EUU, Alm.del - 2014-15 (2. samling) - Bilag 123: Henvendelse af 10/9-15 fra Greenpeace vedr. godkendelse til markedsføring af GMO majs MON 87427

Europaudvalget 2014-15 (2. samling)
EUU Alm.del Bilag 123
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TESTBIOTECH Background 20 - 07 - 2015

Testbiotech comment on the Scientific Opinion

on the application (EFSA-GMO-BE-2012-110)

for the placing on the market of tissue-selective

herbicide-tolerant genetically modified maize

MON 87427 for food and feed uses, import and

processing under Regulation (EC) No

1829/2003 from Monsanto

Andreas Bauer-Panskus & Christoph Then

Introduction

Maize MON 87427 was developed by Agrobacterium tumefaciens-mediated transformation. The

plants express the CP4 EPSPS protein in all tissues except for the male reproductive tissues,

conferring tissue-selective tolerance to the herbicidal active substance glyphosate. Glyphosate

treatment of MON 87427 plants thus eliminates the need for detasseling of female inbred lines, an

agronomic practice currently used in hybrid maize seed production. According to EFSA, no safety

issues and environmental safety concerns arise from molecular characterisation, agronomic and

phenotypic characteristics as well as compositional data of maize MON 87427. The EU application

for MON 87427 is for food and feed, import and processing.

Molecular Characterisation

The process of genetic engineering involves several deletions and insertions in the maize plants. In

order to assess whether the sequences encoding the newly expressed proteins or any other open

reading frames (ORFs) present within the insert and spanning the junction sites raise any safety

issue, the proteins that might emerge from these DNA sequences were assumed as raising no safety

issues.

However, the molecular characterisation of the plants did not take into account the emergence of

new double stranded miRNA that might be transmitted as a biologically active substance at the

consumption level to humans or animals. miRNA might be transmitted to the consumer and there is

dispute over whether it might interact with gene regulation in mammalian cells (see, for example,

Zhang et al., 2011; Lukasik & Zielenkiewicz, 2014). The emergence of new versions, combinations

and concentrations of miRNA was neither assessed in the single plants nor in the stacked event.

Uncertainties related to the emergence of these molecules were not addressed.

According to EU Member States experts, analyses show that CP4 EPSPS protein level in forage

derived from glyphosate-treated plants almost doubled in comparison with the one obtained from

untreated plants. Instead of asking the applicant for explanations for this surprising effect, EFSA

simply concluded that only grain is subject to importation and left aside the data from forage which

are very relevant for the overall risk assessment of the plants.

EUU, Alm.del - 2014-15 (2. samling) - Bilag 123: Henvendelse af 10/9-15 fra Greenpeace vedr. godkendelse til markedsføring af GMO majs MON 87427

Comparative analysis (for compositional analysis and agronomic traits and GM phenotype)

The data presented by Monsanto only contains data from one year while the plants were grown

under 'normal' agricultural conditions.

Under these conditions, analysis of agronomic traits showed that there are several statistically

significant differences in comparison to the isogenic line. However EFSA considered these

differences as being biologically not relevant. Some of the data were based on methodologies that

were considered as not appropriate (such as pollen and seed characteristics), however EFSA did not

request further data.

Also for compositional analysis, several significant differences were shown between maize MON

87427 and its conventional counterpart. Those plants sprayed with glyphosate showed a much

higher number of significant differences.

In summary, there are indications that unintended effects derive from the process of genetic

engineering. Further, environmental interactions might play a role in triggering these significant

differences. It is possible that some of the relevant changes in plant composition and plant

characteristics may only be observed under specific environmental conditions. Thus, the observed

differences should have triggered a request from EFSA for more studies, for example, to grow the

plants under defined environmental extreme stress conditions. Such conditions can also reveal

genetic potential for instability in the expression of the newly introduced DNA (see, for example,

Trtikova et al., 2015).

Toxicity

A subchronic 90 days feeding study was performed with rats. The study showed several significant

differences which were considered incidental by EFSA, for example:



„Higher mean body weights and body weight gains, both statistically significant at most of

the time points, were noted throughout the treatment period in females of the GM diet group

compared with the control group. The difference in terminal body weight was approximately

8 %.“



„Males given the GM maize showed a significantly lower mean serum cholesterol level and

a significantly higher mean chloride level in comparison to the male control group. In

females fed the GM maize mean serum alanine aminotransferase activity was significantly

higher, while urea nitrogen was significantly lower in comparison to the female control

group.“



„Significant differences in some organ weights were noted between females fed the GM diet

and those given the control diet: higher brain weight (absolute only), lower ovary/oviducts

and thymus weight (both relative to body weight only), and lower thyroid/parathyroid

weights (absolute only).“

Further, according to the EFSA opinion, diets were formulated in accordance with the specifications

of the Purina Mills Inc. Certified Rodent LabDiet® 5002. However, recent research has shown that

the same diets might be contaminated with transgenic material (Mesnage et al., 2015). In the study

by Mesnage et al., the Purina 5002 diet was contaminated with around 12.8% GM soy and 35.6%

GM maize and was not labelled. Such contaminations can mask any health effect of the genetically

engineered plants. Based on the data presented from this feeding study, safety of Maize MON87427

can not be concluded.

Glyphosate residues

The plants are usually treated with glyphosate and will contain pesticide residues. However, EFSA

did not assess possible health effects of the residues and there is no data concerning the amount of

EUU, Alm.del - 2014-15 (2. samling) - Bilag 123: Henvendelse af 10/9-15 fra Greenpeace vedr. godkendelse til markedsføring af GMO majs MON 87427

glyphosate residues within MON 87427 plants. This is especially concerning in the light of a recent

report by the International Agency for Research on Cancer. According to the IARC, a body of the

World Health Organisation (WHO), glyphosate was shown to be “probably carcinogenic to

humans” (Guyton et al., 2015). Further, a Testbiotech report (Bauer-Panskus, 2014) concluded that

there are many open questions regarding the risk assessment of glyphosate, on issues such as

subchronic toxicity, long-term toxicity, genotoxicity, endocrine effects and ecotoxicology.

Monitoring

As a legal dossier compiled by Professor Ludwig Kraemer (Kraemer, 2012) shows, EU regulations

require the monitoring of effects on health at the stage of consumption in case of uncertainties. Thus

for example monitoring of health effects, taking into account residues from spraying with herbicides

must be required. Epidemiological parameters that are suitable to detect relevant health effects have

to be defined.

Further, any spillage from the kernels has to be monitored closely.

Conclusion

In the light of the substantial lack of data and major gaps in the risk assessment, no market

authorisation can be given.

References

Bauer-Panskus, A. (2014)Testbiotech comment on the German Renewal Assessment Report (RAR)

on the active ingredient glyphosate.

http://www.testbiotech.org/en/node/1094

Guyton, K.Z., Loomis, D., Grosse, Y., El Ghissassi, F., Benbrahim-Tallaa, L., Guha, N., ... & Straif,

K. (2015) Carcinogenicity of tetrachlorvinphos, parathion, malathion, diazinon, and glyphosate. The

Lancet, Oncology, 16(5): 490-491.

Kraemer, L. (2012) The consumption of genetically modified plants and the potential presence of

herbicide residues, legal dossier compiled on behalf of Testbiotech,

http://www.testbiotech.de/sites/default/files/Legal_Dossier_Kraemer_Pesticide_RA_PMP.pdf

Lukasik, A, & Zielenkiewicz, P. (2014) In Silico Identification of Plant miRNAs in Mammalian

Breast Milk Exosomes – A Small Step Forward? PLoS ONE 9(6): e99963.

Mesnage, R., Defarge, N., Rocque, L.-M., Spiroux de Vendômois, J., Séralini, G.-E. (2015)

Laboratory Rodent Diets Contain Toxic Levels of Environmental Contaminants: Implications for

Regulatory Tests. PLoS ONE 10(7): e0128429.

http://journals.plos.org/plosone/article?

id=10.1371/journal.pone.0128429

Trtikova, M., Wikmark, O.G., Zemp, N., Widmer, A., Hilbeck, A. (2015) Transgene Expression and

Bt Protein Content in Transgenic Bt Maize (MON810) under Optimal and Stressful Environmental

Conditions. PloS one, 10(4): e0123011.

http://journals.plos.org/plosone/article?

id=10.1371/journal.pone.0123011

Zhang, L., Hou, D., Chen, X., Li, D., Zhu, L., Zhang, Y., Li, J., Bian, Z., Liang, X., Cai, X., Yin, Y.,

Wang, C., Zhang, T., Zhu, D., Zhang, D., Xu, J., Chen, Qu., Ba, Y., Liu, J., Wang, Q., Chen, J.,

Wang, J., Wang, M., Zhang, Q., Zhang, J., Zen, K., Zhang, C.Y. (2011) Exogenous plant MIR168a

specifically targets mammalian LDLRAP1: evidence of cross-kingdom regulation by microRNA.

Cell Research, 22(1): 107-126.