The EU dilemma with the GMO industry and independent risk research

DISCLAIMER: All opinions in this column reflect the views of the author(s), not of EURACTIV.COM Ltd.

In contrast to current practices of political decision-making in the EU, the legislation under which the EU regulates the risk assessment of GE organisms stipulates a high level of protection for health and the environment. [Shutterstock]

The EU should give higher priority to the protection of health and the environment, but when it comes to genetically engineered plants, the current standards of risk assessment are not sufficient to fulfil the legal requirements, writes Christoph Then, executive director at Testbiotech.

Testbiotech is a non-profit organisation focusing on independent impact assessment of genetically engineered organisms. Testbiotech has followed EFSA GMO risk assessment practice for ten years.

The EU Parliament has in recent years adopted around 40 resolutions against further approvals for the import of genetically engineered (GE) plants. One of the criticisms was a lack of adequate and sufficient risk assessment.

Experts of several member states raised similar criticism. Nevertheless, the EU Commission gave green light to all these imports. One reason for this undemocratic and scientifically questionable situation is a wide bias within the EU research landscape.

Genetically engineered organisms are controversial in the EU, in particular where they might be released into the environment or used in food production. In this context, the identification and determination of risks, potential hazards and the likelihood of adverse effects are of utmost importance for the environment and health.

However, official discussions on these risks are currently dominated by the agricultural biotech industry. The companies fund and control most research projects on transgenic plants, as well as generate the data informing the approval process.

Their aim is to create the impression that all the risks of GE organisms are manageable and marketed products are safe. The EU political system has so far had largely failed to organise any risk research of GE organisms that is sufficiently independent of those stakeholders.

Currently, there are no GMO research programs primarily prioritising the protection of health and the environment. Consequently, there is a substantial probability that risks and relevant findings are overlooked by the current regulatory system.

In contrast to current practices of political decision-making in the EU, the legislation under which the EU regulates the risk assessment of GE organisms stipulates a high level of protection for health and the environment.

Regulation 1829/2003 requests that, for food and feed products derived from GE organisms, it is “adequately and sufficiently demonstrated” and “must not: have adverse effects on human health, animal health or the environment”. This includes ensuring that the respective products: “…should only be authorised for placing on the Community market after a scientific evaluation of the highest possible standard …”.

Similarly, a high level of environmental risk assessment is requested by EU Directive 2001/18; it also explicitly mentions the need for organising risk research: Member States and the Commission should ensure that systematic and independent research on the potential risks involved in the deliberate release or the placing on the market of GMOs is conducted.”

Currently, more than 70 genetically engineered plants have approval for import into the EU. Most of these plants have more than one trait. One typical example is maize “SmartStax“, developed and marketed by Monsanto (Bayer) and DowDupont (Corteva): it produces six insecticidal Bt toxins and is tolerant to several herbicides.

The gaps in current risk assessment can be exemplified by the fact that this maize was allowed for import into the EU without a single feeding study with the whole food and feed to assess its potential health effects.

There is a long list of gaps in EFSA risk assessment.

We include here just three issues: (i) fundamentally, current EFSA risk assessment does not request empirical data on mixed toxicity of food products derived from crops such as SmartStax; (ii) potential impacts on the immune system are only poorly covered, EFSA claims that adequate and evaluated methods still have to be developed; (iii) in many cases the data from the field trials conducted for the approval processes do  not reflect the real environmental and agricultural conditions under which the GE crops are grown in countries such as the US, Brazil and Argentina.

Consequently, current standards of risk assessment are not sufficient to fulfil the legal requirements.

This problem is frequently hidden behind populist arguments or even attacks on democratic institutions and the EU Court of Justice. Another strategy to avoid discussing risks is to only emphasise the potential future benefits of GE crops without mentioning the risks.

All these elements can be found in a recent op-ed written by the governing body of the genetic engineering industry, EuropaBio, published on 10 October 2019.

There are substantial doubts regarding the benefits as claimed by industry: for example, the data from the harvest of so-called Golden Rice recently presented to the authorities in New Zealand, show that the grains have a much lower concentration of beta carotene than claimed.

In addition, further beta carotene losses have to be expected from the storage and cooking of the grains, so that the real benefits are likely to be minimal. Another disappointing example is drought-tolerant GM maize grown in the US and approved for import into the EU.

Recently, South Africa rejected an application for the cultivation of the maize because it did not show any advantages compared to conventionally bred plants. Finally, the expectation that the cultivation of GE herbicide-tolerant crops would reduce the number of herbicides has proved to be unfounded and the opposite has happened.

However, even if the claimed benefits were true, the risk assessment of GE plants still has to be carried out in accordance with the law to demonstrate safety. Therefore, the EU Parliament is raising the right questions and sending important signals.

We hope, the new EU Commission will deal with this issue much more carefully than its predecessor. It should start to organise comprehensive independent risk research and ensure that EFSA fulfills the legal requirements.

The Commission has a further big task ahead i.e. tackling future policies on new methods of genetic engineering, so-called genome editing: the EU needs to maintain its current regulatory system for mandatory risk assessment of all GM organisms – confirmed by the EU Court of Justice in 2018 –  if there is to be a chance that transparency and necessary controls can be established.

Otherwise, in future, we will have no choice but to believe what EuropBio claims about its products: many benefits, but no risks.

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