EFSA GMO Newsletter February / March 2012

Some recent Testbiotech activities

Backgrounder on MON88017 for cultivation that might lead to unintentional generation of “super bugs” in the fields: http://www.testbiotech.de/node/639

Comment on stacked soy MON87701 x MON89788 for food and feed which is the first stacked soy that might be introduced in the EU market. In the opinion of Testbiotech, this soy poses considerable risks to the immune system: http://www.testbiotech.de/node/632

Letter to the EU Commission on planned new regulation on risk assessment: http://www.testbiotech.org/en/node/629

New complaint forwarded to the EU Ombudsman about the case of Harry Kuiper, the chair of the GMO panel: http://www.testbiotech.org/en/node/638

Discussion in Standing Committee

On 12 and 13 March, EFSA discussed its opinion on MON87701 x MON89788 soybean for food and feed and the updates on the environmental risk assessment and risk management recommendations for maize 1507 and maize Bt11 for cultivation with the Standing Committee on the Food Chain and Animal Health (SCFCAH). No vote was taken.
http://ec.europa.eu/food/committees/regulatory/scfcah/modif_genet/ag1213...

New Opinions

On 23 February, EFSA published a scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. http://www.efsa.europa.eu/en/efsajournal/pub/2561.htm
In cisgenesis, only a gene from the same species or closely related species is used for transformation. This gene includes its introns and is flanked by its native promoter and terminator in normal sense orientation. In intragenesis, new combinations of DNA fragments from the same or from a cross-compatible species are used. Intragenesis can also include gene silencing approaches, e.g. RNA interference (RNAi). Cisgenic and intragenic plants are both produced by the same transformation techniques as transgenic plants. The GMO Panel concluded that similar hazards can be associated with cisgenic and conventionally bred plants, while novel hazards can be associated with intragenic and transgenic plants. Right now, cisgenesis and intragenesis are mostly used in apple and potato. In Europe, several field trials have already been conducted with intragenic and cisgenic apples and potatoes.
The EFSA opinion is part of a request by the EU Commission. The Commission asked EFSA to evaluate the adequacy of EFSA's risk assessment guidelines for several new techniques in plant breeding. EFSA will soon publish a second opinion on this subject, which will cover Zinc finger nucleases and oligonucleotide directed mutagenesis.

On 8 February, EFSA published a scientific opinion on the post market environmental monitoring (PMEM) report from BASF on GM potato EH92-527-1 (Amflora) cultivation in 2010. The Panel did not identify adverse effects on the environment, human and animal health, but found a number of weaknesses in the methodology for General Surveillance (GS). Concerning a field study on potato-feeding organisms, the GMO Panel makes recommendations in order to improve the study. http://www.efsa.europa.eu/en/efsajournal/pub/2558.htm

On 15 February, EFSA published a scientific opinion concerning the “Safety analysis of oilseed rape Ms8 x Rf3 pollen in food or as food”. The GMO Panel found no unintended effects and no indication of concern over the safety of the newly expressed proteins. http://www.efsa.europa.eu/en/supporting/pub/228e.htm

On 8 February 2012, EFSA published a technical report concerning the “Safety analysis of oilseed rape GT73 pollen in food or as food”. The GMO Panel found no unintended effects and no indication of concern over the safety of the newly expressed proteins. http://www.efsa.europa.eu/en/supporting/pub/227e.htm

On 2 February, EFSA published a “Guidance on food and feed RA from GM animals and GM animal health and welfare”. http://www.efsa.europa.eu/en/efsajournal/pub/2501.htm

On 28 March, the GMO and BIOHAZ Panels published a joint opinion concerning the Austrian safeguard clause for Amflora potato. According to the opinion, Austria failed to present new data that would justify the Amflora ban. Austria had focused its critique on the presence of nptII antibiotic resistance marker gene. http://www.efsa.europa.eu/en/efsajournal/pub/2627.htm

On 28 March, the GMO panel published a positive opinion on the continued marketing of MON 531 × MON 1445 cotton for food an d feed uses. MON 531 × MON 1445 cotton is marketed by Monsanto and contains Bt toxin Cry1Ac, cp4epsps gene that confers resistance towards herbicides that contain glyphosate as active ingeredient. The stack also contains nptII antibiotic resistance marker gene. Deadline for comments is 28 April. http://www.efsa.europa.eu/en/efsajournal/pub/2608.htm

Other

Following a request by the European Parliament, EFSA reviewed the scientific content of a new study by Zhang et al.(http://www.nature.com/cr/journal/vaop/ncurrent/full/cr2011158a.html), who found that so called micro RNAs from plants can regulate the expression of target genes in mammals. The GMO Panel acknowledges that “GM plants in which changes in gene expression are targeted using micro RNA will need to be addressed” (information accessed via EFSA register: http://registerofquestions.efsa.europa.eu/roqFrontend/questionsListLoade... ). In a letter to EFSA, Monsanto had claimed that no new risks can be identified from this study.