The iGEM Team of University of Southern Denmark 2012 igem.sdu.2012@gmail.com

Legislation of GMOs in the European Union

– with outlook on the policy of the United States

By Gábor Barna, 2012

Gabor came up to us to our fair, which is part of our outreach that would tell interested university students about iGEM and our project. We talked for a long time and agreed that there was no reason to wait until next year to participate. We agreed that when you produce a new product, it is important to know the laws about this, especially when it comes to food and "over the counter medicine." Gabor joined therefore the team and wrote the part about law together with us.

1. Introduction

While genetically modified organisms (GMOs), food and feed made thereof, and the related biotechnological processes such as genetic engineering are usually criticized because of their supposed risk for human health or the environment, we should not forget about the promising breakthroughs which they have the chance to perform sooner or later, such as helping to terminate starvation in the third world, or for instance – like the project Team SDU is working on – simply ensuring people a healthier, better life.

It would be very easy to argue about the statutory assessment of genetic engineering simply from a rational, economist point of view, to compare the benefits and costs (in this case the risks) and afterwards decide whether it should be allowed to use these techniques and products or not. Reality is a bit more complicated, we have to deal with the ethical questions and consequences of genetic engineering, which is the other very important field of criticism towards GMOs.

This paper will demonstrate the current legislation on GMOs in the European Union in a mostly practical way to show the actual difficulties that a GMO producer has to deal with compared to the general attitude of legislation in the United States without being detailed about the ethical issues because of the boundaries of length and topic of this paper.

However, I do have to mention the connection between law and ethics, which mainly belong to the fields of Philosophy of Law, and therefore is not subject of the following pages. To briefly demonstrate this connection, I would like to recall the legal positivist Jellinek’s definition of law: “Das Recht ist nichts anderes als das ethische Minimum.”[I] which means law is nothing else, but the ethical minimum (standard). Of course, he did not mean it in the way that laws would reflect the ethical standards of legislators, and neither do I intend to express such a meaning. However, this quote can give the reader a good starting point of view to think about the questions discussed below.

2. General Attitudes Towards GMOs

For the better understanding of current rules, a quick look should be taken at the history of jurisdiction on GMOs, environmental and health risks. Vogel and Lynch gave a complex overview on this context in 2001.[II] They demonstrated that a grave change can be recognized in the approach towards these techniques both in the US and the EU in the 1980s, but the difference between their directions did not disappear, in fact they almost replaced each other. As they write about the 1960s and 1970s: “As a general rule American regulatory politics tended to be more contentious, confrontational and adversarial than in Europe. There was less public trust in government officials and more widespread public skepticism about the benefits of new technologies.”[III] Nowadays the situation seems to be the exact opposite: there is a lot stricter and more restrictive jurisdiction in Europe, while the American rules along with the public opinion tend to be in favor of innovation and support new technologies.

The authors also cited statistics that reflected the contrast between the two continents in public support at the edge of the new millennium: while great majority of Americans were willing to buy and consume products made by bioengineering, Europeans highly refused to do so, however they admitted that German opposition seemed to be declining at the time.

Recent facts doesn’t reflect this decline though, as for instance in early 2012 the German BASF – producer of the GM potato Amflora, which is one of the very few GMOs licensed in the EU – announced it is outsourcing its biotech operations and research facilities to America due to the lack of acceptance of these technologies in Europe from both the public, both the legislators. Maurice Moloney’s words summarize the result with a great adequacy: “It is ironic that much of the science that created modern biotechnology came from Europe and yet Europeans have been deprived of the environmental benefits such as the reduction of the use of pesticides and improved soil quality as well as the more obvious economic benefits of cheaper food and agricultural products.”[IV]

3. Jurisdiction in Europe

3.1. Antecedents

Before the currently effective regulations – mentioned below – were accepted by the European Parliament and the Council, the European Union used to apply a de facto moratorium on biotech products by refusing to approve their presence in the Common Market between 1999 and 2003, as World Trade Organization (WTO) concluded in the EC-Biotech case in 2006.[V] WTO’s process was initiated by the US, Canada and Argentina – the main exporting countries of products to the EU effected by the moratorium. Ironically, despite the EU had to bear the wide international opposition, European farmers and companies did not benefit from the acts considered to be protectionist such as the GMO ban or the 1989 ban on importing beef from cattle treated with growth hormones – which for the record has also been found to violate an international treaty, namely the WTO Sanitary and Phytosanitary Standards of the Uruguay Round Trade Agreement – as the amount of imported agricultural products did not reduce, only the countries of origin changed to those that produce non-GM crops and meet without hormone treatment (i.e. Australia, Brazil).[VI]

3.2. Current Regulations

After the EC-Biotech decision, the EU did not appeal, as it already had regulations that were in harmony with its international obligations. The most important sources of community law ruling these issues are Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed[VII] (hereinafter Reg. 1829/2003) and Regulation (EC) No 1830/2003.[VIII] Latter contains the detailed rules of traceability and labeling, while the foregoing gives us the general rules and objectives. In the following paragraphs this paper will demonstrate these rules to give a preview of how difficult job a new GMO producer shall face in order to have its product authorized.

3.2.1. Objectives and Scope

Reg. 1829/2003 has three objectives as follows: (1) ensuring a high level of protection of human and animal life and health, environment and consumer interests in relation to GM food and feed, whilst ensuring the effective functioning of the internal market; (2) provide the procedure of authorization; (3) give provisions on labeling.[IX] The scope of the regulation applies to GMOs for food use, food containing or consisting of GMOs, and food produced from or containing ingredients produced from GMOs. To put it more simply, if the food has any tiny thing to do with GMOs, it is subject of the regulation.

3.2.2. Authorization

The procedure for authorization is relatively slow. First, the application shall be sent to the national authority of a Member State, which on one hand acknowledges receiving the documents in 14 days, on the other hand forwards the case to the European Food Safety Authority (EFSA). The latter is responsible for risk assessment and shall send his report of opinion to the Commission within 6 month. The Commission then submits the case to the Standing Committee on the Food Chain and Animal Health within 3 months after receiving the opinion of EFSA. This step is one of the most important ones since in the best case scenario this can be the last one: if the Committee accepts the proposal, the Commission adopts it. In case it does not accept it, the proposal will be discussed by the Council of Ministers. This of course delays the licensing, however, there is a time limit at this level as well: if the Council cannot reach a position with qualified majority within 3 months, the Commission adopts its proposal. Authorization, as seen above, can take up to a year from publishing the application. This ensures safety, but hardly promotes innovation. Once the authorization is granted, it is valid for 10 years – renewably – throughout the whole Community, but the authorized action is subject to a constant supervision.[X]

3.2.3. Labeling

The fundamental and detailed rules of labeling are also covered by these two regulations. Food and feed products containing GMOs must be labeled as such, i.e. by printing a clearly visible text of “genetically modified” on the product. The only exception applies to products that contain less than 0.9 % GMOs.[XI]

3.2.4. Option to “Opt Out” for Member States

Although the geographical scope of the granted authorization covers the whole Community, there are several Member States that have successfully banned some GM products from their territories. If Member States want to do so, they have to invoke the safeguard clause of Directive 2001/18/EC, but they are supposed to have reasonable cause of the prohibition. For instance, several Member States, including Hungary have banned producing, selling and using GM maize MON810 on their territories. Even though in that specific case the Scientific Panel of EFSA did not find the scientific evidence provided by Hungary enough to justify the prohibition of MON810[XII] , the Council of Ministers rejected the Commission’s proposal to force Hungary along with and Austria to lift their bans.[XIII] I would like to note that Hungary also banned Amflora in 2010[XIV] , and given the abovementioned retreat of BASF in Europe, this ban is also very likely not to be lifted.

Summarizing the EU legislative rules and attitudes, it is very interesting to see how the Community tries to maneuver between promoting innovation and minimizing risks. Back in 1998, the European Parliament and the Council admitted the importance of biotechnology and genetic engineering and talked about their protection with the words: “will certainly be of fundamental importance for the Community's industrial development.”[XV] In my opinion, today’s Europe tends to choose risk minimization over innovation and growth, but only time will be able to tell whether it was the right decision or not.

4. The United States

As mentioned above, the American way of dealing with the GM issue is almost the opposite of the European. Given that the Unites States is the largest GM crops producer in the world, it is not surprising their jurisdiction and government firmly support these new technologies.
Their less restrictive legislation dates back to the 1980s, when the Biotechnology Science Coordinating Committee was established, and the Environmental Protection Agency (EPA), the United States Department of Agriculture (USDA), and the Food and Drug Administration (FDA) were chosen as the three regulatory agencies for biotechnology.[XVI] Both of them did and do promote the use of GMOs.

Authorization process of GMOs also belongs to these agencies, and their process is considered to be faster and more liberal than the one in the EU. This liberalism is also reflected by labeling GM products, which in the US is absolutely voluntary. “FDA determined that labeling was not required on the basis of the method of food production (i.e. genetic engineering), but only if the new food itself posed safety problems for consumers.”[XVII]

The barriers of this paper do not let the American jurisdiction to be presented in details, the objective was to give a brief compartment of the fundamental questions.

5. Conclusion

All 27 Member States of the European Union have signed and ratified the International Covenant on Economic, Social and Cultural Rights, and thus undertook the duty “to improve methods of production, conservation and distribution of food by making full use of technical and scientific knowledge”[XVIII] in order to ensure everyone’s right to be free from hunger. Also in the same covenant they recognized the fundamental scientific freedom by undertaking “to respect the freedom indispensable for scientific research and creative activity”.[XIX]

Are Member States along with the Community really making full use of technical and scientific knowledge? It is not ours to decide, but considering the abovementioned circumstances, the United States seem to be a much more welcoming place for scientists working on GMOs and therefore outsourcing European jobs and loosing European scientists for the US is not really surprising. In this paper I presented the legal procedure of authorizing GMOs in the EU and placed it in a context to be comparable with the American government promotion of scientific innovations. Instead of collecting the short term benefits, the EU made a choice of values, and this should be respected.

[I]: JELLINEK, Georg: Die sozialethische Bedeutung von Recht, Unrecht und Strafe, 2nd Edition, Berlin 1908, p. 45.
[II]: LYNCH, Diahannah – VOGEL, David: The Regulation of GMOs in Europe and the United States: A Case-Study of Contemporary European Regulatory Politics, 2001. Available at: http://www.cfr.org/ genetically-modified-organisms/regulation-gmos-europe-united-states-case-study-contemporary- european-regulatory-politics/p8688 (21 September 2012)
[III]: LYNCH – VOGEL (2001)
[IV]: http://www.rsc.org/chemistryworld/News/2012/January/basf-pull-out-gm-crops-biotech.asp (21st Sept. 2012)
[V]: GONZALEZ, Carmen G. , Genetically Modified Organisms and Justice: The International Environmental Justice Implications of Biotechnology. Georgetown International Environmental Law Review (GIELR), Vol. 19, p. 583, 2007. Available at SSRN: http://ssrn.com/abstract=986864
[VI]: LINCH – VOGEL (2001)
[VII]: Official Journal L 268, 18/10/2003 P. 0001 – 0023, amended by Regulation (EC) No 298/2008 (Official Journal L 097, 09/04/2008 P. 0064 – 0066)
[VIII]: Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (Official Journal L 268, 18/10/2003 P. 0024 – 0028)
[IX]: Reg. 1829/2003 Article 1
[X]: Reg. 1829/2003 Articles 7 – 23
[XI]: Reg. 1829/2003 Articles 24 – 26
[XII]: Request from the European Commission related to the safeguard clause invoked by Hungary on maize MON810 according to Article 23 of Directive 2001/18/EC. The EFSA Journal (2008) 756, 1- 18.
[XIII]: EU Environment Ministers Keep Bans on Transgenic Maize, http://ens-newswire.com/2010/01/12/ eu-environment-ministers-keep-bans-on-transgenic-maize/ (23 September 2012)
[XIV]: FVM határozat genetikailag módosított burgonyából előállított takarmány forgalomba hozatalának tilalmáról, http://www.mebih.gov.hu/attachments/559_Takarmany.pdf (23 September 2012)
[XV]: Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (Official Journal L 213, 30/07/1998 P. 0013 – 0021)
[XVI]: LYNCH – VOGEL (2001)
[XVII]: LYNCH – VOGEL (2001)
[XVIII]: Article 11 paragraph 2. (a), International Covenant on Economic, Social and Cultural Rights, Adopted and opened for signature, ratification and accession by General Assembly resolution 2200A (XXI) of 16 December 1966 (hereinafter: ICESCR)
[XIX]: ICESCR, Article 15 paragraph 3.