José Falck-Zepeda

Investment, regulation, and uncertainty: Managing new plant breeding techniques

As with any technological innovation, time refines the technology, improving upon the original version of the innovative product. The initial GM crops had single traits for either herbicide tolerance or insect resistance. Current varieties have both of these traits stacked together and in many cases other abiotic and biotic traits have also been stacked. This innovation requires investment. While this is relatively straight forward, certain conditions need to exist such that investments can be facilitated. The principle requirement for investment is that regulatory frameworks render consistent and timely decisions. If the certainty of regulatory outcomes weakens, the potential for changes in investment patterns increases. This article provides a summary background to the leading plant breeding technologies that are either currently being used to develop new crop varieties or are in the pipeline to be applied to plant breeding within the next few years. Challenges for existing regulatory systems are highlighted. Utilizing an option value approach from investment literature, an assessment of uncertainty regarding the regulatory approval for these varying techniques is undertaken. This research highlights which technology development options have the greatest degree of uncertainty and hence, which ones might be expected to see an investment decline.

The economic impact of transgenic crops in developing countries : a note on the methods

A vast literature has accumulated since crop varieties with transgenic resistance to insects and herbicide tolerance were released to farmers in 1996 and 1997. A comparatively minor segment of this literature consists of studies conducted by agricultural economists to measure the farm-level impact of transgenic crop varieties, the size and distribution of the economic benefits from adopting them and the implications for international trade. This paper focuses only on the applied economics literature about the impact of transgenic crop varieties in non-industrialised agricultural systems, with a focus on the methods. A number of studies have surveyed the findings for both industrialised and non-industrialised agriculture at various points in time, but surveys of methods are less common and most treat one aspect of economic impact. Clearly, the methods used in research influence the findings that are presented and what they mean. Three levels of impact analysis are considered: farm, industry and trade. We conclude that because the methods used present challenges and limitations, the few transgenic crop-trait combinations released in developing economies and the relatively brief time frame of most analyses, the results are promising but the balance sheet is mixed. Thus, the findings of current case studies should not be generalised to other locations, crops and traits.

Socio-economic Considerations in Biotechnology Regulation

Introduction to Regulating LMOs.- The State of Science-based Regulation and GM crops.- Socio-Economic Considerations and the Regulations of LMOs.- Benefits to Producers and Society.- Consumer Choice.- Environmental Impacts.- Ethical/Equity.- Food Security.- Health Impacts.- Impacts on Biodiversity.- Indigenous Knowledge.- Intellectual Property Rights.- Labor Impacts.- Market Access and Trade.- Producer Choice.- Religious/Cultural.- Animal Welfare.- Potential Consequences from the Inclusion of Socio-economics in Decision Making.- A Decision Making Framework for Implementation Issues.- Ensuring Functional Biosafety Systems.

Strategic environmental assessments for genetically modified organisms

Genetically modified crops appear to provide a promising option in finding sustainable solutions to end global hunger and poverty, but strategic decisions need to be made on how to spend limited agricultural research funds. Potentially, strategic environmental assessment (SEA) may be used as part of an environmental management system to introduce mainstreaming of environmental considerations in the policy research and priority-setting process of development organizations to help achieve international development goals. This paper sets out a possible biotechnology SEA process that integrates qualitative and quantitative assessments with a focus on risk assessment and management within the SEA and policy environmental assessment frameworks. It uses the International Association for Impact Assessment six performance criteria for SEAs: integration; sustainability; focus; accountability; participation; and iteration.

‘If labels for GM food were present, would consumers trust them?’ Insights from a consumer survey in Uganda

Food labelling is costly. Food labelling is often demanded with the introduction of new food products such as genetically modified (GM) food. If consumers do not have trust in the label, scarce resources are wasted. This paper investigates factors affecting the trust in food labels among Ugandan consumers. The results suggest that older, less-educated individuals of smaller household sizes and with trust in government institutions have more trust in food labels. Other factors were also found to be important. The government has to consider those differences in consumer trust when designing a GM labelling policy.

Impact on Biodiversity

The impact of genetically modified organisms (GMOs) on “the conservation and sustainable use of biological diversity,” as stated in Article 26 of the Cartagena Protocol on Biosafety ((Secretariat of the Convention of Biological Diversity 2000, p. 19), has generated a heated and polarized debate. On one side is the position of those who believe that not only economic but ethical, religious, and cultural considerations related to biodiversity should be taken into account. On the other side, stand those who believe that the impact of GMOs on the environment should be circumscribed to environmental assessments. Whatever the position, generating a useful analysis of the impacts of GMOs on biological diversity requires thoughtful definition of concepts and selection of appropriate valuation methods.

Estimates and implications of the costs of compliance with biosafety regulations in developing countries

Estimating the cost of compliance with biosafety regulations is important as it helps developers focus their investments in producer development. We provide estimates for the cost of compliance for a set of technologies in Indonesia, the Philippines and other countries. These costs vary from US

Rationalizing governance of genetically modified products in developing countries

100,000 to 1.7 million. These are estimates of regulatory costs and do not include product development or deployment costs. Cost estimates need to be compared with potential gains when the technology is introduced in these countries and the gains in knowledge accumulate during the biosafety assessment process. Although the cost of compliance is important, time delays and uncertainty are even more important and may have an adverse impact on innovations reaching farmers.

Elevating the conversation about GE crops

137 as well. The main problem is that decisions in Europe are often made on political grounds, rather than on a scientific basis. These decisions then influence the way GM policy is formulated and implemented by national governments in many developing countries5. Indeed, the level of concern in much of South America is sufficiently strong that last August, the agriculture ministers from five major crop-producing countries signed a joint declaration that urged the EU (as well as China) to stop delaying GMO import authorizations6. In countries such as Brazil and India, public research and development of locally important GM crops is impeded by an overly stringent application of the precautionary principle. In India, for example, GM mustard, eggplant and chickpea have been entangled in one legal challenge after another and have faced very onerous regulatory measures over the past decade. Rather than creating greater confidence among consumers and farmers, this has contributed to widespread mistrust that continues to metastasize. One result is that risk-assessment decisions for new GM products in India have been repeatedly delayed. This pattern is repeated in many other developing countries that struggle to develop and deploy local GM products (Box 1). The inclusion of socioeconomic considerations in the Cartagena Protocol conflicts with the science-based approach enforced by the WTO. In particular, the ad hoc approach to taking into account socioeconomics, that is neither structured nor evidence-based, has contributed to a ‘go-slow approach’ in developing functional biosafety policy and limiting crop development in many developing countries for the benefit of the population especially countries in Africa. There has been limited progress in defining how socioeconomics should be used in the Cartagena Protocol. Lack of clear definitions and interpretations of socioeconomic considerations and difficulties in measuring unpredictable factors in ex ante studies continue to Rationalizing governance of genetically modified products in developing countries

The State of Science-Based Regulation and Genetically Modified Crops

VOLUME 35 NUMBER 4 APRIL 2017 NATURE BIOTECHNOLOGY issues of most importance to the public as well as directly involved individuals and groups. The majority of our work involved carefully combing through the literature, focusing more on primary research studies than on reviews. Just for the three report chapters concerning currently commercialized GE crops, our report includes over 900 references. Once our committee developed a full draft of the report, it was sent to 26 reviewers with diverse expertise and perspectives (these reviewers were anonymous to the committee, until they were acknowledged in the final report). Each of the 918 comments and criticisms in the reviews had to be specifically addressed by the committee to the satisfaction of a US National Academies’ independent review board before the report could move forward for the Academies’ approval. Clearly, the report represented more than the opinions of the 20 committee members. Giddings and Miller’s statement that the report’s “unwillingness to overtly back GE crops, and the report’s efforts to give credence to alternative viewpoints —rather like the media’s obsession with giving two sides of an argument equal play, irrespective of which view is supported by the evidence” is, in effect, an uninformed indictment of the US National Academies’ process. Giddings and Miller also charge that we understate how much GE crops have contributed to yield increases, commenting that the report “muddies the debate about yields of GE crops compared with ‘conventionally’ bred crops, [and] gives undue credence and prominence to views backed by paltry peer-reviewed evidence.” In fact, our report carefully states, based on all evidence available to us, that when there was substantial pest pressure, insect-resistance traits did have higher yields compared with conventionally bred crops. However, we also report that many of the early studies purporting to show yield increases due to GE herbicide-resistance and insect-resistance traits were not designed rigorously. Furthermore, we point out that there is less evidence of herbicide-resistance traits increasing yield. So why were these GE Elevating the conversation about GE crops