Designing Regional Systems of Biotechnology Regulation A Transaction Cost Approach to Regulatory Governance

Many developing countries are currently in the process of designing regulatory systems that should make it possible to use the potential of genetically modified organisms (GMOs) for agricultural development, while at the same time managing the risks for food safety and the environment that are potentially associated with these technologies. In view of the considerable costs associated with biotechnology regulation and the scarcity of biosafety specialists, there are processes in various regions of the developing world to establish regional systems of biotechnology regulation. So far, there are major knowledge gaps as to how regional systems of biotechnology regulation can be designed to be effective and efficient and to fulfill principles of good governance, such as transparency, voice and accountability, control of corruption, and avoidance of special interest capture. There is a wide variety of possible regional approaches, which differ with regard to the level of centralization, the scope of a regional system, the types of regional institutions and processes, and the types of financing mechanisms. Based on the literature on environmental and fiscal federalism and transaction costs economics, the paper develops a conceptual framework for the assessment of regional systems of biotechnology regulation. The framework specifies design options and assessment criteria, and identifies major trade-offs as well as the factors affecting these trade-offs. The paper takes West Africa as an example to illustrate this framework and refers to the European Union for comparison. The paper concludes that involving regional experts, stakeholders and policy-makers into debates on the design of a regional regulatory system is an important strategy to fill knowledge gaps and arrive at conclusions regarding the trade-offs involved in regional biotechnology regulation. Key words: regional biotechnology regulation; regulatory federalism; transaction cost economics; West Africa; European Unionregional biotechnology regulation, regulatory federalism, transaction cost economics, European Union, Agricultural and Food Policy, Community/Rural/Urban Development, Consumer/Household Economics, Environmental Economics and Policy, Farm Management, Food Consumption/Nutrition/Food Safety, Food Security and Poverty, International Relations/Trade, Marketing, Production Economics, Research and Development/Tech Change/Emerging Technologies,

Ecological risks of novel environmental crop technologies using phytoremediation as an example:

"Phytoremediation is the use of living plants, known as hyperaccumulators which absorb unusually large amounts of metals in comparison to other plants. The use of classical plant breeding and new molecular techniques offers great potential to develop crops with the ability to clean up polluted sites. While these technologies have gained widespread attention, prior to commercial development, there are risks that must be considered – only a few of which have received even modest examination. Therefore, the focus of this working paper is to explore specific risks associated with phytoremediation and suggest ways in which these risks can be managed so that new, novel, and innovative plant technologies may be applied to provide low cost and efficient environmental solutions. " Authors' AbstractPhytoextraction, Phytomining,

A gap analysis of confined field trial application forms for genetically modified crops in East Africa: evaluating the potential for harmonization

"The regulatory approval of genetically modified crops in the field initially requires small, restricted experimental trials known as confined field trials. These small scale experiments provide researchers with important information on environmental interactions and agronomic performance of the crop in a safe and contained manner. To authorize confined field trials regulatory review is required, with formats for obtaining relevant information differing from country to country. In this paper, a Gap Analysis is used to identify informational gaps and potential for harmonization of confined field trial application processes in three East African countries - Tanzania, Kenya, and Uganda. The basic principle behind gap analysis is a comparison of the status quo to an ideal with the identification of the differences or gaps and the difficulty involved in removing the gaps. The resulting similarity of the application forms provides a potential basis for harmonization of confined field trial application processes between countries leading to potential efficiency gains." Authors' abstractGenetically modified crops, Gap analysis, Confined field trials, biotechnology,

The emergence of insect resistance in Bt-corn: implication of resistance management information under uncertainty

"The successful management of transgenic technology is likely to depend on the economic behavioral response of farmers to the regulated use of transgenic crops. A well-studied example is the widespread use of Bt-corn, in the United States, and elsewhere, to control the European Corn Borer, a major corn pest. The extensive use of Bt-corn has led to concerns about the emergence of insect resistance. The United States Environment Protection Agency addressed this potential problem by developing an insect resistance management strategy, based, in part, on complex mathematical models using detailed biological assumptions about the population genetics and life history of the European Corn Borer. However, seed companies and others have sometimes used simpler deterministic profit models to justify the economics of Bt-corn to potential growers. Therefore an over reliance, by regulatory agencies, on complex modeling approaches may obscure the likely economic behavioral response of farmers who rely on these less complex models. However, the determinants of adoption are numerous, profit being one of them. We develop a simple model for the spread of resistance based on the logistic growth equation and use it to investigate the effect of uncertainty on farmer decisions to plant Bt-corn and follow EPA management rules. The model results suggest that planting Bt-corn is an optimal strategy under the type of uncertainty assumed in the model and that short-term economic behavior is likely to lead to the Environment Protection Agency management rules not being followed. Our results add weight to existing work on this problem." Authors' AbstractBt-corn, logistic growth, Monte Carlo methods, Corn, Environmental protection, Economics Methodology,

Incorporating collateral information using an adaptive management framework for the regulation of transgenic crops:

"A lack of data often makes biological management decisions difficult and has been an area of contention in the debate over the approval of transgenic crops. Our knowledge of agricultural and natural systems is limited and our ability to gain additional information, quickly and effectively, is often handicapped by statistical complexity. To adequately cope with this requires new approaches and models that integrate decision-making and management. This paper describes one possible approach to the integration of decision-making and management, which may have application for the regulatory approval of transgenic crops. In many situations countries wishing to approve transgenic crops will have limited data on the environmental performance of the crop. The approach outlined in this paper looks at how related information, possibly collected from other countries, might be used to help inform decisions about the approval of transgenic crops. This is done within an integrated decision-making and management framework." Authors' AbstractTransgenic plants, Collateral data, Bayesian theory, Inference,

Incorporating project uncertainty in novel environmental biotechnologies: illustrated using phytoremediation

"Pollution of the environment by metals and organic contaminants is an intractable global problem, with cleanup costs running into billions of dollars using current engineering technologies. The availability of alternative, cheap and effective technologies would significantly improve the prospects of cleaning-up metal contaminated sites. Phytoremediation has been proposed as an economical and ‘green' method of exploiting plants to extract or degrade the contaminants in the soil. To date, the majority of phytoremediation efforts have been directed at leaping the biological, biochemical and agronomic hurdles to deliver a working technology, with scant attention to the economic outlook other than simple estimates of the cost advantages of phytoremediation over other techniques. In this paper we use a deterministic actuarial model to show that uncertainty in project success (the possibility that full clean up may not be realized) may significantly increase the perceived costs of remediation works for decision-makers." Authors' Abstractbiotechnology, Soil contaminants, Environmental remediation Economic aspects, Industrial crop technologies,

Analysis for biotechnology innovations using Strategic Environmental Assessment (SEA):

" Meeting the food needs of the world's growing population while reducing poverty and protecting the environment is a major global challenge. Genetically modified crops appear to provide a promising option to deal with this challenge. However there is a need to make strategic decisions on how to spend limited agricultural research funds in order to achieve a maximum impact with regard to finding sustainable solutions to end hunger and poverty. In international development institutions, there is growing interest in the potential use of Strategic Environmental Assessment (SEA) as part of a research based Environmental Management System (EMS) to promote mainstreaming of environmental considerations in policy development. SEA was developed as an approach to integrate environmental considerations at a policy level, where alternatives environmental policies can be evaluated. In this paper, we propose using SEA in a policy research and priority setting process regarding new technologies, taking the development of Genetically Modified Organisms (GMOs) as an example. We propose that this method would be a useful tool for the international agricultural research centers of the Consultative Group for International Agricultural Research (CGIAR), streamlining business processes, strengthening accountability, sharpening the research agenda it supports, fostering broader partnerships, and increasing the relevance and impact of CGIAR research in achieving international development goals. Currently international law requires only Environmental Impact Assessments (EIAs) of specific biotechnology projects. The incorporation of environmental considerations only at the level of specific projects precludes the adoption of alternative environmental policies. In this review, we outline an SEA approach currently being considered at the International Food Policy Research Institute (IFPRI) for use in evaluating biotechnology policies. SEA may be a useful tool to inform the evaluation of biotechnology policies and priorities by taking account of information on the economic, social, and environmental benefits, cost and risks of adopting those policies." Authors' AbstractRisk, Strategic Environmental Assessment, Genetically modified organisms, Living modified organisms,

Sequence selective capture, release and analysis of DNA using a magnetic microbead-assisted toehold-mediated DNA strand displacement reaction

This paper reports on the modification of magnetic beads with oligonucleotide capture probes with a specially designed pendant toehold (overhang) aimed specifically to capture double-stranded PCR products. After capture, the PCR products were selectively released from the magnetic beads by means of a toehold-mediated strand displacement reaction using short artificial oligonucleotide triggers and analysed using capillary electrophoresis. The approach was successfully shown on two genes widely used in human DNA genotyping, namely human c-fms (macrophage colony-stimulating factor) proto-oncogene for the CSF-1 receptor (CSF1PO) and amelogenin

Strategic environmental assessment: assessing the environmental impact of biotechnology

Poverty reduction, Agricultural research, Environmental protection, Genetically modified organisms, Crops, Agricultural biotechnology Research, Investments, Strategic Environmental Assessment,

Reliability and responsiveness of measures of pain in people with osteoarthritis of the knee: a psychometric evaluation

PURPOSE: To examine the fit between data from the Short Form McGill Pain Questionnaire (SF-MPQ-2) and the Rasch model, and to explore the reliability and internal responsiveness of measures of pain in people with knee osteoarthritis. METHODS: Participants with knee osteoarthritis completed the SF-MPQ-2, Intermittent and Constant Osteoarthritis Pain questionnaire (ICOAP) and painDETECT. Participants were sent the same questionnaires 3 and 6 months later. RESULTS: Fit to the Rasch model was not achieved for the SF-MPQ-2 Total scale. The Continuous subscale yielded adequate fit statistics after splitting item 10 on uniform DIF for gender, and removing item 9. The Intermittent subscale fit the Rasch model after rescoring items. The Neuropathic subscale had relatively good fit to the model. Test-retest reliability was satisfactory for most scales using both original and Rasch scoring ranging from fair to substantial. Effect sizes ranged from 0.13 to 1.79 indicating good internal responsiveness for most scales. CONCLUSIONS: These findings support the use of ICOAP subscales as reliable and responsive measure of pain in people with knee osteoarthritis. The MPQ-SF-2 subscales found to be acceptable alternatives. Implications for Rehabilitation The McGill Pain Questionnaire short version 2 is not a unidimensional scale in people with knee osteoarthritis, whereas three of the subscales are unidimensional. The McGill Pain Questionnaire short version 2 Affective subscale does not have good measurement properties for people with knee osteoarthritis. The McGill Pain Questionnaire short version 2 and the Intermittent and Constant Osteoarthritis Pain scales can be used to assess change over time. The painDETECT performs better as a screening measure than as an outcome measure