**4. Surveillance plans**

Post-market release monitoring of GMOs approved both for import and cultivation (European Commission, 2001, 2003c) is one of several requests included in European GMO approval. According to the pre-market risk assessment (RA), this monitoring can be divided into case-specific monitoring (CSM), which covers any identified risk, and general surveillance (GS) for all risks that might not have been identified during the RA. EFSA published a series of documents about RA, CSM, and GS (Bartsch et al., 2006a; EFSA GMO

deployed in Portugal. However, at the same time territory / landscape multi-functionality is requested by the EU, and there is a growing call from consumers, and society as a whole, for both more sustainable production and so called quality-oriented produce as shown by the current yearly increase of ca. 20% of organic and other signs-of-quality based farming (Laisney, 2011). This leads to a conflict as GM produce is not seen as organic, even if it can be produced without, or with less pesticide, although it can definitely be more sustainable with yield increases over conventional farming (Cardwell, 2003; Grossman, 2003; Laurent et al., 2010; Marsden, 2008). Moreover, territory organization, with Natura 2000 areas (protected environmental areas, for example), is not taken into account by the flexible coexistence scheme while their domino impact is highly recognized (Demont et al., 2008). This dichotomy needs to be addressed. Finally, the landscape is highly structured by downstream supply chains (Coléno, 2008; Hannachi et al., 2009; Le Bail et al., 2010; Petit,

Due to the several requests of EU-MS to take into consideration socio-economic aspects into GMO approval, the 2010 updated EC recommendation considers more favorably the possibility of GMO-free areas. However the EC would not accept that requests by EU-MS be based on scientific or environmental grounds which are already assessed by EFSA. This last restriction is currently actively fought at the European Parliament. As a first demonstration of EU policy change, the Portuguese Madeira archipelago was established as the first GMO-

On the opposite side, dissemination over long distance of pollen as well as the practical effect of the contractual threshold of operators militates in favor of dedicated production areas (Brunet et al., 2011; European Commission, 2010b). However, the research work on technical, economic and societal issues raised by this solution are drastically missing and the subject of strong opposition (DEFRA, 2006; Devos, 2008; Dobbs, 2011; European Economic

As soybean is mostly an autogamous plant, numerous issues raised by pollen dissemination should not hamper the soybean cultivation in the EU. Similarly, the absence of out-crossing to wild-relatives, ferals and volunteers should facilitate the cultivation of GM soybean into a coexistence frame. However, the predominant herbicide trait would probably cause the same problems of resistant weeds as observed in the USA (Brasher, 2010; Cerdeira and Duke, 2006, 2007; Roberson, 2010). Transportation of GMO was identified as the cause of several incidental releases in the EU and third countries, including the growth of GM plants

Thus, due to its biological properties and despite the different structure of European farms and territories, the coexistence in the EU of GM and non-GM soybeans should be one of the easiest to implement; as it is in several third countries exporting non-GM soybean despite

Post-market release monitoring of GMOs approved both for import and cultivation (European Commission, 2001, 2003c) is one of several requests included in European GMO approval. According to the pre-market risk assessment (RA), this monitoring can be divided into case-specific monitoring (CSM), which covers any identified risk, and general surveillance (GS) for all risks that might not have been identified during the RA. EFSA published a series of documents about RA, CSM, and GS (Bartsch et al., 2006a; EFSA GMO

free area, though cultivation of maize is relatively scarce in Madeira (Kanter, 2010).

and Social Committee, 2011; Jank et al., 2006; Sabalza et al. 2011).

around harbors (Kawata et al., 2009; Kim et al., 2006; Lee et al., 2009).

important GM soybean cropping.

**4. Surveillance plans** 

2009).

Panel, 2004, 2006a, b, 2010). Several guidance documents and reports on implementation of the monitoring were then published (Bartsch et al., 2006b; Bartsch et al., 2007; EU working group, 2003; European Commission, 2002a, b, c, 2004b, 2008b, 2009a).

Monitoring of the GMOs post-market release should include both health and environmental effects, should be carried out by the GMO consent holders, i.e. the companies having received a grant for a commercial release of a GMO, and may be supported by additional independent actions of EU-MS. The CSM and GS shall cover both GMO and non-GMO cultivated areas (EFSA, 2008; EFSA GMO Panel, 2004, 2006a).

Up to now, most of the surveillance activities of GMOs approved for import and processing have been delegated by the consent holders to European professional unions of importers, transporters, and processors, namely COCERAL, UNISTOCK and FEDIOL. However, the content of agreements between consent holders and such unions remains unknown. Due to the lack of precision, in particular about the methodology used for monitoring imported GMOs, the accuracy of such monitoring plans remains undetermined for the EFSA, GMO national advisory committees, and CA in charge of GMOs (Beissner et al., 2006).

As noted above, health and environmental monitoring, which also means animal health, of predictable and unexpected effects of GMO cultivation is mandatory in the EU on both GMO and non-GMO cropped areas (European Commission, 2001, 2002a, b, 2003c).

## **4.1 Specific surveillance**

In the EU, several GMO CSM protocols have been pursued by notifiers, scientists, and enforcement authorities. A decade after the first GMO cultivation in the EU, a number of guidelines, conceptual frameworks, and reports are available for GMO CSM (Bartsch et al., 2007; Bontemps et al., 2004; Bourguet, 2004; Chaufaux et al., 2002; EU working group, 2003; European Commission, 2009b; Monsanto Co., 2006, 2009a, b). The consent holders8 published results of insect resistance monitoring, but only from GMO cropped areas despite the European rules (Monsanto Co., 2006, 2009a, b).

#### **4.2 General surveillance**

This part of the chapter focuses on the monitoring activities of unexpected effects of GMO cultivation, i.e. general surveillance.

GMO GS frameworks proposed by GMO consent holders in relation to EFSA guidelines include literature survey, development and /or use of existing monitoring surveillance, and specific trials as necessary (EFSA GMO panel, 2006b, 2010).

General surveillance is designed to detect unanticipated effects on general safeguarded subjects such as natural resources, which must not be adversely affected by human activities like GMO cultivation. Monitoring has to be appropriate for detecting direct and indirect effects, immediate and long-term effects, as well as unforeseen effects. In its 2006 opinion, the EFSA GMO panel outlined that: "*general surveillance cannot be hypothesis driven, but should, when possible, make use of existing monitoring systems in addition to more focused monitoring systems (e.g. farm questionnaires). Data quality, management and statistical analysis are of high importance in the design of general surveillance plans and comparison should be made with baseline data*" (EFSA GMO panel, 2006b). A public consultation on the 2010 version of EFSA GMO panel opinion on GS is currently ongoing.

<sup>8</sup> Notifiers having received European approval for GMO import and/or cultivation.

Soybean in the European Union, Status and Perspective 13

 Despite the positive EFSA assessment of the consent holders' monitoring reports, we can observe that, to date, the consent holders do not include non-GMO areas that are in practice delegated to the responsibility of the EU-MS (Alacalde et al., 2007; Lecoq et al., 2007; Monsanto Co., 2006, 2009a, b; Tinland, 2008; Tinland et al., 2007; Wandelt, 2007; Windels et al., 2009). Accordingly, several EU-MS have already, or are planning to, launched GS research projects and networks even in those EU-MS with bans on GMOs (Bartsch et al., 2009; Breckling and Reuter, 2006; de Jong, 2010; Gathmann, 2009; Gathmann and Bartsch, 2006; Pascher et al., 2009). This survey of non-GM cropped areas is however of utmost importance as recently shown in China (Lu et al., 2010). Unfortunately, we can again observe that private interests and benefits are supported by public funding when general goods are concerned, as usual in the "Tragedy of

Most current environmental GS plans focus on changes in *ex ante* baseline and / or biodiversity assessments, sometimes along with a general approach looking at the effect of agricultural practices (Hintermann et al., 2002; Monkemeyer et al., 2006; Sanvido et al., 2007a; Sanvido et al., 2007b, 2009a; Sanvido et al., 2009b; Schmidt et al., 2009). However, the conceptual framework for environmental GS is far from being both a consensus and a reality. This situation motivated the European Commission to launch a call for proposals in 2010 (KBBE.2011.3.5-01) that address environmental GS and possible standardization (ACRE, 2004; Beismann et al., 2007; EFSA GMO panel, 2006b; Finck et al., 2006; Ostergard et al., 2009; Pascher et al., 2009; Sanvido et al., 2005; Schiemann, 2007; Seitz et al., 2010; Wilhelm

The main conclusion that can be drawn from the current situation is that, despite the mandatory involvement of GMO consent holders into GMO GS and the monitoring of non-

However, a number of environmental monitoring procedures are already in place in the EU, several of which partly embrace – episodically or on a longer term - biodiversity, GMO CSM, "epidemio-surveillance", or more general effects of agricultural practices on agroenvironment. In several instances, these monitoring schemes are carried out by citizens in a so-called participatory science. These trends might be correlated with another trend for observing territory from societal and economic viewpoints (Barzman et al., 2005; Bodiguel, 2003; Cardwell and Bodiguel, 2005; Henle et al., 2008). Networks of citizens and/or scientists, as well as enforcement authorities already working on these issues, all have in common (i) a need for long-term studies, (ii) different demands on space and changes over time, (iii) different indicators which (iv) generally have to be reported to national CA and EC, sometimes according to international treaties. But up until now, results appear fragmented, collated in different databases generally without quality assessment or direct connection through a unique Web-based portal or automatic novelty detection capacity

Nonetheless the environmental liability directive and the right of European citizens to have access to environmental information reinforce the need for gathering these fragmented data (Cardwell, 2010; Ebert and Lahnstein, 2008; European Commission, 1985, 2003b, 2004a, c,

In the case that GM soybean cultivation would be allowed in the future, there are thus numerous issues that should be fulfilled by consent holders, particularly for herbicide tolerant crops whose uncontrolled use in third countries leads to numerous herbicide resistant weeds and costly companies' based eradication programs (Adams, 2011; Brasher,

Commons" frame (Hardin, 1968; Hardin, 1998).

et al., 2003; Wilhelm et al., 2009; Wilhelm and Schiemann, 2006).

GMO areas, the main effort appears to be supplied by the EU-MS.

(Haggett, 2008).

2006c, 2007b).

2010; Cerdeira and Duke, 2006, 2007).

The 2010 draft version of EFSA guidelines shows a drastic change of paradigm in the principle of environment GS and still does not establish guidelines for health effects surveillance. This draft version particularly outlines the importance of baselines, use and assessment of indicators after field trials, less oriented biodiversity studies without *a priori*, etc. This difference between 2006 and 2010 version may represent both the change into the EFSA GMO panel composition as well as an attempt of EU-MS, of their enforcement agencies and of the EC to master and retrieve the leadership in a scientific, but also highly political, issue.

For several years now, important scientific conceptual and practical works have indeed been developed in several EU-MS along with reports from national committees in charge of GMO approvals (ACRE, 2004; Breckling and Reuter, 2006; Garcia-Alonso et al., 2006; Graef et al., 2005; Monkemeyer et al., 2006; Wilhelm et al., 2009; Wolt et al., 2010; Zughart et al., 2008).

Most of these scientific works focused on environmental effects, while the effects on human health are roughly "delegated" by the consent holders to national health monitoring networks (Bakshi, 2003; Cellini et al., 2004; Covelli and Hohots, 2003; D'Agnolo, 2005; EFSA GMO panel, 2006b; Filip et al., 2004; Hepburn et al., 2008; Wal et al., 2003). To provide an example of EU-MS, in France, the "Sentinelles" network, ANSES9, and InVS10 might form parts of such a general surveillance plan on human health in application of the WHO and European rules, directives, and regulations. Animal health is relevant to the OIE11 and European rules, directives, and regulations. As for GMO CSM and GS, the French Ministry of Agriculture (DGAl directorate) is in charge of animal health surveillance. However, no GMO-related GS activities in human and animal health are clearly identified in the European activity reports.

Indeed, GS of human and animal health is also particularly important given that GMOs not dedicated to food and feed purposes will rapidly arrive on the market as exemplified by the recent European approval of Amflora® potato for cultivation. For this kind of split approval, we must remember the first such issue raised by the incorrect segregation between food and feed/ industry storage facilities of the USA-approved Starlink™ maize (Alderborn et al., 2010; Beckie et al., 2010; Miller, 2010). Despite the past European experience of segregating crops dedicated to industrial uses as part of a specific derogatory cultivar list, the additional recent request Modena GM potato cultivation approval in the EU can lead us expect that more and more GMO dedicated to industrial use will enter the food chain and raise new controversies about human health.

From a decade of GMO cultivation in the EU, several remarks can be made about environmental GS reported by consent holders, scientists, and enforcement authorities.

 The consent holders include a literature survey and questionnaires to GMO cropping farmers and collaboration with existing networks in their environmental GS, as was done in Germany after the German Competent Authorities (CA) approval. However, in that latter case, a great deal of imprecision remains about the content of agreements with existing networks, the network's possible training, and the surveyed locations, i.e. representativeness and accuracy of the GS, particularly in non-GMO areas. Moreover, no statistics are provided which might alert the CA to start more in depth monitoring.

<sup>9</sup> Agence Nationale de Sécurité Sanitaire

<sup>10</sup> Institut National de Veille Sanitaire

<sup>11</sup> Office International des Epizooties

The 2010 draft version of EFSA guidelines shows a drastic change of paradigm in the principle of environment GS and still does not establish guidelines for health effects surveillance. This draft version particularly outlines the importance of baselines, use and assessment of indicators after field trials, less oriented biodiversity studies without *a priori*, etc. This difference between 2006 and 2010 version may represent both the change into the EFSA GMO panel composition as well as an attempt of EU-MS, of their enforcement agencies and of the EC to master and retrieve the leadership in a scientific, but also highly

For several years now, important scientific conceptual and practical works have indeed been developed in several EU-MS along with reports from national committees in charge of GMO approvals (ACRE, 2004; Breckling and Reuter, 2006; Garcia-Alonso et al., 2006; Graef et al., 2005; Monkemeyer et al., 2006; Wilhelm et al., 2009; Wolt et al., 2010; Zughart et al., 2008). Most of these scientific works focused on environmental effects, while the effects on human health are roughly "delegated" by the consent holders to national health monitoring networks (Bakshi, 2003; Cellini et al., 2004; Covelli and Hohots, 2003; D'Agnolo, 2005; EFSA GMO panel, 2006b; Filip et al., 2004; Hepburn et al., 2008; Wal et al., 2003). To provide an example of EU-MS, in France, the "Sentinelles" network, ANSES9, and InVS10 might form parts of such a general surveillance plan on human health in application of the WHO and European rules, directives, and regulations. Animal health is relevant to the OIE11 and European rules, directives, and regulations. As for GMO CSM and GS, the French Ministry of Agriculture (DGAl directorate) is in charge of animal health surveillance. However, no GMO-related GS activities in human and animal health are clearly identified in the

Indeed, GS of human and animal health is also particularly important given that GMOs not dedicated to food and feed purposes will rapidly arrive on the market as exemplified by the recent European approval of Amflora® potato for cultivation. For this kind of split approval, we must remember the first such issue raised by the incorrect segregation between food and feed/ industry storage facilities of the USA-approved Starlink™ maize (Alderborn et al., 2010; Beckie et al., 2010; Miller, 2010). Despite the past European experience of segregating crops dedicated to industrial uses as part of a specific derogatory cultivar list, the additional recent request Modena GM potato cultivation approval in the EU can lead us expect that more and more GMO dedicated to industrial use will enter the food

From a decade of GMO cultivation in the EU, several remarks can be made about environmental GS reported by consent holders, scientists, and enforcement authorities. The consent holders include a literature survey and questionnaires to GMO cropping farmers and collaboration with existing networks in their environmental GS, as was done in Germany after the German Competent Authorities (CA) approval. However, in that latter case, a great deal of imprecision remains about the content of agreements with existing networks, the network's possible training, and the surveyed locations, i.e. representativeness and accuracy of the GS, particularly in non-GMO areas. Moreover, no statistics are provided which might alert the CA to start more in

political, issue.

European activity reports.

depth monitoring.

9 Agence Nationale de Sécurité Sanitaire 10 Institut National de Veille Sanitaire 11 Office International des Epizooties

chain and raise new controversies about human health.

 Despite the positive EFSA assessment of the consent holders' monitoring reports, we can observe that, to date, the consent holders do not include non-GMO areas that are in practice delegated to the responsibility of the EU-MS (Alacalde et al., 2007; Lecoq et al., 2007; Monsanto Co., 2006, 2009a, b; Tinland, 2008; Tinland et al., 2007; Wandelt, 2007; Windels et al., 2009). Accordingly, several EU-MS have already, or are planning to, launched GS research projects and networks even in those EU-MS with bans on GMOs (Bartsch et al., 2009; Breckling and Reuter, 2006; de Jong, 2010; Gathmann, 2009; Gathmann and Bartsch, 2006; Pascher et al., 2009). This survey of non-GM cropped areas is however of utmost importance as recently shown in China (Lu et al., 2010). Unfortunately, we can again observe that private interests and benefits are supported by public funding when general goods are concerned, as usual in the "Tragedy of Commons" frame (Hardin, 1968; Hardin, 1998).

Most current environmental GS plans focus on changes in *ex ante* baseline and / or biodiversity assessments, sometimes along with a general approach looking at the effect of agricultural practices (Hintermann et al., 2002; Monkemeyer et al., 2006; Sanvido et al., 2007a; Sanvido et al., 2007b, 2009a; Sanvido et al., 2009b; Schmidt et al., 2009). However, the conceptual framework for environmental GS is far from being both a consensus and a reality. This situation motivated the European Commission to launch a call for proposals in 2010 (KBBE.2011.3.5-01) that address environmental GS and possible standardization (ACRE, 2004; Beismann et al., 2007; EFSA GMO panel, 2006b; Finck et al., 2006; Ostergard et al., 2009; Pascher et al., 2009; Sanvido et al., 2005; Schiemann, 2007; Seitz et al., 2010; Wilhelm et al., 2003; Wilhelm et al., 2009; Wilhelm and Schiemann, 2006).

The main conclusion that can be drawn from the current situation is that, despite the mandatory involvement of GMO consent holders into GMO GS and the monitoring of non-GMO areas, the main effort appears to be supplied by the EU-MS.

However, a number of environmental monitoring procedures are already in place in the EU, several of which partly embrace – episodically or on a longer term - biodiversity, GMO CSM, "epidemio-surveillance", or more general effects of agricultural practices on agroenvironment. In several instances, these monitoring schemes are carried out by citizens in a so-called participatory science. These trends might be correlated with another trend for observing territory from societal and economic viewpoints (Barzman et al., 2005; Bodiguel, 2003; Cardwell and Bodiguel, 2005; Henle et al., 2008). Networks of citizens and/or scientists, as well as enforcement authorities already working on these issues, all have in common (i) a need for long-term studies, (ii) different demands on space and changes over time, (iii) different indicators which (iv) generally have to be reported to national CA and EC, sometimes according to international treaties. But up until now, results appear fragmented, collated in different databases generally without quality assessment or direct connection through a unique Web-based portal or automatic novelty detection capacity (Haggett, 2008).

Nonetheless the environmental liability directive and the right of European citizens to have access to environmental information reinforce the need for gathering these fragmented data (Cardwell, 2010; Ebert and Lahnstein, 2008; European Commission, 1985, 2003b, 2004a, c, 2006c, 2007b).

In the case that GM soybean cultivation would be allowed in the future, there are thus numerous issues that should be fulfilled by consent holders, particularly for herbicide tolerant crops whose uncontrolled use in third countries leads to numerous herbicide resistant weeds and costly companies' based eradication programs (Adams, 2011; Brasher, 2010; Cerdeira and Duke, 2006, 2007).

Soybean in the European Union, Status and Perspective 15

With an important increase since 2006 due to the food crisis.

Table 2. 2008 figures of soybeans, oil fats and meals' import, production and processing (sources: Fediol, 2011 and FEFAC, 2011). BE: Belgium; DE: Germany; FR: France; IT: Italy; NL: The Netherlands; PT: Portugal; SP: Spain; SL: Slovenia; UK: United Kingdom.
