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“Framing socio-economic assessment in GMO & chemicals regulation”, 6.-7. December 2012
European Environment Agency,
Kongens Nytorv 6, 1050 Copenhagen, Denmark
Page
1
Framing socio-economic assessment
in GMO & chemicals regulation
Compiled by:
Michael Eckerstorfer
Helmut Gaugitsch
(Environment Agency Austria)
European Environment Agency,
Copenhagen, 6.-7. December 2012
Workshop report
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“Framing socio-economic assessment in GMO & chemicals regulation”, 6.-7. December 2012
European Environment Agency,
Kongens Nytorv 6, 1050 Copenhagen, Denmark
Page
2
Contents
1. Objectives of the Workshop and issues addressed by Workshop
discussions 3
2. Introduction and background 4
2.1. Impact Assessment at the EU level as a general context 4
2.2. Socio-economic assessment in EU chemicals regulation 4
2.3. Socio-economic assessment as an issue for further development of
EU GMO regulation 5
2.4. Challenges for framing socio-economic assessment in environmental
regulation, specifically GMO regulation 5
2.5. Background for framing of socio-economic assessment 6
2.6. Recent developments concerning framing socio-economic assessments
in GMO regulation 6
3. Results of the Workshop from the perspective of the organisers 8
3.1. General conclusions 8
3.2. Framing of socio-economic assessment 9
3.3. Implementation of the socio-economic assessment 13
3.4. Criteria for a well-designed socio-economic assessment 15
4. References 16
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“Framing socio-economic assessment in GMO & chemicals regulation”, 6.-7. December 2012
European Environment Agency,
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Summary report for the Workshop
“Framing socio-economic assessment in GMO & chemicals regulation”,
European Environment Agency, Copenhagen, 6.-7. December 2012
1. Objectives of the Workshop and issues addressed by Workshop
discussions
The workshop “Framing socio-economic assessment in GMO & chemicals regulation” held
on 6
th
and 7
th
December 2012 was organised by European Environment Agency with
assistance provided by Bio Intelligence Service (France) and Environment Agency Austria.
At the workshop, 35 experts from the European Environment Agency, the European
Commission, the European Chemicals Agency (ECHA), representatives of academia and
regulatory experts from Member States discussed the pending questions related to practical
application of socio-economic assessment in GMO & chemicals regulation, specifically
question on how to frame and implement socioeconomic assessments. The workshop
environment involved participants with various backgrounds, including regulators and experts
from different regulatory fields provided a good opportunity to address these cross-cutting
topics.
The workshop aimed to:
• present an overview of the legal basis of socio-economic assessments in chemicals
regulation and in GMO regulation, to identify common aspects as well as differences.
• discuss the state of play of implementation of socio-economic assessment in both
fields, and share initial experiences from the socio-economic assessment, specifically
of chemicals according to REACH.
• discuss how to “frame” socio-economic assessment in GMO regulation as a step to
identify the scientific basis and the methods that could be used or adapted for the
assessment.
• potentially indicate ways to strengthen implementation, while involving relevant
stakeholders.
The workshop specifically discussed two areas:
1) Issues connected to framing of socio-economic assessment, as well as challenges as
regards assessment approaches and methodology
2) Issues of implementation of socio-economic assessment as regards GMO and
Chemicals regulation, e.g. how the results from socio-economic assessment may be
best translated into overall decision making. This is an issue relevant for both GMO as
well as Chemical regulation, however against different legislative backgrounds.
The results of the workshop from the perspective of the organisers are summarised in
Chapter 3 of this report. The agenda of the workshop as well as the list of participants are
attached as annexes to this summary report.
Chapter 2 provides some background information by the organisers for the topics addressed
at the workshop.
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2. Introduction and background
The issue how to adequately consider socio-economic effects in the decision making
processes is actively debated at the EU-level as well as in individual European countries.
However, this question is also an important topic in the general discussion aimed at further
developing the overall EU environmental policy. Therefore the following chapters are meant
to provide some context information as background.
2.1. Impact Assessment at the EU level as a general context
The general nature of the topic is reflected in the general approach to Impact Assessment,
introduced in 2002 by the European Commission. Impact Assessment provides a framework
for integrated and systematic ex ante analysis of economic, social and environmental
impacts of European Commission’s policy proposals and is regarded as a crucial tool to
improve the quality and coherence of the EU policy development process and to facilitate a
better integration of environmental considerations within the European Union policies. The
approach developed by the European Commission for Impact Assessment also takes into
account the European Strategy for Sustainable Development (Mutombo 2012; White 2010).
Impact Assessment should facilitate an effective and efficient regulatory environment by
applying a well-founded approach to assess economic, social and environmental impacts of
policy objectives and options as well as regulatory decisions. Adoption of Impact Assessment
was meant to raise transparency, credibility and legitimacy of decisions as well as to deliver
a better information base for decision makers responsible for policy decisions (White 2010).
Guidelines were prepared by the European Commission to provide general guidance to the
Commission services for assessing potential impacts of different policy options
(http://ec.europa.eu/governance/impact/index_en.htm ). The guidelines were revised in 2009
based on previous experience of the Commission services in preparing impact assessments,
suggestions by the independent Impact Assessment Board and the High Level Group of
National Experts on Better Regulation, as well as by external evaluation and public
consultation (EC 2009).
2.2. Socio-economic assessment in EU chemicals regulation
EU Chemicals regulation according to REACH requires that the socio-economic
consequences of the use of chemicals are assessed to support an appropriate risk
management for these chemicals. Socio-economic assessment is used as a tool to assist
decision making specifically in cases where simple risk control strategies are not feasible,
e.g. if persistent chemicals may cause long-term environmental risks and alternatives are
either not available or also associated with certain risks (ECETOX 2011). The socio-
economic assessment should assess the benefits of the use of a certain chemical, as well as
the long-term consequences of such use or of alternative options. The results of socio-
economic assessment may in some cases support decisions to authorise the use of
chemicals based on an evaluation of risks vs. benefits, or generate results which provide a
basis for justifying restrictions for certain chemicals. For chemicals regulation according to
REACH an outline of information elements relevant for socio-economic assessment is
provided by Annex XVI to the REACH regulation. As stipulated by Annex XVI ECHA has
established guidelines for socio-economic assessment of proposals aimed at restriction of
use of chemicals (ECHA 2008). Initial experiences by ECHA and Member States with a
limited number of restriction proposals are available, e.g. for Dimethylfumarate (DMFu) in
Consumer Products, lead in jewellery, mercury in measuring devices, phenyl mercury
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compounds, 1,4-Dichlorobenzene, Chromium VI in leather articles and phthalates in articles
intended for indoor use. The scope of the respective analyses was quite different, ranging
from a broad scoped analysis aimed at an understanding of the costs for restriction of DMFu
to narrow scoped opinions with a detailed analysis e.g. for lead in jewellery. Experience with
socio-economic assessment of environmental impacts according to REACH however is very
limited - some environmental issues were dealt with in the phenylmercury case.
No socio-economic assessment has yet been filed in the framework of a proposal for
authorization. However such assessments would be specifically instructive for socio-
economic assessment in GMO regulation.
2.3. Socio-economic assessment as an issue for further development of EU
GMO regulation
As regards GMO regulation there is an ongoing discussion about how socio-economic
assessment could be implemented to further develop the present regulatory framework in
Europe. Current EU GMO regulation states that “other legitimate factors” can be taken into
account in addition to the results of the mandatory risk assessment of effects on human
health and the environment. However the regulation does not contain concrete requirements
for an assessment of socio-economic impacts of GMOs.
In comparison the Norwegian law on GMOs (Government of Norway 2005) mandates that
ethical issues and associated benefits for society of GMO use are considered, as well as
impacts on sustainable development (Government of Norway 2005). On the international
level socio-economic considerations may also be taken into account in decision making on
GMO applications according to the Cartagena Protocol on Biosafety. The recent COP-MOP6
meeting in October 2012 decided to advance work to assist Protocol Parties to consider
socio-economic issues associated with GMOs in decision-making according to the Protocol.
2.4. Challenges for framing socio-economic assessment in environmental
regulation, specifically GMO regulation
According to the EEA working definition of the precautionary principle (PP) an appropriate
implementation of the PP in environmental regulation should comprise a well-conceived
socio-economic assessment (Gee 2013). Such an assessment of the impacts of application
of the regulated technologies or products may help to address the limitations associated with
current decision-making to fully address impacts of (emerging) technologies as well as public
concerns and provide for a comparative assessment with alternative options to the assessed
applications. Socio-economic assessment based on appropriate, scientifically based
methods can facilitate a proper evaluation of the options available for decision making and
thus support to estimate the costs and benefits associated with possible decisions as well as
the costs of taking no regulatory actions. It may thus provide additional relevant information
to support decision making and therefore can facilitate “precautionary decision making”.
However conventional cost-benefit evaluation that focuses primarily on narrow and limited
monetary considerations might not be sufficient to achieve this objective.
The question how to frame the socio-economic assessment to meet the above purpose is
therefore a pertinent one. A clear definition of socio-economic aspects and guidance on the
use of appropriate methods and criteria for evaluation is currently not available for several
fields of environmental regulation, specifically for GMO regulation.
Furthermore necessary information for such assessments can be lacking. The European
Commission recently published an initial report regarding socio-economic implications of
GMO cultivation which underlines the general importance of the matter, but identifies a
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current lack of adequate information concerning assessment of socio-economic impacts of
GMOs (EC 2011a).
2.5. Background for framing of socio-economic assessment
A growing body of experiences is currently building up, e.g. as regards approaches to socio-
economic assessment and cost-benefit evaluation in different fields as well as from ongoing
development of scientific methods. Such available experience, e.g. from chemicals regulation
among others, should therefore be considered for developing approaches in different fields,
such as GMO regulation.
Several general lessons may be drawn as regards the challenges associated with the socio-
economic assessment of chemicals and GMOs:
• A rigorous understanding of the impacts resulting from chemicals or GMO use as well
as of the applying regulatory measures are key to robust assessments.
• The specifics inherent to individual fields of regulations need to be considered
adequately.
E.g. the evaluation of GMO use will need to address a diverse set of issues (see next
section), some of which are not closely associated with the risk assessment
conducted for these GMOs.
• Which aspects of a socio-economic assessment can or cannot be based solely on an
economical analysis in monetary terms need to be considered.
Some aspects, which are considered important for the socio-economic assessment of
GMOs, benefits of safeguarding biodiversity or consumer choice, are not easily
tangible and cannot be expressed in monetary values.
• The assessments need to be based on well-founded scientific approaches and data.
Modelling is a crucial tool for socio-economic assessment. However the application of
models should be carefully evaluated for appropriateness and be based on the best
available input data.
The sensitivity of results according to the assumptions taken for modelling and
assessment as well as uncertainties associated with the analysis need to be
indicated.
2.6. Recent developments concerning framing socio-economic assessments in
GMO regulation
In recent years several institutions addressed the issue of framing socio-economic
assessment within GMO regulation:
•
On the one hand the European Commission initiated activities to follow up the report
from 2011 by a conference (JRC 2012) and by setting up a working-group including
Member States experts addressing the methodological framework for socio-economic
assessment of GMOs in 2013, as well as by establishing the European Socio-
Economic Bureau at the JRC.
•
On the other hand several Member States were investigating how an assessment of
socio-economic impacts may be conducted, while considering the specific
characteristics of GMO applications as well as the national backgrounds in a
meaningful way (COGEM 2009, Spök 2011, Umweltbundesamt 2011). In France, the
High Council for Biotechnology was created in 2008, and includes a scientific
committee and an economic, ethical and social committee that support decision-
making.
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These considerations are based on the notion that socio-economic assessment would be
conducted in addition to and separate from the already implemented risk assessment
procedures to assess adverse effects of GMOs on human health and the environment
(involving EFSA and competent authorities from Member States). The European
Commission suggests that the socio-economic assessment of GMOs should particularly
address the following issues (EC 2011b):
1. Socio-economic impacts associated with effects of GMOs on human health and the
environment (as identified by the environmental risk assessment according to Dir.
2001/18/EC):
whereas EFSA is conducting an assessment of the likelihood and the environmental
and health consequences of adverse effects by GMOs. In addition the economic and
socio-economic impacts of such effects would be addressed.
• Impacts due to changes of the agricultural management (e.g. changes in tillage
activities, use of agrochemicals – fertilizer and pesticides, crop rotation patterns, etc.)
are considered specifically important in this respect;
2. Socio-economic impacts as regards general environmental policy objectives which are
different from those addressed in GMO regulation (Directive 2001/18/EC and
Regulation (EC) No 1829/2003); e.g.:
• maintenance of certain type of natural and landscape features ;
• maintenance of certain habitats and ecosystems (i.e. preservation of the conservation
status quo);
• maintenance of specific ecosystem functions and services (e.g. preservation of
nature-oriented regions of particular natural and recreational value to citizens);
• conservation of biodiversity in agricultural and natural ecosystems;
3. Socio-economic impacts associated with the presence of GMOs in other products, i.e.
impacts related to:
• preservation of organic and conventional farming systems ;
• avoiding the presence of GMOs in other products such as particular food products
under GM-free schemes;
• avoiding the distortion of competition in relation to the practicality and cost of the
measure laid down in Article 26a for avoiding the unintended presence of GMOs in
other products;
4. Socio-economic impacts associated with social policy objectives, e.g.:
• keeping certain type of rural development in given areas to maintain current levels of
occupation (such as specific policy for mountain regions);
• to support equitable distribution of costs and benefits;
5. Socio-economic impacts on town and country planning/land use;
6. Socio-economic impacts on relevant issues of cultural policy; e.g. related to:
• preservation of societal traditions in terms of traditional farming methods;
• preservation of cultural heritage linked to territorial production processes with
particular characteristics.
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3. Results of the Workshop from the perspective of the organisers
The following summary intends to give an account of the outcomes of the workshop from the
perspective of the organisers. The summary addresses presentations and discussions during
plenary sessions as well as in the breakout groups. However it is not intended as a
comprehensive account of all input presented at the workshop and of all interventions during
discussion.
Workshop participants were invited to review the contents of this report and the received
comments were taken into account for finalization of this publication.
The summary is structured into three sections, sections two and three addressing issues
discussed in two breakout groups as well as in plenary:
• General conclusions
• Framing of socio-economic assessment
• Implementation of socio-economic assessment
3.1. General conclusions
An important overall conclusion shared by most, if not all participants at the workshop, was
that the purpose of the workshop to discuss the issue of socio-economic assessment across
regulation fields, i.e. for both chemicals and GMO regulations proved to be a very useful and
stimulating exercise.
It was recognised that prior to this workshop little, if any, cross-talk between regulators and
experts from different fields of environmental regulation has been established to discuss the
respective challenges and approaches and to share experiences and lessons learnt. Despite
different regulatory backgrounds and frameworks it is considered very important to further
promote and establish such a cross-border discussion to be able to integrate available
insights and know-how in the development of approaches to socio-economic assessment in
individual regulation fields. Specifically in fields where the discussion is only at an early
stage, like in GMO regulation, such "cross breeding" with other related fields, e.g. chemicals
regulation among others, will be instrumental to ensure rapid development of appropriate
approaches.
Similar to the cross-talk between regulatory fields it was considered very important to
promote a multi-disciplinary approach to socio-economic assessment within individual fields.
For a meaningful assessment it will be crucial to bridge to some extent “the respective silos
of knowledge”, which are built by the individual scientific disciplines involved in socio-
economic assessment and promoted by the current system of allocation of (scientific)
funding.
Another important general conclusion of the workshop was that conceptual clarity of the
objectives of socio-economic assessment is instrumental for promoting meaningful exchange
within and across different fields of regulation. Conceptual clarity is necessary to avoid
confusion among the wide range of stakeholders involved in socio-economic assessment
which can significantly impair any discussion on the subject matter. It was reported that
activities to improve conceptual clarity are the first steps taken for implementation of socio-
economic assessment under the Cartagena Protocol on Biosafety according to a decision at
COP-MOP6 in 2012. However, it also seems to be necessary to avoid confusion between
different understandings of socio-economic assessment and other related approaches, e.g.
impact assessment or strategic environmental assessment.
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To facilitate the discussions at the workshop the following working definition for socio-
economic assessment was developed by the organisers as a reference point. The working
definition was developed in response to an introductory discussion of the issue, taking into
account documents relevant for the framing of socio-economic assessment in GMO
regulation (EC 2011b) as well as the relevant section of the REACH-Regulation (Annex XVI).
Other general conclusions are that socio-economic assessment should be regarded as a tool
to inform, but not replace decision-making. In addition, it must be recognised that a socio-
economic assessment developed for the purpose of supporting decision-making will
necessarily be restricted in time and resources, so that it provides timely inputs. Assessors
need to take into account that a high level of transparency needs to be pursued for
communication of the applied approaches as well as the conclusions of an assessment
towards decision makers and the general public. Scope, robustness and context of
assessments need to be transparently communicated to decision makers as well as
uncertainties of the assessment, e.g. due to the specific approach taken or due to lack of
methods and data to address issues regarded as important.
A further general conclusion is that the task of producing a socio-economic assessment can
be highly complex. E.g. the socio-economic assessment of GMO applications was regarded
to be such a complex task. The complexity as regards the approach to socio-economic
assessment in turn is reflected in the complexity to interpret the results of such an
assessment.
The implementation of socio-economic assessment would also not necessarily mean that
results of such assessments would consistently be either negative or positive. According to
the case specific characteristics of applications and of the assessment approach used for
analysis the results can turn out to be positive and/or negative. Assessors as well as decision
makers need to be aware that the framing of the socio-economic assessment will very much
influence the results. Furthermore, they need to take into account that the results for different
issues analysed during an assessment may not be pointing in the same direction. It may not
be possible to arrive at unanimous overall conclusions, creating a more demanding situation
for intelligibility of results and decision making.
However appropriate socio-economic assessment can be a contribution towards more
transparency on how societal or political opinions emerge, and in that regard the results may
influence political positions.
3.2. Framing of socio-economic assessment
The framing of the socio-economic assessment was regarded as a crucial aspect for further
discussions and for implementation. The following conclusions were drawn against the
background of experiences from both regulatory fields - GMO regulation as well as chemicals
Working definition
:
Other legitimate factors in the context of decision making going beyond an
environmental risk assessment including risks to human health, such as
- Environmental and human health benefits
- Social risks and benefits
- Economic risks and benefits
- Ethical issues
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regulation. Experience from other fields of environmental regulation should also be taken into
account in an issue-specific manner.
The following points can be taken from the discussion at the workshop:
The different regulatory backgrounds in the respective legislative fields need to be taken into
consideration to frame the assessment appropriately. The discussions at the workshop
demonstrated that significant differences exist, e.g. between socio-economic assessment in
chemicals and GMO-regulation. However, beyond these general differences certain
important similarities exist. Based on such similarities relevant lessons can be learnt from
available experience to accelerate setting up a framework for socio-economic assessment in
fields with only initial experience to date, such as GMO-regulation.
An important lesson is that in general a similar approach might be applicable for socio-
economic assessment, even if different issues need to be addressed. It was pointed out that
socio-economic assessment should start from an appropriate problem formulation, i.e. a
qualitative identification of potential impacts. During the discussion participants were
concerned that quantitative data is usually given more weight than qualitative information.
However the selection and prioritisation of issues for assessment should be based on a good
qualitative analysis, which needs to be well documented.
As noted in the previous section (3.1) conceptual clarity is needed to appropriately address
(i) reversible or irreversible effects, (ii) short term or long term effects, which may be very
pertinent in the GMO context and (iii) private or societal impacts. In this respect it was noted
that not only farm level effects need to be addressed, but also systemic effects on the
European society, if GMOs are used for cultivation in the EU.
Furthermore a number of additional questions were addressed, which were considered
relevant for framing:
• How to frame socio-economic assessment in the implementation of the precautionary
principle?
• How to frame socio-economic assessment in the context of proportionality?
• How to frame socio-economic assessment in the context of sustainability
assessment?
As regards the first question the results of socio-economic assessment may reduce the
uncertainties associated with costs and benefits of either risk management measures or
regulatory inaction and therefore facilitate application of the precautionary principle in
decision making. Furthermore socio-economic assessment may be a tool to better consider
different management options, which is a step to implement a “precautionary” approach in
decision making.
Appropriate framing of socio-economic assessment is also a means to assure proportionality
of measures, however it was noted that due to methodological issues this target might often
be difficult to achieve in practice, e.g. if a comprehensive demonstration of costs and benefits
is not feasible.
Application of the concept of sustainability to frame socio-economic assessment of GMOs is
tested as an element of the authorization procedure for GMOs in Norway, or explored as a
concept for socio-economic assessment of GMOs in the EU (Umweltbundesamt 2011). It
was considered to be fairly challenging to establish and operationalize such an assessment
approach. However factors linked to sustainability, e.g. long-term resilience in agriculture, are
important for assessing large-scale socio-economic impacts. Such factors should not be
disregarded due to the reason that they are not addressed sufficiently by the current
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approaches (compare: JRC 2012). On the contrary they may be developed into relevant
indicators for assessing applications as well as research and development activities.
It was noted that prioritisation of impacts to be addressed in an approach considering
sustainability will be based on societal values and therefore require social participation (see
also following section).
Generally it needs to be acknowledged that value choices should have an important role in
framing socio-economic assessment in order to achieve an efficient and effective
assessment. For example, the “problem(s) formulation(s)” which is considered a prerequisite
for the assessment unavoidably is associated with value choices.
Overall framing should be approached in a structured and iterative way that takes into
account interlinkages between the 3 areas:
• Environmental risk assessment, including human health
• Socio-economic assessment
• Decision making
Generally a clear borderline between risk assessment in strict sense and socio-economic
assessment is difficult to draw. Beside the fact that risks and consequences of environmental
and health dangers may be assessed differently according to different socio-economic
backgrounds, information established during environmental risk assessment is relevant for
an appropriate framing of socio-economic assessment. Assessors therefore need to be
aware of the issues addressed during environmental risk assessment to frame the socio-
economic assessment – with the assessment aiming at different assessment endpoints. For
those GMO applications where the risk assessment concludes to having only negligible
environmental risks, socio-economic assessment will mainly focus on other issues.
To operationalize socio-economic assessments a clear definition of socio-economic impacts,
criteria for evaluation, as well as guidance on appropriate methods for assessment is
needed. A similar scientific rigour should be applied for socio-economic assessment as for
environmental/health risk assessment, in order to be transparent and meaningful. Challenges
are to decide and transparently communicate: How to monitor impacts? Which indicators or
data to use and which baseline to compare to?
The choice of comparators/baseline (also called “business as usual” scenarios in other fields)
is very important for an assessment. Experience from other fields, e.g. assessment of air
pollution impacts, indicate that the development of certain baselines demand allocation of
significant resources in terms of time, effort and money. With GMO applications
comparators/baseline will be dynamic based on agricultural development without introduction
of GMO(s) over a certain timeframe, rather than a simple replacement of non-GM crops by
GM crop applications. Appropriate comparators should include other agricultural
developments which will be established in the future and thus may represent different
development scenarios.
Ex-post analysis of data from countries with a relevant level of GM crop application may be
important for the development of a baseline in the GMO area. Data from the USA as well as
from other countries using GM-crops may be used as a “laboratory”, however the
significance of the data and the framework for their generation need to be scrutinised.
As considered in the discussion group on “Framing of socio-economic assessments &
Methodological challenges” examples of publication of apparently precise, yet contradictory
data suggest that such data need to be carefully evaluated to differentiate effects due to GM
traits from other developmental trends. One example for such contradictory results can be
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found in publications on the effects of introduction of GM cotton in India (compare Gruere &
Sum 2012; Kathage & Qaim 2012; Stone 2012).
Ex-post data may also be used to assess whether “expected benefits” consistently accrue
over time, or whether assumption of such benefits cannot be taken for granted.
Generally an adequate description of the methodology used for the analysis (ex-ante & ex-
post) should be given, regardless whether these methods are inclusive or exclusive,
quantitative or qualitative, for facilitating interpretation of results by decision makers or other
evaluators. It was reported at the workshop that ambition and skill levels of assessors of
specific socio-economic assessments may be very different and the approach taken for
individual assessments as well as their results may thus be quite different. Furthermore it
was acknowledged that information asymmetries exist between assessors and their target
audience, i.e. on the one hand decision makers and on the other hand the general public.
To facilitate interpretation of quantitative economic results, such data should be put in
context, e.g. by supplying supplementary (quantitative) information on the underlying
environmental impacts, i.e. physical changes responsible for socio-economic effects.
Furthermore the methods for calculating economic data should be made transparent for the
recipients of the socio-economic assessment.
Socio-economic assessment commonly aims at a quantification of economic impacts in
monetary terms. For socio-economic assessments we need to develop and apply pertinent
and transparent economic models. The development of such methods is a significant
challenge (cf. Andersen & Clubb 2013). Assessors are often expected to be able to attach a
meaningful price-tag not only to natural resources, but also to the more intangible assets of
clean water and air, as well as to species and biodiversity at large. However in socio-
economic assessments, specifically the ones addressing systemic impacts on society and
environmental change, quantification will not necessarily mean monetization. The guiding
principle “You can manage what you measure” should be revisited, as there are things which
are not easily measurable or translatable into monetary measures, but which have relevant
(societal) value. Some relevant social and environmental impacts can hardly be quantified at
all, but still can be analyzed qualitatively, e.g. by approaches from social sciences.
The presentation of quantitative data needs to be transparent concerning the associated
uncertainties due to approach and methodology of the assessment. Also the background for
the interpretation of quantitative results in a socio-economic assessment needs to be
transparent for the addressees, i.e. stakeholders and regulatory authorities.
For socio-economic assessment of GM crops the economic perspective involves different
levels: farm level, agri-food sector level, macroeconomic level. For some impacts e.g. farm-
level costs and benefits monetary assessments may be easily conducted. For impacts on
larger-scale levels indirect economic indicators may be developed as demonstrated in
different fields (see e.g. EC 2008), but should be used in a transparent and cautious way.
(Economic) assessments need also take into account that distribution of benefits and costs
may be highly unequal across society and that average numbers will hide such distributional
effects. To appropriately address unequal distribution of benefits and costs between different
stakeholders is considered a particular challenge for the assessment of GMO applications
(compare Quist et al. 2013, Franke et al. 2011). Due to this potential dissymmetry of impacts
of GMO applications, stakeholder involvement in the process of socio-economic assessment
is crucial (cf. next section 3.3).
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Also the ability to quantify the costs and benefits will often be distributed unevenly between
these two sides of the assessment. This is e.g. seen with socio-economic assessment of
chemicals, where the cost of a regulatory measure aimed at restriction of use is easier to
calculate than the benefits of such a measure (i.e. the costs of environmental and health
damages that might occur due to unregulated use).
Broader societal impacts should not be underestimated or disregarded on the sole reason
that they may be less tangible to an economic assessment.
3.3. Implementation of the socio-economic assessment
Socio-economic assessments are invoked by decision-makers to play a significant role in
more and more areas of European policy-making. There appears to be from many sides a
firm hope, that socio-economic assessments can help guide decision-making in a more
transparent direction, one that helps strike a good balance between on the one hand
protection of the environment - including human beings - and on the other hand indicate the
possible costs of regulatory actions and inaction. The workshop noted that these general
challenges as regards implementation of socio-economic assessments need to be discussed
against the specific regulatory background of individual policy fields. However even if the
regulatory framework is different as e.g. in chemicals and GMO-regulation some similarities
with respect to implementation are apparent.
The challenge at hands is to implement an institutional framework to define a robust set of
factors to properly capture ex ante and ex post socio-economic consequences of GMO
cultivation, build up a methodological framework to define socio-economic indicators, and
define appropriate system for data collection.
Committees assisting in socio-economic assessment play an important role in
implementation, e.g. at the European level the Socio-Economic Analysis Committee (SEAC)
according to REACH, or the European GMO Socio-Economics Bureau (ESEB), which is
starting its work in 2013 for GMO regulation. Similar committees with an advisory function
exist at the Member States level, e.g. the Economic, ethical and social committee of the High
Council for Biotechnologies in France. These committees may be multidisciplinary by
composition, and may include non-experts (stakeholders) as members. However, it is
important to remember that whether a risk is acceptable or not has to be decided by the
regulatory authorities.
Stakeholder involvement may serve different purposes: e.g. to represent different societal
opinions/values to ensure transparency of activities as regards framing and assessment, to
assure stakeholder inclusion and participation in the process, as well as to ensure
cooperation of data holders and thereby access to relevant data, etc. As outlined in the
previous section (3.2.) there is a need to engage stakeholders at an early stage as
assessment of socio-economic impacts is (partly) based on societal values. Inclusive
strategies for assessment to address the issues regarded as crucial by the public require
social participation processes to be established. This is specifically important for regulation
fields such as GMO regulation, which is characterised by significant uncertainties as regards
socio-economic impacts and a low consensus on acceptability of applications of GMOs in
agriculture, specifically for cultivation of GM crops.
In turn the question needs to be addressed how to include stakeholder input in the
assessment. Since stakeholders may be involved for different purposes, the respective input
will be needed at different phases of the assessment: At the beginning of the framing
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process for delineating issues; during assessment, e.g. for providing data, at the end for
reviewing conclusions and providing opinions. Involvement may also be based on different
means of participation and/or consultation. Furthermore the issue needs to be addressed
how to interlink expert and stakeholder input. While stakeholder input will be very relevant for
value-dependent considerations, it should not be assumed that stakeholder positions
represent a balanced view or that they are based on scientific considerations alone.
Socio-economic assessment may be implemented according to different possible
approaches:
• no need to do socio-economic assessment,
• environment/health and socio-economic assessment need to be done but separate,
• integrated approach necessary (cultural, social, economic, ethical - values)
In addition the following considerations were offered with regard to interaction between
Environmental Risk Assessment (ERA) and socio-economic assessment:
Basically four cases may be distinguished based on the different result combinations for ERA
and the socio-economic assessment: Assessment conclusions of both tasks may indicate
either negligible risk or identify certain risks (or costs/benefits). An issue is how to deal with
situations where results of both assessments are not pointing in the same direction.
However not all 4 combinations of outcomes will be relevant for both GMO and chemicals
regulation. This is partly due to the different approaches taken in the specific legislations.
E.g. GMO-legislation is based on the EU food law principle, to ensure food safety as its
prime objective. Thus an ERA indicating significant risks, which cannot be addressed
appropriately by risk management, would not be followed up by a socio-economic
assessment. Thus the ERA conclusions may not be leveraged by a socio-economic
assessment resulting in a positive conclusion, while in chemicals regulation some measures
aimed at restriction of a chemical associated with a certain risk might not be taken if the
socio-economic assessment concludes that the socio-economic assessment is not in favour
of the measure.
A related, important question is concerning the timing of the environmental risk
assessment/health assessment and the socio-economic assessment. In certain cases each
exercise is conducted in parallel, with some cross-exchange e.g. at framing of the socio-
economic assessment. In other cases the exercises are sequential, for example the socio-
economic assessment is performed only if the ERA results in negligible risks.
The socio-economic assessment results may be qualitative, quantitative, and/or if possible in
monetary terms. As indicated previously it needs to be acknowledged that e.g. in case of
biodiversity impacts the latter might be difficult or impossible to achieve.
The uncertainties associated with socio-economic assessment are substantial at present,
since the respective scientific evidence remains insufficient, inconclusive or uncertain in most
cases. The methodology for socio-economic assessment is not yet quite at the stage where it
can account for as much as policy makers sometimes boldly assume – getting there is
requiring further efforts and data, as well as new conceptual approaches to deal with
uncertainty and risks. The Stern report on climate change prepared for the UK government is
an example for this challenge in a particular difficult area (Stern 2006). Uncertainty of the
estimates will also be endemic to most of the issues that have to be dealt with in socio-
economic assessment of GMO applications. However the preliminary scientific evaluation
which is possible may nevertheless indicate some potential magnitude of the priority impacts
if appropriately communicated.
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The relevance of the type of GMOs to be considered in socio-economic assessment was
also discussed. Currently, direct (economic) benefits from GMO use are mainly seen at the
farm level, with little obvious benefits to the consumer or other actors of the food chain
(possible exceptions mentioned by workshop participants are e.g. a decrease of mycotoxin-
contamination in Bt-maize or a decrease in pesticide use in Bt-crops at a significant level of
pest pressure by susceptible species). It was noted that the debate may change e.g. for
GMOs which may provide health benefits for society.
Development of guidance was considered instrumental to make socio-economic assessment
operational and fit for the purpose. Guidance development may also contribute to
establishment of common methodology.
3.4. Criteria for a well-designed socio-economic assessment
• Socio-economic assessment should enable a systematic analysis of the main impacts
of an application or risk management measure.
• It should be proportionate to the problem which is addressed; i.e. scope and depth
will require case-by-case considerations.
• The socio-economic assessment will typically be a multidisciplinary and iterative
process to address all relevant costs and benefits with as little bias as possible.
Common sense reasoning should ensure that the assessment is only as extensive as
necessary – it should be taken into account that socio-economic assessment is not a
scientific exercise in itself, but a tool to support decision making, thus it is very
important to define the purposes of its application.
• (An) appropriate baseline(s) need(s) to be defined for assessment based on the best
available knowledge. Uncertainties and assumptions should be comprehensively
outlined to facilitate interpretation.
• Socio-economic assessment should be used wisely within a regulation framework,
mindful that it is not a panacea for all problems. However in contentious regulation
fields socio-economic assessment might be able to address important questions that
are not in the remit of other elements of the regulation process, e.g. environmental
risk assessment.
• Communication is a key requirement for a well-implemented socio-economic
assessment:
o communication between stakeholders and regulators at an upfront framing
process,
o communication between different experts from the different scientific
disciplines involved in the assessment,
o communication of assessment specifics and results by the assessors to the
decision makers, and
o communication of the objectives, results and significance of a socio-economic
assessment to the general public.
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