The document summarizes the role of the European Food Safety Authority (EFSA) in evaluating the environmental risk assessment of genetically modified (GM) maize NK603. EFSA is responsible for providing independent scientific advice on GM plant authorization applications. For maize NK603, EFSA evaluated potential risks related to unintended effects on plant fitness, gene transfer to other plants or microorganisms, interactions with target and non-target organisms, and impacts on human and animal health and the environment. Based on the application details, scientific literature, and additional studies, EFSA concluded the risks of maize NK603 were similar to conventional maize and unlikely to cause adverse environmental effects.

1. The role of EFSA in the environmental
risk assessment of GM plants:
maize NK603 as case study
RR maize symposium: the European perspective
22-24 March 2010
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Yann Devos (PhD) – Junior Scientific Officer
GMO Unit – EFSA
Yann.Devos@efsa.europa.eu

2. 1. Legal aspects
EU legal framework
– D 2001/18/EC deliberate release into the environment
– R 1829/2003 marketing of GM food and feed
Authorisation required prior to market entry
– Protection
• Human and animal health
• Environment
– Risk assessment (RA)
• Characterisation of potential adverse effects associated with the
use of GM plants
– Direct; indirect; immediate; delayed; cumulative effects
European Food Safety Authority (EFSA)
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3. 2. What do we do?
Independent and transparent science-based advice
– Scientific opinions / statements
• GM plant market authorisation applications
– Import and processing for food and feed uses
– Cultivation
• National safeguard clauses
• Specific issues
– Guidance documents:
– GM plants and derived food and feed (2006)
– Stacked GM plant events (2007)
– GM plants used for non-food/feed purposes (2009)
– Statistical considerations for the safety evaluation of GMOs (2009)
• Environmental risk assessment of GM plants (2010)
– Public consultation!
– Submission of comments possible until 30 APRIL 3

4. 2. GM plant market authorisation
applications for cultivation
Application Crop Transformation event MS(∗); status EFSA status
UK-2005-17 Maize 1507xNK603 ES; ∞ ∞
NL-2005-22 & RX-NK603 Maize NK603 ES;
NL-2005-23 Maize 59122 NL; ∞
NL-2005-24 Soybean 40-3-2 DE; ∞
NL-2005-26 Maize MON810xNK603 ES; ∞ ∞
NL-2005-28 Maize 1507x59122 NL; ∞
UK-2006-30 Maize 59122x1507xNK603 BE; ∞ ∞
NL-2007-46 & RX-T25 Maize T25 UK; ∞ ∞
CZ-2008-54 Maize MON88017 BE; ∞ ∞
UK-2008-60 Maize GA21 CZ; ∞
DE-2008-63 Sugarbeet H7-1 DE; ∞ ∞
NL-2009-69 Potato AV43-6-G7 SW; - CC(∗∗)
BE-2009-71 Maize MON89034xMON88017 BE; ∞ ∞
NL-2009-72 Maize MON89034xNK603 NL; ∞ ∞
RX-MON810 Maize MON810 ES; 4
(∗) 1 Member State (MS) performs initial ERA evaluation; (∗∗) Completeness check by EFSA GMO Unit

5. 3. Brains behind advice?
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6. 4. Maize NK603 as case study:
Environmental risk assessment evaluation
Sources of information:
– GM plant cultivation authorisation applications of maize NK603
– Additional information provided by applicant
– Scientific comments submitted by Members States (Annex G)
– Environmental risk assessment report of Spanish Competent
Authority (Annex H)
– Relevant scientific literature
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7. 4. Maize NK603 as case study:
Environmental risk assessment evaluation
Environmental issues:
– Unintended effects on plant fitness
– Potential for gene transfer
• Vertical gene transfer – plant to plant
• Horizontal gene transfer – plant to microorganisms
– Interactions between GM plant and target organisms
– Interactions between GM plant and non-target organisms
– Effects on human and animal health
– Effects on biogeochemical processes & interactions with abiotic
environment
– Impacts of cultivation, management and harvesting techniques
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8. 4a. Unintended effects on plant fitness
Altered persistence and invasiveness ability?
– Maize NK603 behaves like non-GM maize
– No significant selective advantage
• Except when glyphosate-based herbicides are applied
– Maize is highly domesticated
• Management intervention needed for its survival
• Survival limited by:
– Low competitiveness
– Lack of dormancy
– Susceptibility to plant pathogens, herbivores and cold climatic
conditions
• Volunteers only observed in EU regions with mild winters
– Volunteers tolerant to glyphosate-based herbicides
– Controllable by a range of other herbicides or cultivation techniques
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9. 4a. Unintended effects on plant fitness
Altered persistence and invasiveness ability?
– Herbicide tolerance does not significantly alter
persistence and invasiveness ability of maize NK603
– GMO Panel conclusion:
• Likelihood of unintended environmental effects due to the
establishment and survival of maize NK603 will be no different to
that of conventional maize varieties
• Conclusion of GMO Panel = Spanish Competent Authority
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10. 4b. Vertical gene transfer: plant to plant
Altered persistence and invasiveness ability?
– Exposure routes:
• Pollen
• Seed
– Pollen-mediated transfer:
• No cross-compatible wild maize relatives in the EU
• Other maize varieties/types are only recipients
• Maize NK603 safe from food/feed viewpoint
– GMO Panel conclusion:
• Cross-pollination between maize is not considered an
environmental risk, but a coexistence issue that is not within the
remit of the GMO Panel
• Conclusion of GMO Panel = Spanish Competent Authority
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11. 4b. Vertical gene transfer: plant to plant
Altered persistence and invasiveness ability?
– Seed-mediated transfer:
• Dispersal of maize NK603 seeds outside
cropped area
– Seed spillage during harvesting and post-harvest activities
• No feral maize populations observed despite centuries of maize
cultivation
– GMO Panel conclusions:
• It is very unlikely that maize NK603 will establish feral
populations under European environmental conditions
• Likelihood of unintended environmental effects due to the spread
of genes from maize NK603 is considered to be extremely low
• Conclusion of GMO Panel = Spanish Competent Authority
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12. 4c. Horizontal gene transfer: plant to
microorganism
Transfer resulting in selective advantage?
– Exposure routes:
• Microorganisms in digestive tract of humans and animals
– Consumption of food and feed
• Microorganisms in environment
– Decaying plant material
– Manure and faeces of animals fed GM maize
– Horizontal gene transfer of non-mobile DNA fragments
between plants and microorganisms is extremely unlikely
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13. 4c. Horizontal gene transfer: plant to
microorganism
Transfer resulting in selective advantage?
– GMO Panel conclusion:
• Taking into account the origin and nature of epsps genes and lack
of selective pressure in intestinal tract or environment, the
likelihood that horizontal gene transfer would result in increased
fitness or other selective advantages in microorganisms is very
limited
• It is very unlikely that epsps genes from maize NK603 would
become transferred and established in genome of microorganisms
• In the unlikely event that horizontal gene transfer would take
place, no adverse effects on human and animal health or
environment are expected, as no new trait would be introduced
into or expressed in microbial communities
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14. 4d. Interactions between GM plant and non-
target organisms
Adverse effects on non-target organisms?
– Applicant reported on laboratory and field studies performed
inside and outside the EU
• No adverse effects on different types of non-target organisms:
– Test material:
» CP4 EPSPS pure protein
» Roundup Ready maize, soybean and wheat plant tissues
– Non-target organisms:
» Earthworms, bees, lacewings, collembolans, green clover worm,
non-target invertebrate pests
• Request for additional in planta studies on
– Pollinators (such as bees)
– Exposed plant-dwelling predators (such as coccinellids)
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15. 4d. Interactions between GM plant and non-
target organisms
Adverse effects on non-target organisms?
– Additional studies confirmed absence of direct effects of maize
NK603 to non-target organisms
– GMO Panel conclusions:
• It is unlikely that maize NK603 will have direct adverse effects on
non-target organisms
• Indirect effects on non-target organisms can occur depending
upon weed management regime applied to maize NK603 (see
section on impacts of specific cultivation, management and
harvesting techniques)
• Conclusion of GMO Panel = Spanish Competent Authority
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16. 4e. Effects on biogeochemical process and
abiotic environment
Adverse effects on biogeochemical processes?
– No direct effects of maize NK603 on biogeochemical processes
and abiotic environment
– GMO Panel conclusions:
• It is unlikely that maize NK603 will have direct adverse effects on
biogeochemical processes and abiotic environment
• Indirect effects on biogeochemical processes and abiotic
environment can occur depending upon weed management
regime applied to maize NK603 (see section on impacts of specific
cultivation, management and harvesting techniques)
• Conclusion of GMO Panel = Spanish Competent Authority
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17. 4f. Impacts of specific cultivation,
management & harvesting techniques
Adverse effects on farmland biodiversity, weeds or soil
microbial communities?
– Extensive review of environmental impacts of herbicide regimes
used in GM herbicide tolerant cropping systems
– GMO Panel conclusions:
• Potential impacts of maize NK603 are indirect effects entirely
associated with the use of complementary herbicide regimes
– Weed shifts or depletion → reductions in farmland biodiversity
– Evolution of weed resistance
– Effects on soil microbial communities
• Magnitude of effects will depend on specific herbicide regime
applied at the farm level
– A diversity of herbicide regimes is likely to be used in maize NK603
across the EU
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18. 4f. Impacts of specific cultivation,
management & harvesting techniques
Adverse effects on farmland biodiversity, weeds or soil
microbial communities?
– Spanish Competent Authority recommendation:
• Case-specific monitoring
– GMO Panel recommendation:
• Management and mitigation measures
– Use glyphosate on maize NK603 in management regimes that have
similar or reduced environmental impacts compared with
conventional maize cultivation
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19. 4g. Post-market environmental monitoring
Post-market environmental monitoring (PMEM) plan
adequate?
– GMO Panel conclusion and recommendations:
• Structure of PMEM plan in line with requirements of
– Directive 2001/18/EC
– GMO Panel scientific opinion on PMEM
• Case-specific monitoring
– Not considered necessary for maize NK603 itself, as environmental
risks due to herbicide management only
• General surveillance
– Modifications & clarifications related to
» Content and format of farm questionnaire
» Use of surveillance networks
» …
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20. 4g. Conclusions & recommendations
Conclusions
– Maize NK603 is unlikely to cause any direct adverse effects on
the environment
– Potential adverse environmental effects of maize NK603
cultivation are indirect effects entirely associated with the use
of complementary glyphosate-based herbicides
• Magnitude of effects will depend on the specific herbicide
management applied at the farm level
Recommendations
– Use glyphosate on maize NK603 in management regimes that
have similar or reduced environmental impacts compared with
conventional maize cultivation
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21. 5. Thank YOU for your attention!
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