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Implementation of General Surveillance for Amflora Potato Cultivation – Data Management

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Implementation of General Surveillance for Amflora Potato Cultivation – Data Management J. Verbr. Lebensm. 2 (2007) Supplement 1: 70 – 71 1661-5751/07/050070-2 Journal für Verbraucherschutz und Lebensmittelsicherheit DOI 10.1007/s00003-007-0240-5 Journal of Consumer Protection and Food Safety © Birkhäuser Verlag, Basel, 2007 Implementation of General Surveillance for Amflora Potato Cultivation – Data Management C. Wandelt BASF Plant Science Holding GmbH, Agricultural Center, 67117 Limburgerhof, Germany Received: August 1, 2007 Key words: General surveillance, cultivation, closed-loop sy- 2. Starch potato Amflora stem, farm questionnaire, potato. The GM plant to be cultivated is a potato variety with an in- Abstract: The potato variety Amflora, a starch potato with an creased amylopectin content in tuber starch compared to increased content of amylopectin in tuber starch, is close to be conventional potato tubers. The mother variety, a starch po- approved within the EU under Directive 2001/18/EC for cultiva- tato variety, was transformed with a construct carrying a tion and processing into starch for industrial uses. General sur- fragment coding for the granule bound starch synthase in veillance as outlined in the monitoring plan for Amflora details antisense. As a result of the genetic modification the expres- approaches, methods and responsibilities proposed to be used sion of the endogenous granule bound starch synthase, res- within the frame of a closed-loop cultivation system. This system, ponsible for the biosynthesis of amylose, is inhibited thereby also referred to as an identity preservation (IP) system, con- leading to an increase in the branched starch component stitutes an important management tool in order to preserve the amylopectin (>98%) in the tuber. Unique qualities are at- unique characteristics and the value of the potatoes modified tributed to this special type of almost pure amylopectin potato for an increased amylopectin content in the tuber. Elements of starch. the IP system, for example the farm questionnaire will be used as a basis to collect relevant data on plant growth, characteristics 2.1 Closed-loop system – Identity preservation system and treatments as well as to record general observations per- Starch potato cultivation and starch production under the EU formed by the grower during cultivation and will thus allow for quota system operates in a closed-loop system. Similarly the monitoring for any unanticipated or unforeseen effects during unique quality of the Amflora potatoes is secured via applying cultivation of amylopectin potatoes in the agricultural envi- an identity preservation system (IPS). BASF Plant Science (BPS) ronment. manages and is accountable for the system and within the closed-loop system or IPS BPS is the owner of all seed potato material. Seed potato multiplication is contracted out to 1. Introduction breeders. A contract between BPS and starch processors hands over ownership over the certified seed potatoes to the starch Amflora, a genetically modified (GM) potato, is awaiting its processor, which, based on the starch quota system, contracts approval according to Directive 2001/18/EC for cultivation and the production of starch potatoes out to growers. Growers processing. The required steps in order to prepare for market under contract by the starch processor are reimbursed accor- introduction are taken and respective stakeholders in this ding to the quality and quantity of Amflora starch potatoes process have been addressed. More specifically, plant variety delivered to the starch processor, who then produces the rights are secured, plant variety registration will come into starch. A comprehensive set of measures contained in the IPS force after the consent for cultivation is obtained, seed multi- plan ensures that the identity and quality of the Amflora starch plication is in preparation in collaboration with growers and potatoes is preserved. starch processors, and customers, after having experimentally tested the product in diverse applications, are awaiting the marketing approval. Preparations also include the first steps 3. General surveillance – Approach towards implementing post-market monitoring as specified in the decision by the Commission. “An unanticipated adverse effect is most likely to occur where the level of environmental exposure is highest. Thus, an eva- luation of how and where the GM plant will be grown and the Implementation of General Surveillance 71 associated environmental exposure is considered a good previous crop, planting, fertilisation, crop protection mea- starting point in any general surveillance plan” (EFSA, 2006). sures), harvest (e.g. yield, quality, destination of harvest), The objective of general surveillance as defined in Directive general observations during cultivation (e.g. weather condi- 2001/18/EC is to identify the occurrence of adverse effects of the tions, soil fertility, plant development, disease and pest pres- GMO or its use on human health or the environment, which sure), general observations post harvest (e.g. volunteer ma- were not anticipated in the environmental risk assessment. In nagement) and any unusual observations. System test-runs implementing general surveillance the different parameters were performed with conventional starch potatoes in the are observed. The monitoring measures will focus on the cul- Czech Republic in 2005 and in Germany in 2006. tivation of the GM plant, whereby the approach is determined case-by-case taking into account the characteristics of the GM 4.2 Data acquisition, analysis and quality assurance plant, the scale of the release and the type of intended use. The data from the field-plot index cards representative for the General surveillance will be conducted in those environments range of cultivation regions will be collected, whereby the that are representative for the commercial release of the GM number of available datasets will be determined by the scale of plant. If possible use will be made of existing national sur- cultivation, but should be sufficient in number to achieve veillance systems. statistical power. Growers’ experience in cultivating starch potatoes will serve as baseline. Observations by extension 3.1 General surveillance – Closed-Loop System services during seed potato production will complement data The identity preservation system for Amflora is based on an acquisition. Further analyses of general surveillance data existing system that ensures quality and quantity control for based on the farm questionnaire will be available for inspec- starch potato production in the EU under the starch quota tion by the relevant competent authority. system. The participating farmers are under contract to cul- tivate seed and starch potatoes. They are operating with forms 4.3 Data administration and reporting and field-plot index cards in order to ensure traceability and The data are administered in a database set up and managed quality of the Amflora potato production. The processors by the consent holder and combines the input from the res- contract out the production of starch potatoes meeting spe- pective networks, e.g. seed potato producer – extension ser- cific quality and quantity requirements. They are operating vice, grower – starch processor. The general surveillance plan with forms and standard operating procedures. Thus the clo- for the Amflora potato foresees annual reporting on the de- sed-loop system allows to set a framework for general sur- scriptionACHTUNGRE of the monitoring activities, the results of monito- veillance: (a) It determines responsibilities and operating ring, and adaptations, if applicable, to the monitoring design. procedures, (b) it enables training, observation, recording and The recipients of the annual reporting will be the competent reporting, (c) it facilitates comparison to routine experience authority and the EU Commission as specified in the consent (baseline) and (d) it allows for auditing of the entire process. for cultivation. In the unlikely event of any unanticipated ad- verse effects, these will be reported immediately to the com- petent authority of the rapporteur member state and to the 4. Approach to data management competent authority of the member state where the effect was observed. Data management comprises the following elements: data acquisition (by the grower and starch processor), data analysis (statistical evaluation and verification), data quality assurance 5. Conclusion (certification and audits), database administration and data reporting (annual/immediate reporting). Different cultivation systems can address the obligation of environmental general surveillance for GM plants in the EU. 4.1 Data acquisition – Field-plot index cards One such system is the closed-loop cultivation system for the The field-plot index cards serve as a ‘farm questionnaire tool’. Amflora starch potato. The system is well positioned to provide This tool is routinely used by the growers under contract. the framework for general surveillance, with regard to re- Therefore familiarity with this system is already well esta- cording of any observations and as a basis for audit and re- blished. Further the grower is best positioned to complete the porting and thereby addresses the regulatory requirements for questionnaire to make observations and identify any unex- general surveillance. The harmonized approach of using the pected effects. The unique experience allows the grower to farm questionnaire tool for general surveillance is applicable. judge what is unexpected compared to the normal. The type Data management is sufficiently comprehensive and robust and range of information collected in the field-plot index cards since it is based on existing systems. or farm questionnaire includes: the agricultural practice (e.g. To access this journal online: http://www.birkhauser.ch/JVL.
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