There is an increasing international consensus that decision-makers need to consider a broader range of issues, beyond the environmental and health-related aspects, when assessing the use of agricultural biotechnologies [1
]. A broader assessment represents a way to emphasise social responsibility towards present and future generations [4
], and to acknowlegde environmental and socio-economic aspects while taking into account the possible costs of both regulatory action and inaction [5
]. In the regulatory or academic documents there is at present no general definition of what the “socio-economic considerations” that should be assessed are. According to the Interorganizational committee on principles and guidelines for social impact assessment in the US [6
], social aspects consider “the consequences to human populations of any public or private actions that alter the ways in which people live, work, play, relate to one another, organize to meet their needs and generally cope as members of society. The term also includes cultural impacts involving changes to the norms, values, and beliefs that guide and rationalize their cognition of themselves and their society
”. As regards to the dimensions or aspects included as “socio-economic considerations”, the AdHoc Technical Group on Socio-Economic Considerations (AHTEG-Sec) of the Convention of Biological Diversity, recognised that there is no single agreed definition but considered that the scope of the term includes five dimensions: (a) economic; (b) social; (c) ecological; (d) cultural/traditional/religious/ethical; and (e) human-health related [7
This inclusion of a broader range of issues is being called for in international frameworks (e.g., article 26 of the Cartagena Protocol on Biosafety), European (e.g., [8
]) and African fora (e.g., African Biosafety Model Law), as well as in an increasing number of national regulations on GMOs. For instance, the Norwegian Gene Technology Act (1993) is the pioneering example. It emphasizes the need to consider the social utility and contribution to sustainability of GMOs, as well as their direct and indirect impacts on agricultural practice and the socio-technological context. At the European level, the aim to take socio-economic considerations into account when making decisions on GMOs has initiated several activities. These activities includes for instance, the organisation of workshops on socio-economic considerations (e.g., the International workshop on socio-economic impacts of GMOs organised by JRC and FAO in November 2011; the European Environmental Agency workshop “Framing socio-economic assessment in GMO & chemicals regulation” in December 2012), the creation in 2013 of a working-group including Member States’ experts to address methodological frameworks for the assessment of socio-economic considerations of GMOs, as well as by the establishment of the European Socio-Economic Bureau at the Joint Research Center, the publication of national reports (see, e.g., [11
]), and the organisation of workshops on socio-economic considerations (e.g., the International workshop on socio-economic impacts of GMOs organised by JRC and FAO in November 2011; the European Environmental Agency workshop “Framing socio-economic assessment in GMO & chemicals regulation” in December 2012). Finally, in March 2015 a new directive on GMOs was approved (Directive (EU) 2015/412), allowing a Member State (or region) to adopt measures restricting or prohibiting the cultivation in all or part of its territory of a GMO, or of a group of GMOs defined by crop or trait, based on compelling grounds such as those related to socio-economic impacts, avoidance of GMOs presence in other products, agricultural policy objectives or public policy (article 1.3).
At the international level, the sixth meeting of the Conference of the Parties serving as the meeting of the Parties (COP-MOP) to the Cartagena Protocol on Biosafety also recognized the need, expressed by several Parties, for further guidance when choosing to take into account socio-economic considerations (decision BS-VI/13 (http://bch.cbd.int/protocol/decisions/?decisionID=13246
)), and recalled operational objective 1.7 of the Strategic Plan of the Cartagena Protocol on Biosafety for the period 2011–2020. The objective 1.7 aims: “To, on the basis of research and information exchange, provide relevant guidance on socio-economic considerations that may be taken into account in reaching decisions on the import of living modified organisms
”. For this purpose, the Secretariat of the Convention on Biological Diversity (CBD) launched several on-line discussions and appointed an Ad Hoc Technical Expert Group (AHTEG-Sec). This work will be continued following agreement reached at COP-MOP 7 to reconvene the group of experts to further develop clarity on the issue and to develop an outline for guidance on the implementation of socio-economic considerations in biosafety decision-making [14
An increasing number of countries are aiming to include an assessment of a broader range of issues. However, the need for robust methodologies or frameworks (including criteria, indicators and comparators) able to capture ex-ante and ex-post socio-economic considerations related to GMO cultivation, for gaining grounded empirical knowledge, and for appropriate systems for data collection has been recognised [5
]). These gaps have driven, and are at the same time a result of, a rather contentious debate among biosafety policy-makers and scholars on the desirability of including such considerations. There are also disagreements on what socio-economic considerations should be taken into account, both in the regulatory and the research fields (see [18
] for a review of the debates on article 26 of the Cartagena Protocol). Contentions have emerged around the scope, methods and disciplines involved, timing of consideration, baselines and comparators, criteria and indicators, “endpoints” or targets, the role of public participation and the precautionary principle, and the relationship with other fields of knowledge and with other dimensions of risk assessment (mainly environmental and health-related issues) [12
]. Some of the implications by the selection of specific approaches in national regulatory frameworks have been reviewed in Spök [12
] and Falck-Zepeda [22
]. In these two reviews, the number of countries reported was restricted to 12 and 18 countries or regions respectively, and only a small selection of topics were analysed in detail. An overview commissioned by the CBD Secretariat [23
], which, using a descriptive approach, compiled information from a greater number of countries (33). The present paper analyses the inclusion of socio-economic considerations in 34 countries. Compared to Spök [12
] and Falck-Zepeda [22
], our literature study include information on the implementation experience, a description of the protection goals and considerations taken into account, a description of the methodological approaches in each country and the role of public participation in the GMO regulation related to SEC.
The objective of this paper is to describe and analyse the state of the art of existing biosafety institutional frameworks, legislation and policies with provisions on socio-economic considerations. The aim is to recognise the advances achieved so far internationally and to reflect on the main challenges and lessons learnt based on a deeper analysis of a selected case (Norway).
2. Methodology and Information Sources
The present study reviews information regarding the inclusion of socio-economic considerations for commercial approvals in biosafety decision-making in 34 countries. Countries that have not included socio-economic considerations are not included in the study. This concerns also countries that have ratified the Cartagena Protocol but that at present do not have any national biosafety legal framework that includes socio-economic considerations. The primary sources of information were the laws, regulations and national policy frameworks, as well as other national official reports, if any. Most of the information was retrieved using the Biosafety Clearing House established by the Cartagena Protocol of Biosafety or the National Clearing Houses established by the national Focal Points of the Protocol, or directly through the official websites for non-signatory countries of the Protocol (e.g., Argentina).
Additionally, the CBD Secretariat has compiled a series of summaries and reports [23
], as well as national surveys in order to assess how socio-economic considerations are taken into account [24
]. These documents have also been reviewed to gather information relative to the state of the art of the implementation experience of socio-economic considerations in decision-making, as well as on capacity-building needs. Additionally, a literature review on the implementation of socio-economic considerations in biosafety decision-making has been conducted. This literature review of policy reports and academic papers allowed the identification of key contentious issues [14
], most of them also identified by Parties of the CBD as aspects that could contribute to the development of conceptual clarity on socio-economic considerations [7
]: (a) how socio-economic considerations are defined (including the definition of socio-economic considerations in the analysed regulatory frameworks, the scope (protection goals, criteria for inclusion and potential impacts taken into account)); (b) the methodological options (relation between the health and environmental risks and the socio-economic impact assessment, definition of baselines, factors affecting the methodological approaches, role of socio-economic expertise in the decision-making, data availability and the inclusion of participatory approaches) and (c) the role of participatory processes and stakeholders involvement in the GMO-related decision-making. The results section of the paper is structured following these categories. With the aim to analyse the practical implementation of socio-economic impact assessments we then describe the case of Norway. It was the first country to integrate a broader range of issues in its biosafety regulatory framework.
The regulatory documents were analysed in their original language when it was English, French, Italian or Spanish, and English translations were used for all other languages. Detailed information on the documents analysed can be found in Table A1
. The first legislation integrating socio-economic considerations is the Norwegian Gene Technology Act from 1993 while the last reviewed regulations are from 2013. The retrieval of the regulations was performed in September 2014.
All the regulatory documents are analysed and classified per type and topics included, and the classifications we have used are explained below in more detail.
Type of regulatory framework
. This classification differentiates between laws, regulations and guidelines. The classification of the different sources can be found in Table A1
. We also recorded the existence of specific biosafety legislation versus
a generic one covering also GMO-related issues.
. For signatory countries of the Cartagena Protocol, we analysed the experience in adopting socio-economic considerations in decision-making on GMOs using the Second National Reports on the implementation of the Cartagena Protocol. These reports are based on the declarations made by the national authorities (see http://bch.cbd.int/protocol/cpb_natreports.shtml
). The national surveys conducted by the CBD Secretariat in 2014 were also used as information sources [24
]. For the case of Argentina (non-signatory), information we retrieved was from the Ministry of Agriculture webpage.
Definition approach. The description of socio-economic considerations were coded and classified in prescriptive versus descriptive approaches. The prescriptive approach defines socio-economic considerations while the descriptive approach identify first a series of protection goals and then list, in a non-exhaustive manner, potential impacts. Moreover, we recorded if the socioeconomic dimension included the environment.
Protection goals and socio-economic considerations
. We extracted and classified the information on protection goals and socio-economic considerations using a mix of top-down and bottom-up approaches. We coded and labeled the protection goals and socio-economic consideration expressed in the laws, regulations and guidelines. Then, the list of protection goals and socio-economic considerations was simplified by merging of closely related labels, and classified by using the five dimensions identified by the AHTEG-Sec [7
We coded the methodological approaches that are described in the information sources using the same terminology as in the AHTEG-Sec document [7
] and by Falck-Zepeda and Zambrano [21
]. We left the list open, so that other methodologies could also be registered.
Indicators are a measure of the progress/harm of specific actions in a time frame. In some cases (e.g., Norway) the framework establishes guiding questions instead of indicators. We registered and classified the indicators using the five dimensions defined in the AHTEG-Sec report [7
As in environmental risk assessment, baselines also need to be defined for socio-economic assessment in order to establish which impacts are considered acceptable, desirable or avoidable are discussed [13
]. We established three options for the use as comparator: conventional agriculture, organic agriculture and others.
Conditions for approval. In some cases, normative frameworks establish socio-economic considerations as a condition for approval. In these cases, we chose to take a bottom-up approach, coding the different issues expressed in the analysed frameworks trying to maintain the original wording and, when possible, merging similar concepts.
Inclusion of risks and benefits. This aspect analyses if the assessment considers only risk (and cost) aspects (as it is done in the environmental and health risk assessment) or if it includes also benefits.
Direct and indirect impacts. Direct impacts include impacts that arise as a result of the modifications to the crop itself while indirect effects are those arising from the effects of the GM crops management (e.g., co-technologies such as herbicides used with herbicide-resistant crops).
Relation between the socio-economic impact assessment and the environmental and health risk assessment.
The CBD document prepared for the AHTEG-Sec points out that countries can follow different options when choosing to perform socio-economic assessment for biosafety decision-making [23
]. We classified the documents according to the options described in the CBD document: “Three general routes were observed: (i) address socio-economic considerations in the risk assessment; (ii) have an independent socio-economic considerations assessment; and (iii) evaluate socio-economic considerations through public participation in the decision-making process” [23
Level of analysis. This aspect analyses whether the regulatory system will require a specific assessment for each submission or if it considers other possibilities such as that the assessment needs to be based on the trait or trait-crop level.
Socio-economic expertise in decision and advisory bodies. This aspect analyses which bodies that are in charge of conducting the socio-economic assessment and decision-making, and if these bodies (both for national authorities and advisory committees) have experts with “social sciences” background. We did not include experts in related areas of expertise such as “agriculture” or “biodiversity”, neither representatives of Ministries nor other official institutions selected by their affiliation.
Inclusion of the precautionary principle. We classified the countries depending on if they had included the precautionary principle as a basis for taking decisions in their biosafety frameworks.
Participatory approaches. We took into account three aspects when analysing the role of public participation in the GMO assessments: public awareness and educational aspects, the access to information (if final assessments are published or made available to the public upon request), and if public participation are integrated in the decision-making process.
We carried out the coding and analysis of the data using the computer assisted mixed method (quantitative and qualitative) data analysis software Dedoose. The coding process was done by one of the authors. In case of doubts, the coding and classification was discussed with the second author. The two authors have performed the analysis of the data.
5. Conclusions: Needs and Recommendations
The review has pointed out that there are challenges related to achieving an effective and systematic implementation of socio-economic considerations in biosafety regulations. For instance, very few of the analysed regulations establish robust methodologies during the processes of framing, data gathering, assessment and decision-making related to socio-economic considerations. In addition, there are uncertainties associated with socio-economics since the respective scientific evidence and data remain insufficient, inconclusive or uncertain. There is therefore a need for both more empirical data and for competence in on how to perform assessments of socio-economic considerations. The case study of Norway shows that one of the outcomes by experience is a greater scope and depth of detail in the assessment of GMOs.
It is necessary to make explicit the normative values during the assessment of socio-economic consideration and in the decision-making phases. The implementation of socio-economic assessments, in most of the cases, would result in contradictory or divergent results (not only between different socio-economic aspects but also between socio-economic assessment and the environmental and health risk assessment), according to the framing used, the different assessment endpoints, or to the applied methods. Thus, it is difficult to arrive at unanimous overall conclusions, creating a more demanding need for transparency, openness and accuracy in the communication of this process.
There is also a need to characterize the different roles played by stakeholders in the analysed regulatory frameworks at different phases of the assessment: e.g., at the beginning of the process so as to frame the issues, during the assessments so as to provide data or at the end of the process for reviewing conclusions and providing opinions, as well as on the possible means of participation and/or consultation.