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An Introduction to ERA: advances and challenges Alan Gray Centre for Ecology and Hydrology UK [email protected] EXPO 2015 – Milan 16 th October 2015
An Introduction to ERA: advances and challenges
Alan Gray
Centre for Ecology and Hydrology UK
EXPO 2015 – Milan 16th October 2015
ERA: advances and challenges
Aim of this talkTo provide an introduction to the talks which follow
by reviewing the developments in ERA for GM crops, identifying advances and noting some remaining challenges
DisclaimerAny views expressed in this presentation are mine
and not necessarily shared by any organisation with which I am or have been associated
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)
Current challenges
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
ERAs of GM plants are made for commercial release, confined field trials and import for
food, feed and processing
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.
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?)
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)
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
ERA: advances and challenges
The regulatory framework covering ERA for GM crops in the EU is somewhat broader……
(1)persistence/invasiveness of GM plant orcompatible 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 andeffect 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
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
ERA: advances and challenges
Research and >25 years of growing GM crops has indicated that several initially envisioned ‘harms’ pose very low ornegligible 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
ERA: advances and challenges
The Early YearsLooking for models – the alien/invasive species model
Heracleum
mantegazzianum
Impatiens
glandulifera
Reynoutria
japonica
ERA: advances and challengesAlien species models rejected (in favour of ‘crop’ model) as
having poor predictive power – cf ‘weediness’ models
Predicting weediness from Baker traits -Williamson
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)
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)
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.
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 Reviewshttp://www.icgeb.org/biosafety/publications/collections.html
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
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
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)
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,…”
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 adverseeffects 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
ERA: advances and challengesDeriving 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
Agricultural
‘sustainable
agricultural
production’
Different habitats in heterogeneous farmed
landscapes have different protection goals
Semi-natural
‘maintenance
of biodiversity
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
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
ERA: advances and challenges
We cannot protect everything – conflicts arise and valuesshould be made explicit and debated openly
(Devos et al (2014) Transgenic Research 23:933-943)
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)
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
But will require a ‘paradigm shift’ in the currentEU 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….
