Advice on rephrased questions to the applicant of maize line 59122
In June 2007 COGEM advised on the application for cultivation of 59122 maize. COGEM was of the opinion that the studies and data provided on the possible effects of maize line 59122 on non-target organisms (NTOs) were of poor quality and did not provide the information necessary to perform a reliable environmental risk assessment on the cultivation of maize line 59122. Therefore, conclusions on the possible effects of maize line 59122 on NTOs could not be drawn. COGEM was of the opinion that additional data from laboratory experiments as well as field experiments was necessary to perform a reliable environmental risk assessment.
Based on the remarks of COGEM the Dutch Competent Authority formulated three questions for additional information to the applicant, which were sent to EFSA as they maintain communication with the applicant. EFSA has rephrased one of the questions and asked for clarification on the necessity of data from additional laboratory studies. The ministry of VROM has asked COGEM for advice on these matters.
In COGEM’s view the essence of the questions and remarks that COGEM had on the studies on possible effects of maize line 59122 on NTOs has been lost when the question was rephrased. The questions on laboratory and field studies have been combined which has led to incorrect connections. Probably, these questions will not provide the information necessary to perform a reliable environmental risk assessment.
COGEM would like to emphasize that additional laboratory studies are necessary. These studies should be performed with NTOs which are representative for the European agronomic situation in maize. Furthermore, COGEM is of the opinion that data from additional field studies are necessary. These field studies should be comparable to current agricultural practice and should be performed at the time of year that maize is normally cultivated. The design of both the laboratory and the field studies should allow sufficient statistical power to allow conclusion on the possible effects of maize line 59122 on NTOs to be drawn.
In conclusion, COGEM is of the opinion that the original questions that were formulated by the Dutch Competent Authority better suit the remarks and questions that were made by COGEM and are therefore more likely to provide the information that is necessary to perform a reliable environmental risk assessment. The question concerning data from additional laboratory studies should be rephrased in order to emphasize that additional laboratory studies are necessary.