Testbiotech EU Newsletter 2/2017 (August 2017)

Risk assessment of new sequencing information on genetically modified soybean event 40-3-2
On 7 August, EFSA published a report on new nucleic acid sequencing and updated bioinformatics data for soybean event 40-3-2 provided by the applicant. According to Monsanto, the sequence of soybean event 40-3-2 as present in the stacked soybean 305423 × 40-3-2 contains an additional nucleotide in the 5′ flanking region of a 72 bp additional insert of CP4 EPSPS. According to EFSA, the new information does not give rise to safety issues.
http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4968/full

Risk assessment of new sequencing information on genetically modified soybean event 305423
On 7 August, EFSA published a report on new nucleic acid sequencing data and updated bioinformatics data for soybean event 305423. The new data provided by Monsanto indicated a four base pair (bp) difference compared to the sequencing data originally provided: one bp located in the genomic 3′ flanking region, two bp located in a gene silencing cassette and one bp in a partial promoter. According to EFSA, the new sequencing data and analyses performed on the new sequence did not give rise to safety issues.
http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4967/full

Scientific Opinion on maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122 and subcombinations by Monsanto
On 1 August, EFSA published an opinion regarding the authorisation of maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122. The five-event stack was made resistant to glyphosate, glufosinate and produces six Bt toxins Cry1A.105, Cry2Ab2, Cry1F, Cry3Bb1, Cry34Ab1 and Cry35Ab1. The GMO Panel concluded “that the five-event stack maize is as safe and as nutritious as the non-GM comparator and tested non-GM reference varieties in the context of the scope of this application.”
No experimental data were provided for 14 sub-combinations.
http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4921/full

Contrary to the usual practice, no deadline has yet been published for public comments.

Scientific Opinion on maize MON 87427 × MON 89034 × NK603 and sub-combinations by Monsanto
On 1 August, EFSA published an opinion regarding the authorisation of the three-event stack maize MON 87427 × MON 89034 × NK603. The maize contains two genes for glyphosate resistance. Further, it produces the Bt toxins Cry1A.105 and Cry2Ab2. The GMO Panel concluded that “the three-event stack maize is as safe and as nutritious as the non-GM comparator and the tested non-GM reference varieties”.
However, no experimental data were provided for the two sub-combinations MON 87427 × MON 89034 and MON 87427 × NK603.
http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4922/full
Comments can be posted here - the deadline for comments is 5 September:
https://ec.europa.eu/food/plant/gmo/public_consultations

Scientific opinion on maize 59122 by Pioneer and Dow AgroSciences
On 29 June, EFSA published an opinion regarding the renewal of authorisation for maize 59122. The GMO Panel concluded that “no new hazards or modified exposure and no new scientific uncertainties were identified that would change the conclusions of the original risk assessment on maize 59122.”
http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4861/full

New guidance for securing EFSA independence
The European Food Safety Authority (EFSA) published new guidance for securing its independence. Testbiotech is demanding substantial improvements: EFSA should prioritise more independence specifically in regard to curbing the influence of the agrifood industries. In this respect, the EFSA position should be to give preference to the interests of the general public and, more particularly, the protection of health and the environment.
http://www.testbiotech.org/en/node/2009

Guidance on allergenicity assessment of genetically modified plants
On 18 May, EFSA published new guidance regarding the allergenicity of genetically engineered plants.
Main findings are:

• For non-IgE-mediated adverse immune reactions to food: “detailed risk assessment considerations are provided to determine the safety profile of the protein or peptide under assessment with regard to its potential to cause celiac disease.”
• For in vitro protein digestibility tests: “the EFSA GMO Panel considers that additional investigations are needed before any additional recommendation in the form of guidance for applicants can be provided.”
• For assessing endogenous allergenicity of GM plants and to support the practical implementation of mandatory requirements in Implementing Regulation EU (No) 503/2013: “the guidance provides further information on: (i) relevant crops subjected to such analysis; (ii) relevant allergens that should be quantified; (iii) methodology to be used for quantification; and (iv) principles to be followed for data interpretation and risk assessment considerations.”

http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4862/full

A technical report was published on the “Outcome of the public consultation on the draft guidance on allergenicity assessment of genetically modified plants”.
http://www.efsa.europa.eu/en/supporting/pub/1259e

Literature review of baseline information to support the risk assessment of RNAi-based GM plants
On 9 June, EFSA published an external review of information regarding risk assessment of RNAi plants. Amongst others, main findings of the report are:

• “Mobile RNA silencing exists in plants and some animals.
• RNA silencing, and RNAi in particular, operates with unique (though not absolute) selectivity and is being explored in many different ways in biomedicine and biotechnology.
• In some cases, RNA silencing can spread across cellular boundaries, which can extend into systemic silencing. Systemic silencing is restricted to specific taxons and RNA silencing pathways. While the framework for understanding the molecular basis of systemic silencing in different model systems was established, the knowledge is still fragmented and far from complete.
• Even less clear is the horizontal transmission of RNA silencing, especially into species, where primarily cell-autonomous silencing is expected.”

http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2017.EN-1246/abstract

Annual post-market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2015 from Monsanto
On 8 May, EFSA published its annual report regarding the post-market environmental monitoring of maize MON810. EFSA found similar “methodological shortcomings to those observed in previous annual PMEM reports on maize MON 810“.
http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4805/full

EFSA opinion on application regarding glufosinate-ammonium and glyphosate-tolerant oilseed rape MON 88302 × MS8 × RF3 by Monsanto
On 10 April, the GMO Panel published an opinion regarding oilseed rape MON 88302 × MS8 × RF3. The GMO Panel concluded “that the three-event stack OSR is as safe and as nutritious as its conventional counterpart and the tested non-GM reference varieties.”
http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4767/full