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.”
(Article 4.1).
Regulation 1829/2003 sets out a set of labelling requirements in article 13. If the GM food or feed is different than its conventional counterpart as regards its nutritional value, composition, intended use or has implications for certain sections of the population,or where it could raise concerns ethically or religiously, the authorisation may come with a requirement that further information is provided. The EFSA would argue for rigorous labelling legislation, ( see section )
Directive 2001/18/EC , deliberate release into the environment of GMO.
Under this directive the authorisation procedure is a little different, with the EFSA opinion only seeked if there are objections and they are maintained throughout the first stages of application. The MS are involved in the early stages of risk assessment and the EFSA only becomes involved if scientific divergences cannot be resolved amongst the MS. The application is first given to the member state where the GMO shall be place on the market and they carry out a risk assessment. It is then sent to the EC for forwarding to all MS, “community period”, for any input. If there are are objections and they cannot be resolved amongst member states, only then is the EFSA asked to compile an opinion focusing on the point of contention between member states. And again based on The EFSAs opinion the EU and the MS take a decision on the application.
The process for regulation 1829/2003 is more transparent, as public consultation has a bigger more effective role. If the EFSA are not involved from the beginning, there should be public consultation periods before the risk assessment is given to the EC an drawn up in an opinion as is with the EFSA. It would give for a more certain process if the EFSA was involved from the beginning.
(Adapted from The EFSA GMO Fact sheet)
Directive 2001/18/EC is a result of improvements on directive 90/220/EEC, directives and regulations are continually being scrutinised and improved. It covers a large range of important legal issues. Directive 2001/18/EC objectives are to approximate the existing laws, regulations and administrative provisions of the MS and to protect human and animal health and the environment. It recognises that:
- GMOs may reproduce across national borders and this may be irreversible.
- all MS should be assessing risk with the same methodology, effectively harmonising
procedures and criteria for the case-by-case evaluation of potential risks arising from the deliberate release of GMOs.
- monitoring should be carried out post-release and the environmental risk assessment should be based on independent scientific advice and takes into account long-term effects.
- all international trade agreements should be respected.
- the EC should be committed to the requirements of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity.
- The intended GMO release must be tested in the habitat for their intended use but also the habitat that could potentially be affected.
- The European group on Ethics in Science and New Technology should be consulted with a view to obtaining advice on ethical issues.
Directive 2001/18/EC covers all agricultural GMOs and any not assessed according to these directives cannot be imported into the community. But it doesn't cover any GMO used in medicinal products. Council regulation (EEC) No 2309/93 is used and has high standards of assessment and is used in conjunction with directive 2001/18/EC.
The step-by-step process which GMO applicants must adhere to is to ensure the protection of humans, animals, and the environment. The containment of the GMO is becomes more and more reduced and the scale of release is gradually increased. The GMO can only proceed to the next step if earlier steps have indicated its safety towards human and animal health and the environment. This process is also promoted by FAO and the WHO shown in their joint agreement, Codex Alimentarius. Directive 2001/18/EC details the procedures for submitting a notification for undertaking a deliberate release into the environment of a GMO or the placing on the market, and is complemented by the EFSA guidance notes ( page 1).
The Risk Assessment and Monitoring
With conventional foods that have been around for generations there is little concern over their safety, they are considered safe based on experience. GM and novel foods don't have this fortune therefore their safety must be scientifically proven. Each GMO case is carried out by the EFSAs GMO panel made up of 21 independent experts from the EC. Each case is assessed individually guided by the EFSAs guidance document for risk assessment. The reason it must undergo safety tests is due to the introduction of new genes, these lead to proteins new to human consumption and could have possible effects on human health. Tests carried out target molecular characterisation contrasting it to the crop its intended to replace. nutritional value, vitamin content toxicity and allergenicity are all tested and the environmental impact of the GMO. Any disadvantageous changes from the products they intend to replace could deem it unsafe.
All studies are carried out by independent laboratories, on behalf of and financed by the applicant as the onus is on the applicant to prove the safety of the GMO. Whenever the EFSA are not fully satisfied by the tests carried out, as happened in the majority of the cases, the applicant is required to submit further data for the EFSA GMO panel to assess.
Long term effects are a concern and are a fundamental aspect of the EFSAs remit. Applicants assessments of long term adverse effects on human, animal and the
environment must be included in the application. Several months field trial are carried out, along with 90 day feeding trials in most cases (not compulsory). In addition it is required that a post market environmental monitoring plan, this demonstrates how longer term effects on possible adverse effects of GMO. Together these allow for close monitoring of GMO and allow for detection of any unanticipated effects that GMO may have in its first 10 years before it has to be re-evaluated.(GMO-compass, bibliography)
Labelling and Traceability
It is essential for the success of the entire GMO industry to be open and transparent, and one of the main ways to do this is to accurately label all products. The full scope of labelling should be in the EFSAs remit. Labelling is one keystone of risk communication. Regulation (EC) No 1830/2003 aims to harmonise national laws, regulations and administrative provisions on the traceability and labelling of genetically modified organisms (GMOs) within the EU. GMOs used as food or feed are treated differently than other GMOs, GMOs used in medicinal products are exempt from this regulation (article 2.2) in line with the Cartagena protocol. It is important to have effective traceability as this enables for effective long term monitoring, risk management and if necessary withdrawal of GMO products.
Labelling allows for an informed choice by the consumer and allows operators to keep records to assist with traceability as operators are required to keep these records for 5 years
These policies aren't totally infallible. The EFSA advocates a lowering of the 0.9% adventitious or technically unavoidable presence of GMO in non-GMO products threshold in regulation 1830/2003, article 7 (added to directive 2001/18/EC article 21) to below 0.5%.
The EFSA recognises the gap in labelling in secondary products, the EFSA back any proposals of labelling meat, dairy or poultry products that have been fed/grazed on GMO products or have been treated with medicinal GMO products. There is a legislation gap with regards processing aids, and these should be included in any new amendments of regulation 1830/2003. These improvements would be supported by the EC, FAO and the Environmental Alliance.
Accidental Release
The environmental liability directive 2004/35/CE (ELD) venerates the “polluter pays” principle. However member states may exempt operators from clean-up costs if the damage:
- is caused by pollution released within the terms of emission permits; or
- occurred despite the use of best practice.
- was caused by a third party and occurred despite the fact that appropriate safety measures were in place; or
- where the operator was complying with an instruction from a public authority (unless, for example, it is a notice requiring action following an emission/ incident caused by the operator).
There are also two other ways whereby an operator has defence to liability; the “permit defence”, acting in accordance with the conditions of the authorisation, and the “state of the art defence” , where at the time of authorisation they were not considered likely to cause environmental damage.
Therefore if a GMO has passed through all possible steps and passed all risk assessment for release it may be the operator may be exempt from liability and if this happens If this happens, governments nor the polluter will not be obliged to cover the costs themselves.
The EFSA would suggest a change in the ELD to protect the environment and human well-being. An operator wishing to release a GMO into the environment should accept the responsibility that if a disaster occurs its their responsibility to pay, advocating the polluter pays principle. In addition the EFSA would also advocate compulsory insurance schemes as a remedy strategy. But the EFSA also recognise that prevention is better than cure. In introducing a mandatory insurance scheme it would be stipulated that state of the art technology must be used at all times, ensuring that companies don't rely on insurance companies to give pay outs on their behalf as a result of negligence of using old technologies. (Netregs, bibliography), (Scottish environment protection agency)
Recommendations
The EFSA have an open and transparent relationship with the public and stakeholders as part of its effective corporate philosophy and believe this is the way to encourage support and confidence in the GMO industry.
There are difficulties in growing GM crops and non-GM crops together (co-existence). Currently there are some GM free zones within the EC, agreed upon by local farmers, however these are historically flawed and usually have little success. The EFSA wouldn't advocate member state enforced GM free zones (UK, France, Austria,Spain,Greece, Italy) as this could be disadvantageous for some farmers from within that zone. The current voluntary system could be tightened by agreements being drawn up for set amounts of time and democratically elected zones from local authorities. One successful situation is the North Essex Seed Zone (NESZ), but this isn't entirely voluntary. The complexities of land ownership and fragmented land hinders any completely voluntary scheme. Therefore it is necessary that strong legal frameworks are put in place to prevent GM contamination, and to ensure that liability is clear if contamination does occur. The EU Commission fully support any adaptation of GM free buffer zones. These buffer zones should coincide with the lifting of involuntary GMO free zones as it conflicts with human rights issues.
Self-Tasking Activities
Besides product-specific risk assessments, the EFSA also identify particular areas which they feel necessary to conduct further research so it initiates its own work “self-tasking activities” in order to stay at the cutting edge of scientific developments and to further our understanding of GMO. The EFSA are carrying out studies on;
- Statistics
- Allergenicity assessments
- The use of animal feeding trials
- Post-market environmental monitoring of GMOs and
- Plants used as a production platform for non-food/feed products.
Conclusion
As a result of the 16th of December session there has been a marked effort in re-assessing the GMO regulations within Europe. Labelling was one of the main contentious issues and the EFSA see big policy changes over the coming years of regulation 1830/2001, but also recognise that it could possibly be one of the biggest changes seen in the GMO industry, and a tough area to change. So much of our meat and dairy products have come in contact with GMOs that it will have to be a phasing out process rather than a blanket labelling regulation.
There needs to be constant monitoring and assessment of GMOs, to advance our understanding of GMO the long term and the effect, if any, it has on the human physiology. As our understanding grows so will the technology that accompanies GMOs and this will be the gateway to GMO safety and its ability to curb global hunger.
Bibliography
Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms.
Regulation (EC) No 1829/2003 on genetically modified food and feed.
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Directive 2004/35/CE, accessed 2nd December 2007;
The EFSA Home, Accessed 29th November 2007
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Further Reading
Friends of the earth, GM contamination briefing, accessed 2nd December 2007; .
GMO free Europe, accessed 2nd December 2007;
Network of GMO-free Regions in Europe: (c) Land Oberösterreich
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Regulation (EC) No 641/2004 on detailed rules for the implementation of regulation (EC) No 1829/2003.
Regulation (EC) No 65/2004 on establishing a system for the development and assignment of unique identities for genetically modified organisms.
Regulation (EC) No 178/2002 on the general principles and requirements of food law.
Regulation (EC) No 258/97 on novel foods and novel food ingredients.
Council directive 89/107/EEC on the approximation of the laws of the member states concerning food additives authorised for use in food stuffs intended for human consumption.
Council directive 88/388EEC on the approximation of the laws of the member states relating to flavourings for use in food stuffs and to source materials for their production.
Council Directive 82/471/EEC on products used in animal nutrition.
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labelling of certain foodstuffs produced from genetically modified organisms
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University of Bradford, gateway to geonmics accessed 2 December 2007
Elements of Precaution:Recommendations for the Regulation of Food Biotechnology in Canada, accessed 29th November 2007,