The Norwegian Environment Agency and the Norwegian Food Safety Authority requested the Norwegian Scientific Committee for Food Safety for an opinion of potential risks to biodiversity and agriculture in Norway associated with import of seeds and cultivation of insect-resistant and herbicide-tolerant genetically modified maize 1507.

VKM was also requested to assess the applicant´s post-market environmental monitoring plan, and the management measures suggested in the draft implementing decision of the European Commission.

Maize 1507

The genetically modified maize 1507 has been developed to provide protection against certain lepidopteran target pests, such as the European corn borer (ECB, Ostrinia nubilalis), and some species belonging to the genus Sesamia. The insect resistance is achieved by the expression of a synthetic version of the truncated cry1F gene.

Maize 1507 also expresses the phosphinothricin-N-acetyltransferase (pat) gene, from the soil bacterium Streptomyces viridochromogenes. The encoded PAT protein confers tolerance to the herbicidal active substance glufosinate-ammonium. The PAT protein produced by maize 1507 has been used as a selectable marker to facilitate the selection process of transformed plant cells and is not intended for weed management purposes.

Environmental risks

Maize is the only representative of the genus Zea in Europe, and there are no cross-compatible wild or weedy relatives outside cultivated maize with which maize can hybridise and form backcross progeny.The risk of pollen flow from maize volunteers is negligible under Norwegian growing conditions.

Since maize 1507 has no altered agronomic and phenotypic characteristics, except for the specific target insect resistance and herbicide tolerance, the likelihood of unintended environmental effects as a consequence of spread of genes from maize 1507 is considered to be extremely low.

There are no reports of the target lepidopteran species attaining pest status on maize in Norway. Since there are no Bt-based insecticides approved for use in Norway, and lepidopteran pests have not been registered in maize, issues related to resistance evolution in target pests are not relevant at present for Norwegian agriculture.

Published scientific studies show that the likelihood of negative effects of Cry1F protein on non-target arthropods that live on or in the vicinity of maize plants is low. Cultivation of maize 1507 is not considered to represent a threat to the prevalence of red-listed species in Norway.

Exposure of non-target organisms to Cry proteins in aquatic ecosystems is likely to be very low, and potential exposure of Cry proteins to non-target organisms in aquatic ecosystems in Norway is considered to be negligible.

VKM concludes that, although the data on the fate of the Cry1F protein and its potential interactions in soil are limited, the relevant scientific publications analysing the Cry1F protein, together with the relatively broad knowledge about the environmental fate of other Cry1 proteins, do not indicate significant direct effects on the soil environment.

Coexistence

VKM concludes that isolation distances of 200 meters most likely will ensure coexistence between genetically modified maize and conventional and organic maize varieties in Norway.

Background

Maize 1507 is approved for import, further processing and for use as food and feed in the EU. An application for approval of the maize for cultivation has been processed in the EU system since 2001. The European Food Safety Authority, EFSA, has considered the application a number of times from 2005 to 2016. In 2016, the Commission submitted a proposal to approve the application.

This risk assessment is an update of a health and environmental risk assessment of maize 1507 for all uses made by VKM in 2014. In the update, VKM was asked to assess the risk of adverse impacts on biodiversity and agriculture in Norway and to emphasize special Norwegian conditions. The assessment is part of the Norwegian Environment Agency`s preparation for possible approval in the EU.

The VKM Panel on Genetically Modified Organisms has conducted this opinion.