How the Exemption became Standard: The Role of Consumer Behavior & the Safeguard Clause Engagierte Bürger-involved with something Offizielle erklärung-official/formal declaration Antragsteller-applicant,petitioner Vorgaben-guidelines, specifications Einigen-agree, settle on sth Voraussetzung-condition, requirement, precondition Exkurs-digression Aufgabe-function Katja Rath (Ass. iur.) – IUCN Colloquium Wuhan 2009

Outline Pros and Cons of GMO-Use GMO-Use in Numbers GMO-Regulation in Europe The Safeguard Clause Custom Behavior & Political Reactions Outlook

The Problem Pros and Cons of GMO use relating to Biodiversity Positive effects Negative effects Potential to increase food production without the need to convert more land to cultivation Potential to reduce the dependence on chemical insectices and herbicides Horizontal gene flow Potential to transfer traits to organic relatives > Invasive potential of “superweeds” > Irreversibility Potential to expose non target organisms to Bt-Toxin (Lady Bug Butterflies) 1. European Corn Rootworm turnip rape (rübsen) – mustard (ackersenf) 2. Western Corn Borer 3. Monarch Butterfly 4. Two Spotted Lady Beetle Potential benefits Attacks by herbicides Sexual repruduction Biodiverstiy: species diversity, ecosystem diversity, genteic dversity 2001/18 .genetically modified organism (GMO). means an organism, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination; 3

World-leading countries in Bt-Maize Cultivation Transgen.de http://www.transgen.de/anbau/eu_international/531.doku.html source: www.transgen.de

World-leading countries in Bt-Maize Cultivation 2005: 54.000 ha 2007:110.000ha In million hectars source: www.transgen.de

The Legal Framework: Multi-Level-Governance International Law: The Legal Framework: Multi-Level-Governance International Law: Convention of Biological Diversity >Cartagena Protocol European Community Law: Art. 4 Directive 2001/18/EC German Federal Law: Genetic Engineering Act “…control the risks associated with the release of GMO…“ “...all appropriate measures are taken to avoid adverse effects on…the environment…” Each Contracting Party shall: g) Establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity… 2001/18 Member States shall, in accordance with the precautionary principle, ensure that all appropriate measures are taken to avoid adverse effects on … the environment which might arise from the deliberate release or the placing on the market of GMOs. § 14 GenTG “…permit required for the Placing on the market of a GMO”

Time Bar: “Placing on the Market” Application Permit Increase of Risk Harm to Biodiversity Ex ante Ex post t Approval Process Monitoring Liability Action of jurisdictional Authority: Safeguard Clause

Standard Permit Procedure Application submitted to one Member State Authority Member State gives opinion (favorable/ non-favorable) All Member States get informed, usually some objections If objections > Conciliation phase among Member States If objections are maintained > Community Procedure Commission takes decision after - EFSA - Regulatory Committee If favorable Opinion by RC, Commission assigns original Member State Authority to issue the Permit Cultivation of gm-plant allowed all over Europe direct/indirect/delayed - cumulative, long term effects t

Standard Permit Procedure Application submitted to one Member State authority If favorable opinion of the Member State All Member States get informed, usually some objections If objections > Conciliation phase among Member States If objections are maintained > Community Procedure Commission takes decision after - EFSA - Regulatory Committee If favorable Opinion by RC, Commission assigns original Member State Authority to issue the Permit Cultivation of gm-plant allowed all over Europe direct/indirect/delayed - cumulative, long term effects t

Standard Permit Procedure Application submitted to one Member State authority If favorable opinion of the Member State All Member States get informed, usually some objections If objections > Conciliation phase among Member States If objections are maintained > Community Procedure Commission takes decision after - EFSA - Regulatory Committee If favorable Opinion by RC, Commission assigns original Member State Authority to issue the Permit Cultivation of gm-plant allowed throughout Europe direct/indirect/delayed - cumulative, long term effects t

Art. 23 Deliberate Release Directive „Where a Member State, as a result of… - new or additional information… affecting the environmental risk assessment or - reassessment of existing information on the basis of new or additional scientific knowledge, …has detailed grounds for considering that a GMO which has been properly notified under this Directive constitutes a risk to human health or the environment, that Member State may provisionally restrict or prohibit the use of that GMO on its territory.” With this technology, DNA molecules from different sources are combined into one molecule to create a new set of genes. This DNA is then transferred into an organism, giving it modified or novel genes.

source: www.gmo-free-regions.org http://www.gmo-free-regions.org/food-democracy-april-2009/programme/safeguard-clause.html source: www.gmo-free-regions.org

EU-Network: GMO-Free-Regions 164 Regions and 4.500 Municipalities

Countries using the Safeguard Clause Austria “New evidence concerns…that it is not possible to exclude cross-pollination between GMO fields and GMO-free fields at a local scale.” Greece “Environmental impacts of MON810 maize…potential adverse effects on non-target fauna (green lacewing)…” Hungary “In the soil of the field under the transgenic plant, the entire biological activity was lower than in the control field.” Germany “higher mortality in two dotted-ladybug when fed with Cry1Ab…” They are all using basically the same scientific literature Usually not new

Standard procedure after ban MS must inform Commission > and other MS Commission asks for expert participation EFSA If the ban is scientifically not justified Community Procedure RC decides after a suggestion from the Commission If no Majority, ban still exists even though EFSA did not find sufficient scientific background Political Decision direct/indirect/delayed - cumulative, long term effects t

EFSA´s Task 1) Whether new scientific evidence presented by the MS would change the risk assessment conducted on the GMO Whether scientific evidence was supplied which indicate that the environment or ecology of that MS was different from other regions BUT: The scientific evidence provided by these MS as justification for their measures …was in all cases lacking evidence which would justify overturning the original permit.

Standard Procedure after ban MS has to inform Commission > and other MS Commission asks for expert participation EFSA If the ban is scientifically not justified: Community Procedure RC decides after a suggestion from the Commission If no Majority, ban still exisits even though EFSA did not see scientific background justifying the ban Political Decision direct/indirect/delayed - cumulative, long term effects t

Is the European Framework a dead end? Sept. 2009: EU Agriculture Commissioner Mariann Fischer-Boel „Commission President José Manuel Barroso wants to look at whether we can give the member states more freedom on this issue," … advocate speeding up market approval for new GM maize lines„ Council of the European Union 2008 “ notes that GMO-free zones can be created on the basis of voluntary agreement…” http://docs.google.com/gview?a=v&q=cache:FPegc-_xhQoJ:www.consilium.europa.eu/ueDocs/cms_Data/docs/pressData/en/envir/104509.pdf+notes+that+GMO-free+zones+can+be+created+on+the+basis+of+voluntary+agreement+which&hl=de&gl=de&pid=bl&srcid=ADGEESg5Xe-eXt6ntt9ki14BEVhfuFApozYAUi1P_3t4MtxOQvnm-CDcVx6R3fAOX4qR5TsBo3LsG45XxlEx8I4dHi7rWp7VLTeAU65QoyOpB3l7jmQHdySBqQOBDqG8OA27Im5X6Qdr&sig=AFQjCNFGFZOH7feT2nTKa9zp_2YCmX-n4g advocate speeding up market approval for new GM maize lines to lift trade barriers that have emerged as a result of asynchronous approval… “. European Biotechnology Science & Industry News jump to search | jump to navigation Commissioner looks at national GMO bans 09.09.09 Brussels – The European Commission is considering allowing member states to ban EU-approved GM crops. Commission President José Manuel Barroso wants to "look at whether we can give the member states more freedom on this issue," said EU Agriculture Commissioner Mariann Fischer Boel yesterday during the Agriculture Council in Brussels. She added that she would support these ideas, and also advocated speeding up market approval for new GM maize lines to lift trade barriers that have a emerged as a result of asynchronous approval of GMOs in the EU and in GMO export countries. Fischer Boel said that a distinction must be made between the importation of genetically modified plants and fruits grown in the EU itself. "I know that cultivation is a very sensitive issue," said the Danish commissioner.To date, member states do not have the right to prohibit the cultivation of GMO crops on their territory once it has been authorised in the EU, except if evidence is provided that the GMO is harmful for human health or the environment. Because there is little or no public acceptance for GMO acreage among the public, a majority of EU member states lobby to change this practice.Industry, however, is concerned about this development, favouring as it does a science-based approach that is based on a comprehensive safety assessment prior to market authorisation. After over 10 years of commercial GMO acreage throughout the world, no concrete evidence has been provided to date that biotech plants can lead to significant damage of human health or the environment.

Conclusion Consumer Behavior & Political Reaction Consumer Behavior leads to use of the Safeguard Clause by MS Safeguard Clause is used by MS without new scientific evidence (political decision) Review of the Safeguard Clause by the Regulatory Committee not objective (political decision) Current Regulatory Framework on GMO is a dead end due to… Consumer Behavior & Political Reaction

Thank you. katja.rath@ufz.de