Efforts by the EU to improve its regulatory framework for importing GM food and feed have done nothing to make the process easier and more predictable for applicants.
The first genetically modified (GM) maize hybrids were registered in the Commercial Variety Register in Spain on 26 March 1998. The registered hybrids, Compa CB and Jordi CB, were carrying the genetic modification identified as event "Bt-176". This genetic modification expresses the Cry1Ab protein from Bacillus thuringiensis for protection against the insect pests: European Corn Borer Ostrinia nubilalis and the Mediterranean Corn Borer Sesamia nonagrioides. Since then and until 2005, Spanish farmers have planted Bt-176 maize on their farms, growing to well over 22,000 hectares annually (5 % of total acreage). As part of the Spanish hybrid registration, the Spanish Authorities required that a post-market monitoring plan be implemented, which addressed several points. Syngenta presented a monitoring plan which was further developed and carried out in collaboration with public research institutions in Spain. The monitoring plan has been in effect and results are now available. The results support the initial conclusions from the regulatory safety assessments, which were that Bt-176 maize is as safe as its conventionally bred counterpart, and indicate that Bt-176 maize does not have any unexpected negative impacts to the environment in Spain. The results of the post-market monitoring plan and our commitment to stewardship for Bt-176 maize in Spain are reviewed in more detail, and we describe how these studies reinforce the conclusions from the initial regulatory assessments.
The objective of general surveillance is to identify the occurrence of unanticipated adverse effects of GM crops on human health or the environment that were not covered in the environmental risk assessment. EuropaBio is harmonizing an approach to non-hypothesis driven post-market environmental monitoring relating to the cultivation of different GM crops, comprising a farmer questionnaire, existing surveillance systems as well as other data sources. As an unanticipated adverse effect is most likely to occur where the level of environmental exposure is highest, general surveillance focuses on the agricultural environment and those agronomic zones that are representative of commercial GM crop cultivation. The farmer questionnaire is one element of the general surveillance approach, and is largely based on routine observations by farmers cultivating GM crops. It aims at recording data and observations capturing the interaction of one GM event with the agricultural environment. Due to its modular structure, the farmer questionnaire can be used for different GM crops and traits as well as combinations of traits. Existing surveillance systems, which are not GM crop focused, are another element of the harmonized approach to general surveillance and provide information based on e.g. plant health and soil surveys, ecological and environmental observations. The aforementioned elements, in association with the assessment of results from research projects published in peer reviewed publications relating to the environmental safety of GM crops, individual company stewardship activities and issue alerts complete the EuropaBio approach which should allow for the identification of any potential adverse effects arising from the presence of GM crops.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.