1. 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

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

3. 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

4. World-leading countries in Bt-Maize Cultivation
Transgen.de
source:

5. World-leading countries in Bt-Maize Cultivation
2005: ha : ha
In million hectars
source:

6. 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”

7. 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

8. 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

9. 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

10. 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

11. 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.

12. source: www.gmo-free-regions.org
source:

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

14. 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

15. 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

16. 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.

17. 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

18. 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…”
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
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Commissioner looks at national GMO bans
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.

19. 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

20. Thank you. katja.rath@ufz.de