Available online at www.sciencedirect.com
ScienceDirect Public funded field trials with transgenic plants in Europe: a comparison between Germany and Switzerland Henrik Nausch1, Christof Sautter2,4, Inge Broer1 and Kerstin Schmidt3 Field trails are indispensable for the scientific analysis of risks and potential benefits of genetically modified plants (GMP). The dramatic reduction of field trials in the European Union (EU) coincides with increasing safety demands, decreases in funding, and changes in the European directives. In parallel, opposition from non-governmental organizations (NGOs) has grown, and public acceptance has decreased. The cultivation of events approved by the EU is still allowed in principle, nevertheless, at least in Germany, there is a de facto moratorium on cultivation. In Switzerland, where development was much more hesitant compared to Germany, field trials are now possible, and a protected site has been established by the government. Public acceptance for scientific trials in Switzerland has risen, despite the continued moratorium on the cultivation based on a referendum. Addresses 1 Agrobiotechnology, University of Rostock, Justus-von-Liebig-Weg 8, 18059 Rostock, Germany 2 Plant Sciences, ETH Zurich, Chrischonaweg 2, 8197 Rafz, Switzerland 3 BioMath GmbH, Schnickmannstraße 4, 18055 Rostock, Germany 4 Retired. Corresponding author: Sautter, Christof ([email protected])
Current Opinion in Biotechnology 2015, 32:171–178 This review comes from a themed issue on Plant biotechnology Edited by Inge Broer and George N Skaracis For a complete overview see the Issue and the Editorial Available online 19th January 2015 http://dx.doi.org/10.1016/j.copbio.2014.12.023 0958-1669/# 2015. Elsevier Ltd. All right reserved.
In 2014 only 12 field trials have been conducted in 5 EU partner countries [2], whereas it was once a driving force in GMP research with more than 250 trials in 13 countries in 1997. France had already conducted the first GMP trial in 1986 — the same year as the USA; however, while the number of trials in the EU was always below 300 (Figure 1), in the USA up to 1200 trials per year were conducted [2,3]. A potent and well-organized public opposition campaign on the part of a minority of citizens managed to stimulate legislation for an increasing regulatory burden on field trials [4]. Although European directives provide basic guidelines, the approval or rejection of the release of transgenic events and the conditions for field trials are delegated to national authorities, resulting in very divergent conditions [5]. The regulation in nonEU member states like Switzerland, however, is independent, and to illustrate this, we compare Germany and Switzerland. Germany conducted the first trial in 1989 (Figure 1), and the first projects on risk assessment were funded in 1990 [6]. Switzerland started a comprehensive national funding program in 2005 [7]. Currently, Germany has not approved any release request since 2012, whereas Switzerland installed a ‘protected site’ where field trails can be conducted, and the first trial began in 2014 [8,9].
Germany Historical development
Up to 2009, the German federal government stated in the coalition agreements that they aimed for a reasonable development of Green Gene Technology as important highly innovative technology [10–13]. However, in 2013, Green Gene Technology was not even mentioned in the coalition program [14]. This dramatic change coincides with the increasing success of NGOs and some small activist groups.
Introduction In October 2014, several prominent European scientists published an open letter to decision makers in Europe demanding that plant scientists must be able to perform field experiments with GMPs. Indeed, in most European countries field trials with GMP are completely blocked either by legislation or by systematic destruction of trials. The authors claim that ‘the de facto moratorium on transgenic plant approvals has been detrimental for applied plant science and has effectively eliminated possibilities for publicly funded research’ [1]. www.sciencedirect.com
In the early nineties, NGOs in Germany, particularly Friends of the Earth Germany (BUND) and Greenpeace-Germany, established working groups that cooperated with local farmers’ associations and citizens’ initiatives in the regions where field trials were performed [15,16]. In addition to these subgroups of NGOs, citizens founded their own independent associations, dealing exclusively with GMPs and GMP-derived products, with the Gen-ethische Netzwerk e.V. as first one in 1986 [17]. Joint petitions against field trials were signed by several of Current Opinion in Biotechnology 2015, 32:171–178
172 Plant biotechnology
Figure 1
300
250
200
Switzerland 150
EU Germany
100
50
0 1986 1989 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Current Opinion in Biotechnology
Deliberate releases in Europe, Germany and Switzerland.
these organizations, although they did not officially cooperate with one another [18,19]. Although in the beginning opposition focused mainly on safety issues, which were, as much as possible, addressed by scientific risk assessments, the denial was more and more based on defaming scientists, politicians, and competent authorities. This was initiated by two brochures published by a small activist group accusing scientists of corruption and cronyism (e.g. [20–23]). Although the big NGOs initially dissociated themselves, they increasingly began to adopt this strategy. For example in 2012 the Green Party [24] questioned the neutrality of the governmentally funded homepages (German: www.biosicherheit.de/, English www.gmo-safety.eu) as well as the head of the program GRACE (GMO Risk Assessment and Communication of Evidence) in the German parliament. In this climate, the German Law on Genetic Engineering was revised in major points to parallel changes in the Current Opinion in Biotechnology 2015, 32:171–178
Directives of the European Commission (EC Directives), leading to increasingly stringent requirements (Table 1). In 2004 two new aspects were introduced: (a) liability without any fault or guilt and (b) a collective responsibility if the direct cause cannot be identified. Since 2005 a public registry precisely records all sites used for the field testing of transgenic plants (see Table 1). This has led to serious impediments of field trials and increasing field destructions (Figure 2) since fields are now easily identifiable. Even if destroyers were captured, the highest penalty was a 6-month imprisonment for the leading protagonist [25]. In addition, governmental funding changed. From 1987 to 2011 the Federal Ministry of Education and Research (BMBF) supported the program ‘Biological Safety Research’. Projects that dealt with GMP and the communication of the obtained scientific data [26] were funded with nearly 55.8 mn s [6]. After a funding www.sciencedirect.com
Field trials in Germany and Switzerland Nausch et al. 173
Table 1 Regulation of Genetic Engineering, focusing on field trials Germany The German Gene Technology Act is a national law based on EU directives 90/220/EC (replaced by 2001/18/EG), 2003/701/EC & 2004/ 35/EC. It has been in force since 1990.
Several governmental agencies are involved in the approval procedure: Federal Office of Consumer Protection and Food Safety (BVL) — leading house, Federal Agency for Nature Conservation (BfN), Robert Koch Institute (RKI), Federal Institute for Risk Assessment (BfR), Julius Ku¨hn Institute (JKI), the federal state(s) where the release experiment is planned, and the Central Committee on Biological Safety (ZKBS).
Switzerland The Swiss regulation initially relied on the European standards before passage of a national law (similar to Germany, see left). The national ‘Gene Law’ was only passed in 2004 and is more restrictive than the German law with respect to the use of antibiotic resistance genes. The following parties are involved in the approval procedure: Federal Office for the Environment (FOEN) — leading house, Federal Office of Public Health (FOPH), Federal Office for Agriculture (FOAG), Federal Food Safety and Veterinary Office (FSVO), Swiss Expert Committee for Biosafety (SECB), Federal Ethics Committee on Non-Human Biotechnology (ECNH), and a committee of the canton at the site of the release experiment. NGOs are not involved in this process.
Citizens and NGOs may express their objections. General terms: - Application must include information about type of genetic modification & the location of the field trial (no. of residents, details of flora & fauna, nature sanctuaries) - List of participating persons - Labeling of the field - Separation of the field by a wire mesh fence for protection against animals - Weekly compliance checks - Further separation & inspection of the trial area for at least two years - Annual reports to authorities - Immediate reports of any (un)intended change in the trial 1993: simplification of the approval procedure by abolishing the hearings 1991 and 1992: first approval of field tests directly by the for citizens and NGOs government without a release ordinance. 1996: commitment to detailed records of field trials and to notification of 1999 first Swiss release ordinance for GM organisms. EU institutions (the Commission, among others.) 2005: implementation of new directive 2001/18/EC: 1999 referendum ‘Genschutz Initiative’ failed, thus allowing research. - Liability provision for unintended contaminations 1999 release ordinance granted - German GMO Location register: mandatory public notification of field 2003 revision of the release ordinance trials - Expansion of the application content 2004 Gen Lex passed the parliament - Determination of the response time 2005 referendum for a moratorium on commercial release of GMP, prolonged until 2013, further prolongation beyond 2017 under discussion. 2008: Ordinance on Good Practice in the Production of GM Plants (GenTPflEV) - Co-existence of transgenic and conventional crops (determination of the minimum distance) - Revision of the public notification registry 2010: implementation of novel demands for nature protection 2013: only formal changes without changes in the content 2012 establishment of a protected site for GMP field tests at a federal research station. 2014 first GM wheat trials at the protected site 2014 discussion of GM potato trials for 2015
break, the BMBF invited proposals comparing conventional, organic, and GMP farming in 2013; however, no project involving GMP was funded. In Groß Lu¨sewitz (Mecklenburg-Western Pomerania) the establishment of a research centre for innovative sustainable agriculture was funded by the local government with support from the federal government and the EU [27], and between its opening in 2004 and 2011, a total of 7.1 mn s were invested in GMP risk assessment projects, and about 50 field trials were conducted. From 2008 on trials were repeatedly destroyed, including two trails with transgenic KP4-wheat [28] that had already been released in www.sciencedirect.com
Switzerland in 2004. The only exception was 2010 when the field was massively protected [25] (Figure 2). Under this pressure, companies like Bayer, BASF, and Monsanto have stopped all projects on GMP in Germany. Public discussion and communication
Several attempts have been made to inform the public and support a scientific debate. The results of the BMBFfunded projects, which — despite extraordinary efforts — could not identify any hazardous effects of transgenic plants on human health, animals, or the environment, were published on an Internet platform (www.biosicherheit.de/, Current Opinion in Biotechnology 2015, 32:171–178
174 Plant biotechnology
Figure 2
35
30
25
20 Switzerland Germany 15
10
5
0 1986 1989 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Current Opinion in Biotechnology
Field occupations and destructions in Germany and Switzerland.
www.gmo-safety.eu). Additionally, public seminars, involving all stakeholders were organized [29]. This attempt to spark a dialogue between proponents and opponents was also attempted in a technology assessment on herbicide resistant plants in 1990, where 50 representatives from industry, NGOs, competent authorities, and science joined the debate for three years [30]. Despite 10 days of intense and controversial debate and the analysis of nearly 20 independent expert reports, none of the NGOs signed the final statement that herbicide-resistant GMPs neither pose a significant risk nor benefit [31]. In 2009/2010 the BMBF tried to initiate a dialogue by hosting round table discussions on GMP [32]. Although none of the safety concerns raised by the NGOs were left unaddressed, an agreement was still not possible. In 2010 the German research funding organization (DFG) published a brochure describing the possibilities provided by the technology. Unfortunately, this sparked a scientific debate regarding some of the statements in the brochure [33,34]. In another instance, the DFG quickly reacted to refute the data achieved in a rat study on potential risks of transgenic maize in feed [35]. The study was withdrawn from the journal as a consequence [36], but it reduced the Current Opinion in Biotechnology 2015, 32:171–178
trust in science and supported the negative image of GMP [37,38]. In 2014, the BMBF published the brochure ‘25 Years of Biological Safety Research on Genetically Modified Plants’ [6]. In its conclusions, it is stated that (1) GMPs have the potential to support sustainable agriculture, (2) up to now no risks could be identified that are specifically associated with GMPs, (3) independent and unbiased research to investigate and assess the concerns of the people are necessary, and (4) there is a need to expand the knowledge about GMOs for an adequate ‘evidencebased’ assessment and management of GMPs. The brochure also stated however that public perception is hardly affected by scientific arguments and that new ways of communication and discussion between the scientific community, policy makers, and society need to be found. They conclude that future research programs should not focus only on environmental risk assessment but should also involve the analysis of socio-economic impact. In 2014 neither field trails nor commercial plantings have been conducted in Germany. This seems to be a great success for the NGOs, nevertheless, farmers, especially those in the eastern part of Germany where coexistence www.sciencedirect.com
Field trials in Germany and Switzerland Nausch et al. 175
Table 2 Field trial of the KP4-wheat Germany 2008–2010 & 2011–2013 (reference nos.: 6786-01-0195 & 6786-01-0209) Governmental permission procedure
Specific regulatory stipulations
Switzerland 1999–2004
USA
- As described in Table 1, sole responsibility of the BVL
Officially within 90 days, but the whole process took 4 years
2008: first application, 80 days (64 in BVL, 14 in Ministry) 2011: second application, 96 days (75 in BVL, 21 in Ministry)
1999: 1st application not accepted
Site at a USDA Federal Research Station with a general permission for field testing of wheat Short form (3 pages)
2008–2010 (first period): Mandatory bird net and fence 3 m conventional wheat barrier and a minimum 50m separation from other commercial wheat fields 2011–2013 (second period): For commercially grown wheat outside the zone, checks for outcrossing events for 150 m
Number of objections
Presence in the media & protests
1st period: 3 by residents and local farmers 2nd period: 7 by residents & local farmers, 1 class-action lawsuit by NGOs [62] Several reports in the newspapers, on-site protests, field destructions [63] Complaint against the project leader to the police Open letter from NGOs against the field trial including accusations against the project leader [19,62]
November 2000: 2nd application February 2001: additional requests Oct. 2001: rejection and appeal by ETH 2002: approval of appeal in all points followed by permission 2003: an appeal by neighbors and Greenpeace (GP) was affirmed by Supreme Court citing an legal gap in the release ordinance. 2004: final permission and experiment. Mandatory location disclosure, inventory of other crop plants within 500 m, and roster of all participants 2 m fence, bird net, snail barrier, pollen-sealing tents, and 24-hour observation Conventional wheat or barley barrier with a minimum 200 m separation from other wheat fields
Decision after 6 weeks
Beyond the general wheat permission: 30 m separation from other wheat fields
Regular reports to authorities and visits by experts After the experiment: Burn above ground plant material, autoclave top 10 cm of soil PCR for fragments of trans-genes until 12 months Due to fragments of ampicillin-resistance genes, no field trials with KP4-wheat after 2004 2003: 1 objection by neighbors supported by GP
Regular newspaper and television reports from 2001 to 2005. In 2002 and 2003 this issue was the main focus of the majority of news reports concerning the ETH March 2003: GP destroyed the field site before start of the test March 2004: 40 GP activists occupied the field site for 1 day. June 2004: demonstration by organic farmers
with GMPs is possible due to the size of the individual farms [39], and scientists working on new GMP strategies for sustainable agriculture are the losers in this game. This also holds true for those companies like KWS AG and BASF who had to stop all trials despite high financial and human investments.
Switzerland
legislative process. This may be a handicap with respect to rapid developments like gene technology but also has the advantage of forcing voters to deal with complicated topics and leads to broadly accepted decisions. The first small-scale research field tests in Switzerland were directly permitted by the Federal Government in the early nineties without a valid law [9,40].
Historical development and funding
Switzerland is a small country in the geographical centre of Europe but not a member of the EU. Its democratic system involves public referenda and therefore has a slow www.sciencedirect.com
In 1994 a National Research Program ‘Biotechnology’ was launched by the Swiss National Science Foundation (SNF) containing a section entitled ‘Plant Biotechnology’. The Current Opinion in Biotechnology 2015, 32:171–178
176 Plant biotechnology
program also funded a library about biotechnology (B.I.C.S.) [41] and resulted in a field test in 2004 (Figure 1), which was a historical and political landmark for legislation and public communication in Switzerland. Due to its importance, all the folders and files have been taken over by the Swiss Federal Institute of Technology Zurich (ETH Zurich) archive. Two other applications for GMP field trials were not permitted until 2005, one by a university and one by a company [28]. Before 2005 no other National Research Program dealt with GMP. Public discussion and legislation
GMP-opposing NGOs formulated the ‘Basler Appell’ in 1988 [42] and founded the ‘Schweizerische Arbeitsgruppe fu¨r Gentechnologie’ (SAG, [43]) in 1990. Particularly the Swiss Small Farmers Union and organic farmers collaborated in some cases with these opposing NGOs. In 1992 these groups collected votes for a public referendum. This so called ‘Genschutzinitiative’ (Gene Protection Initiative) was very restrictive [44] and would have made research practically impossible. After a unique, and impressive public demonstration by scientists in the streets of Zurich, this initiative was rejected in 1998 by 66% of the voting population [45]. All of the discussions about the topic and surrounding the initiative was publicly reported by the media and can be found in a detailed study included in the NFP59 [46]. The GMP field trial with KP4-wheat [28] (Table 2) in 1999 was applied for per the first release ordinance in Switzerland, adapted largely from the European release ordinance (90/220/EWG, [47]) and took effect August 1999 (Table 1); however, a law specifically regulating gene technology did not yet exist. This field test application was accompanied by much public attention over several years. The rejection of this application by the authorities was followed by an appeal by ETH Zurich. After the success of this appeal and a judicial odyssey to the Swiss Supreme Court, this experiment became a political issue, which was widely reported in all newspapers and television [48]. ETH Zurich started mediation with members of opposing organizations in a confidential round table with members of anti-gene-technology NGOs — only Greenpeace did not join [49,50]. At the end of the discussion, none of the GMP opponent groups signed the protocol. Meanwhile, the so-called Gen Lex, regulating, among other things, the deliberate release of GM organisms, passed the parliament in 2004 [51,52,53–55]. By contrast to European regulations, the Gen Lex did not allow for antibiotic resistance genes (ARG) in deliberately released GMP, regardless of the importance and distribution of the antibiotic or the ARG (Gen Lex, Art. 6, §2c; see: [53]). The new ‘Gentech Moratorium’ initiative begun by the SAG sought to prevent the release of GM plants for Current Opinion in Biotechnology 2015, 32:171–178
agricultural use for 5 years. It excluded research, which should still be possible under strong conditions [56]. This initiative was accepted in a referendum in November 2005, and in 2012 the moratorium was prolonged by the government until 2017, and some members of parliament want a further extension beyond 2017 [57]. Only after the acceptance of the Gentechnik Moratorium [56] was a second National Research Program (NFP59, ‘Benefit and Risks of Genetically Modified Plants’) launched, also including risk assessment studies for the first time [7]. The NFP59 conceptually included projects of gene-technology-skeptical scientists and institutions, legal studies, sociological studies, and literature collections. After 3 years of field testing (2008–2011) the program was terminated in 2012, and a summary of the results was published by the leading house of the NFP ([7] page 301). With regard to the high costs for the nonscientific expenses ([51]), the NFP59 leading house proposed to create a protected site for GMP field tests in order to maintain Swiss plant research for knowledge acquisition and competence for monitoring. This protected 3 ha site was established on the Federal Research Station for Agronomy in Reckenholz ‘Agroscope’ [58]. The site is surrounded by a double fence, is supervised by a guard, and includes an alarm system. Agroscope is in charge of the technical safety and the agronomic performance as well as the technical and scientific coordination of the experiments in close partnership with the scientists of the projects. The financial expenses of 750,000 Swiss francs per year are part of the mandate of Agroscope until 2017 [8]. The first experiment was applied for in January 2013, permitted in August 2013, and included repeated field tests with GM wheat between 2014 and 2018 for fungal resistance against mildew. The first tests were performed in 2014 [8]. Permission was given in a reasonable amount of time after application, and the risks have been judged much more realistically, which is remarkable progress compared to 2003. Recent media information from Agroscope states that an application has been submitted for an anticipated field test with GMP potato resistant against Phytophthora infestans in collaboration with scientists from Wageningen (NL) [8,59]. In conclusion, the current situation in Switzerland allows for research field tests but does not permit commercial release of GMP crops. This seems to please more or less all stakeholders: (1) Industry does not invest in GMP in this small country, where the largest crop area is wheat with less than 100,000 ha, of which only a part could be GMP. Thus, the investment could not be amortized. (2) Scientists are satisfied, because they can experiment under reasonable conditions, and (3) NGOs are pleased, since they can lodge complaints www.sciencedirect.com
Field trials in Germany and Switzerland Nausch et al. 177
whenever a new experiment is applied for, and (4) the consumers and farmers are happy, because the moratorium prohibits agricultural use of GMP, and the public is weary of dealing with the issue in the media [46].
4.
Go´mez-Galera S, Twyman RM, Sparrow PAC, Van Droogenbroeck B, Custers R, Capell T, Christou P: Field trials and tribulations — making sense of the regulations for experimental field trials of transgenic crops in Europe. Plant Biotechnol J 2012, 10:511-523.
5.
The_Greens_European_Free_Alliance_in_the_European_Parliament. GMO authorisation ‘No must mean no’, as MEPs vote to strengthen GMO opt-outs for member states and regions (DOI: http://www.greens-efa.eu/gmo-authorisation-13076.html). Press Release; 2014.
Conclusion and outlook What are the reasons for the divergent development in Germany and Switzerland? The main difference in the specific policies seems to be the direct involvement of the public in Switzerland, the very open funding policy that includes all aspects, and even topics like how to measure risk [60]. This strategy provides the basis for an open discussion and for the recognition of scientific facts. As stated in the BMBF brochure, the enormous amount of scientific data collected in Germany did not lead to a change in the public opinion [61]. It is very obvious that the intensive risk assessment funded by the government and the in some cases excellent public relations did not assuage the public worries. Interestingly, the effect of unscientific attempts to undermine the trust in scientists was much more effective than scientific arguments against GMP, and vague risk scenarios and accusations laid a solid groundwork for a broad denial of the technology. Based on this history, the use of GMP in Germany will, in our opinion, only be possible after the development of a plant that provides significant and publicly visible advantages for the consumer. Currently, funding agencies seem to be hesitant to fund even research on the development of innovative plants, but change can only come with precisely these innovations, and we should not forget that it takes up to 20 years from the first experiment to application. The BMBF points to European programs that are still funding transgenic plants like Era Net, however, to compete with the rest of the world, Germany has to set up its own programs including field trials.
Acknowledgements We thank Kerstin Mo¨nch, Gerd Spelsberg, Christiane Saeglitz, and Gregor Leggewie for their support. Gerd Spelsberg and Alex Rajewski are acknowledged for critically reading the manuscript.
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44. Homepage: http://www.admin.ch/ch/d/pore/vi/vis240t.html. 45. Schweizerische_Eidgenossenschaft. Swiss Confederation Bureau 1998 result of the referendum ,Genschutzinitiative’ DOI: http://www.admin.ch/ch/d/pore/va/19980607/index.html. 46. Bonfadelli H: Landwirtschaft mit transgenen Pflanzen – wer will sie, wer nicht? Und warum?. — Die gru¨ne Gentechnologie in der O¨ffentlichkeit. Nutzen und Risiken der Freisetzung gentechnisch vera¨nderter Pflanzen — Nationales Forschungsprogramm NFP 59; 2013. This study reviews the public debate about GMP in Switzerland between 1999 and 2012, concluding that currently the stakeholders are tired to continue the discussion. 47. Kohler S: Freisetzung von gentechnisch vera¨nderten Organismen in der Schweiz. University St. Gallen; 2004:. Thesis No 2939:247. 48. ETHZ: www.Feldversuch.ethz.ch. 49. Kaufmann A, Aude´tat M, Petriccione BB, Joseph C, November A, Perret H: The Future of Plant Biotechnology in Switzerland — forum with researches, experts and public actors. RiBios and IUED 2005:62. 50. Welti M: Gentechnik — Forscher und Umweltorganisationen im Dialog. Science et Cite´ 2007:26. 51. Bernauer T, Gilardi F: Publication output of swiss political science departments. Swiss Political Sci Rev 2010, 16:279-303. 52. Bernauer T, Tribaldos T, Luginbu¨hl C, Winzeler M: Government regulation and public opposition create high additional costs for field trials with GM crops in Switzerland. Transgenic Res 2011, 20:1227-1234. the paper shows that the financial efforts necessary according to the regulation and to protect field sites against vandals in Switzerland are about twice the expenses for research of the project. 53. Schweizerische_Eidgenossenschaft: 814.91 — Bundesgesetz u¨ber die Gentechnik im Ausserhumanbereich (Gentechnikgesetz, GTG) (DOI: http://www.admin.ch/opc/de/ classified-compilation/19996136/index.html). 2004. 54. Die_Bundesversammlung_-_Das_Schweizer_Parlament: http:// www.parlament.ch/d/suche/Seiten/geschaefte. aspx?gesch_id=19963363. 55. Schweizer RJ, Errass C, Kohler S: Koexistenz der Produktion mit und ohne gentechnisch vera¨nderte Organismen in der Landwirtschaft. Rechtsvergleich sowie Grundlagen und Vorschla¨ge fu¨r die Regulierung in der Schweiz 2012:320. 56. Homepage: http://www.gentechfrei.ch/text.htm. 57. Die_Bundesversammlung_-_das_schweizer_Parlament: Prologation of the moratorium beyond 2017; 2013, request in parliament (http://www.parlament.ch/d/suche/seiten/ geschaefte.aspx?gesch_id=20133649). 58. Agroscope-Homepage: http://www.agroscope.admin.ch/ biosicherheit/06948/index.html?lang=en. 59. Agroscope-Homepage: http://www.agroscope.ch/aktuell/00198/ 05299/05494/index.html?lang=de&msg-id=55144. 60. Ammann D: How to measure risk — basic principles for protection targets in handling GM plants. Nutzen und Risiken der Freisetzung gentechnisch vera¨nderter Pflanzen — Nationales Forschungsprogramm NFP 59; 2013. 61. Erber-Schropp MSJM: Chancen und Risiken der modernen Biotechnologie. Springer-Spektrum; 2014. 62. Feddersen D: Risk perception in agricultural genetic engineering: an analysis about the differences and similarities of risk perception of laymen and experts in the case of selected field trial applications of the University of Rostock. Master Thesis — Leuphana Universita¨t Lu¨neburg; 2012. 63. Bundesverband_deutscher_Pflanzenzu¨chter_E.V.: Feldzersto¨rungen gefa¨hrden den Wirtschafts- und Forschungsstandort Deutschland. 2011.
www.sciencedirect.com
ScienceDirect Public funded field trials with transgenic plants in Europe: a comparison between Germany and Switzerland Henrik Nausch1, Christof Sautter2,4, Inge Broer1 and Kerstin Schmidt3 Field trails are indispensable for the scientific analysis of risks and potential benefits of genetically modified plants (GMP). The dramatic reduction of field trials in the European Union (EU) coincides with increasing safety demands, decreases in funding, and changes in the European directives. In parallel, opposition from non-governmental organizations (NGOs) has grown, and public acceptance has decreased. The cultivation of events approved by the EU is still allowed in principle, nevertheless, at least in Germany, there is a de facto moratorium on cultivation. In Switzerland, where development was much more hesitant compared to Germany, field trials are now possible, and a protected site has been established by the government. Public acceptance for scientific trials in Switzerland has risen, despite the continued moratorium on the cultivation based on a referendum. Addresses 1 Agrobiotechnology, University of Rostock, Justus-von-Liebig-Weg 8, 18059 Rostock, Germany 2 Plant Sciences, ETH Zurich, Chrischonaweg 2, 8197 Rafz, Switzerland 3 BioMath GmbH, Schnickmannstraße 4, 18055 Rostock, Germany 4 Retired. Corresponding author: Sautter, Christof ([email protected])
Current Opinion in Biotechnology 2015, 32:171–178 This review comes from a themed issue on Plant biotechnology Edited by Inge Broer and George N Skaracis For a complete overview see the Issue and the Editorial Available online 19th January 2015 http://dx.doi.org/10.1016/j.copbio.2014.12.023 0958-1669/# 2015. Elsevier Ltd. All right reserved.
In 2014 only 12 field trials have been conducted in 5 EU partner countries [2], whereas it was once a driving force in GMP research with more than 250 trials in 13 countries in 1997. France had already conducted the first GMP trial in 1986 — the same year as the USA; however, while the number of trials in the EU was always below 300 (Figure 1), in the USA up to 1200 trials per year were conducted [2,3]. A potent and well-organized public opposition campaign on the part of a minority of citizens managed to stimulate legislation for an increasing regulatory burden on field trials [4]. Although European directives provide basic guidelines, the approval or rejection of the release of transgenic events and the conditions for field trials are delegated to national authorities, resulting in very divergent conditions [5]. The regulation in nonEU member states like Switzerland, however, is independent, and to illustrate this, we compare Germany and Switzerland. Germany conducted the first trial in 1989 (Figure 1), and the first projects on risk assessment were funded in 1990 [6]. Switzerland started a comprehensive national funding program in 2005 [7]. Currently, Germany has not approved any release request since 2012, whereas Switzerland installed a ‘protected site’ where field trails can be conducted, and the first trial began in 2014 [8,9].
Germany Historical development
Up to 2009, the German federal government stated in the coalition agreements that they aimed for a reasonable development of Green Gene Technology as important highly innovative technology [10–13]. However, in 2013, Green Gene Technology was not even mentioned in the coalition program [14]. This dramatic change coincides with the increasing success of NGOs and some small activist groups.
Introduction In October 2014, several prominent European scientists published an open letter to decision makers in Europe demanding that plant scientists must be able to perform field experiments with GMPs. Indeed, in most European countries field trials with GMP are completely blocked either by legislation or by systematic destruction of trials. The authors claim that ‘the de facto moratorium on transgenic plant approvals has been detrimental for applied plant science and has effectively eliminated possibilities for publicly funded research’ [1]. www.sciencedirect.com
In the early nineties, NGOs in Germany, particularly Friends of the Earth Germany (BUND) and Greenpeace-Germany, established working groups that cooperated with local farmers’ associations and citizens’ initiatives in the regions where field trials were performed [15,16]. In addition to these subgroups of NGOs, citizens founded their own independent associations, dealing exclusively with GMPs and GMP-derived products, with the Gen-ethische Netzwerk e.V. as first one in 1986 [17]. Joint petitions against field trials were signed by several of Current Opinion in Biotechnology 2015, 32:171–178
172 Plant biotechnology
Figure 1
300
250
200
Switzerland 150
EU Germany
100
50
0 1986 1989 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Current Opinion in Biotechnology
Deliberate releases in Europe, Germany and Switzerland.
these organizations, although they did not officially cooperate with one another [18,19]. Although in the beginning opposition focused mainly on safety issues, which were, as much as possible, addressed by scientific risk assessments, the denial was more and more based on defaming scientists, politicians, and competent authorities. This was initiated by two brochures published by a small activist group accusing scientists of corruption and cronyism (e.g. [20–23]). Although the big NGOs initially dissociated themselves, they increasingly began to adopt this strategy. For example in 2012 the Green Party [24] questioned the neutrality of the governmentally funded homepages (German: www.biosicherheit.de/, English www.gmo-safety.eu) as well as the head of the program GRACE (GMO Risk Assessment and Communication of Evidence) in the German parliament. In this climate, the German Law on Genetic Engineering was revised in major points to parallel changes in the Current Opinion in Biotechnology 2015, 32:171–178
Directives of the European Commission (EC Directives), leading to increasingly stringent requirements (Table 1). In 2004 two new aspects were introduced: (a) liability without any fault or guilt and (b) a collective responsibility if the direct cause cannot be identified. Since 2005 a public registry precisely records all sites used for the field testing of transgenic plants (see Table 1). This has led to serious impediments of field trials and increasing field destructions (Figure 2) since fields are now easily identifiable. Even if destroyers were captured, the highest penalty was a 6-month imprisonment for the leading protagonist [25]. In addition, governmental funding changed. From 1987 to 2011 the Federal Ministry of Education and Research (BMBF) supported the program ‘Biological Safety Research’. Projects that dealt with GMP and the communication of the obtained scientific data [26] were funded with nearly 55.8 mn s [6]. After a funding www.sciencedirect.com
Field trials in Germany and Switzerland Nausch et al. 173
Table 1 Regulation of Genetic Engineering, focusing on field trials Germany The German Gene Technology Act is a national law based on EU directives 90/220/EC (replaced by 2001/18/EG), 2003/701/EC & 2004/ 35/EC. It has been in force since 1990.
Several governmental agencies are involved in the approval procedure: Federal Office of Consumer Protection and Food Safety (BVL) — leading house, Federal Agency for Nature Conservation (BfN), Robert Koch Institute (RKI), Federal Institute for Risk Assessment (BfR), Julius Ku¨hn Institute (JKI), the federal state(s) where the release experiment is planned, and the Central Committee on Biological Safety (ZKBS).
Switzerland The Swiss regulation initially relied on the European standards before passage of a national law (similar to Germany, see left). The national ‘Gene Law’ was only passed in 2004 and is more restrictive than the German law with respect to the use of antibiotic resistance genes. The following parties are involved in the approval procedure: Federal Office for the Environment (FOEN) — leading house, Federal Office of Public Health (FOPH), Federal Office for Agriculture (FOAG), Federal Food Safety and Veterinary Office (FSVO), Swiss Expert Committee for Biosafety (SECB), Federal Ethics Committee on Non-Human Biotechnology (ECNH), and a committee of the canton at the site of the release experiment. NGOs are not involved in this process.
Citizens and NGOs may express their objections. General terms: - Application must include information about type of genetic modification & the location of the field trial (no. of residents, details of flora & fauna, nature sanctuaries) - List of participating persons - Labeling of the field - Separation of the field by a wire mesh fence for protection against animals - Weekly compliance checks - Further separation & inspection of the trial area for at least two years - Annual reports to authorities - Immediate reports of any (un)intended change in the trial 1993: simplification of the approval procedure by abolishing the hearings 1991 and 1992: first approval of field tests directly by the for citizens and NGOs government without a release ordinance. 1996: commitment to detailed records of field trials and to notification of 1999 first Swiss release ordinance for GM organisms. EU institutions (the Commission, among others.) 2005: implementation of new directive 2001/18/EC: 1999 referendum ‘Genschutz Initiative’ failed, thus allowing research. - Liability provision for unintended contaminations 1999 release ordinance granted - German GMO Location register: mandatory public notification of field 2003 revision of the release ordinance trials - Expansion of the application content 2004 Gen Lex passed the parliament - Determination of the response time 2005 referendum for a moratorium on commercial release of GMP, prolonged until 2013, further prolongation beyond 2017 under discussion. 2008: Ordinance on Good Practice in the Production of GM Plants (GenTPflEV) - Co-existence of transgenic and conventional crops (determination of the minimum distance) - Revision of the public notification registry 2010: implementation of novel demands for nature protection 2013: only formal changes without changes in the content 2012 establishment of a protected site for GMP field tests at a federal research station. 2014 first GM wheat trials at the protected site 2014 discussion of GM potato trials for 2015
break, the BMBF invited proposals comparing conventional, organic, and GMP farming in 2013; however, no project involving GMP was funded. In Groß Lu¨sewitz (Mecklenburg-Western Pomerania) the establishment of a research centre for innovative sustainable agriculture was funded by the local government with support from the federal government and the EU [27], and between its opening in 2004 and 2011, a total of 7.1 mn s were invested in GMP risk assessment projects, and about 50 field trials were conducted. From 2008 on trials were repeatedly destroyed, including two trails with transgenic KP4-wheat [28] that had already been released in www.sciencedirect.com
Switzerland in 2004. The only exception was 2010 when the field was massively protected [25] (Figure 2). Under this pressure, companies like Bayer, BASF, and Monsanto have stopped all projects on GMP in Germany. Public discussion and communication
Several attempts have been made to inform the public and support a scientific debate. The results of the BMBFfunded projects, which — despite extraordinary efforts — could not identify any hazardous effects of transgenic plants on human health, animals, or the environment, were published on an Internet platform (www.biosicherheit.de/, Current Opinion in Biotechnology 2015, 32:171–178
174 Plant biotechnology
Figure 2
35
30
25
20 Switzerland Germany 15
10
5
0 1986 1989 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Current Opinion in Biotechnology
Field occupations and destructions in Germany and Switzerland.
www.gmo-safety.eu). Additionally, public seminars, involving all stakeholders were organized [29]. This attempt to spark a dialogue between proponents and opponents was also attempted in a technology assessment on herbicide resistant plants in 1990, where 50 representatives from industry, NGOs, competent authorities, and science joined the debate for three years [30]. Despite 10 days of intense and controversial debate and the analysis of nearly 20 independent expert reports, none of the NGOs signed the final statement that herbicide-resistant GMPs neither pose a significant risk nor benefit [31]. In 2009/2010 the BMBF tried to initiate a dialogue by hosting round table discussions on GMP [32]. Although none of the safety concerns raised by the NGOs were left unaddressed, an agreement was still not possible. In 2010 the German research funding organization (DFG) published a brochure describing the possibilities provided by the technology. Unfortunately, this sparked a scientific debate regarding some of the statements in the brochure [33,34]. In another instance, the DFG quickly reacted to refute the data achieved in a rat study on potential risks of transgenic maize in feed [35]. The study was withdrawn from the journal as a consequence [36], but it reduced the Current Opinion in Biotechnology 2015, 32:171–178
trust in science and supported the negative image of GMP [37,38]. In 2014, the BMBF published the brochure ‘25 Years of Biological Safety Research on Genetically Modified Plants’ [6]. In its conclusions, it is stated that (1) GMPs have the potential to support sustainable agriculture, (2) up to now no risks could be identified that are specifically associated with GMPs, (3) independent and unbiased research to investigate and assess the concerns of the people are necessary, and (4) there is a need to expand the knowledge about GMOs for an adequate ‘evidencebased’ assessment and management of GMPs. The brochure also stated however that public perception is hardly affected by scientific arguments and that new ways of communication and discussion between the scientific community, policy makers, and society need to be found. They conclude that future research programs should not focus only on environmental risk assessment but should also involve the analysis of socio-economic impact. In 2014 neither field trails nor commercial plantings have been conducted in Germany. This seems to be a great success for the NGOs, nevertheless, farmers, especially those in the eastern part of Germany where coexistence www.sciencedirect.com
Field trials in Germany and Switzerland Nausch et al. 175
Table 2 Field trial of the KP4-wheat Germany 2008–2010 & 2011–2013 (reference nos.: 6786-01-0195 & 6786-01-0209) Governmental permission procedure
Specific regulatory stipulations
Switzerland 1999–2004
USA
- As described in Table 1, sole responsibility of the BVL
Officially within 90 days, but the whole process took 4 years
2008: first application, 80 days (64 in BVL, 14 in Ministry) 2011: second application, 96 days (75 in BVL, 21 in Ministry)
1999: 1st application not accepted
Site at a USDA Federal Research Station with a general permission for field testing of wheat Short form (3 pages)
2008–2010 (first period): Mandatory bird net and fence 3 m conventional wheat barrier and a minimum 50m separation from other commercial wheat fields 2011–2013 (second period): For commercially grown wheat outside the zone, checks for outcrossing events for 150 m
Number of objections
Presence in the media & protests
1st period: 3 by residents and local farmers 2nd period: 7 by residents & local farmers, 1 class-action lawsuit by NGOs [62] Several reports in the newspapers, on-site protests, field destructions [63] Complaint against the project leader to the police Open letter from NGOs against the field trial including accusations against the project leader [19,62]
November 2000: 2nd application February 2001: additional requests Oct. 2001: rejection and appeal by ETH 2002: approval of appeal in all points followed by permission 2003: an appeal by neighbors and Greenpeace (GP) was affirmed by Supreme Court citing an legal gap in the release ordinance. 2004: final permission and experiment. Mandatory location disclosure, inventory of other crop plants within 500 m, and roster of all participants 2 m fence, bird net, snail barrier, pollen-sealing tents, and 24-hour observation Conventional wheat or barley barrier with a minimum 200 m separation from other wheat fields
Decision after 6 weeks
Beyond the general wheat permission: 30 m separation from other wheat fields
Regular reports to authorities and visits by experts After the experiment: Burn above ground plant material, autoclave top 10 cm of soil PCR for fragments of trans-genes until 12 months Due to fragments of ampicillin-resistance genes, no field trials with KP4-wheat after 2004 2003: 1 objection by neighbors supported by GP
Regular newspaper and television reports from 2001 to 2005. In 2002 and 2003 this issue was the main focus of the majority of news reports concerning the ETH March 2003: GP destroyed the field site before start of the test March 2004: 40 GP activists occupied the field site for 1 day. June 2004: demonstration by organic farmers
with GMPs is possible due to the size of the individual farms [39], and scientists working on new GMP strategies for sustainable agriculture are the losers in this game. This also holds true for those companies like KWS AG and BASF who had to stop all trials despite high financial and human investments.
Switzerland
legislative process. This may be a handicap with respect to rapid developments like gene technology but also has the advantage of forcing voters to deal with complicated topics and leads to broadly accepted decisions. The first small-scale research field tests in Switzerland were directly permitted by the Federal Government in the early nineties without a valid law [9,40].
Historical development and funding
Switzerland is a small country in the geographical centre of Europe but not a member of the EU. Its democratic system involves public referenda and therefore has a slow www.sciencedirect.com
In 1994 a National Research Program ‘Biotechnology’ was launched by the Swiss National Science Foundation (SNF) containing a section entitled ‘Plant Biotechnology’. The Current Opinion in Biotechnology 2015, 32:171–178
176 Plant biotechnology
program also funded a library about biotechnology (B.I.C.S.) [41] and resulted in a field test in 2004 (Figure 1), which was a historical and political landmark for legislation and public communication in Switzerland. Due to its importance, all the folders and files have been taken over by the Swiss Federal Institute of Technology Zurich (ETH Zurich) archive. Two other applications for GMP field trials were not permitted until 2005, one by a university and one by a company [28]. Before 2005 no other National Research Program dealt with GMP. Public discussion and legislation
GMP-opposing NGOs formulated the ‘Basler Appell’ in 1988 [42] and founded the ‘Schweizerische Arbeitsgruppe fu¨r Gentechnologie’ (SAG, [43]) in 1990. Particularly the Swiss Small Farmers Union and organic farmers collaborated in some cases with these opposing NGOs. In 1992 these groups collected votes for a public referendum. This so called ‘Genschutzinitiative’ (Gene Protection Initiative) was very restrictive [44] and would have made research practically impossible. After a unique, and impressive public demonstration by scientists in the streets of Zurich, this initiative was rejected in 1998 by 66% of the voting population [45]. All of the discussions about the topic and surrounding the initiative was publicly reported by the media and can be found in a detailed study included in the NFP59 [46]. The GMP field trial with KP4-wheat [28] (Table 2) in 1999 was applied for per the first release ordinance in Switzerland, adapted largely from the European release ordinance (90/220/EWG, [47]) and took effect August 1999 (Table 1); however, a law specifically regulating gene technology did not yet exist. This field test application was accompanied by much public attention over several years. The rejection of this application by the authorities was followed by an appeal by ETH Zurich. After the success of this appeal and a judicial odyssey to the Swiss Supreme Court, this experiment became a political issue, which was widely reported in all newspapers and television [48]. ETH Zurich started mediation with members of opposing organizations in a confidential round table with members of anti-gene-technology NGOs — only Greenpeace did not join [49,50]. At the end of the discussion, none of the GMP opponent groups signed the protocol. Meanwhile, the so-called Gen Lex, regulating, among other things, the deliberate release of GM organisms, passed the parliament in 2004 [51,52,53–55]. By contrast to European regulations, the Gen Lex did not allow for antibiotic resistance genes (ARG) in deliberately released GMP, regardless of the importance and distribution of the antibiotic or the ARG (Gen Lex, Art. 6, §2c; see: [53]). The new ‘Gentech Moratorium’ initiative begun by the SAG sought to prevent the release of GM plants for Current Opinion in Biotechnology 2015, 32:171–178
agricultural use for 5 years. It excluded research, which should still be possible under strong conditions [56]. This initiative was accepted in a referendum in November 2005, and in 2012 the moratorium was prolonged by the government until 2017, and some members of parliament want a further extension beyond 2017 [57]. Only after the acceptance of the Gentechnik Moratorium [56] was a second National Research Program (NFP59, ‘Benefit and Risks of Genetically Modified Plants’) launched, also including risk assessment studies for the first time [7]. The NFP59 conceptually included projects of gene-technology-skeptical scientists and institutions, legal studies, sociological studies, and literature collections. After 3 years of field testing (2008–2011) the program was terminated in 2012, and a summary of the results was published by the leading house of the NFP ([7] page 301). With regard to the high costs for the nonscientific expenses ([51]), the NFP59 leading house proposed to create a protected site for GMP field tests in order to maintain Swiss plant research for knowledge acquisition and competence for monitoring. This protected 3 ha site was established on the Federal Research Station for Agronomy in Reckenholz ‘Agroscope’ [58]. The site is surrounded by a double fence, is supervised by a guard, and includes an alarm system. Agroscope is in charge of the technical safety and the agronomic performance as well as the technical and scientific coordination of the experiments in close partnership with the scientists of the projects. The financial expenses of 750,000 Swiss francs per year are part of the mandate of Agroscope until 2017 [8]. The first experiment was applied for in January 2013, permitted in August 2013, and included repeated field tests with GM wheat between 2014 and 2018 for fungal resistance against mildew. The first tests were performed in 2014 [8]. Permission was given in a reasonable amount of time after application, and the risks have been judged much more realistically, which is remarkable progress compared to 2003. Recent media information from Agroscope states that an application has been submitted for an anticipated field test with GMP potato resistant against Phytophthora infestans in collaboration with scientists from Wageningen (NL) [8,59]. In conclusion, the current situation in Switzerland allows for research field tests but does not permit commercial release of GMP crops. This seems to please more or less all stakeholders: (1) Industry does not invest in GMP in this small country, where the largest crop area is wheat with less than 100,000 ha, of which only a part could be GMP. Thus, the investment could not be amortized. (2) Scientists are satisfied, because they can experiment under reasonable conditions, and (3) NGOs are pleased, since they can lodge complaints www.sciencedirect.com
Field trials in Germany and Switzerland Nausch et al. 177
whenever a new experiment is applied for, and (4) the consumers and farmers are happy, because the moratorium prohibits agricultural use of GMP, and the public is weary of dealing with the issue in the media [46].
4.
Go´mez-Galera S, Twyman RM, Sparrow PAC, Van Droogenbroeck B, Custers R, Capell T, Christou P: Field trials and tribulations — making sense of the regulations for experimental field trials of transgenic crops in Europe. Plant Biotechnol J 2012, 10:511-523.
5.
The_Greens_European_Free_Alliance_in_the_European_Parliament. GMO authorisation ‘No must mean no’, as MEPs vote to strengthen GMO opt-outs for member states and regions (DOI: http://www.greens-efa.eu/gmo-authorisation-13076.html). Press Release; 2014.
Conclusion and outlook What are the reasons for the divergent development in Germany and Switzerland? The main difference in the specific policies seems to be the direct involvement of the public in Switzerland, the very open funding policy that includes all aspects, and even topics like how to measure risk [60]. This strategy provides the basis for an open discussion and for the recognition of scientific facts. As stated in the BMBF brochure, the enormous amount of scientific data collected in Germany did not lead to a change in the public opinion [61]. It is very obvious that the intensive risk assessment funded by the government and the in some cases excellent public relations did not assuage the public worries. Interestingly, the effect of unscientific attempts to undermine the trust in scientists was much more effective than scientific arguments against GMP, and vague risk scenarios and accusations laid a solid groundwork for a broad denial of the technology. Based on this history, the use of GMP in Germany will, in our opinion, only be possible after the development of a plant that provides significant and publicly visible advantages for the consumer. Currently, funding agencies seem to be hesitant to fund even research on the development of innovative plants, but change can only come with precisely these innovations, and we should not forget that it takes up to 20 years from the first experiment to application. The BMBF points to European programs that are still funding transgenic plants like Era Net, however, to compete with the rest of the world, Germany has to set up its own programs including field trials.
Acknowledgements We thank Kerstin Mo¨nch, Gerd Spelsberg, Christiane Saeglitz, and Gregor Leggewie for their support. Gerd Spelsberg and Alex Rajewski are acknowledged for critically reading the manuscript.
References and recommended reading Papers of particular interest, published within the period of review, have been highlighted as: of special interest of outstanding interest 1.
Baldwin IT, Baulcombe DC, Buchmann N, Chase M, Fernie AR, Foyer CH, Friml J, Gershenzon J, Gruissem W, Inze´ D et al.: Open Letter to Decision Maker in Europe. University of Umea; 2014:. DOI: http://www.umu.se/digitalAssets/151/ 151958_open-letter-to-decision-makers-in-europe.pdf. This letter decribes the current situation of scientists that conduct research on GMPs. 2. 3.
6.
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