The use of GMOs: A Critique, from the EFSA

Food is a necessity for life and its safety is incremental in today’s society. More and more our food is being grown in ever increasingly exotic places and in exotic ways. The European Food Safety Authority (EFSA) intends to keep all of our food safe for consumption. And to let our stakeholders make an informed decision about what they eat. The EFSA is a risk assessor and risk communicator within the twenty five EU member states, they provide sound independent scientific advice on all issues concerning food safety.

The public is always at the heart of these decisions, and their health and welfare is at the utmost importance including that of animal and plant welfare and the environment. The EFSAs remit includes the use of directive 2001/18/EC on the deliberate release of GMO’s whether it be onto the market, experimental release or anything else and regulation (EC) No 1829/2003 on food and feed. Together they ensure a rigorous safety process is in place at all times during the application and monitoring after the GMO has been released.

The precautionary principle is taken into account at all times, a GMO will never be allowed to increase its scale of release unless first proving that it creates no concern for food safety based on previous experience. Within this process there are potential problems and areas of weakness which will be identified and addressed. Labelling is a huge area of concern and many problems have been identified . Methods of how to approach these problems have been put forward. About the EFSA The European Food Safety Authority was established in January 2002 in the wake of a series of food scares in the late 90’s.

It’s aims are to provide independent scientific advice and communication on the entire food chain within the European Union (EU). The EFSA improve and monitor food safety, protect consumers and strive to provide a high level of consumer confidence in the EU food supply. The EFSA assess all potential food risks within the EU and consequently provide sound scientific advice to ensure a solid base for EU policies and legislation to support the European Commission (EC), European Parliament and EU Member States (MS) in deciding effective risk management strategies.

The EFSAs future goals are to become globally recognised as world leaders on food and feed safety, nutrition, animal health and welfare, plant protection and plant health. The EFSA risk assessments are all independently carried out and this ensures that EU citizens are among the best protected and best informed in the world about the food they eat. (EFSA Website,Bibliography) The EFSA on GMOs: A critical analysis The potential problems of the EFSAs role within the EU regulatory framework

The EFSA risk assessment, of GMOs, is one of the strictest in the world. This could have implications to trade as the World Trade Organisation (WTO) pointed out but these regulations are also a consumer safety net, and consumer confidence builder. Before any GMO can be released onto the market within the EU it must first pass an approval system in which its safety towards human, animals and the environment is thoroughly assessed. This process is advantageous to GMO trade as it proves to the public the safety of GMOs.

In line with the regulation 1829/2003 on GM food and feed, the EC asked the EFSA to produce a guidance document to assist applicants in the preparation and presentation of their application for the authorisation of their GM food or feed. Continuing to involve its stakeholders, the EFSA gave a four week period for public consultation and also benefited from feedback received from stakeholder consultation in May 2004. The document provides detailed guidance for any potential applicant of GM food or feed and is within the framework of directive 2001/18/EC and therefore covers the full risk assessment of GM plants, food and feed.

In spite of this guidance, in most cases the EFSA have to re-assess the potential risks. (Tiberghien and Starrs 2004, Greenpeace, bibliography, Guidance document 2006) GMO’s wishing to be released within the EU must first comply with EU directives and regulations; Directive 2001/18/EC, Directive 98/81/EC, Regulation EC 1829/2003, Commission regulation (EC) No 641/2004, Regulation EC 1830/2003, Commission regulation (EC) No 65/2004. The EFSA acts upon two of these legal bases; Directive 2001/18/EC, and Regulation EC 1829/2003 and draws up opinions on any potential risk.

The Precautionary Principle and its strengths and weaknesses The linchpin of risk assessment is the precautionary principle. It dictates that where there is uncertainty as to the existence or extent of risk to human health or the environment, the relevant authority should take protective measures without waiting until the reality and seriousness of those risks become fully apparent. Again the WTO recognised that a precautionary approach is a barrier to trade and unnecessary.

But as it is stressed that it may only be applied when there is clear scientific knowledge available to indicate that there is reason to believe that harmful effects might develop, the EFSA recognise its potential to advert potential adverse health effects. The precautionary principle within food safety assessment is essential and justifiable because we can not be certain about the short or long term impacts and repercussions of such technologies such as genetically modified crops (GM crops).

The EFSA acknowledge the complexities of inserting single genes into organisms and releasing them onto the global market and with this accept the reality of uncertainties and in the interest of the public exercise caution in its decision making. The precautionary principle does not aim to halt any new technologies including GMO but its objectives are to make aware potential harmful effects of new technologies. It animates new and innovative solutions to complex problems.

The precautionary principle must be used wisely, if it where to be used very strongly it could have the possibility of paralysing the entire global economy. (The EU-US biotechnology, consultative forum, Raffensperger and Barrett 2001) The GMOs Authorisation Process’ problems and strengths There are two processes used by the EU in granting approval of a GMO, regulation 1829/2003 and directive 2001/18/EC. The EFSA provide opinions at certain steps in the processes; Regulation (EC) No 1829/2003, genetically modified food and feed.

First the application is given to a member state and it is then forwarded onto the EFSA who must submit an opinion within 6 months. All member states have access to the application and accompanying studies so as any concerns or comments that member states have can be voiced. If the application is for cultivation of a GMO, the member state must also carry out an environmental risk assessment (ERA). When all the data is given to the EFSA, an opinion is given to the EC along with all other information required under regulation 1829/2003 within six months.

The public are kept informed and have access to the publicly available data on the internet. Comments can be made on the EFSAs opinion via the EC website. The member state and the EC take the final decision on the application. The EFSA does not make any decision on the market release, it provides risk assessment that underpins the decision. Under this regulation all MS have the opportunity to assess and comment on the GMO application (EFSAnet), this in turn aids the EFSAs final risk assessment report.

During the cultivation of the GMO the MS are required to carry out their own risk assessments and monitoring for the EFSA. Any comment and suggestions made by the MS are listed in the EFSAs opinions in annexes, in the interests of clear and transparent work. (Adapted from The EFSA GMO Fact sheet) If a GMO is granted authorisation, it is valid throughout the EC for ten years on a renewable basis and is entered into a publicly available register of GM food and feed.

Regulation 1829/2003 objectives state that Community policies should ensure a high level of protection of human life and health. Differences of national laws, regulations and administrative provisions on GM food and feed may hinder GMO free movement and thus create unequal and unfair trade. In order to deal with this in a fair way regulation 1829/2003 approximates these existing laws, regulations and administrative provisions of the MS on GM food and feed, making for a more harmonised community.

It also lays down Community procedures for the authorisation and supervision of genetically modified food and feed and lays down provisions for the labelling of genetically modified food and feed. One of the most important points in regulation 1829/2003 states that GMO food must not “differ from the food which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for the consumer. “