An Introduction to ERA: advances and challenges. Alan Gray Centre for Ecology and Hydrology UK

Transcription

1 An Introduction to ERA: advances and challenges Alan Gray Centre for Ecology and Hydrology UK EXPO 2015 Milan 16 th October 2015

2 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 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 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 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) 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 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 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 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 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 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 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 The Early Years Looking for models the alien/invasive species model Heracleum mantegazzianum Impatiens glandulifera Reynoutria japonica

14 Alien species models rejected (in favour of crop model) as having poor predictive power cf weediness models Predicting weediness from Baker traits -Williamson

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

17 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 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

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? 2 Can we envision a way in which they could be harmed? 3 How can we assess whether they are likely to be harmed? Identify assessment endpoints from protection goals Trace pathways to harm and develop conceptual models Formulate risk hypotheses and devise analysis plans 4 Does it matter? Decide regulatory context

20 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:

21 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 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 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 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 Band sprayed first time Garcia-Alonso M & Raybould A (2014) Transgenic Research, 23:

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

26 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 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:

28 We cannot protect everything conflicts arise and values should be made explicit and debated openly (Devos et al (2014) Transgenic Research 23: )

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

32 Thank you for your attention Alan Gray (CEH)