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24Proceeding of the 4 rd International Symposium“NEW RESEARCH IN BIOTECHNOLOGY” USAMV Bucharest, Romania, 2011Table 1. Post commercialization monitoring system for ERA of GM cotton in PakistanNo. Step Description123RiskIdentificationAssessmentEndpointsEffectDefinition4 Effect sizeIncreased resistance in targeted lepidopteransComparison of resistant individuals’ i.e. lepidopterous larvae feeding on plantparts of IR cotton.Hypothesis: IR cotton provides LD 99 against target insect species.Minimum and maximum effect will range from 0.1% to 10 % of the populationsize of the crop plants in case of ferals.5 Spatial Scale Cotton growing belt of Punjab especially Southern Punjab6 Temporal Scale789101112Sampling PlanVariableSelectionData collectionData AnalysisDataEvaluationRegulatoryDecision13 Communication An optimum size study consists of the minimum number of assessment endpoints at a given time to make the study economical and time saving. The studywill focus on one assessment end point (max.2) at a time and will commenceafter three years of approval for commercial scale cultivation of the GM crop tolet the GM crop plants and their effects assimilate into the local environment ina variety of growing areas. However, in case of illegal/unapproved cultivation in pockets of crop area, thestudy may begin earlier due to the factors of varied quantity and quality of toxinproduction. At least two crop seasons must go through rigorous assessment. The principal scientific officer will contemplate the sampling scheme withconsultation of the statistician to arrange the variables and border line of thedata to be collected. 50 sites of GM crop and 50 sites of non-GM cultivation are selected (on anaverage) in a province for two years. GM and its comparator will bear the datafor 300 crop years collectively at the end of data collection period. Composite index of insect population size in each habitat—fled margins,ruderal areas, undisturbed grassland area. For insect collection, the number of insects on crop plants per 1m 2 ring afterevery 5 meters distance will be counted in a representative 1 ha area per oneevaluation site.For insects, the variable is the comparative number of insects per 1 ha. area inboth crop types.Weather data for each site compiled from the closes meteorological stationFerals: minimum of 25 1-m 2 quadrate measurements in each of field.For insects data is collected on weekly basis throughout the growing season tillmaturity.Analysis of variance using a mixed model, with site and year considered asrandom effects and treatments as a fixed effect (significance level of P ≤0.10for insects.Repeated measures analysis to detect any changes over time.Means comparison test (t test) to determine if effect size exceeded.Data analyzed within farming system by district and combined data set.Determine the frequency of susceptible and resistant target and non targetinsects in the vicinity.Environmental risk assessment is validated if null hypothesis accepted (effectsize never exceeded).Buffer zones are setup in districts where the nullhypothesis is rejected (effect size exceeded; expand mitigation measure if effectsize is increased into two or more regions over the study period.Decision by the NCB will be communicated to farmers and the public ingeneral in conjunction with the study participants.
Proceeding of the 4 rd International Symposium“NEW RESEARCH IN BIOTECHNOLOGY” USAMV Bucharest, Romania, 20114. CONCLUSIONSFor the ecological management of the released GM event,there is no official mechanism forsystematic post commercial monitoring of GM crops.It is possible that the unwanted flowof transgenes is detected in large scale agriculture that went undetected during preapprovalfield trials because the trials are of relatively small scale and have short duration.There aresufficient assessment criteria for new GM crops before their commercialization.But,becasueuncertainties exist,it is useful to establish some probalistic framework and compareexpected environmental benefits and costs.REFERENCES1. Graef, F., W. Zughart, A. Bezler, F. Berhorn, and U.Sukopp.2007.Monitoringgenetically modified plants (GMP): Data harmonization and coordination on multiplelevels to ensure data quality and comparability.J.Verbr.Lebensm.2(Suppl.):2-75.2. James C: “Global Status of Commercialized Transgenic Crops. ISAAA Briefs No. 24-2011.” Ithaca: International Service for the Acquisition of Agri-Biotech Applications,2011.3. Kjellsson, G.; Strandberg, M. 2001: Monitoring and surveillance of geneticallymodified higher plants: guidelines for procedures and analysis of environmentaleffects. Basel, Birkhäuser Verlag. 119 p.4. Raybould, A. (2006) Problem formulation and hypothesis testing for environmentalrisk assessment of genetically modified crops. Environmental Biosafety Research5,119-125.5. Snow AA, Andow DA, Gepts P, Hallerman EM, Power A, Tiedje JM, Wolfenbarger LL(2005) Genetically engineered organisms and the environment: current status andrecommendations. Ecol Appl 15:377–404.25
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