Part II. Economic Considerations
Chapter 23. Including Socio-Economic Considerations in Regulatory Systems Governing Biosafety and
23.1. Considerations and parameters for inclusion of socio-economic factors in regulatory systems governing biosafety and biotechnology
When including socio-economic considerations (SECs) in the regulatory process, some of the considerations needed are, but not limited to:
i) Which socio-economic factors to include in the methodological framework.
ii) The appropriate level and scope of analysis. For instance, whether to include or exclude SECs that arise outside the nation’s borders; the time frame in which analysis should operate; whether both living (e.g. plants and seeds) and non-living products (e.g. meal) should be included; if analysis should be concerned with all potential uses of GM products, e.g. in biofuel, for animal feed and/or human food products; if analysis should be limited to SECs that arise from impacts on imports, exports, cultivation, etc.
iii) The reference alternative/null value that the GM crop product should be compared to.
iv) At what stage(s) during the regulatory process SECs should be incorporated (e.g. during deliberate release, post-release monitoring, commercialisation, etc.).
v) How results should be analysed and how they should be weighed in relation to data obtained from biophysical evaluations (e.g. effects on biodiversity, gene flow, non-target organisms, allerginicity/toxicity, etc.).
vi) Which institution(s) that should be responsible for the assessment.
vii) At what level the competent authority will either accept or reject approval of the technology.
viii) Public participation as a way of identifying and resolving socio-economic issues.
Note: List adapted from Fransen et al. (2005) and Horna et al. (2013).
23.2. Socio-economic considerations in selected international and East African biosafety and biotechnology frameworks and policies
23.2.1. International
Article 26.1 of the Cartagena Protocol provides Member States with the option of including socio-economic impacts as part of the decision-making concerning biosafety, but narrowly defines impacts as those arising from LMOs on biological diversity and conservation, especially with regards to indigenous and local communities (CBD Secretariat, 2000; MacKenzie et al., 2003). The Protocol further states that implementation of SECs must be “consistent with international obligations”, such as the WTO’s provisions for socio-economic considerations associated with trade, which includes the General Agreement on Tariffs and Trade (GATT), the Sanitary and Phytosanitary Measures (SPS), the TRIPs Agreement and the Technical Barriers to Trade (TBT) Agreement (Smyth & Falck-Zepeda, 2014).
However, the Protocol makes no reference to SECs under Article 15 concerning risk assessment, thus do not provide clear guidelines on how or when such considerations should be taken into account (MacKenzie et al., 2003). Consequently, there are currently on-going efforts and discussiosn among the signatories of the Cartagena Protocol – as well as within the European Union – on how to incorporate socio-economic aspects into the risk assessment for GMOs (COGEM, 2009; UNEP, 2014;
European Union, 2015). In this respect, Norway has been one of the pioneer countries, as it was one
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of the first to include assessment criterias related to ethics, societal utility and sustainable development in their regulatory frameworks (Miljøverndepartementet, 1993).
23.2.2. The AU Model Law
As already touched upon in Chapter 7, the AU Model Law recognises the need of including socio-economic and ethical considerations during risk assessment of GMOs and GM products. The Model Law exhibits a broader scope than the CPB and defines SECs as: “i) Anticipated changes in the existing social and economic patterns; ii) Possible threats to biological diversity, traditional crops or other products and, in particular, farmers' varieties and sustainable agriculture; iii) Impacts likely to be posed by the possibility of substituting traditional crops, products and indigenous technologies (…);
iv) Anticipated social and economic costs due to loss of genetic diversity, employment, market opportunities and, in general, means of livelihood of the communities; v) Possible countries and/or communities to be affected in terms of disruptions to their social and economic welfare; vi) Possible effects, which are contrary to the social, cultural, ethical and religious values of communities”
(African Union, 2007). Any GMO or GM product found to have “adverse socio-economic impacts” or do not fulfill requirements of “according with the ethical values and concerns of communities and does not undermine local community or indigenous knowledge and technologies” are to be witheld from release.
23.2.3. Socio-economic considerations in East African regulatory systems
In line with the AU Model Law, the regulatory systems of Kenya, Uganda, Tanzania and Ethiopia all state that socio-economic implications shall be taken into consideration during regulatory decision-making, and that approval shall not be given in case of adverse impacts (Government of the Federal Republic of Ethiopia, 2007; Republic of Kenya, 2006, 2009b; Republic of Uganda, 2004, 2008, 2012;
United Republic of Tanzania, 2004a, 2004b, 2005, 2009). However, as the Biotechnology and
Biosafety Bill has yet to be passed into law, Uganda has strictly speaking not made a final decision on whether or not – and in what way – to include SECs in their framework.
Kenya
The Kenyan Biosafety Act of 2009 states that the authority (NBA) shall take into account “socio-economic considerations arising from the impact of the genetically modified organism on the environment (…)” when evaluating an application (Republic of Kenya, 2009b). The NBA has listed certain SECs that applicants for environmental release must provide information on, including issues related to comingling, farmers’ income and trade implications (Appendices 3, Appendix A).
Uganda
The National Biotechnology and Biosafety Bill of Uganda states that one of the functions of the Competent Authority is to “consider necessary measures to avoid adverse effects on (…) socio-economic conditions arising from a GMO” (Republic of Uganda, 2012). The National Biotechnology and Biosafety Policy requires applicants for general release to: “(i) identify any potential positive or negative socio-economic effects of the proposed general release activity in Uganda or within the target population; (ii) identify any possible bio-ethical aspect of the general release activity; (iii) suggest measures to limit any potential negative socio-economic or ethical considerations” (Republic of Uganda, 2012). The Policy further recognise the following statements and actions associated with aspects of socio-economics: “Bioethics and Biosafety” (“mechanisms will be put in place to develop and apply Biotechnology in accordance with acceptable societal morals”); “Indigenous Knowledge and Practices” (“indigenous knowledge will be integrated in the development and application of
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modern Biotechnology”); “Gender Considerations and Equity” (“biotechnology is a technology that has a big potential of reducing the burden of manual labour. (…) less frequency of weeding, effectively use water reserves and are more convenient to harvest, (…) will reduce on the time spent by the women and the children (who form the majority) on the farm”) (Republic of Uganda, 2008).
Tanzania
The Tanzanian Biosafety Regulations of 2009 define SECs as set by the AU Model Law (United Republic of Tanzania, 2009). Additionally, the National Biosafety Framework states that “socio-economic and ethical concerns arise due to companies control of their processes, genes and chemicals. Socio ethical concerns revolve around ethical or dietary implications of vegetarians or certain religious groups and choice of consumers” (United Republic of Tanzania, 2004b). The biosafety guidelines also raise issues associated with IPRs (including protection of indigenous varieties, traditional knowledge and biodiversity), comingling of products, consumer choice and religious implications (United Republic of Tanzania, 2005; Mtui, 2012).
Ethiopia
In the outline of the draft NBF, it is stated that the EIA shall “address social, socioeconomic, political and cultural conditions”. SECs are to be incorporated during risk assessment and should “include a cost-benefit or socio-economic analysis”. In the case where there is “imminent and serious danger to (…) socioeconomic conditions or cultural norms of local communities (…)”, the authority (EPA) shall withdraw any authorisation and carry out the appropriate mitigation measures (Government of the Federal Republic of Ethiopia, 2007).
The original Ethiopian Biosafety Proclamation contained strict provisions for socio-economic assessment which focused mostly on the potential risks rather than benefits (Abraham, 2013). The Proclamation defined socio-economic impacts as “direct or indirect adverse effect that results from a transaction on the social or cultural conditions, the livelihood or indigenous knowledge systems or technologies of a local community, including on the economy of the country”, and further defined risks as “direct or indirect, short, medium or long-term danger that may befall (…) socio-economic or cultural conditions of local communities or the economic condition of the country from any
transaction” (Federal Democratic Republic of Ethiopia, 2009). Directive No. 2/2009 further
elaborated on potential risks, including effects on employment, market and trade, traditional crops and indigenous technologies, and religion and ethics (Government of the Federal Republic of Ethiopia, 2008; Abraham, 2013).
The revised Proclamation expand slightly on the definition of risks, namely “short, medium or long-term danger that may befall on (…) socio-economic conditions arising from the impact of modified organisms on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity, indigenous knowledge systems and local communities” (Federal Democratic Republic of Ethiopia, 2015). To the best of this authors knowledge, the directives have yet to be approved by the Ministerial Council to be made available to the public (as of May 2017), thus it remains to see whether the new Directives will contain addition information on SECs and how to incorporate these during risk assessment (and whether the provisions will be considered less strict as those set by the original directives).
173 Concluding remarks
There is a lack of clear guidelines both internationally and in the East African region on how to incorporate SECs into regulatory decision-making. For instance, articles related to SECs in East African regulatory frameworks have several limitations, such as the lack of (i) a clear definition of which SECs to incorporate during assessment (the Tanzanian Biosafety Regulations of 2009 and Ethiopian Proclamation provide the clearest definitions, while the Kenyan NBA has listed a few for the
conditional approval for environmental release; Appendices 3, Appendix A); (ii) guidelines for safety assessment, e.g. how and when to include SECs; and (iii) how the data should be analysed (Jaffe, 2006).
23.3. Implementing socio-economic considerations in biosafety decision-making: Challenges and opportunities
By implementing SECs in the safety assessment of GMOs, one can minimise or avoid potentially irreversible social, cultural, ethical and economic costs. However, some argue that socio-economic factors are “too vague”, “outside the domain of biosafety” or “uncontrollable” (Daño, 2007).
Furthermore, the inclusion of SECs in regulatory decision-making remains controversial due to several ill-defined parameters (e.g. defining the scope, identifying target populations, analysing risk-benefits, how to measure SECs that cannot be directly quantified e.g. in terms of monetary costs, etc.), as well as the various options for design, methodologies and implementation in the regulatory process.
Additionally, there is limited available information on socio-economic impacts of biotech crops, as well as lack of practical experience in including such issues in regulatory decision-making.
Furthermore, including provisions on socio-economics does not guarantee compliance with the law, and requires judicial support and strong political will to be implemented effectively (Collier & Moitui, 2009). All such considerations increase the complexity of risk assessment and consequently the time and budgetary requirements, which can be particularly constraining in countries with limited
monetary, human and infrastructural resources (Daño, 2007; Chambers, 2013; Horna et al., 2013;
Chambers et al., 2014).Thus, including SECs may become a limiting factor on the number of
potentially advantageous biotech crop varieties that make it through the regulatory process, which ultimately may have negative impacts on food security.
Consequently, SECs need to be incorporated in a way that is adaptable (e.g. to different crops and technologies), transparent, predictable, consistent, inclusive (to all relevant stakeholders), robust, scientific, testable, and time and cost effective, while still complying with international agreements and obligations to which countries may be bound (Garforth, 2004; Falck-Zepeda & Zambrano, 2011;
RAEIN-Africa, 2012; Chambers et al., 2014).
174 Recommendations
Fransen et al. (2005) and Horna et al. (2013) have listed a set of practical recommendations for integrating SECs into biosafety decision-making, of which some include:
i) Governments need to define those criteria listed under “inclusion of socioeconomic considerations in the biosafety regulatory system” (Fransen et al., 2005), especially with poor, smallholder farmers in mind. This might require a distinction between “real”
concerns and those that do not weigh heavily enough to prevent adoption of new technology. In this respect, it might be beneficial to rule out SECs that are not suitably dealt with using policies and regulations that govern biosafety and biotechnology due to conceptual and/or practical reasons. For instance, IPRs or issues associated with
consumers may be better addressed by laws related to patenting and consumer rights, respectively (Fransen et al., 2005).
ii) In order to facilitate transparency and cost-efficiency, governments should employ independent social scientists to carry out assessments, as well as establishing strict time frames and streamlined procedures (Fransen et al., 2005).
iii) One should use scientifically-sound research tools and methods (see below) that are carried out in an objective, analytically sound, multidisciplinary and independently conducted manner, while still considering time and budget constraints (Fransen et al., 2005; Horna et al., 2013).
iv) One should allow for inherent uncertainties that arise during assessment by including a range of values for the chosen parameters being evaluated (e.g. yield, technology efficiency and price) (Horna et al., 2013).
v) The scientific community should employ mechanisms for assessing socio-economic issues that arise during the research process, and include socio-economic assessments in the work plan, time frame and the budget of a project (Fransen et al., 2005).
vi) The biotechnology industry should aim to identify potential socio-economic concerns as early on in the process of development as possible (Fransen et al., 2005).
vii) The technical ability of NGOs and civic society groups should be enhanced in order to improve the ability of identifying and analysing socio-economic factors in a peer-reviewed manner, and as a way of engaging scientists, companies and government agencies (Fransen et al., 2005).
viii) Public awareness and participation should be promoted and made part of the legislation and institutional arrangements (Fransen et al., 2005).
175 Tools and methodologies
It is beyond the scope of this thesis to investigate the various methodologies for assessing socio-economic implications of biotech crops in any detail. However, Table 23.1 outlines some of the possible approaches and examples of considerations that such methods address.
Table 23.1. Research approaches for assessing socio-economic implications of genetically modified (GM) crops.
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Table adapted from Fransen et al., 2005.
Limitations
Most of the methods for assessing SECs address a limited number of factors (for instance, cost-benefit analyses are less applicable to ethical and religious factors), thus should be used in conjunction to capture the full range of socio-economic impacts. Furthermore, many SECs are considered ex ante, which pose certain limitations. For instance, impact assessment of a yet-to-be-released technology under farming conditions is limited due to the lack of primary information;
instead, the best available data is generated during confined field trials (CFTs) which also face certain challenges, such as difficulties in capturing the full range of agro-ecological and farming conditions (Horna et al., 2013). For example, the successful adoption of a biotech crop variety may vary greatly across locations and individual farms due to producer heterogeneity (e.g. differences in incidence and prevalence of pest and disease). Including such heterogeneity in ex ante studies is challenging and homogeneity bias may be introduced as a result (Horna et al., 2013). Additionally, certain assumptions have to be made in terms of the size and value of each variable included in the
analytical model (Horna et al., 2013). Furthermore, ex ante impact assessments are often carried out over a short time frame due to time and budget constraints, which limit the ability to capture the impact that climatic and environmental variability may have on the outcome (Ludlow et al., 2014).
Finally, socio-economic impacts may be influenced by production and market factors that appear ex post. Consequently, it may be necessary to incorporate in-depth studies during the initial stages of commercialisation to uncover any potential bottlenecks (Horna et al., 2013).
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