Surrogate Species Selection for Assessing Potential Adverse Environmental Impacts of Genetically Engineered Plants on Non-Target Organisms: Conference Proceedings
Most regulatory authorities require that developers of genetically engineered insect-resistant crops evaluate the potential for these crops to have adverse impacts on organisms not intended to be controlled by the trait, referred to as non-target organisms (NTOs). Conducting NTO testing poses both conceptual and logistical challenges for researchers, and the challenges are likely to increase as these crops are considered for commercial planting in a growing number of new geographic locations. The key is to select test species that best represent the valued NTOs in the area in which the GE crop is going to be introduced, and there are many variables to be considered: surrogates must be either field collected and reared, or purchased, as large, uniform populations; they must perform well on an artificial diet and be amenable to manipulation under laboratory conditions; and validated test protocols must be available. But the most important goal, from the standpoint of regulatory decision making, is that the data derived from surrogates should accurately predict any adverse impacts likely to be observed from the use of the crop in the agricultural context. These issues were the subject of the conference "Surrogate Species Selection for Assessing Potential Adverse Environmental Impacts of Genetically Engineered Plants on Non-Target Organisms" convened by the Center for Environmental Risk Assessment (CERA), ILSI Research Foundation, June 26-28, 2012. This report summarizes the proceedings of the conference, including the presentations, case studies, breakout and plenary discussions, and the points of consensus agreed to by the participants.
Suggested citation: CERA. (2013). Surrogate Species Selection for Assessing Potential Adverse Environmental Impacts of Genetically Engineered Plants on Non-Target Organisms: Conference Proceedings. Center for Environmental Risk Assessment (CERA), Washington, D.C. http://cera-gmc.org/uploads/pub_01_2013.pdf
An Analysis of the Development and Regulation of Agricultural Biotechnology in Pakistan
Andrew Roberts, Hina Nazli, Michael Wach and Yusuf Zafar
In Pakistan, a significant investment has been made in technologies and research to support the development of indigenous GE plants. In addition, Pakistan is a Party to the Cartagena Protocol on Biosafety which requires, among other things, that decisions related to the movements of LMOs across borders (i.e., transboundary movement) be informed by a risk assessment. In response to this, and other domestic and international obligations, the Government of Pakistan (GoP) has promulgated a biosafety regulatory system. This system has been in operation since 2005 and has achieved some success in regulating the introduction of GE plants in Pakistan, particularly in allowing field trials under confined conditions.
The purpose of this analysis is to present the context for biosafety regulation in Pakistan, including the investment and infrastructure currently dedicated to advanced agricultural technologies, and to review the legal and regulatory framework present in the country. It presents the historical context for the introduction and regulation of Bt cotton, the only GE plant to receive commercial regulatory approval in Pakistan, as well as reviewing some of the challenges facing the biosafety system. Finally, it looks at opportunities for advancing the biosafety regulatory system in order to improve the ability of the government and people of Pakistan to adopt technologies that will bring benefit to Pakistani agriculture while ensuring an adequate level of protection for the environment.
Suggested citation: Roberts, A., Nazli, H., Wach, M. and Zafar, Y. (2012). (2012). An Analysis of the Development and Regulation of Agricultural Biotechnology in Pakistan. Center for Environmental Risk Assessment (CERA), Washington, D.C. http://cera-gmc.org/uploads/pub_02_2012.pdf
Genetically modified crops and aquatic ecosystems: considerations for environmental risk assessment and non-target organism testing
Keri Carstens, Jennifer Anderson, Pamela Bachman, Adinda De Schrijver, Galen Dively, Brian Federici, Mick Hamer, Marco Gielkens, Peter Jensen, William Lamp, Stefan Rauschen, Geoff Ridley, Jorg Romeis, Annabel Waggoner. (2012). Transgenic Research 21(4):813-842.
Environmental risk assessments (ERA) support regulatory decisions for the commercial cultivation of genetically modified (GM) crops. The ERA for terrestrial agroecosystems is well-developed, whereas guidance for ERA of GM crops in aquatic ecosystems is not as well-defined. The purpose of this document is to demonstrate how comprehensive problem formulation can be used to develop a conceptual model and to identify potential exposure pathways, using Bacillus thuringiensis (Bt) maize as a case study. Within problem formulation, the insecticidal trait, the crop, the receiving environment, and protection goals were characterized, and a conceptual model was developed to identify routes through which aquatic organisms may be exposed to insecticidal proteins in maize tissue. Following a tiered approach for exposure assessment, worst-case exposures were estimated using standardized models, and factors mitigating exposure were described. Based on exposure estimates, shredders were identified as the functional group most likely to be exposed to insecticidal proteins. However, even using worst-case assumptions, the exposure of shredders to Bt maize was low and studies supporting the current risk assessments were deemed adequate. Determining if early tier toxicity studies are necessary to inform the risk assessment for a specific GM crop should be done on a case by case basis, and should be guided by thorough problem formulation and exposure assessment. The processes used to develop the Bt maize case study are intended to serve as a model for performing risk assessments on future traits and crops.
Problem Formulation for the Environmental Risk Assessment of RNAi Plants: Conference Proceedings
The application of RNA interference (RNAi) to produce genetically engineered crops with improved agronomic, nutritional, industrial and food-processing traits is becoming increasingly common. As new products approach commercialization, it is timely to consider whether the approach currently applied to the environmental risk assessment (ERA) of genetically engineered crops expressing novel proteins remains appropriate for the ERA of genetically engineered plants utilizing RNAi approaches. This question was the subject of the conference “Problem Formulation for the Environmental Risk Assessment of RNAi Plants” convened by the Center for Environmental Risk Assessment (CERA), ILSI Research Foundation June 1-3, 2011. The objectives of the conference were:
1. To share information about current applications of RNAi for genetically engineered plants;
2. To use case studies to explore whether problem formulation for RNAi plants leads to new or additional risk hypotheses when compared with non-RNAi plants expressing similar traits, or if new risk assessment methodologies are necessary.
This report summarizes the proceedings of the conference, including presentations, case studies, a summary of discussions, and the points of consensus agreed by the participants.
Recommendations for the design of laboratory studies on non-target arthropods for risk assessment of genetically engineered plants
Jorg Romeis, Richard L. Hellmich, Marco P. Candolfi, Keri Carstens, Adinda De Schrijver, Angharad M. R. Gatehouse, Rod A. Herman, Joseph E. Huesing, Morven A. McLean, Alan Raybould, Anthony M. Shelton, Annabel Waggoner. (2011). Transgenic Research 20: 1-22.
This paper provides recommendations on experimental design for early-tier laboratory studies used in risk assessments to evaluate potential adverse impacts of arthropod-resistant genetically engineered (GE) plants on non-target arthropods (NTAs). While we rely heavily on the currently used proteins from Bacillus thuringiensis (Bt) in this discussion, the concepts apply to other arthropod-active proteins. A risk may exist if the newly acquired trait of the GE plant has adverse effects on NTAs when they are exposed to the arthropod-active protein. Typically, the risk assessment follows a tiered approach that starts with laboratory studies under worst-case exposure conditions; such studies have a high ability to detect adverse effects on non-target species. Clear guidance on how such data are produced in laboratory studies assists the product developers and risk assessors. The studies should be reproducible and test clearly defined risk hypotheses. These properties contribute to the robustness of, and confidence in, environmental risk assessments for GE plants. Data from NTA studies, collected during the analysis phase of an environmental risk assessment, are critical to the outcome of the assessment and ultimately the decision taken by regulatory authorities on the release of a GE plant. Confidence in the results of early-tier laboratory studies is a precondition for the acceptance of data across regulatory jurisdictions and should encourage agencies to share useful information and thus avoid redundant testing.
Problem formulation in the environmental risk assessment for genetically modified plants
Wolt, J.D., Keese, P., Raybould, A., Fitzpatrick, J.W., Burachik, M., Gray, A., Olin, S.S., Schiemann, J., Sears, M. and Wu, F. (2010). Transgenic Research 19(3):425-436.
Problem formulation is the first step in environmental risk assessment (ERA) where policy goals, scope, assessment endpoints, and methodology are distilled to an explicitly stated problem and approach for analysis. The consistency and utility of ERAs for genetically modified (GM) plants can be improved through rigorous problem formulation (PF), producing an analysis plan that describes relevant exposure scenarios and the potential consequences of these scenarios. A properly executed PF assures the relevance of ERA outcomes for decision-making. Adopting a harmonized approach to problem formulation should bring about greater uniformity in the ERA process for GM plants among regulatory regimes globally. This paper is the product of an international expert group convened by the International Life Sciences Institute (ILSI) Research Foundation
Problem formulation in environmental risk assessment of genetically modified crops: a Brazilian workshop
Fitzpatrick, J.W., Cheavegatti-Gianotto, A., Aparecido Ferro, J., Grossi-de-Sa, M.F., Keese, P., Layton, R., Lima, D., Nickson, T., Raybould, A., Romano, E., Romeis, J., Ulian,E., and Berezovsky, M. (2009). BioAssay 4(5): 1-11.
A workshop organized by the International Life Sciences Institute (ILSI) Research Foundation, ILSI Brasil, and Brazilian Agricultural Research Corporation (EMBRAPA) brought together scientists from government, industry and academia to explore problem formulation for environmental risk assessment (ERA) of genetically modified crops. The workshop focused on the application of current scientific knowledge related to the ERA of GM crops in the Brazilian context of the National Biosafety Technical Commission (CTNBio) Normative Resolution #05 requirements and the local environment. Due to the importance of cotton and sugarcane to Brazil’s economy and the potential environmental impacts associated with introducing genetically modified varieties, these crops were used as case studies to illustrate and discuss the general concepts in problem formulation. This report is a summary of the discussions from this workshop.
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