In this talk: Why monitor GM crops? The system in the European Union Some concerns about monitoring

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Debra Pitts
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1 Post Release Environmental Monitoring (PREM) Alan Gray Centre for Ecology and Hydrology UK May New Delhi

2 In this talk: Why monitor GM crops? The system in the European Union Some concerns about monitoring

3 Why monitor GM crops? After all: *all agriculture is harmful *crops produced by traditional breeding are not monitored *genetic engineering not inherently risky *now long history of safe use (15yrs, 1b ha, >15m farmers in 29 countries)

4 Why monitor GM crops? Because: *initial unfamiliarity with process *potential for novelty and harm *challenge presented by novel traits *societal concerns and public pressure *now subject to international law However.

5 For the monitoring of GM crops: There is no global standard-setting setting body Treated differently in different countries In the European Union post-release environmental monitoring i is mandatory for all GM crops under specific legislation

6 Why is PREM mandatory in the EU? Regulatory aspects > explicit consent for release, no substantial equivalence, Directive seeks assessment of indirect and long-term effects, no break at marketing Environmental aspects > large % land surface agricultural, intimate landscapes, managed ecosystems, few wilderness areas Cultural and political aspects > high food security, strong environmental and organic lobbies, risk-averse populations p hostile to GMOs, campaigning press, member state consent See: Gray, AJ (2004) Ecology and government policies: the GM crop debate. J Appl. Ecol. 41,

7 The European system for Post Market Environmental Monitoring (PMEM) The regulatory and conceptual framework (case-specific specific monitoring and general surveillance) Examples of PMEM programmes for Bt maize > case-specific specific monitoring in Spain > general surveillance in Germany

8 PMEM of GM plants in the EU is MANDATORY (Directive 2001/18/EC) (applicants must submit a PMEM plan as part of the notification for marketing) Scientific quality of PMEM plans assessed by European Food Safety Authority (EFSA) GMO Panel See: Opinion of the Scientific Panel on Genetically Modified Organisms on the Post Market Environmental Monitoring (PMEM) of genetically modified plants. The EFSA Journal (2006) 319, 1-27

9 The OBJECTIVES of PMEM are: (1) To confirm any assumptions about potential adverse effects made in ERA by CASE-SPECIFIC SPECIFIC MONITORING (2) To identify the occurrence of adverse effects which were not anticipated in ERA by GENERAL SURVEILLANCE

10 CASE-SPECIFIC SPECIFIC MONITORING focuses on specific risks presented by the GM crop which were identified in pre-market ERA hypothesis-driven and can thus use tests and experiments may need standardized methods/protocols (eg parallel system without GM crop) must define effect sizes and detection limits to give defined trigger values can be terminated after defined time (if hypothesis confirmed or rejected) egs: emergence of resistant pests, loss of beneficial insects

11 GENERAL SURVEILLANCE a general overseeing of the geographical regions where GM crop grown with no specific hypotheses re adverse effects aims to detect events not anticipated in the pre- market ERA as no risk has been identified no risk hypothesis can be tested (and GS is not time-limited) can make use of existing monitoring networks but may need additional studies should be based on general protection ti goals (air, soil and water quality, biodiversity) can not determine cause of change observed changes may need specific risk assessment

12 What it.can provide Case Specific Monitoring (Scientific-experimental experimental character) Confirmation or rejection of a previously formulated hypothesis Draw conclusions on the cause of detected changes General Surveillance (Surveillance, no experiments) Provide information on the state of the environment Provide basic data to forecast the likely development of the environment.can not provide Draw conclusions on the long term development of the environment Determine the cause of an environmental change modified after Sanvido et al. 2005

13 A PMEM plan in the EU should (1): be on a case-by-case basis take account of the characteristics of the GMO, its intended use and the range of environmental conditions include general surveillance and (if necessary) case-specific specific monitoring facilitate systematic observation of the release in the receiving environment and interpretation of safety for human health and the environment

14 A PMEM plan in the EU should (2): identify who will monitor, who is responsible for plan s executionandhow and at what intervals events will be reported consider the mechanisms for identifying and confirming any adverse effects ects enable the consent holder or competent authority to take measures to protect human health and the environment

15 Case-specific specific monitoring of Bt maize in Spain ( ) With thanks to: Esteban Alcalde, Syngenta Spain Felix Ortego, Centro de Investigaciones Biologicas Lucia Roda, Ministry i of the Environment and Rural and Marine Affairs

24 General surveillance of Bt maize (MON810) in Germany Thanks to Detlef Bartsch Bundesamt fuer Verbraucherschutz und Lebensmittelsicherheit (BVL), Germany

25 Cultivation area MON Hectares Year

26 German GMO Location register

27 GM Location Register Technical Details Frontend: 100% open source Java Web Application (free) Runs on all common Browsers Requires JEE5 Application Server Multi Language support Backend: Database: Oracle 10g + Oracle Spatial Extension (commercial) Outlook: Oracle independent open source geo web server (beginning 2009) Contact: JANA.STORCH@BVL.BUND.DE

28 Post-release monitoring of GM crops in the EU Development of PMEM plan for MON810 Developed by consent holder (Monsanto) in discussion with stakeholder representatives ERA of MON810 suggested a negligible risk for non-target organisms But limited number of existing potentially useful monitoring systems for General Surveillance Selection from draft list based on key protection goals Disproportionate to expect CH to establish new surveillance systems

29 General Surveillance MON810 - Strategy Data and expertise : where possible use public information from existing monitoring systems (raw data helpful). Expertise (to assess unusual effects) is located primarily inside these systems Surveillance of protection goals : unusual effect observed? check whether adverse. If adverse check whether correlation with GMO. If yes, take measures Reporting obligation : Yearly about monitoring activities. Every three year detailed analysis. Immediately in case of adverse effects observed EFSA 2006 (PMEM Opinion)

30 Evaluation of surveillance systems for Germany by Monsanto Pro otection goal Water Biodiversity Human Health Animal Health Soil Plant Health Regionale Programme Länder- Programme ÖFS Natur- und Artenschutz Arbeitnehmerschutz Gewässergüte Nachhaltigkeitsindikator Biodiversität Wildtiere Bienen Singvögel Libellen Umweltprobenbank Lebensmittel-Monitoring Futtermittel-Monitoring/VDLUFA Wildtier Fütterung Bienenvergiftungen Bodendauerbeobachtung Bodenanalysen/ VDLUFA Umweltprobenbank PS Service/ISIP WG Resistenzen FFH Greifvögel/Eulen l Schmetterlinge Brutvögel Sortenprüfung / scientific lite erature / farme er / stewardsh ip programs Sustainable Agriculture PSM Umweltindikator System Standortregister Sortenprüfung Region Federal Länder Germany Europe Qu uestionnaires Spatial allocation

31 Surveillance systems selected by Pro otection goal Water Biodiversity Human Health Soil Plant Health Monsanto Game animals Bees Soil Monitoring Plant health inspection Lepidoptera Breeding birds er / stewartsh ip programs / scientific lit terature / farm Sustainable Agriculture Environmental indicator system GMO location register Region Federal Länder Germany Europe Questionaires Spatial allocation

32 German Bee Monitoring Bee Monitoring project helps to determine the cause of the periodic observed loss of bee populations. Data collection: Site specific data (climate, flower & nectar availability, plant protection measures) Development and health of bee colonies

33 Monitoring of Common Breeding Birds Task: Monitoring of trends for detecting serious and persistent population changes in time. If detected, in depth analyses and measures can be initiated to prevent loss of specific c breeding birds Intended monitoring at 1000 sites starting dda web de

34 German Butterfly Monitoring Task: Monitoring of the long-term development of specific butterfly species to quantify the reduction. Butterflies are used as indicators for landscape changes in the environment. Volunteer experts contribute to monitor 400 transects in Germany.

35 General Assessment of MON810 plan The 8 identified surveillance systems address the protection goals listed in the MON810 plan There is room for improvement but the plan is adjustable to new conditions The German CA BVL is of the opinion that the monitoring plan and the national implementation is currently satisfactory (cultivation ceased in 2009) (Thanks to Detlef Bartsch)

36 Some concerns about post-release monitoring especially general surveillance Ecological monitoring linking the change to a cause (especially population change) General vigilance and looking for unknown unknowns (no hypothesis) Judging the adversity of effects Why GS for GM crops only? More risks? Negative externalities the effects of the extra burden on marketing

37 Some concerns about post-release monitoring especially general surveillance Ecological monitoring linking the change to a cause (especially population change) * limits to detection (of biodiversity change) > statistical problems with small pops p > the changing baseline comparator * limits to understanding (the biological significance of observed changes)

38 What it.can provide Case Specific Monitoring (Scientific-experimental experimental character) Confirmation or rejection of a previously formulated hypothesis Draw conclusions on the cause of detected changes General Surveillance (Surveillance, no experiments) Provide information on the state of the environment Provide basic data to forecast the likely development of the environment.can not provide Draw conclusions on the long term development of the environment Determine the cause of an environmental change modified after Sanvido et al. 2005

39 Variance and scale-dependence Variability Parameter r to be mo onitored Mean frequency Deviation from mean frequency Time

40 Populations of wild birds (UK):

41 Farmland biodiversity Driven by concerns about exacerbating the decline in farmland bird populations leading, in April 1999 to the Farm Scale Evaluations of 3 HT crops

42 UK Farm-scale Evaluations of GM HT crops

43 The Farm Scale Evaluations of GMHT crops A huge study (60+ paired fields, X 3-4 years, $6-10m) of comparative herbicide management regimes for 3 arable crops Clear and consistent effect on abundance of infield weeds and range of invertebrates GMHT OSR and beet had fewer weeds, seeds and weed- dependent species (e.g. butterflies, true bugs, seed eating beetles) than conventional counterpart. But springtails and their predators more abundant GMHT forage maize had higher weed density and biomass than conventional, and more butterflies and bees Rejected null hypothesis of no change but between-crop differences in biodiversity greater than between GMHT and conventional pairs See Phil. Trans. Roy. Soc. B, 358, No. 1439

44 Post-release environmental monitoring of GM crops Comparing crops Treatment Conventional GMHT Crop SOSR WOSR Maize Beet winter crops spring crops 0.25 decreasing biodiversity 27% varianc ce a/c is 2 PCO Ax increasing biodiversity PCO axis 1 58% variance a/c

45 CHANGES IN BIODIVERSITY ATTRIBUTABLE TO THE DEVELOPMENT OF AGRICULTURE Natural and semi-natural populations Biodiv versity Unplanned populations (weeds etc) Planned populations (crops etc) 10,000BC 1900 AD Today Redrawn from Edwards & Hilbeck, 2001

46 Changes in grassland management ( ) 1990) Inorganic N Livestock sheep cattle Year Year Hay? Silage? Year?? Year

47 Post-release environmental monitoring of GM crops Post Biodiversity losses due to GM are likely to be relatively small and can probably be managed managed (1999)

48 Thank you for your attention ti

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