GMOs in the environment and conservation – the German approach

1. GMOs in the environment and conservation – the German approach Beatrix Tappeser, Head of Division II 3.3 - GMO Regulation, Biosafety Federal Agency for Nature Conservation

2. Outline • BfN (German Federal Agency for Nature Conservation) and its role in the approval process of GMO in Germany (Part B) and Europe (Part C). • Framework of ERA and protection goals • First conclusions • ERA – what do we do and what do we know • Promises, hazards and realities • Conclusions II

3. Role of the Federal Agency BfN is the central scientific authority at federal level for national and international nature conservation and landscape management BfN is one of the Competent authorities in Germany involved in the regulation of GMOs on national and European level

4. Tasks Main task within the approval procedures: Evaluation and performance of environmental risk assessment Evaluation and development of monitoring plans Evaluation of monitoring data

5. Convention on Biological Diversity - Preamble ... Noting that it is vital to anticipate, prevent and attack causes of significant reduction or loss of biological diversity at source Noting also that where there is a threat of significant reduction or loss of biological diversity lack of full scientific certainty should not be used as a reason for postponing measures to avoid or minimize such a threat Noting further that the fundamental requirement for the conservation of biological diversity is the in situ conservation of ecosystems and natural habitats and the maintenance and recovery of viable populations of species in their natural surrondings ... Cartagena Protocol on Biosafety - Recital: … Recognizing also the crucial importance to humankind of centres of origin and centres of genetic diversity… Directive 2001/18/EG – Preamble, Para 5 The protection of human health and the environment requires that due attention be given to controlling risks from the deliberate release into the environment of genetically modified organisms(GMOs) Framework of Environmental Risk Assessment

6. The Millenium Development Goals agreed upon 2000 have as one of its main Goals (7A) to integrate the principles of sustainable development into country policies and programs; reverse loss of environmental resources and (7B) to reduce biodiversity loss achieving by 2010 a significant reduction in the rate of loss. Directive 2001/18 foresees (only) a comparative approach when assessing the risks of GMO taking into account immediate and delayed, direct and indirect and cumulative longterm effects. The ERA should be done in accordance with the precautionary principle There is scientific consensus that our current highly intensified agricultural practices contribute to and are an important reason of environmental degradation and biodiversity loss. Framework of Environmental Risk Assessment

7. Framework of Environmental Risk Assessment Rockström et al.2009

8. Interim - Conclusions • It is not enough to stick to the status quo but agricultural practice has to be much more sustainable meaning less resource intensive and much more nature protective regarding soil, biodiversity and water • Protection goals and agreed policy goals (eg stop the loss) should be important conditions during problem formulation for ERA of a GM plant. • Organic farming and other agro-ecological farming practices should be part of a comparative assessment (also in their potential to contribute to solutions for identified problems) • The assessment should be system based – look at the whole picture and solution possibilites

9. ERA Catogeries to consider • Gene Flow and its consequences • Persistence, Weediness and Invasiveness • Effects on Organisms and Food Webs • Effects on Soil Function • Changes in Management Practices • Effects on Plant Health, and Incidental Exposure to Animals and Humans • Effects on Biodiversity

10. Pollen dispersal Pollen viability and pollination specifics, possible spatial pollen distribution; Timing of pollen production vs. ability to being pollinated (mechanisms developed in some species to ensure in-crossing); Seed dispersal Seed dormancy and viability; Abiotic distribution (wind, water, floods etc.); Biotic distribution via animals including humans; Vegetative dispersal Other/new dispersal pathways, e.g. seed dispersal via commodity fruits. Distribution pathways

11. Interactions • with symbiotic microorganisms/mykorrhiza; • with soil organisms including decomposers and pest organism; • with above ground invertebrates (including predators and pests); • with birds; • with wildlife.

12. Complexity of possible effects (e.g., Bt-corn) Bt uptake by herbivores Food chain effects Bt pollen ? ? ? ? Biodegradation of plant material Higher lignin content Bt accumulation in soil Soil organisms

13. Pollen deposition in-situ Chenopodium album; (200x) Aug 2010; >2800 pollen cm2 Chenopodium album; (200x) Aug 2010; 250 pollen cm2 Rumex; (200x) July 2008; ca. 3600 pollen cm2 Urtica dioica; (200x) August 2010; ca. 2400 pollen cm2

14. Promises and reality Replace more-toxic herbicides Reduce total amount of herbicide use Simplify and improve weed management Unlikely weeds would develop resistance Trans-gene facilitated pesticide treadmill Return to older, more problematic herbicides, Stacked traits and new recommendations will increase total herbicide use, facilitates resistance by increasing selection pressure Is there a way out ? Herbicide use increases and resistence is widespread Taken from Egan 2012; slightly adapted

15. Identified hazards HR-plants Impacts on biodiversity – FSE 2004/2005, EFSA 2012, Pleasants & Oberhauser 2012 Emergence of resistent weed – Grube et al. 2011, Heap 2012 Increase in herbicide use: amounts and number of active ingredients – Grube et al. 2011, Benbrook 2012 Impact on soil health and quality – EFSA 2009, Zablotowicz & Reddy 2007, Cakmak et al. 2009 Impact glyphosate on amphibians – Relyea 2005, 2012: Brühl et al. 2012 IR-plants Resistence development – Tabashnik et al. 2009, Oswald et al. 2012 Emergence of secondary pests - Then 2010 Impact on non target species (terrestrial and water stream insects) – Hilbeck et al. 2006, 2012. Rosi-Marshall et al. 2007, Lang & Otto 2010, Bohn et al. 2010, EFSA 2012

16. The problem with data generation and evidence • Because of patent restrictions no independent research is possible • Standardised tests to look into e.g.non-target effects are based on pesticides (single compounds) • No monitoring or empirical research has taken place until now • The basic concept underlying RA is additive and does not mirror the dynamic and complex interactions of organisms and communities

17. ERA Catogeries to consider The ways to sustainable agriculture are known and manifold described Pimentel et al. 2005, Pretty et al. 2006, Badgley et al. 2007, ISTAAD-Report 2008, DB-Research 2009, Chappell &LaValle 2009, Olivier de Schutter 2010, EU-SCAR-Report 2011, Altieri et al. 2011 ,

18. ERA Catogeries to consider The problems are acknowledgement and competing interests

19. Federal States in Germany with a self obligation not to grow GM plants(February 2013)

20. Conclusions II • It is important to be comprehensive when selecting the relevant protection goals • Choose the right comparators and comparisons. • Clearly communicate the level of uncertainty regarding the outcome of a RA • Enforce the precautionary principle

21. Thanks for listening! Beatrix Tappeser II 3.3 - GMO Regulation, Biosafety