Making effective use of existing data for case‐by‐case risk assessments of genetically engineered crops

Abstract

Many crops in developing countries suffer devastating attacks from insect pests. Expression of insecticidal proteins in genetically engineered (GE) crops is a potentially powerful means of controlling such pests. Potentially harmful effects of these crops on non‐target organisms (NTOs) is of major concern as many of those provide important ecological functions such as pest regulation. Consequently, the likelihood of adverse effects of insect‐resistant GE crops on NTOs is assessed case‐by‐case as part of environmental risk assessments that inform regulatory decision‐making. While risk assessments should be rigorous, it is vital that regulatory barriers do not unnecessarily restrict or prevent the application of genetic engineering to important crops in those countries. Efficient regulatory decision‐making should make effective use of published information on the biology and ecology of the crop in the country where approval is sought, along with regulatory data produced for GE insect‐resistant crops that have received regulatory approvals elsewhere. Just as the risks are assessed for each GE crop individually, the amount of new regulatory data required for a GE crop should vary between crops depending on the amount of existing data and the severity of the perceived risks: new data should be collected only if existing data do not corroborate identified risk hypotheses with sufficient certainty. In this paper, we illustrate how such an approach could work using risks to NTOs from insect‐resistant GE pigeonpea in India as an example.

Tier‐1 assays for assessing the toxicity of insecticidal proteins produced by genetically engineered plants to non‐target arthropods

“…Furthermore, Tier‐1 tests have the advantage of allowing general conclusions about the toxicity of an IP to the test species independent of the plant background. Thus the results also support the risk assessment of other IRGE crops expressing the same IPs (Li et al ., , ; Romeis et al ., ; Raybould & Quemada, ; Huesing et al ., ).…”

Bt crops and food security in developing countries: realised benefits, sustainable use and lowering barriers to adoption

“…Although nontarget organism faunae in developing countries may contain different species from those in developed countries, provided that the taxonomic and functional groups likely to be exposed to a particular Bt protein are adequately represented by the existing effects studies, it should not be necessary to perform additional laboratory studies on that protein with non-target species from developing countries; nor should it be necessary to carry out field studies specifically to measure effects on non-target organisms in developing countries. Field studies to measure agronomic performance and insecticidal protein concentration should be sufficient to complete an effective environmental risk assessment (Romeis et al 2009). …”

Formulação de Problema em Análise de Risco Ambiental de Cultivos Geneticamente Modificados: Workshop no Brasil

“…The application of the surrogate species concept enhances the transferability of data from lower tier tests to a wide range of regions and crops (e.g., Romeis et al, 2009). …”