Final Health and Environmental Risk Assessment of Genetically Modified LLcotton25
Åshild Andreassen *
Norwegian Scientific Committee for Food Safety (VKM), Norwegian Institute of Public Health (FHI), Norway.
Anne Marie Bakke
Norwegian Scientific Committee for Food Safety (VKM), Norway.
Olavi Junttila
Norwegian Scientific Committee for Food Safety (VKM), Norway.
Arne Mikalsen
Norwegian Scientific Committee for Food Safety (VKM), Norway.
Ville Erling Sipinen
Norwegian Scientific Committee for Food Safety (VKM), Norway.
Rose Vikse
Norwegian Scientific Committee for Food Safety (VKM), Norwegian Institute of Public Health (FHI), Norway.
Per Brandtzæg
Norwegian Scientific Committee for Food Safety (VKM), Norway.
Knut Helkås Dalen
Norwegian Scientific Committee for Food Safety (VKM), Norway.
Knut Tomas Dalen
Norwegian Scientific Committee for Food Safety (VKM), University of Oslo, Norway.
Richard Meadow
Norwegian Scientific Committee for Food Safety (VKM), Norwegian University of Life Sciences, Norway.
Inger Elisabeth Måren
Norwegian Scientific Committee for Food Safety (VKM), University of Bergen, Norway.
Kåre M. Nielsen
Norwegian Scientific Committee for Food Safety (VKM), Institute of Marine Research, Norway.
Monica Sanden
Norwegian Scientific Committee for Food Safety (VKM), Institute of Marine Research, Norway.
Hilde-Gunn Opsahl-Sorteberg
Norwegian Scientific Committee for Food Safety (VKM), Oslo and Akershus University College of Applied Sciences, Norway.
*Author to whom correspondence should be addressed.
Abstract
Genetically modified LLcotton25 from Bayer Crop Science expresses the bar gene from Streptomyces hygroscopicus ATCC21705 encoding the phosphinothricin-acetyl–transferase (PAT) enzyme, which confers tolerance to the active herbicide glufosinate-ammonium.
Updated bioinformatics analyses of the inserted DNA and flanking sequences in LLCotton25 have not indicated potential production of putatively harmful toxins or allergens caused by the genetic modification. Genomic stability of the functional insert and consistent expression of the bar gene have been shown over several generations of LLCotton25.
Data from field trials indicate that with the exception of the newly introduced trait, LLCotton25 is compositionally, phenotypically and agronomically equivalent to its conventional counterpart Coker 312 and other cotton cultivars.
A 33-day nutritional assessment trial with broilers has not revealed adverse effects of cottonseed meal from LLCotton25. Toxicity testing of the PAT protein in a repeated-dose dietary exposure test with rats did not indicate adverse effects. The PAT protein produced in LLCotton25 does not show amino acid sequence resemblance to known toxins or IgEdependent allergens, nor has it been reported to cause IgE-mediated allergic reactions. It is therefore unlikely that the PAT protein will cause toxic or IgE-mediated allergic reactions to food or feed containing LLCotton25 compared to conventional cotton cultivars.
Cotton is not cultivated in Norway, and there are no cross-compatible wild or weedy relatives of cotton in Europe.
Based on current knowledge and with the exception of the introduced traits, the VKM GMO Panel concludes that LLCotton25 is nutritionally, compositionally, phenotypically and agronomically equivalent to and as safe as its conventional counterpart and other cotton cultivars.
Considering the intended uses, which exclude cultivation, the VKM GMO Panel concludes that LLCotton25 does not represent an environmental risk in Norway.
Keywords: VKM, risk assessment, Norwegian Scientific Committee for Food Safety, Norwegian Food Safety Authority/Norwegian Environment Agency, GMO, cotton (Gossypium hirsutum L.), LLCotton25, unique identifier ACS-GHØØ1-3, EFSA/GMO/NL/2005/13, glufosinate tolerance, PAT protein, bar gene, food/feed safety, human and animal health, import and processing, Regulation (EC) No 1829/2003.