title: Quality of laboratory studies assessing effects of Bt-proteins on non-target organisms: minimal criteria for acceptability.
abstract: The potential risks that genetically modified plants may pose to non-target organisms and the ecosystem services they contribute to are assessed as part of pre-market risk assessments. This paper reviews the early tier studies testing the hypothesis whether exposure to plant-produced Cry34/35Ab1 proteins as a result of cultivation of maize 59122 is harmful to valued non-target organisms, in particular Arthropoda and Annelida. The available studies were assessed for their scientific quality by considering a set of criteria determining their relevance and reliability. As a case-study, this exercise revealed that when not all quality criteria are met, weighing the robustness of the study and its relevance for risk assessment is not obvious. Applying a worst-case expected environmental concentration of bioactive toxins equivalent to that present in the transgenic crop, confirming exposure of the test species to the test substance, and the use of a negative control were identified as minimum criteria to be met to guarantee sufficiently reliable data. This exercise stresses the importance of conducting studies meeting certain quality standards as this minimises the probability of erroneous or inconclusive results and increases confidence in the results and adds certainty to the conclusions drawn.
authors.affiliation: Biosafety and Biotechnology Unit, Scientific Institute of Public Health, Juliette Wytsmanstraat 14, 1050, Brussels, Belgium. Adinda.DeSchrijver@wiv-isp.be.
authors.forename: Adinda
authors.initials: A
authors.lastname: De Schrijver
authors.affiliation: GMO Unit, European Food Safety Authority (EFSA), Via Carlo Magno 1A, 43126, Parma, Italy.
authors.forename: Yann
authors.initials: Y
authors.lastname: Devos
authors.affiliation: Department of Crop Protection, Ghent University, Coupure Links 653, 9000, Ghent, Belgium.
authors.forename: Patrick
authors.initials: P
authors.lastname: De Clercq
authors.affiliation: Unit 404: Coexistence, GMO-Monitoring, Federal Office of Consumer Protection and Food Safety (BVL), Mauerstraße 39-42, 10117, Berlin, Germany.
authors.forename: Achim
authors.initials: A
authors.lastname: Gathmann
authors.affiliation: Institute for Sustainability Sciences, Agroscope, Reckenholzstrasse 191, 8046, Zurich, Switzerland.
authors.forename: Jörg
authors.initials: J
authors.lastname: Romeis
mesh_terms: D000818:Animals; D000083722:Bacillus thuringiensis Toxins; D001426:Bacterial Proteins / Q000235:genetics* / Q000633:toxicity*; D017753:Ecosystem; D004731:Endotoxins / Q000235:genetics* / Q000633:toxicity*; D004777:Environment; D006460:Hemolysin Proteins / Q000235:genetics* / Q000633:toxicity*; D060434:Herbivory; D007313:Insecta; D007753:Laboratories; D030821:Plants, Genetically Modified; D054817:Pollination; D015203:Reproducibility of Results; D018570:Risk Assessment / Q000379:methods* / Q000592:standards
chemical_list: D000083722:Bacillus thuringiensis Toxins; D001426:Bacterial Proteins; D004731:Endotoxins; D006460:Hemolysin Proteins; C030956:insecticidal crystal protein, Bacillus Thuringiensis
keywords: Bt-maize; Cry34/35Ab1; DAS-59122-7; Environmental risk assessment; Non-target effects