NOTE: The following information about EU regulatory responses has been compiled with the help of Chris Hayes.
Note in particular the damning comments in the appraisal of the Austrian Federal Department for Health, who completely reject the lax regulatory approach being promoted.
EXTRACT: "Insecticidal Cry proteins produced by GM plants as well as transproteins conferring tolerance to herbicides constitute a sum of new plant constituents possibly interacting within the organism. So far, there is absolutely no scientific knowledge about such new combinations and possibly resulting additive and/or synergistic effects."
SmartStax in Europe
A major scandal is emerging over the lax treatment of SmartStax by regulators, with approvals being rushed through in Canada, the US and Japan, and there are good indications that many regulators in Europe will try to treat what's been described as one of the most complicated genetically engineered plants ever created in the same way. The concerns are obviously heightened by the EU food safety authority (EFSA)'s reputation for liking GMOs so much they don't bother to treat them scientifically.
SmartStax is listed by the Canadian Food Inspection Agency (CFIA) as "the combined trait corn product containing events MON 89034, TC 1507, MON 88017 and DAS-59122-7". These events have links at http://www.inspection.gc.ca/english/plaveg/bio/bt/smartstaxe.shtml
In the EU there's an application for a GM maize (corn) variety: MON89034 x 1507 x MON88017 x 59122.
GMO-Compass is a pro-GM industry-linked site set up with EU monies which claims to provide a GMO Database that "Contains information on every GM plant that has been approved or is awaiting authorisation in the EU." It lists an application for "Import and processing; Food and Feed" for this maize at:
More technical details of the application, including composition of the gene-constructs (like the fact that some contain CAMV-35 elements) can be found here:
There's also evidence that approval for cultivation will be sought, with applications for field trials in the EU, such as:
*B/SK/09/02 Slovakia19/02/2009 Slovak Agricultural Research CentreNotification according to Directive 2001/18/EC, Part B, for the deliberate release of MON 89034 × 1507 × MON 88017 × 59122 for the use in field trials in Slovakia.
Slovakian, Romanian and Spanish field trial notifications:
*B/ES/09/02 Spain18/02/2009 Monsanto Europe, S.A.Notification according to Directive 2001/18/EC, Part B, for the deliberate release of MON 89034 × 1507 × MON 88017 × 59122 for the use in field trials in Spain.
*B/RO/09/05 Romania25/03/2009Monsanto CompanyNotification according to Directive 2001/18/EC, Part B, for the deliberate release of MON 89034 × 1507 × MON 88017 × 59122 for the use in field trials in Romania.
"MON 89034 × 1507 × MON 88017 × 59122 was field tested in multiple sites in maize producing states of the U.S. corn belt and southern corn growing regions to assess performance, efficacy, hybrid evaluation, seed production, yield and to collect regulatory data and materials. It was also tested in three locations in Chile to assess performance, efficacy, yield, breeding, and for hybrid evaluation.
The results of the releases in these countries showed no evidence that MON 89034 × 1507 × MON 88017 × 59122 is likely to cause any adverse effects to human or animal health and the environment. Except for its protection against certain lepidopteran and coleopteran insect pests and its tolerance to glyphosate and glufosinate herbicides, MON 89034 × 1507 × MON 88017 × 59122 could not be distinguished from conventional maize."
Safety precautions: visual inspection.
National advisory documents for the respective EU governments ======================================================================
Within the EU, the Netherlands and Austria provide contrasting regulatory responses.
The consistently pro-GM Dutch advisory institute COGEM, advises: "no problem", arguing effectively that: "We already know the traits. We already said OK, so why do you even ask? Maize seeds do not survive in our winter, so there is no problem."
This view is echoed by the UK's equally pro-GM ACRE (Advisory Committee on Releases to the Environment). According to meeting minutes from last December: "Members... considered a new application to import and process a GM maize (and use as food / feed), EFSA/GMO/CZ/2008/62. This is a quadruple stack, which includes 3 events with which ACRE is familiar - 1507, MON88017 and 59122 maize. Information on the remaining event (MON89034) has been considered by ACRE as there is an application to import/process a GM maize containing this single event in the system already. ACRE concluded it did not require further information as this application did not raise any concerns."
As thorough as the Dutch!
By contrast, the Austrian Federal Department for Health does not buy into this "We already know all these traits so everything's hunky dory" line. They state:
"A stacked organism has to be regarded as a new event, even if no new modifications have been introduced. The gene‐cassette combination is new and only minor conclusions could be drawn from the assessment of the parental lines, since unexpected effects (e.g. synergistic effects of the newly introduced proteins) cannot automatically be excluded. Furthermore, it should not be neglected that two of the parental lines, GM maize MON89034 and GM maize MON88017, have not yet gained authorisation within the European Union."
Statement overview at http://www.bmgfj.gv.at/cms/site/downloads.html?thema=CH0697
The abridged version (confidential parts not included, but listed) in English at: http://www.bmgfj.gv.at/cms/site/attachments/9/7/5/CH0808/CMS1228994124985/ages_stn__-_mais_mon89034x1507xmon88017x59122_public_version.pdf
The Austrian Federal Department for Health also notes:
"In the technical dossier, the notifier says that the safety of all transproteins, Cry1A.105, Cry2Ab2, Cry1F, Cry3Bb1, Cry34Ab1, Cry35Ab1, PAT and CP4 EPSPS, expressed in the test material GM maize MON89034x1507xMON88017x59122 have been discussed in detail in other applications for authorisation. This concerns, amongst other things, history of safe use, structural description and digestion in simulated gastric fluid. In contrast to this, we would like to point out that:
*there is no history of safe use of the new recombinant protein expressed by an artificially arranged insert such as Cry1A.105.
*concerning all Bt toxins, a history of safe use cannot be argued on the basis of the safety of Bt sprays applied in organic farming. The inserted genes are truncated and arranged with expression modulating DNA parts originating from different
organisms and permanently expressed compared to a tight timely Bt spraying schedule (Lewis et al. 1997; Sexton et al. 2007).
*all eight transproteins used in acute toxicity tests (Cry1A.105, Cry2Ab2, Cry1F, Cry3Bb1, Cry34Ab1, Cry35Ab1, pat CP4 EPSPS) originated from microbial expression systems. Establishing structural and functional equivalence of this test proteins and the plant derived proteins adds uncertainties to the interpretation of the animal tests (Spök et al. 2008), thus, only limited information about the plant expressed transproteins can be obtained.
Additionally, a 90‐day rat feeding study with GM maize 59122 (Malley 2004) showed alterations of total protein and albumin levels, and we are still of the opinion that this study should be repeated, as recommended and remarked by Austria in the scientific comment on triple stack GM maize 59122x1507xNK603 transferred to EFSA in September 2007.
Furthermore, according to EFSA, a potential for increased toxicity and/or allergenicity to humans and animals or for modified nutritional value due to the stacked events may arise from additive, synergistic or antagonistic effects of the gene products or by these produced metabolites (EFSA 2007). But the safety of all newly expressed proteins in animal models applied simultaneously and combined was not assessed in the dossier.
Insecticidal Cry proteins produced by GM plants as well as transproteins conferring tolerance to herbicides constitute a sum of new plant constituents possibly interacting within the organism. So far, there is absolutely no scientific knowledge about such new combinations and possibly resulting additive and/or synergistic effects. Therefore, at least one subchronic feeding study (90‐days) with rodents with the whole GM maize plant (MON89034x1507xMON88017x59122) should be carried out."