Online discussions on socio-economic considerations

Participants are invited to comment on and add views to the submission by Norway in this thread.

Excellent & insightful report on the Norwegian approach, reflecting a sovereign approach based on socio-economic-ethical issues in Norway.

I want to confirm, however, that in considering socio-economic issues related to Maize line 1507 and the 3 rapeseed lines, no SE studies were actually commissioned? I see reference to a large variety of existing 'data' & processes, including public consultation, risk assessment processes, regulatory body opinions and final assessments, surveys of public opinion & associated publications, and political support statements, but this all appears to be pre-existing to the actual decisions?

Thanks!
Ben Durham (RSA)

Greetings from Ethiopia.

The Norwegian Environment Agency has recommended that Norway
should not prohibit maize line 1507 under the Gene Technology Act. The Ministry agrees
with the Agency’s assessment that the intended uses of maize line 1507 do not represent
an increased health or environmental risk in Norway, but has nonetheless come to the10
conclusion that a prohibition should be imposed in Norway under section 10, sixth
paragraph of the Gene Technology Act, in light of the ethical problems that arise in
connection with the intended use.  So our question is that while the assessment revealed  no health impact,  why the public refused its use ? May be luck of proper communication?

Assefa Gudina
Cartagena protocol focal point
Ethiopia

Thank you for Your question #9872 regarding the Norwegian LMO prohibition despite minimal or no health/environmental risk in this specific case. The intended use  was import for animal feed and industrial use, only,  no cultivation, nor use as human Food. The Norwegian Gene Technology Act has five evaluation criteria. In addition to Health and environmental issues, considerable weight should also be given to sustainable Development, social utility and ethical aspects. The ethical Dimension was of particular importance in this particular case and in the end there was a political will to give this decisive weight at that time (2017). Best wishes, Casper.

There is no communication problem. The maize line has conferred resistance to the herbicide glufosinate ammonium, which has been classified as having both acute and chronic adverse effects on mammal health, including reproductive health and foetal development. This herbicide was withdrawn from the Norwegian market in 2008 due to adverse effects on health and the environment. Importing maize line 1507 that is produced using glufosinate ammonium in another country is perceived by sizeable user groups in Norway as ethically problematic and unsustainable. With regards to the moral views of the Norwegian people, factors such as solidarity with farmers in developing countries and establishment of sustainable agricultural production systems are considered important in issues in relation to GMOs.

O.A.El-Kawy

Thanks Ben, for Your question in #9871. You are right, Norway did not commision a socio-economic study as such. Input was made from a variety of Sources, as you stated, among them, statements from the Norwegian Biotechnology Advisory Board (NBAB) were particularly relevant. THis Board constitutes a wide range of views and expertise. Best wishes, Casper

I think Norway presented a very good study. And I believe that much is to be learned from it for socio-economic considerations. The crystallized parts of this study can be used in the guidelines as examples. First of all, very good regulatory examples are given - national legislation of the country, and bilateral and multilateral agreements are given, including ethical considerations, sustainability and benefit to society, which can influence the decision-making process.
Secondly, in spite of the fact that Casper commented that no socio-economic research was conducted as such, the review already shows that provided expert opinions of the Norwegian Biotechnology Advisory Board (NBAB) and Norwegian Scientific Committee for Food and Environment (VKM) covered key socio-economic considerations in accordance with the Gene Technology Act, as well as the bilateral and multilateral agreements cited in the review. Norwegian act differs from legislation in most other countries in that in it  in addition to environmental and human health risk assessment significant weight is given to ethical considerations, sustainability and benefit to society. In the cases being evaluated, despite the fact that environmental risks and risks to human health were not established for GM-maize lines, and for GM-rape lines - risks to human health, the NBAB decided it would negatively affect sustainable development if Norway were to permit the import of a GMO produced for use with the herbicide glufosinate ammonium (to which there is a different attitude in the world, in some countries it is allowed, in others it is forbidden), and which is prohibited in Norway. Thus, the ban was justified enough and included not only considering that glufosinate -resistant lines are safe for human health, but it considered such a question as the fact that both GM- rapeseed and GM-corn will be grown using glufosinate . Despite the fact that GM-lines will not be imported into the country for cultivation, NBAB decided that permit for import could have ethical issues (double standards) for Norway.

Best regards,
Galina.

I consider Norway as a good example for European Countries on handling SE Considerations. On the other hand it may not be appropriate for developing countries. Using 'sustainable development, social utility and ethics' as criteria is fine if well defined methodologies and guidelines are available.  Of the five health and environment are very important and if a LMO is found to meet these , then using ethics or sustainable development to prohibit should be justifiable.
krishna ravi srinivas

What I personally like about the Norwegian example is their candid position they provide: "Norway [is] restrictive with regard to GMOs".  This makes it fairly clear to developers and traders that they should seek a market elsewhere (except perhaps for flowers!).

I realise that because of the absolute requirement for science-based decision making (WTO, TRIPS etc), this requires some convoluted hoop jumping(!) to justify. But from a Developing Country perspective this is useful: Surely it is far better to know the status of a country wrt LMO's, than getting mixed messages, where a country's biosafety framework may appear permissible of LMO's, but regulatory authorities then go to great lengths to avoid allowing an introduction of LMOs, using every means, including possibly a lengthy SE study (that may well be inconclusive), to justify a rejection - all costing substantial amounts of time and money.  It is much simpler knowing up front that the chance of an LMO introduction is unlikely.

Again, from a Developing World perspective (and these do vary, so it is just one of many), economic development is a major objective.  In South Africa we have almost a mantra of "Poverty; Unemployment; Inequality" that guides government intervention.  Providing the introduction and use of LMO's are consistent (and managed appropriately) with government objectives, then there are clear benefits to be had (China's case study is a very useful reference) from LMOs.

Ben Durham (RSA)

Thank you to Dr. Galina Mozgova, of Belarus for the post. Based on Canadian science-based regulations, which are modelled on the Organisation for Economic Co-operation and Development’s risk assessment methodology, risks for the environment and human health a part of every risk assessment on LMOs. With science-based risk assessment methodologies already structured and functioning that examine risks to the environment and human health, it would seem an inefficient allocation of resources to review the socio-economic aspects of the two topics.

The WTO has defined risk assessment as science-based. The SPS Agreement allows for the adoption or enforcement of measures necessary to protect the environment or human, animal or plant life or health. However, criteria are specified as to the application of any such measures. The SPS specifies that: (1) any measure(s) should not discriminate between countries; (2) standards which conform to international standards developed by international organizations (ie Codex, OIE, IPPC) are presumed to be consistent with the obligations outlined in the SPS Agreement; (3) standards that are in excess of established international standards or where no international agreement exists must be based on scientific principles and the completion of a risk assessment; and (4) measures shall not constitute a disguised restriction on international trade. The EU has already lost one WTO case due to the inability to quantify scientific risks exist regarding consumption of GM foods (https://www.wto.org/english/tratop_e/dispu_e/cases_e/ds291_e.htm).

The use of expert opinions would not contribute to Principle 5 of the Elements of Conceptual Clarity, which states, “Taking socio-economic considerations into account in decision-making on living modified organisms should be clear, transparent, and non-discriminatory”. Making use of ‘expert opinions’ could fall short of this principle. Rigourous and proven methodologies for socio-economic consideration are essential, allowing for clear and transparent reviews of the decision-making process.

Stuart Smyth
University of Saskatchewan

Nigeria's Biosafety framework is in tandem with article 26 of the Cartagena Protocol on Biosafety (CPB).
         
       The Legalized authority on biosafety issues strictly outlines measures on socio- economic considerations
1) Anticipated changes in the existing social and economics patterns resulting from the introduction of the Genetically Modified Organism (GMO) or it's derivatives.
2)  Possible effects which are contrary to the social, cultural, ethical and religious values of communities arising from the use of release of the gmo or it's derivatives.
3) Possible countries and communities to be affected in terms of disruption  to other social and economic welfare.
4)  Possible threats to biological diversity, traditional crop and other products, particularly  farmers varieties and sustainable agriculture.

Quite insightful submission from Norway that makes a good case study on using a socioeconomic consideration "ethical consideration" as a base for a prohibition decision. The section on the WTO and how it accommodates socioeconomic considerations is good example showing how you can comply with your international obligations under 2 different instruments that are applied to the same issue in a mutually supportive way.

O.A.El-Kawy

The cases shared by Norway highlight their consideration of ethical concerns as an important barrier to the import of several LMOs.  This approach is consistent with their laws and regulations, as well as their “restrictive position” concerning LMOs.  Parties have the sovereign right to make decisions about the import of LMOs consistent with their laws, regulations and international obligations.  This includes taking socio-economic considerations into account consistent with Article 26(1).

The SEC guidance document is a voluntary, systematic approach for assessment of socio-economic considerations. This assures that Parties that elect to use the guidance document when taking socio-economic considerations into account can follow a stepwise process that is guided by the listed principles and consistent with Article 26(1) of the Protocol.  The guidance document describes a two-stage, process-based approach, led by regulators and assessors, to undertake assessment of socio-economic considerations that have not been previously considered as part of a science-based risk assessment, based on national laws and procedures.  Article 26(1) is included verbatim and in its entirety to ensure that the guidance that follows is consistent with and faithful to its intent.

The definition of socio-economic considerations in the context of Article 26 includes a broad array of socio-economic aspects.  While unsettling for Parties that hold to a narrower definition, it is important to recognize that a broad definition does not imply or impose on Parties an obligation to assess a broad array of socio-economic aspects.  Furthermore, the operational definition is only a starting point, and the assessment process that follows is designed to focus and frame the boundaries of the assessment, including expressly defining the relationship between the assumed impact of the LMO and the related socio-economic concerns to be assessed.

There is a wide array of methodological approaches available to assess socio-economic effects and each has strengths and limitations. Importantly, the methods chosen should be science-based and evidence-based and be reliable and applied in a transparent and verifiable manner. This emphasis is to ensure that Parties that undertake assessment of possible socio-economic effects in the context of Article 26(1) take into consideration their need to meet their international obligations. Parties also may choose methods that are based on other accepted approaches where scientific methods are not applicable, subject to national practices and requirements. The emphasis on use of science-based and reliable methods and the condition that use of unscientific approaches must be consistent with national practices and requirements, serves as an important barrier to the use of nonscientific methods in the assessment of socio-economic considerations (Principle 4).

Dear all

I think the Norway case studies provide a good example of how socioeconomic considerations, including ethical considerations, can be taken into account in decision-making. The Norwegian Gene Technology Act establishes that the socioeconomic criteria of sustainability, benefit to society and ethics are included in the impact assessment of GMOs in Norway.

I’m also aware that the Norwegian Biotechnology Advisory Board (NBAB) has a central role in the implementation of these concepts as laid out in the Act and subsequent Regulations, as well as in providing assessments of the impacts of specific applications/products on these socioeconomic criteria. The NBAB has produced clear and transparent guidance documents on such socioeconomic assessment, which are useful for our discussions on the “Guidance on the Assessment of Socio-Economic Considerations in the Context of Article 26 of the Cartagena Protocol on Biosafety”. See “Sustainability, Benefit to the Community and Ethics in the Assessment of Genetically Modified Organisms: Implementation of the Concepts set out in Sections 1 and 10 of the Norwegian Gene Technology Act” (http://www.bion.no/filarkiv/2010/07/2009_11_18_diskusjonsnotat_baerekraft_engelsk.pdf) and “Herbicide-resistant genetically modified plants and sustainability” (http://www.bioteknologiradet.no/filarkiv/2014/09/Herbicide-resistant_genetically_modified_plants_and_sustainability_NBAB.pdf.

kind regards
Lim Li Ching
Third World Network