Environmental Risk Assessment of Genetically Modified Crops: General Principles and Risks to Non-target Organisms

Abstract

Análise de Risco Ambiental de Plantas Geneticamente Modificadas: Princípios Gerais e Riscos aOrganismos Não-Alvos RESUMO -O presente trabalho discute que a análise de risco deveria ser abordada segundo o modelo de desenvolvimento contínuo do saber científico proposto por Karl Popper. Nesse contexto, a análise de risco deveria começar com o problema e busca de respostas para esse problema mediante testes de hipóteses. A análise de risco sendo considerada como teste de hipóteses, a segurança não pode ser provada, porém pode ser indicada pelos testes de hipóteses que prevêem baixo risco. A confiabilidade na análise de risco é dada pelo rigor com que hipóteses de risco são testadas; sendo que os testes devem ser iniciados em condições mais prováveis para demonstrar que as hipóteses de risco são falsas. Se as hipóteses de risco são corroboradas nessas condições, há confiança de que os riscos impostos pelas plantas geneticamente modificadas são baixos. O aumento no rigor nos testes de hipóteses auxilia para justificar o estabelecimento da solicitação de dados adicionais, e pode reduzir o risco ambiental mediante prevenção de atrasos excessivos no registro de produtos ambientalmente benéficos. PALAVRAS-CHAVE -Método científico, formulação de problema, teste de hipóteses.ABSTRACT -This paper argues that risk assessment should be viewed as conforming to the model of the continuous development of scientific knowledge proposed by Karl Popper. As such, a risk assessment should begin with a problem and search for answers to that problem by testing hypotheses. Regarding a risk assessment as hypothesis testing recognises that safety cannot be proved, but can be indicated by tests of hypotheses that predict low risk. Confidence in the risk assessment is provided by the rigour with which the risk hypotheses are tested; it follows that testing should begin under conditions most likely to reveal that the risk hypothesis is false. If the risk hypothesis is corroborated under those conditions, there can be confidence that the risks posed by the genetically modified plant are low. Application of a criterion of increased rigour for hypothesis testing helps to establish whether requests for additional data are justified, and may reduce environmental risk by preventing undue delay in the registration of environmentally beneficial products.

Development of a Tier-1 Assay for Assessing the Toxicity of Insecticidal Substances Against <I>Coleomegilla maculata</I>

“…In Tier-1 testing, the test species can be exposed to a much higher concentrations of test material compared with what it may encounter under Þeld conditions. Thus, the results in those laboratory tests are more conservative than studies conducted under Þeld conditions, and may better support the risk assessment because they provide robust data about the lack of toxicity of a test compound to a NTO (Duan et al 2010;Raybould 2007;Romeis et al, 2010). In addition, Tier-1 laboratory testing also allows general conclusions about the susceptibility of the test species to the toxins independent of the test crop varieties, thus the data can be expanded to other GE crops expressing the same toxin (Romeis et al 2006, Raybould andQuemada 2010).…”

“…Such effects or toxicity tests are typically conducted in the laboratory and referred to as Tier-1 studies. In these tests, surrogate NTOs representing particular taxonomic or functional guilds can be exposed to insecticidal proteins under exposure conditions that exceed the level of exposure in the Þeld (Dutton et al 2003, Raybould 2007, Romeis et al 2008b. Based on characteristics of the toxin, a dietary exposure assay may be required in which the test substances (i.e., the insecticidal protein) can be incorporated into a diet substrate at a high dose.…”

Regulatory considerations surrounding the deployment Of Bt-expressing cowpea in Africa

“…The ERA of all GM plants, including Bt-cowpea, is designed to answer very specific, relevant and realistic questions about the potential risks of introducing those plants into the environment. 19,[22][23][24] The ERA process includes three main phases, namely, problem formulation, analysis (data collection) and risk characterization. 20,22,[25][26][27] In the problem formulation phase the protection goals are identified (e.g., the protection of beneficial insects or wild plant relatives).…”

“…19,[22][23][24] The ERA process includes three main phases, namely, problem formulation, analysis (data collection) and risk characterization. 20,22,[25][26][27] In the problem formulation phase the protection goals are identified (e.g., the protection of beneficial insects or wild plant relatives). The information that is considered during problem formulation comes from the published scientific largely undeveloped, there are potential export markets in South America and Europe as well.…”

“…These are then addressed in the analytical phase of the risk assessment. 20,22,[25][26][27] Finally, an analysis plan is constructed that is consistent with the risk hypotheses and which establishes the relationship between the transgene and the ecological impacts of concern. 19 To address key issues associated with the environmental safety of Bt-cowpea an international panel of experts was convened at the Donald Danforth Plant Science Center in St. Louis, Missouri, USA, March 2-6, 2009.…”