The document presents an introduction to environmental risk assessment (ERA) for genetically modified (GM) crops, highlighting advancements and ongoing challenges. It covers the historical context of GM crop development, various potential environmental harms, and the evolution of regulatory frameworks and assessment practices. Key topics include the shift from generic to case-specific assessments and the need for operational goals aligned with policy protections amidst a landscape of conflicting agricultural and environmental interests.

1. An Introduction to ERA:
advances and challenges
Alan Gray
Centre for Ecology and Hydrology UK
ajg@ceh.ac.uk
EXPO 2015 – Milan 16th October 2015

2. ERA: advances and challenges
 Aim of this talk
To provide an introduction to the talks which follow
by reviewing the developments in ERA for GM
crops, identifying advances and noting some
remaining challenges
 Disclaimer
Any views expressed in this presentation are mine
and not necessarily shared by any organisation
with which I am or have been associated

3. ERA: advances and challenges
In this talk:
 The early years – first reactions and
trends
* an infinity of ‘harms’
* the search for models
 Conceptual and structural change
* generic to case-by-case (Plato  Aristotle)
* from science-led to policy-led approaches
(problem formulation)

4. ERA: advances and challenges
 Environmental Risk Assessment (working
definition):
An evaluation of the probability and
consequences (severity) of harm to the
environment, and to human and animal
health, from the cultivation of a GM plant.
It is part of a larger Risk Analysis process
which also includes Risk Management and
Risk Communication and its purpose is to
inform decision making

5. ERAs of GM plants are made for commercial
release, confined field trials and import for
food, feed and processing

6. ERA: advances and challenges
The Early Years
 1973 – first GE bacteria, 1975 Asilomar and govt
oversight and voluntary guidelines for recombinant
DNA research in labs
 c1983 – first GM plant in lab, regulatory frameworks in
some developed countries established by 1986 using
principles derived from other activities (e.g.
agrochemical and plant quarantine regulations)
 1994-1996 – first commercial introductions of GM
crops with similar ERAs in different countries using
different legislation (cf USA, Canada, Australia and
EU) but mostly treating GM crops as ‘different’
 1990s  International agreements (1992 Rio, 1993
CBD, 1995 WTO, 2004 Cartagena) establish broad
principles of ERA.

7. ERA: advances and challenges
The Early Years
 An infinity of harms
Meanwhile environmental scientists (at the ‘what could go
wrong?’ stage) came up with long lists of all imaginable
harms (and were even challenged to look for
‘unimaginable’ harms – ‘unknown unknowns’)
(Distrust of a (simple) agrochemical/pesticide approach?
‘Genie out of the bottle’. A love of complexity?)

8. ERA: advances and challenges
A shortlist of imagined harms drawn up by
an ecologist
• Creation of new weeds
• Creation of new crop pests
• Build-up of resistance to pesticides
• Increased soil erosion
• Interference with nutrient cycles
• Interference with decomposition processes
• Loss of biodiversity
• Loss of genetic diversity
• Loss of valued species
• Invasions of natural habitats (after Crawley 1994)

9. ERA: advances and challenges
More tractable lists of ‘harms’ have evolved such as the
‘5 pillars’ of the ERA for plants with novel traits (PNTs)
in the Canadian legislation
(1)potential of PNT to become a weed of
agriculture or invasive of natural habitats
(2)potential for gene flow to wild relatives
whose hybrids may be invasive or weedy
(3)potential to become a plant pest
(4)potential impact on non-target species
including humans
(5)potential impact on biodiversity

10. ERA: advances and challenges
The regulatory framework covering ERA for GM crops in the EU
is somewhat broader……
(1)persistence/invasiveness of GM plant or
compatible relatives including gene transfer
(2)plant to micro-organism gene transfer
(3)interaction with target organisms
(4)interaction with non-target organisms
(5)impact of cultivation and harvesting and
effect on production systems
(6)effects on biogeochemical processes
(7)effects on animal and human health
…….and includes some ‘harms’ which are arguably more difficult
to evaluate or have a socio-economic element

11. ERA: advances and challenges
 National jurisdictions vary and arguments
continue but the most commonly envisioned
potential harms are: (abbreviated)
* GM a weed or invasive
* Gene flow – hybrid weedy/invasive
* Adverse impact on NTOs
* Adverse impact on biodiversity
* Adverse impact on agricultural processes
* Adverse impact on soils

12. ERA: advances and challenges
 Research and >25 years of growing GM
crops has indicated that several initially
envisioned ‘harms’ pose very low or
negligible risks to the environment:
* horizontal gene transfer from GM plants
* emergence of novel virus diseases from viral
recombination in virus-resistant plants
* variations in soil microbial diversity (as opposed
to functionality)
* invasions of ‘natural’ habitats by GM plants or
GM/wild relative hybrids

13. ERA: advances and challenges
The Early Years
Looking for models – the alien/invasive species model
Heracleum
mantegazzianum
Impatiens
glandulifera
Reynoutria
japonica

14. ERA: advances and challenges
Alien species models rejected (in favour of ‘crop’ model) as
having poor predictive power – cf ‘weediness’ models
Predicting weediness from Baker traits -Williamson

15. ERA: advances and challenges
Conceptual and structural change – key trends
From broad ideas/generalisations (Plato) to specific detail and
analysis (Aristotle)
From generic to case-by-case and trait-based approaches
From the process to the product (effectively PNTs)
(From molecular biology to assessment of the phenotype)

16. ERA: advances and challenges
Conceptual & Structural change
From a science-led to a policy-led approach
to ERA:
 The most significant advance in the last
10-15 years has been the widespread
inclusion of a problem formulation step in
the risk assessment (implicit in some
jurisdictions but not always formalised)

17. ERA: advances and challenges
 Problem formulation (working definition)
The framing of the ERA in a way which
identifies protection goals, asks what
harm may occur to them by the cultivation
of the GM crop and defines what
information is needed to assess the
likelihood and seriousness of the harm
occurring.

18. ERA: advances and challenges
At a very simple level Problem Formulation can
be expressed as four questions *
1 What do we not want to see harmed?
What must be protected?
2 Can we envision a way in which they
could be harmed?
3 How can we assess whether they are
likely to be harmed?
4 Does it matter?
*Gray AJ (2012) Collection of Biosafety Reviews
http://www.icgeb.org/biosafety/publications/collections.html

19. Which are equivalent to the formal stages of PF……
QUESTION PROBLEM FORMULATION
1 What do we not want
to see harmed? What
must be protected?
Identify assessment
endpoints from
protection goals
2 Can we envision a way
in which they could be
harmed?
Trace pathways to harm
and develop conceptual
models
3 How can we assess
whether they are likely
to be harmed?
Formulate risk
hypotheses and devise
analysis plans
4 Does it matter? Decide regulatory
context

20. ERA: advances and challenges
Key Features of Problem Formulation
 Initially develops Operational Protection Goals (and
assessment endpoints) from Policy Protection Goals
 Sets the context and scope of the risk assessment
(depending on the type of release, crop, trait,
receiving environment, etc)
 Seeks to formulate and test specific risk hypotheses
and focuses on the data needed to test them, thus:-
(1) avoids the ‘deficit model’ of ERA
(2) decides ‘need’ v ‘nice’ to know science, and
(3) promotes ‘ecotoxicological’ versus ‘ecological’
methods*)
* Raybould A (2007) Plant Science 173: 589-602

21. ERA: advances and challenges
Current challenges
 Translating broad policy protection goals into agreed operational
protection goals (and then into assessment and measurement
endpoints) and agreeing criteria for ‘harm’
 Dealing with multiple stressors and conflicting goals
 Making ERAs more contextual - uncoupling new biotechnology
from increasing agricultural industrialisation and weighing
potential benefits alongside harms
 Harmonisation of approaches so that risk assessors can use each
others data
 Developing ERAs for organisms other than annual crop plants
(trees, fish, insects, etc)
 Developing ERAs for new technologies (RNAi, cisgenesis,
genome editing, gene drive technologies)

22. ERA: advances and challenges
Policy protection goals such as in the
Cartagena Protocol (SCBD 2000 Annex III)
are typically very broadly stated ….
“the objective of risk assessment…..is to
identify and evaluate the potential adverse
effects of living modified organisms on the
conservation and sustainable use of
biological diversity in the likely potential
receiving environment,…”

23. ERA: advances and challenges
Policy protection goals such as in the
Cartagena Protocol (SCBD 2000 Annex III)
are typically very broadly stated ….
“the objective of risk assessment…..is to
identify and evaluate the potential adverse
effects of living modified organisms on the
conservation and sustainable use of
biological diversity in the likely potential
receiving environment,…”
….and often include normative concepts
that are scientifically challenging

24. ERA: advances and challenges
Deriving operational protection goals from policy protection goals
 An ecosystem services approach can
help to define operational protection
goals and assessment endpoints:
‘crop pollination’  populations of
insect pollinators)
or
‘sustainable agricultural production’
 populations of in-field weeds
Garcia-Alonso M & Raybould A (2014)
Transgenic Research, 23:945-956
Band sprayed
first time

25. Agricultural
‘sustainable
agricultural
production’
Different habitats in heterogeneous farmed
landscapes have different protection goals
Semi-natural
‘maintenance
of biodiversity

26. ERA: advances and challenges
 But (e.g. in the EU)
different protection
goals may lead to
conflict where they
relate to the same
environment.
(farmland birds and
weed-free crops)
A suitable situation for
risk management?
Conventionally treated beet

27. ERA: advances and challenges
Conflicts also arise in the non-agricultural
environment e.g. shorebirds & hedgehogs on Uist
Webb & Raffaelli (2008) J. app Ecol. 45, 1198)
Further scientific research is unlikely to resolve the
conflict and could make it worse*
*Sarewitz (2004) Env Science and Policy 7:385-403

28. ERA: advances and challenges
We cannot protect everything – conflicts arise and values
should be made explicit and debated openly
(Devos et al (2014) Transgenic Research 23:933-943)

29. Making ERAs more contextual – increasing their scope to
consider past and future agriculture (both GM and
conventional), changing baselines and possible benefits
(including risks of not adopting new agricultural technology)

30. ERA: advances and challenges
….. the baseline comparator is also changing due to a
range of different drivers
E.g. the huge changes in grassland management in the
UK (haystacks bales  silage and permanent
pasture  temporary leys)
Uncoupling GM crops and modern biotechnology from
the harms inflicted by increasing industrialisation

31. But will require a ‘paradigm shift’ in the current
EU approach (ACRE 2007,EFSA 2008,
Devos et al 2014)
The wider context is especially important in
view of the reality of conventional (non-GM)
agriculture in the tropics….

32. Thank you for your attention
Alan Gray (CEH)
ajg@ceh.ac.uk