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Proceeding of the 4 rd International Symposium“NEW RESEARCH IN BIOTECHNOLOGY” USAMV Bucharest, Romania, 2011PROJECT MANAGEMENT AND MONITORING PROCEDUREOnce the environmental risk (assessment endpoints and testable hypothesis) arecharacterized, the next phase is project management and monitoring. A sound governancestructure is essential for successful PCM. A principal investigator would coordinateplanning and execution of the study. It would be prudent to have national and internationaladvisors to provide expert advice on all aspects of the PCM program.a) THE MONITORPakistan has a long history of conducting field and farmer surveys by public researchers orextension workers. However the same level of cooperation between farmers and employeesof the technology developers may not be as forthcoming because of perceptions of bias ortrust.In Pakistan, neither the regulator i.e. National Agriculture Research Council (NARC) northe technology developer multinational companies has the expertise or infrastructure toconduct PCM. Much more importantly real or perceived conflicts of interests should beavoided by having public academic lead PCM, not the developer with a vested interest inthe commercial success of the GM crop or the regulators that approved the unconfinedenvironmental release of a GM crop; because there is the risk of bias in validating theiroriginal decision.Public academia should have access to these protocols directly from NARC as a conditionof the regulatory process for a genetically modified crop (GMC). Without these molecularprotocols it would be impossible to confirm the presence of a transgene of interest in GMcrop populations.b) THE FINANCERCost sharing should reflect the value of the information to private developers, the publicgood and the policy development. Technology developers should bear the majority of costsbecause they gain the major financial gains through seed or pesticide sales. A 20 yearspatent on the technology ensures a monopoly for that duration and an acceptable rate ofreturn on investment. Moreover results from the PCM provide technology developers withnew information to help farmers adopt best management of GMCs and optimize economicbenefits.c) SPATIAL SCALEDepending on the size of the risk being monitored or regional scale of GM crop cultivation,multiple monitoring sites with different eco-regions will be required to determine thevariation in magnitude of measured variables. Data often would be collected in cultivatedfields, field borders margins, and/or adjacent ruderal or natural areas for areas adjacent toGMC cultivation, pollen flow and seed dispersal distances will influence the spatial scale ofmonitoring.d) TEMPORAL SCALEThe duration of PCM should generally be 5 years from time of market release and widespread cultivation of a GM crop (Kjellsson and Strandberg, 2001).The responsibility ofpossible longer term (5 yrs) PCM to detect potential interactive or cumulative GM crop20
Proceeding of the 4 rd International Symposium“NEW RESEARCH IN BIOTECHNOLOGY” USAMV Bucharest, Romania, 2011specific effects (e.g. invasiveness) should lie with a reporting network of trained observers.Existing personnel in agriculture (extension specialists), environment and natural resourcemanagement could constitute a reporting network after receiving training in recognizingspecial ecological effects of GM crops.e) DATA COLLECTIONA plethora of data will be collected from PCM. Quality control is essential in data entry,storage compilation and analysis. A common template for standardized data entry usingcommon or comparable database software will facilitate efficient data compilation andmanagement. Graef et al., (2007) stressed data harmonization and coordination among allstakeholders for ensuring data quality and comparability. Given the significant costs incollecting PCM data, it is imperative that proper checks and balances are in place forprofessional data base management.f) DATA ANALYSISBoth univariate and multivariate statistics are employed for data analysis. Because datavariability is inheritability greater in the field or landscape scale experiments than smallplot research, the type I error rate in univariate statistical analysis is generally greater than0.05—typically 0.10-0.20.A statistician specialized in analyzing large data sets fromfield/landscape research is an integral part of the PCM team.g) DATA EVALUATIONAfter the data are statistically analysed a final report will be written and scientificpublications submitted for peer review. Technology developers should not be allowed torestrict or impose conditions in legally binding agreements on contents of reports or peerreviewed publications. The full results must be made available in a timely manner to thescientific community and society at large. A transparent system is essential for allayingconcerns that any perceived environmental risks are being trivialized.THE REGULATORY DECISIONThe results of the data analysis to confirm or refute the hypothesis will dictate the decisionby National Biosafety Committee (NBC). Once a decision is made it must be conveyed toall stakeholders particularly farmers via means of mass communication. Once the PCM of aGMC is terminated, a cost benefit analysis conducted by the third party may improve theefficiency and effectiveness of future PCM activities. A model monitoring Plan for theEnvironmental management of commercially approved GM crops in Pakistan is presentedbelow (figure 1).Sites for the GMC invasiveness would be established in all crop growing areas mostly inPunjab and Sindh where GMC and non GMC crops are mostly adopted by the farmers. Foreach site, monitoring will terminate at the end of study period. If the effect size wasexceeds at a site; monitoring may continue for two more years. The life span of the cropmay influence the temporal scale of monitoring. In addition, the adoption rate of the GMcrop may also influence the duration of monitoring. Here a model monitoring plan isdesigned for GM cotton in Punjab (table 1).The selection of baseline for comparative risk assessment is important. In case of cottoncrop in Pakistan, as the pest control measures are of practical relevance so the consumptionrate of pesticides in transgenic versus non transgenic crop cultures can make a baseline as arisk assessment factor.21
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