EFSA Reconfirms the Safety of BASF’s Genetically Modified Potato

In its current scientific opinion, EFSA concluded that “no new scientific evidence has become available that would prompt the Panel to change its previous opinions“ on the use of the npt2 marker gene.

12/06/09 EFSA, the European Food Safety Authority, has published its scientific assessment of a gene that is present in Amflora, as well as in other genetically modified products. In the past, EFSA has repeatedly assessed the use of this gene with the scientific name ‘npt2’ and has again concluded that the gene is safe for humans, animals and the environment and that no further scientific work is needed. The mandate to carry out an additional safety assessment on the npt2 gene was given by the EU Commission in May 2008.
 
“Today’s assessment gives the entire EU Commission the final scientific clarity to approve Amflora,” said Dr. Stefan Marcinowski, Member of the Board of Executive Directors of BASF SE. “I am pleased, since the EU Commission stated in May 2008 that it will approve Amflora “if and when“ EFSA has confirmed the safety of the product.”
 
In its current scientific opinion, EFSA concluded that “no new scientific evidence has become available that would prompt the Panel to change its previous opinions“ on the use of the npt2 marker gene. These previous opinions stated that the use of the npt2 gene does not pose a risk to human or animal health or to the environment. “Two minority opinions were expressed and extensively considered during the preparation of the joint opinion and no further clarification or scientific work were needed at this time,” according to EFSA’s website.
 
Meanwhile EFSA’s GMO Panel reviewed its previous assessments of individual GM plants containing ARMG taking into account the findings and conclusions of the joint opinion of the GMO and BIOHAZ Panels. The GMO Panel concluded that its previous risk assessments on the use of the nptII marker gene in GM plants are consistent with the risk assessment strategy described in the joint opinion and that no new scientific evidence has become available that would prompt it to change its previous opinions on these GM plants.

Following the adoption of the joint opinion of the GMO and BIOHAZ Panels, EFSA asked the panels to consider whether the minority opinions required any clarification of the joint opinion or additional scientific work. The Panel chairs responded that the minority opinions had been extensively considered during the preparation of the joint opinion and no further clarification or scientific work were needed at this time.

In their joint opinion, the GMO and BIOHAZ Panels concluded that transfers of ARMG from GM plants to bacteria have not been shown to occur either in natural conditions or in the laboratory. The key barrier to stable uptake of antibiotic resistance marker genes from GM plants to bacteria is the lack of DNA sequence identity between plants and bacteria.

The Panels concluded that the antibiotic resistance genes nptII and aadA occur at different frequencies in different bacterial species and strains, and environments. Recent analyses of total bacterial populations using the most advanced technologies have demonstrated that resistance genes to the antibiotics kanamycin, neomycin and streptomycin are present in all environments investigated. The presence of antibiotics in the environment and antibiotic usage are key factors in driving the selection and dissemination of antibiotic resistance genes.

The Panels underlined limitations related among others to sampling, detection, challenges in estimating exposure levels and the inability to assign gene transfer to a defined source. Sampling and detection issues are technical aspects of experiments which may limit the validity of results. Furthermore, it is often not possible to find out precisely from which organism an ARM gene present in another organism may have originated nor to give a precise estimation of the extent of the phenomenon.

In collaboration with the European Medicines Agency (EMEA) and the European Centre for Disease Prevention and Control (ECDC), the Panels also considered the clinical importance for human and veterinary medicine of the antibiotics to which the ARMG confer resistance. NptII confers resistance to the antibiotics kanamycin and neomycin. These are categorised by the World Health Organization (WHO) as ‘highly important antimicrobials’. Kanamycin is used as a second-line antibiotic for the treatment of infections with multiple drug-resistant tuberculosis (MTB); increasing resistance of MTB to such antibiotics is of concern globally. However, the Panels noted that nptII has not been implicated in resistance to kanamycin in the treatment of MTB.

The GMO Panel also reviewed its previous opinions on the use of nptII in GM plants following the findings from the joint opinion of the GMO and BIOHAZ Panels. The GMO Panel concluded, in another opinion, that its previous risk assessments on the use of nptII in maize MON 863 and hybrids, as well as starch potato EH92-527-1, are in line with the risk assessment strategy described in the joint opinion of the GMO and BIOHAZ Panels. The GMO Panel also underlined that no new scientific evidence has become available that would prompt the Panel to change its previous opinions on these GM plants.

BASF’s idea of developing Amflora originated in the European starch industry. The aim was to improve industrial starch potatoes. Potatoes produce two types of starch – amylose and amylopectin. For many applications, such as in the paper, textile and adhesives industries, amylopectin is preferred. With plant biotechnology, BASF found a solution to avoid the production of the unwanted starch component amylose. With its pure amylopectin starch, higher quality starch can be extracted from Amflora. The industry benefits, since paper produced with high-quality Amflora starch has a higher gloss, and concrete and adhesives can be processed for a longer period of time. Industrial processes can thus be optimized, which results in savings in raw material such as water, additives and energy.
 
Europe ’s farmers and the starch industry have estimated that the product and processing benefits as well as the savings in raw materials and energy use can be translated into a potential added value of €100-200 million per year. In addition, BASF expects peak income from licenses in the range of €20-30 million per year.