Download SF3-it3-doc1 Methodology risk assessments

EUROPEAN COMMISSION
DIRECTORATE-GENERAL
ENVIRONMENT
Directorate B – Natural Capital
ENV.B.2 - Biodiversity
Ref: SF3-item3-doc1
WORKING DOCUMENT
RISK ANALYSIS METHODOLOGY
The two major components of risk analysis are risk assessment and risk management.
Risk assessment is used to assess the risk posed by an invasive alien species (IAS), while
risk management provides a structured assessment of measures that can be used to reduce
risk.
1.
RISK ASSESSMENT
The following information is required in order for a RA to comply with Article 5(1) of
Regulation 1143/2014.
1
1a
Legal basis Sections on risk assessment
requirements for risk
assessments in
Regulation 1143/2014
- Article 5(1)
Information on the organism
Art 5(1)(a) a
Taxonomy
description of the
- Provide the taxonomic family, order and class to
species with its
which the species belongs.
taxonomic identity, its - Provide the scientific name and author of the
history, and its natural species, as well as a list of the most common
and potential range;
synonym names (a list of synonyms needs to be
developed to support the implementation of a trade
ban). While as a general rule a risk assessment
should be developed for one single species, there
may be cases where it may be justified to develop
one risk assessment covering more than one
species (e.g. similar species, belonging to the same
genus, with similar characteristics and similarly
invasive). In any event, if the choice is made to
include more than one species in a single risk
assessment, this choice must be properly justified
and the scope of the risk assessment must be
clearly stated.
- Describe the most common varieties, breeds or
hybrids (the scope of the risk assessment should be
very precisely delineated, e.g. if it includes
hybrids, which hybrids it includes or if it excludes
some varieties, e.g. sterile varieties).
- Provide information on the existence of other
species that look very similar:
 Other alien species with similar
Confidence
level (see
horizontal
guidance)
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

invasive characteristics, to be avoided
as substitute species (in this case
preparing a risk assessment for more
than one species together may be
considered)
Other alien species without similar
invasive characteristics, potential
substitute species
Native species, potential
misidentification and mis-targeting
History
- Provide a brief invasion history of the species (in
the EU or elsewhere if relevant).
Natural and potential range
- Indicate continent or part of a continent –
climatic zones - habitats where the species is
naturally occurring and potential changes thereof
1b
Art 5(1)(e) a
description of the
current distribution of
the species, including
whether the species is
already present in the
Union or in
neighbouring
countries, and a
projection of its likely
future distribution;
Current distribution in the Union or in
neighbouring countries
- List biogeographic region(s) 1 or marine
subregion(s) 2 in the EU where the species is
present, where it has established and where it is
widely spread
- List Member States and neighbouring countries
where the species is present, where it has
established and where it is widely spread3
Projection of its likely future distribution in the
Union or in neighbouring countries
- List biogeographic region(s)4 or marine
subregion(s)5 in the EU where the species could
establish.
- List Member States and neighbouring countries
where the species could establish
1c
Art 5(1)(h) a
description of the
Known uses for the species
- List and describe known uses in the EU and third
1
Use http://www.eea.europa.eu/data-and-maps/figures/biogeographical-regions-in-europe-1
2
Use http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:164:0019:0040:EN:PDF (Article
4)
3
See Annex 1 – To be developed on the basis of SF3-item3-doc2 "Description of presence, establishment
and widely spread"
4
Use http://www.eea.europa.eu/data-and-maps/figures/biogeographical-regions-in-europe-1
5
Use http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:164:0019:0040:EN:PDF (Article
4)
2
known uses for the
species and social and
economic benefits
deriving from those
uses.
countries if relevant
Social and economic benefits deriving from those
uses
- Describe the environmental, social and economic
relevance of each of those uses (quantitative
and/or qualitative depending on what is available,
regardless of the geographic area and scale.
Quantifying the above at EU scale might not be
possible, but qualitative data or different case
studies from across the EU, or third countries if
relevant, may provide useful information to inform
decision making)
2
2a
Probability of entry
Art 5(1)(c) a
description of the
potential pathways of
introduction and
spread of the species,
both intentional and
unintentional,
including where
relevant the
commodities with
which the species is
generally associated
Intentional pathways of introduction
- List6, describe and classify pathways according
to their importance, where possible give details
about the specific origins and end points of the
pathways. Give an indication of the propagule
pressure, including the likelihood of reinvasion
after eradication.
Unintentional pathways of introduction
- List7, describe and classify pathways according
to their importance, where possible give details
about the specific origins and end points of the
pathways. Give an indication of the propagule
pressure, including the likelihood of reinvasion
after eradication.
Commodities with which the species is generally
associated
- List, describe and classify commodities
according to their importance
2b
Art 5(1)(d) a thorough
assessment of the risk
of introduction,
establishment and
spread in relevant
biogeographical
regions in current
conditions and in
foreseeable climate
change conditions;
Thorough assessment of risk of introduction in
current conditions and foreseeable climate change
conditions
- This assessment should provide insight in the risk
of introduction into the EU
- It should explain how foreseeable climate change
conditions will influence this risk. The risk
assessment does not intend to provide a full range
6
Use the following classification of pathways: https://www.cbd.int/doc/meetings/sbstta/sbstta18/official/sbstta-18-09-add1-en.pdf
7
Use the following classification of pathways: https://www.cbd.int/doc/meetings/sbstta/sbstta18/official/sbstta-18-09-add1-en.pdf
3
of simulations on the basis of different climate
scenarios, but to inform decision making: in this
sense a description of likely introduction within a
medium timeframe scenario, with a clear
explanation of the assumptions made would be
sufficient.
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3a
Probability of establishment
Art 5(1)(b) a
Reproductive patterns and dynamics, including
description of its
availability of suitable environmental conditions in
reproduction and
the EU
spread patterns and
dynamics including an - List and describe the reproduction mechanisms
assessment of whether of the species in relation to the environmental
the environmental
conditions in the EU.
conditions necessary
- Give an indication of the propagule pressure of
for its reproduction
each of those reproduction mechanisms in relation
and spread exist;
to the environmental conditions in the EU.
3b
Art 5(1)(d) a thorough
assessment of the risk
of introduction,
establishment and
spread in relevant
biogeographical
regions in current
conditions and in
foreseeable climate
change conditions;
4
4a
Probability of spread
Art 5(1)(c) a
description of the
potential pathways of
introduction and
spread of the species,
both intentional and
unintentional,
including where
relevant the
commodities with
which the species is
generally associated
Thorough assessment of risk of establishment in
current conditions and foreseeable climate change
conditions
- This assessment should provide insight in the risk
of establishment in (new areas in) the EU.
- It should explain how foreseeable climate change
conditions will influence this risk. The risk
assessment does not intend to provide a full range
of simulations on the basis of different climate
scenarios, but to inform decision making: in this
sense a description of likely introduction within a
medium timeframe scenario, with a clear
explanation of the assumptions made would be
sufficient.
Intentional pathways of spread
- List8, describe and classify pathways according
to their importance, where possible give detail
about the specific origins and end points of the
pathways. Give an indication of the propagule
pressure, including the likelihood of reinvasion
after eradication.
Unintentional pathways of spread
- List9, describe and classify pathways according
to their importance, where possible give detail
about the specific origins and end points of the
pathways. Give an indication of the propagule
8
Use the following classification of pathways: https://www.cbd.int/doc/meetings/sbstta/sbstta18/official/sbstta-18-09-add1-en.pdf
9
Use the following classification of pathways: https://www.cbd.int/doc/meetings/sbstta/sbstta18/official/sbstta-18-09-add1-en.pdf
4
pressure, including the likelihood of reinvasion
after eradication.
Commodities with which the species is generally
associated
- List, describe and classify commodities
according to their importance
4b
4c
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5a
Art 5(1)(b) a
description of its
reproduction and
spread patterns and
dynamics including an
assessment of whether
the environmental
conditions necessary
for its reproduction
and spread exist;
Spread patterns and dynamics, including
availability of suitable environmental conditions in
the EU
Art 5(1)(d) a thorough
assessment of the risk
of introduction,
establishment and
spread in relevant
biogeographical
regions in current
conditions and in
foreseeable climate
change conditions;
Thorough assessment of risk of spread in current
conditions and foreseeable climate change
conditions
Probability of impact
Art 5(1)(f) a
description of the
adverse impact on
biodiversity and
related ecosystem
services, including on
native species,
protected sites,
endangered habitats,
as well as on human
health, safety, and the
economy including an
assessment of the
potential future impact
- List and describe the spread mechanisms of the
species in relation to the environmental conditions
in the EU.
- Give an indication of the speed of each of those
spread mechanisms in relation to the
environmental conditions in the EU.
- This assessment should provide insight in the risk
of spread into (new areas in) the EU
- It should explain how foreseeable climate change
conditions will influence this risk. The risk
assessment does not intend to provide a full range
of simulations on the basis of different climate
scenarios, but to inform decision making: in this
sense a description of likely introduction within a
medium timeframe scenario, with a clear
explanation of the assumptions made would be
sufficient.
Describe and assess10 known and potential future
impact on biodiversity and related ecosystem
services, with reference to:
- the different biogeographic regions where the
species could establish
- native species, including red list species and
species listed in the Birds and Habitats Directives
- protected sites, in particular Natura 2000
- endangered habitats, in particular habitats listed
in the Habitats Directive
- ecosystem services11
Describe known and potential future impact on
10
See Annex 2 – To be developed on the basis of SF3-item3-doc3 "Discussion document on the topic of
scoring impacts"
11
See for example classification of ecosystem services: http://biodiversity.europa.eu/topics/ecosystemservices
5
having regard to
available scientific
knowledge;
human health, safety, and the economy:
- human health
- safety
- the economy
Clearly differentiate between known and potential
future impacts. Known impacts should be
described for the EU and for third countries, if
relevant. Potential future impacts should be
described for the EU only.
5b
Art 5(1)(g) an
assessment of the
potential costs of
damage;
Assessment of the potential costs of damage on
biodiversity and ecosystem services
- Describe potential costs in financial or other
terms (quantitative and/or qualitative depending on
what is available, regardless of the geographic area
or scale. Quantifying the above at EU scale might
not be possible, but qualitative data or different
case studies from across the EU or third countries
may provide useful information to inform decision
making.)
Assessment of the potential costs of damage on
human health, safety, and the economy
- Describe potential costs in financial or other
terms (quantitative and/or qualitative depending on
what is available, regardless of the geographic area
or scale. Quantifying the above at EU scale might
not be possible, but qualitative data or different
case studies from across the EU or third countries
may provide useful information to inform decision
making.)
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Conclusion
 Probability of entry (conclusion of section 2)
 Probability of establishment (conclusion of section 3)
 Probability of spread (conclusion of section 4)
 Probability of impact (conclusion of section 5)
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8
Bibliographic references
Information on the quality assurance
 Author: name, title, affiliation, city, country
 Peer reviewer 1: name, title, affiliation, city, country
 Peer reviewer 2: name, title, affiliation, city, country
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2.
RISK MANAGEMENT
The following information on risk management is not required in order for a risk
assessment to comply with Article 5(1) of Regulation 1143/2014. Nevertheless, Article
4(4) requests Member States to provide evidence that all criteria in Article 4(3) are met.
Thus, it is required that this information is compiled by the party submitting the Risk
Assessment and annexed to it, to complement it and to further support decision making.
In order to allow the Commission to apply those criteria with due consideration to the
costs indicated in Article 4(6), Member States should also include such cost information,
where available.
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9a
Risk management information12
Legal basis - Criteria for
listing in Regulation 1143/2014
- Article 4(3), with due
consideration to Article 4(6),
not covered by the
requirements for risk
assessments in Article 5(1)
Art 4(3)(e) it is likely that
inclusion on the Union list will
effectively prevent, minimise or
mitigate their adverse impact
Sections on risk management
Confidence
level
Effective prevention, minimisation or
mitigation measures
- Provide information on existing
techniques and their effectiveness, as
relevant to the species considered in
particular on:
- measures to prevent
introduction, establishment and
spread into (new areas in) the
EU
- early detection and rapid
eradication measures;
- management measures where
the species is widely spread
(techniques for eradication,
population control or
containment of a population)
Coverage of the entire EU will likely not
be possible, but data or different case
studies from across the EU or third
countries may provide useful
information to inform decision making.
As far as possible, impacts on human
health and the environment, especially
non-targeted species and their habitats
should also be described for the above
measures.
9b Art 4(6) […] apply with due
consideration to the
12
Implementation cost for Member States
See Annex 3 – To be developed on the basis of SF3-item3-doc4 "Discussion document on good practices
on how to report risk management information."
7
implementation cost for Member
States
- Provide quantitative and/or qualitative
information (depending on what is
available) on the costs linked to the
techniques described above regardless of
the geographic area or scale.
Quantifying the above at EU scale will
likely not be possible, but qualitative
data or different case studies from across
the EU or third countries may provide
useful information to inform decision
making
9c
Cost of inaction
Art 4(6) […] apply with due
consideration to the cost of
inaction
9d Art 4(6) […] apply with due
consideration to the costeffectiveness
- Summarise the cost of inaction (or
benefit of action) based upon the
information foreseen in Art 5(1)(f) and
(g) (see section 5a and 5b)
Cost-effectiveness (quantitative and/or
qualitative depending on what is
available)
- Evaluate implementation costs (see
section 9b) against the effectiveness (see
section 9a)
9e
3.
Art 4(6) […] apply with due
consideration to the socioeconomic aspects
Socio-economic aspects
Summarise the socio-economic aspects,
based upon
- the information on the uses as foreseen
under Art 5(1)(h) (see section 1c)
- the assessment of the potential costs of
damage on human health, safety, and the
economy as foreseen under Art. 5(1)(g)
(see section 5b)
HORIZONTAL GUIDANCE ON THE COMPLETION OF RISK ANALYSIS

Each section should be supported by primary bibliographical references.

Each section should include the confidence level (high, medium or low confidence),
according to a documented methodology13.

The scoring of confidence level and impact classification systems used should be
referenced by including a link to the underlying publication.
13
Use for example:
 Harmonia+: http://ias.biodiversity.be/harmoniaplus
 EPPO: https://www.eppo.int/QUARANTINE/Pest_Risk_Analysis/PRA_intro.htm
 http://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.1001850, see text S1
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
The European dimension should be sufficiently covered, i.e. including the current and
potential distribution in the EU (Member States, biogeographical regions and
habitats), the known uses in different parts of the EU and the known and potential
future impact in the EU.

Authors should cover all elements under Article 5(1) of Regulation 1143/2014 and
answer all questions required by the Risk Assessment methodology they use. In case
there is no available information, authors should explicitly state this and not leave
questions unanswered.

The risk analysis should be subjected to quality assurance system, including at least:
o The risk analysis should have been reviewed by at least two peer
reviewers.
o Each peer reviewer should have the relevant taxonomic expertise.
o The author and the peer reviewers could be working in the same country,
but cannot be affiliated to the same scientific institution.
The peer review procedure should be briefly described.

Please note that every risk analysis will be made publicly accessible online as soon as
it is sent to the Commission: authors and peer reviewers may choose not to have their
names publicly disclosed.
9