A future task in good hands

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

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

Role of the Federal Agency

BfN is one of the Competent authorities in Germany involved in the regulation of GMOs on national and European level

BfN is the central scientific authority at federal level for national and international nature conservation and landscape management

Main task within the approval procedures:

Evaluation and performance of environmental risk assessment

Evaluation and development of monitoring plans

Evaluation of monitoring data

Tasks

Framework of Environmental Risk Assessment

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

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

Rockström et al.2009

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

Interim - Conclusions

ERA Catogeries to consider

1. Gene Flow and its consequences

2. Persistence, Weediness and Invasiveness

3. Effects on Organisms and Food Webs

4. Effects on Soil Function

5. Changes in Management Practices

6. Effects on Plant Health, and Incidental Exposure to Animals and Humans

7. Effects on Biodiversity

Distribution pathways

Pollen dispersalPollen 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.

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.

Complexity of possible effects (e.g., Bt-corn)

Bt pollen

Bt uptake by herbivores

Higher lignin content

Food chain effects

Bt accumulation in soil

?? ? ?

Biodegradation of plant material

Soil organisms

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

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

Herbicide use increases and resistence is widespread

Is there a way out ?

Taken from Egan 2012; slightly adapted

Identified hazards

HR-plantsImpacts on biodiversity – FSE 2004/2005, EFSA 2012, Pleasants & Oberhauser 2012Emergence of resistent weed – Grube et al. 2011, Heap 2012Increase in herbicide use: amounts and number of active ingredients – Grube et al. 2011, Benbrook 2012Impact on soil health and quality – EFSA 2009, Zablotowicz & Reddy 2007, Cakmak et al. 2009Impact glyphosate on amphibians – Relyea 2005, 2012: Brühl et al. 2012IR-plantsResistence development – Tabashnik et al. 2009, Oswald et al. 2012Emergence of secondary pests - Then 2010Impact 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

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

ERA Catogeries to considerThe 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,

ERA Catogeries to considerThe problems are

acknowledgement and competing interests

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

Sachsen

BB

B

Bayern

BaWü

RLP

SA

HessenThüringen

NRW

Sa-Anh..

Nieders.

HBHH

MV

SHGrüne Farbe = Gentechnikf reie Bundesländer

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

Conclusions II

A future task in good hands

Thanks for listening!

Beatrix Tappeser

II 3.3 - GMO Regulation, Biosafety