CERA Publications

Transportability of Confined Field Trial Data for Environmental Risk Assessment of Genetically Engineered Plants: A Conceptual Framework
It is commonly held that confined field trials (CFTs) used to evaluate the potential adverse environmental impacts of a genetically engineered (GE) plant should be conducted in each country where cultivation is intended, even when relevant and potentially sufficient data are already available from studies conducted elsewhere. The acceptance of data generated in CFTs ''out of country'' can only be realized in practice if the agro-climatic zone where a CFT is conducted is demonstrably representative of the agro-climatic zones in those geographies to which the data will be transported. In an attempt to elaborate this idea, a multi-disciplinary Working Group of scientists collaborated to develop a conceptual framework and associated process that can be used by the regulated and regulatory communities to support transportability of CFT data for environmental risk assessment (ERA). As proposed here, application of the conceptual framework provides a scientifically defensible process for evaluating if existing CFT data from remote sites are relevant and/or sufficient for local ERAs. Additionally, it promotes a strategic approach to identifying CFT site locations so that field data will be transportable from one regulatory jurisdiction to another. Application of the framework and process should be particularly beneficial to public sector product developers and small enterprises that develop innovative GE events but cannot afford to replicate redundant CFTs, and to regulatory authorities seeking to improve the deployment of limited institutional resources.
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Suggested citation: Garcia-Alonso, M., Hendley, P., Bigler, F., Mayeregger, E., Parker, R., Rubinstein, C., Satorre, E., Solari, F. and M.A. McLean. (2014). Transportability of confined field trial data for environmental risk assessment of genetically engineered plants: a conceptual framework. Transgenic Research DOI 10.1007/s11248-014-9785-0.

Low-Level Presence in Seed: A Science Based Approach to Expedited Environmental Risk Assessment - Workshop Proceedings
The widespread adoption of genetically engineered (GE) plants means that there is increasing likelihood of incidences of seed trade disruption due to the low level presence (LLP) of GE events that have been approved in the country of origin, and that are present in seed shipments to importing countries that have yet to approve these events. LLP situations are the consequence of two realities: (1) at the country level, there are disparate approaches to the regulation of GE crops and, particularly, the time it takes from submission of a regulatory dossier to a risk management decision by the appropriate competent authority; and (2) a zero tolerance of unapproved GE events in imported seed is currently the regulatory norm in many countries throughout the world. There are opportunities to mitigate the seed trade disruptions that can arise from asynchronous decision-making about GE events. One of these - to address the potential adverse environmental impacts that might arise from an LLP in seed situation using a consistent and scientifically defensible approach to environmental risk assessment - was the subject of a workshop held in Buenos Aires, Argentina from 18-19 December 2013.
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Suggested citation: CERA. (2014). Low-Level Presence in Seed: A Science Based Approach to Expedited Environmental Risk Assessment - Workshop Proceedings. Center for Environmental Risk Assessment (CERA), Washington, D.C.

Environmental Risk Assessment of GE Plants Under Low-Exposure Conditions
The requirement for environmental risk assessment (ERA) of genetically engineered (GE) plants prior to large scale or commercial introduction into the environment is well established in national laws and regulations, as well as in international agreements. Since the first introductions of GE plants in commercial agriculture in the 1990s, a nearly universal paradigm has emerged for conducting these assessments based on a few guiding principles. These include the concept of case-by-case assessment, the use of comparative assessments, and a focus of the ERA on characteristics of the plant, the introduced trait, and the receiving environment as well as the intended use. In practice, however, ERAs for GE plants have frequently focused on achieving highly detailed characterizations of potential hazards at the expense of consideration of the relevant levels of exposure. This emphasis on exhaustive hazard characterization can lead to great difficulties when applied to ERA for GE plants under low-exposure conditions. This paper presents some relevant considerations for conducting an ERA for a GE plant in a low-exposure scenario in the context of the generalized ERA paradigm, building on discussions and case studies presented during a session at ISBGMO 12.
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Suggested citation: Roberts, A., Devos, Y., Raybould, A., Bigelow, P., Gray, A. (2013). Environmental risk assessment of GE plants under low-exposure conditions. Transgenic Research 10.1007/s11248-013-9762-z.

Surrogate Species Selection for Assessing Potential Adverse Environmental Impacts of Genetically Engineered Insect-Resistant Plants on Non-Target Organisms
Most regulatory authorities require that developers of genetically engineered insect-resistant (GEIR) crops evaluate the potential for these crops to have adverse impacts on valued non-target organisms (NTOs), i.e., organisms not intended to be controlled by the trait. In many cases, impacts to NTOs are assessed using surrogate species, and it is critical that the data derived from surrogates accurately predict any adverse impacts likely to be observed from the use of the crop in the agricultural context. The key is to select surrogate species that best represent the valued NTOs in the location where the crop is going to be introduced, but this selection process poses numerous challenges for the developers of GE crops who will perform the tests, as well as for the ecologists and regulators who will interpret the test results. These issues were the subject of a 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, ILSI Research Foundation. This report summarizes the proceedings of the conference, including the presentations, discussions, and the points of consensus agreed to by the participants.
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Suggested Citation: Carstens, K., Cayabyab, B., De Schrijver, A., Gadaleta, P.G., Hellmich, R.L., Romeis, J., Storer, N., Valicente, F.H., Wach, M. (2014). Surrogate species selection for assessing potential adverse environmental impacts of genetically engineered insect-resistant plants on non-target organisms. GM Crops and Food: Biotechnology in Agriculture and the Food Chain 2014; 5:0 - -1.

Genetically Engineered Trees for Plantation Forests: Key Considerations for Environmental Risk Assessment
Forests are vital to the world's ecological, social, cultural and economic well-being yet sustainable provision of goods and services from forests is increasingly challenged by pressures such as growing demand for wood and other forest products, land conversion and degradation, and climate change. Intensively managed, highly productive forestry incorporating the most advanced methods for tree breeding, including the application of genetic engineering (GE), has tremendous potential for producing more wood on less land. However, the deployment of GE trees in plantation forests is a controversial topic and concerns have been particularly expressed about potential harms to the environment. This paper, prepared by an international group of experts in silviculture, forest tree breeding, forest biotechnology and environmental risk assessment (ERA) that met in April 2012, examines how the ERA paradigm used for GE crop plants may be applied to GE trees for use in plantation forests. It emphasizes the importance of differentiating between ERA for confined field trials of GE trees, and ERA for unconfined or commercial-scale releases. In the case of the latter, particular attention is paid to characteristics of forest trees that distinguish them from shorter-lived plant species, the temporal and spatial scale of forests, and the biodiversity of the plantation forest as a receiving environment.
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Suggested citation: Haggman, H., Raybould, A., Borem, A., Fox, T., Handley, L., Hertzberg, M., Lu, M.-Z., Macdonald, P., Oguchi, T., Pasquali, G., Pearson, L., Peter, G., Quemada, H., Seguin, A., Tattersall, K., Ulian, E., Walter, C. and McLean, M. (2013). Genetically engineered trees for plantation forests: key considerations for environmental risk assessment. Plant Biotechnol. J. 11(7): 785-798.

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.
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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
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.
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Suggested citation: Roberts, A., Nazli, H., Wach, M. and Zafar, Y. (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
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.
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Suggested Citation: Carstens, K., Anderson, J., Bachman, P., De Schrijver, A., Dively, G., Federici, B., Hamer, M., Gielkens, M., Jensen, P., Lamp, W., Rauschen, S., Ridley, G., Romeis, J., and Waggoner, A. (2012). Genetically modified crops and aquatic ecosystems: considerations for environmental risk assessment and non-target organism testing. Transgenic Research 21(4):813-842.

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.
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Recommendations for the Design of Laboratory Studies on Non-Target Arthropods for Risk Assessment of Genetically Engineered Plants
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.
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Suggested citation: Romeis, J., Hellmich, R.L., Candolfi, M.P., Carstens, K., De Schrijver, A., Gatehouse, A.M.R., Herman, R.A., Huesing, J.E., McLean, M.A., Raybould, A. Shelton, A.M. and Waggoner, A.. (2011). Recommendations for the design of laboratory studies on non-target arthropods for risk assessment of genetically engineered plants. Transgenic Research 20: 1-22.

Problem Formulation in the Environmental Risk Assessment for Genetically Modified PlantsProblem 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
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Suggested Citation: 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). Problem formulation in the environmental risk assessment for genetically modified plants. Transgenic Research 19(3):425-436.

Problem Formulation in Environmental Risk Assessment of Genetically Modified Crops: A Brazilian Workshop
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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Suggested Citation: 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). Problem formulation in environmental risk assessment of genetically modified crops: a Brazilian workshop. BioAssay 4(5): 1-11.

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