood
and can be better controlled. These titles also introduce the
possibility for more animals to be registered and traced through
electronic means, promoting simplicity and better regulation,
and reducing administrative burden. The third title on other
animals is introduced only for possible future provision, should
new threats emerge.
PART V: ENTRY INTO THE EU AND EXPORT
2.9 This sets the standards and requirements
for third countries sending animals, germinal products, products
of animal origin and other material which may transmit animal
diseases into the EU, in order to prevent diseases being introduced.
It also sets out requirements for export. No practical changes
are envisaged from existing legislation, which is considered to
function well.
PART VI: EMERGENCY MEASURES
2.10 Emergency measures are a crucial part of
disease management, and this Part lays down the procedures to
be followed in such cases, ensuring a rapid and consistent EU
response. Only a few practical changes are envisaged from the
existing legislation, which is considered to function very well.
PART VII: FINAL AND TRANSITIONAL PROVISIONS
2.11 These set out the national provisions, the
conditions for adopting delegated acts, repeals, and other necessary
legal provisions.
The Government's view
2.12 The Government's views are set out in an
Explanatory Memorandum of 22 May 2013 from the Minister of State
at the Department for Environment, Food and Rural Affairs (Mr
David Heath), together with further material he provided with
a letter of 1 July 2013. He says that the Commission's objectives
broadly match UK goals, and that the Government can support these
in principle, although examination of the high level principles
contained within the framework Regulation suggests that some potential
impacts will need to be clarified during discussion in the Council
and in the subsequent development of more detailed tertiary legislation.
2.13 These include:
- The protection of Farm Animal
Genetic Resources in order to avoid disease control decisions
having a negative impact on rare breed farmers.
- The need to ensure that derogations are available
where necessary to address any unintended consequences resulting
from the harmonisation of the framework across a wide range of
species for sectors (such as bee keepers) which have not previously
been subject to EU legislation in all of the areas covered by
the proposed Regulation, and that the categorisation of bee and
other diseases is appropriate.
- The need for transparency about the implications
of a risk and science-based approach in order to reduce farmer
mistrust, and so realise the potential for securing the significant
benefits from greater industry commitment to disease prevention
and surveillance measures.
- Science- and evidence-based categorisation of
diseases has the potential to bring significant benefits through
more efficient allocation of resources to the areas of highest
impact, and is fundamental to understanding the implications of
most of the provisions of the Regulation, but it is impossible
to calculate these benefits until categorisation is complete.
- The provisions on the responsibilities of those
in the private sector actors are at present very high-level, and,
if these were to become more prescriptive during negotiations,
there would be a potential burden on those concerned: also, the
impact on the responsibilities of Member States cannot be assessed
until the Commission has clarified the interpretation of the proposed
text (which is expected during the first read-through in Council).
- Subject to clarification and confirmation from
the relevant experts, the provisions for laboratories and others
handling disease agents and other biological products could give
rise to an increased burden, and an expansion of EU competence
in this area. On the other hand, there could be benefits of increased
security and harmonisation, as envisaged by the review carried
out following the outbreaks of Foot and Mouth Disease in the UK
in August 2007.
2.14 The Minister also comments on the procedural
implications of the proposal, pointing out that, as the vast majority
of the existing EU animal health legislation is contained in Directives
which have been transposed in each part of the UK, there will
ultimately be a significant simplification of legislation, which
should benefit Government, regulators, enforcers and industry.
He adds that there will also be considerable better regulation
benefits resulting from having a framework Regulation which would
be directly applicable in Member States, along with the tertiary
legislation made by delegated and implementing acts, resulting
in better consistency of application of the laws between Member
States. In particular, it is likely that the only secondary legislation
required after the repeal of large quantities of redundant statutory
instruments will be the relatively straightforward domestic enforcement
provisions in each part of the UK.
2.15 The Minister adds that, although it is perhaps
too early to predict, there is a possibility that certain primary
legislation can also be repealed when the whole EU package is
introduced, which would be welcomed by those involved in the enforcement
of the Animal Health Act 1981, as many of its provisions are very
outdated and patch-work, with most updates having simply involved
the consolidation of existing framework and structures which are
no longer fit for the twenty first century. He says that having
new simplified procedures for handling disease outbreaks and trade
in all the related products should make it possible in future
to see more clearly than at present how all these animal health
related measures fit together, and that the Government supports
a consistent and complementary approach to safeguarding animal
health, whilst still promoting safe trade.
2.16 The Minister also comments on the different
aspects of the proposed Regulation. He says that Parts V and
VI would have a minimal impact, as the current provisions would
largely continue to apply, but that the impacts in the other areas
are set out in Annex A (attached).
2.17 The Minister enclosed with his Explanatory
Memorandum an initial impact checklist, but says that a full Impact
Assessment will not be possible until the details to be contained
in subordinate delegated and implementing acts are clearer. He
also says that negotiations will commence under the Lithuanian
Presidency in the second half of this year, but are likely to
continue into 2014.
Conclusion
2.18 The scrutiny of documents which consolidate,
and amend, existing EU legislation presents major difficulties,
as it is virtually impossible, without a close knowledge of the
measure(s) in question, to identify in any detail their content
or the changes which are being made. Those considerations are
particularly acute in the case of a proposal of this kind, which
aims to update and simplify a large number of detailed and technical
measures going back over many years. The role of the Explanatory
Memorandum provided by the Government is therefore more than usually
important in such cases in enabling a proper assessment to be
made of a document's importance, and a coherent Report to be provided
to the House.
2.19 Since we did not feel that the Minister's
initial Explanatory Memorandum provided us with sufficient guidance,
we asked him to amplify his comments, which he did subsequently
in a note attached to his letter of 1 July 2013, the contents
of which are set out earlier in this chapter and in the attached
Annex. These demonstrate that, whilst the general principles
underlying the proposal are in line with UK objectives, a large
number of aspects need to be clarified, not only during negotiations
in the Council, but also in the formulation of subsequent delegated
and implementing acts to be adopted by the Commission.
2.20 In view of this, we can do little more
at present than to report the situation to the House, retain the
document under scrutiny, and ask the Government to keep us informed
of developments.
10 (28950) 13292/07: see HC 41-xxxvi (2006-07), chapter
5 (24 October 2007). Back
11
Animal sub-populations contained in one or more establishments
under a common biosecurity management system with a distinct health
status with respect to a specific disease, subject to appropriate
surveillance, disease control and biosecurity measures. Back
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