1 Environmental Monitoring For the import of oilseed rape from event T45 (ACS-BNØØ8-2) for food, feed and industrial uses 1. Introduction Authorisation holders have the obligation to implement, if appropriate, a GMO monitoring plan for Environmental Monitoring according to Articles 13(2), 19(3) and 20 of Directive 2001/18/EC and in particular Annex VII of this Directive. As stated in Annex VII, the objective of the monitoring plan is to: Confirm that any assumption regarding the occurrence and impact of potential adverse effects of the GMO or its use in the e.r.a. [environmental risk assessment] are correct, and identify the occurrence of adverse effects of the GMO or its use on human health or the environment which were not anticipated in the e.r.a.. Annex VII is supplemented by Council Decision 2002/811/EC, which establishes guidance notes for the design of monitoring plans. 2. General The scope of this application is the import of grain derived from ACS-BNØØ8-2 for food, feed and industrial uses, similar to conventional commodities of non-gm oilseed rape, excluding cultivation. The commercialization of T45 oilseed rape seeds in third countries was stopped after the 2005 planting season and this event is currently being phased out. Therefore it will only be present in low level in the imported commodities. As there are already existing monitoring programs developed for the import of GM Canola from North America the same recommendations are applicable for ACS-BNØØ8-2. Based on the conclusions of the environmental risk assessment (e.r.a.), monitoring can address the identified potential risks of the GMO to human health or the environment on a case-by-case basis, and confirm the related assumptions in the e.r.a. This is referred to as case-specific monitoring. The identification of potential adverse effects of the GMO on human health and the environment, which were not anticipated in the e.r.a., can be addressed under the general surveillance. As there are other technology providers for GM oilseed rape and the shipments entering the European harbours might be co-mingled, i.e. might contain other GM oilseed rape event(s) than the ACS-BNØØ8-2, it is essential to develop a monitoring principle with an industry wide approach. 3. Interplay between environmental risk assessment and monitoring The scope of this application is the import of grain derived from ACS-BNØØ8-2 for food, feed and industrial uses. The only potential environmental adverse effect associated with import could be the establishment of feral herbicide tolerance oilseed rape populations with a possible outcross of the herbicide-tolerance to commercial oilseed rape fields or to wild Brassica relatives, if imported grain is spilled in transit. These transit areas are predominantly situated in seaport harbours or along the River Rhine, as most oilseed rape crushers plants handling overseas imported grains are situated in these areas. The EU
2 crushing industry is HACCP compliant and the three large operators who dominate the local processing industry are at various stages of ISO implementation. Therefore systems are in place that describe the procedures to be followed, including environmental procedures and how to deal with them, ensuring that compliance is assessed at regular intervals by independent control bodies. Consequently operators are trained to avoid or minimize spillage and to ensure that spills are cleaned up promptly as the adverse consequence can be very costly in terms of fines and the revocation of operating licenses. In the unlikely event that spillage, germination and flowering of a GM derived oilseed rape plant occurred in the ports and associated crushing plants, their location in industrial areas makes it highly unlikely that gene transfer to non-gm Brassicae would occur. These areas usually do not support oilseed rape growth or their wild relatives. No risk is to be expected in these areas because there is no selective advantage expected for herbicide-tolerant crops as long as the herbicide glufosinate ammonium is not used. If herbicide-tolerant oilseed rape were to spill at the port or along the roadside or at a crushing facility, it is unlikely that it would establish herbicide-tolerant feral oilseed rape population or herbicide-tolerant wild relatives. The consequences of spillage would be the same as for any other oilseed rape. The only difference, tolerance to the herbicide glufosinate ammonium, would not provide a survival advantage as long as the herbicide glufosinate ammonium is not used in an attempt to destroy any volunteer plants that might germinate. Due to the limited exposure, and this only at import facilities or processing plants, it is unlikely that a possible spill of ACS-BNØØ8-2 will have any influence on human or animal health or the environment. The GMO Panel has carried out the scientific assessment of the genetically modified oilseed rape T45 and considered that T45 oilseed rape is unlikely to have adverse effects on human and animal health or on the environment in the context of its intended uses. 4. Case-specific GM plant monitoring The GMO Panel evaluated the environmental monitoring plan proposed by the authorization holder and considered that there is non need for a case-specific monitoring since no adverse effects were identified. The monitoring plan consisting in a general surveillance plan is in line with the intended uses for the GMO. 5. General Surveillance of the impact of the GM plant The scope of this application is the import of oilseeds and derived products of ACS-BNØØ8-2 for food, feed and industrial uses, and no authorization for cultivation is requested in the Member States of the European Union. The EFSA Guidance Document describes the approach and principles of the General Surveillance for GM plants intended for import and processing only. According to this Guidance the authorization holder has to show that environmental exposure will be at levels or in a form that does not present a risk to other living organisms or the abiotic environment, through monitoring of substantial loss, spillage and establishment. The general surveillance will be focused on those domains involved from import to crushing facilities. The essential elements of the surveillance plan are:
3 i. By its nature, the prediction of unanticipated adverse effects does not lend itself to the formulation of a clear scientifically valid testable hypothesis, or the identification of those factors most likely to be adversely affected by the GM crop. In order to allow detection of the broadest possible scope of unanticipated adverse effects, the general surveillance should be performed by either selected, existing networks or organisations and/or by specific company monitoring programmes. ii. The best possible chance of detecting an unanticipated adverse effect would be ensured by having an adequate number of people, with relevant experience, involved in the surveillance process. It follows, therefore, that those persons or organizations normally involved in the receiving environment and human and livestock health, will be in the best position to participate in a general surveillance plan. iii. While the principles for the entire EU should be the same, the intensity of surveillance activities is unlikely to be the same in each of the different EU countries since, for example, certain GM crops may not be imported, processed and used in all Member States. Instead, the approach to surveillance should include the concept of general observation in representative environments and should be responsive to indications of possible adverse effects. Finally, the availability, extent and composition of existing networks in the different EU countries could have a direct influence on the existence and availability of baseline and surveillance information. iv. Where there is valid evidence of a potential adverse effect (whether direct or indirect), linked to the genetic modification, then further evaluation of the consequence of that effect should be science-based and compared with baseline information. In many cases it may not be possible to establish a causal link between a potential adverse effect and use of a particular GM crop. v. The surveillance plan should be focused and should not attempt to include all research, stewardship or other programmes ongoing during the commercialisation of the GM crop. It is recognized that independent research and other programmes will be undertaken which are not associated with the detection of unanticipated adverse effects. Implementing General Surveillance. Upon approval of ACS-BNØØ8-2 in the EU, the authorization holder shall inform the operators and users concerning the safety and general characteristics of the product and of the conditions as to general surveillance: Inform European operators, especially traders and processors of bulk mixtures of oilseed rape grain, that ACS-BNØØ8-2 has been authorized in the EU for import and use thereof as any other oilseed rape, excluding cultivation in the EU; Supply European operators, especially traders and processors of bulk mixtures of oilseed rape grain, with information about ACS-BNØØ8-2 products and their safety in accordance with the requirements of Directive 2001/18/EC, relating to the Placing on the Market of the GM crop; Inform European operators involved in the import of oilseed rape grain that labelling of products for the European market must be executed in accordance with article 4 and 5 of Regulation (EC) 1830/2003 of the European parliament and of the Council of 22 September 2003 concerning traceability and labelling of GMOs and traceability of food and feed products produced from GMOs and amending Directive 2001/18/EC;
4 Supply European operators involved in the import of oilseed rape grain with the Unique Identifier Code: ACS-BNØØ8-2; Review with European operators involved in the import and processing of oilseed rape grain the existing measures to minimize grain spillage and clean-up practices in the frame of good manufacturing practices and environmental management systems already in place for crushing facilities and ports in the EU; Invite European operators involved in the import and processing of oilseed rape grain, to provide regular feedback on the general surveillance; Request from European operators involved in the import and processing of oilseed rape grain, to report in timely fashion any unanticipated adverse effects associated with the use of the product, so that decisive (if necessary remediating) action can be taken, including risk-reducing measures; In addition, the authorization holder experts will actively screen for information on the product which could be publicly available on the web or published in literature and to inform the Commission in case adverse effects will be reported, in particular with respect to human, animal and/or environmental safety; Provide to European operators involved in the import and processing of oilseed rape grain, the reference to the Register: In addition, further information on the product and relevant legislation shall be available from a number of sources, including industry and government websites, official registers and government publications. Inform operators that the possibility of and consequences arising from accidental spillage of T45 oilseed rape have been evaluated by the European Food Safety Authority (EFSA) in the context of its intended uses and maintain regular contacts with operators to ensure that they are informed of any changes to current practice which may change the conclusions of the environmental risk assessment; Ensure that operators are alert to the possibility that accidental spillage of imported oilseed rape grains in ports and crushing facilities may result in the germination and establishment of volunteer plants, including T45 oilseed rape; In the event that volunteer oilseed rape plants include T45 oilseed rape, inform operators that these plants should be eradicated to minimize the potential for unanticipated adverse effects arising from T45 oilseed rape and provide operators with appropriate plans for eradicating volunteer oilseed rape plants including T45 oilseed rape. The Post Market Monitoring will be executed in analogy with already existing monitoring recommendations for imports of current commercial available GM oilseed rapes in North America (GT73 and MS8/RF3). Primary sources of surveillance information The primary source of surveillance information will be the network formed from the federations involved in oilseeds import and processing.
5 These federations present the major international groups as well as many small firms. This network of companies operates across the European Union and cover the majority of the oilseeds handling and processing activities. One of the federations providing information on General Surveillance is FEDIOL. FEDIOL represents the interests of the European seed and bean crushers, meals producers, vegetable oils and producers/processors. FEDIOL members amount to 80% of the EU industry and is composed of 147 oilseeds processing and vegetable oils and fats production facilities across Europe, employing approximately 20,000 people. In 2005, FEDIOL members crushed 30 million tons of oilseeds a year, what makes of FEDIOL one of the largest oilseed crusher federations worldwide. With a production of 9 million tons of vegetable oils and a further processing of 13.5 million tons (including imported oils), the FEDIOL members serve the second largest world market of vegetable oils after China. FEDIOL members also produce 20 million tons of meals supplying the largest world meal market (52 million tons). Another federation involved in providing information is COCERAL. COCERAL is the representation of the cereals, rice, feedstuffs, oilseeds, olive oil, oils and fats and agrosupply trade in the European Union. The members of COCERAL are the national trade organisations of most of the EU-27 Member States, who for their part represent collectors, distributors, exporters, importers and agribulk storers of the above mentioned commodities. The members are essentially composed of private traders and in some countries also farmers' cooperatives. COCERAL members are collecting cereals and oilseeds from EU farmers and selling them to the first processing industry. All imports of cereals and feedstuffs are carried out by COCERAL members This represents some 10 million tons of cereals and some 36 million tons of feedstuffs, most of them derived from soybeans, rapeseed, sunflower, maize and cotton. These products arrive in the EU by sea and transit through sea-port silos. The European association representing these sea-port silos is UNISTOCK and is also a member of COCERAL. To meet the requirements of the Traceability and Labelling regulations, shipments of oilseeds derived from genetically modified plants will be identified as such in the invoice and import documents. The industry is experienced in tracking shipments with full documentation of the origin of the oilseeds. Experience has shown that this network ensures a continuous and efficient communication link from the exporter to the importer/processor, especially in relation to complaints about oilseed quality parameters. Thus, they would provide a key surveillance network for possible adverse effects. This network, whose day-to-day work gives them regular experience of this environment, is best suited to surveillance of the broader receiving environment in which the oilseed derived from a GM plant is imported and processed. Other sources of surveillance information Although not a formal part of the surveillance plan, it is appropriate to note that there is an extensive information network, with global reach, which will provide additional information on possible unanticipated adverse effects arising from the use of GM crops. These include new and rapid means of access to information from across the globe through telecommunications, the media and Internet access. Through these means, many groups, including agronomists, ecologists, health professionals, and the general public now have unprecedented access to reports on the use world-wide of GM crops. In addition, electronic discussion sites, for example those of WHO, OECD, FAO, and consumer organisations, are valuable sources of information and communication for professionals and, in many cases, the general public.
6 Information collection and analysis Surveillance information will be collected from two primary sources: 1. Feedback from selected networks can be gained by an active surveillance in collaboration with organisations and/or federations. In this respect the authorization holder works in agreement with the GM industry dealing with oilseed rape. This process of information sharing and feedback with the operators is coordinated by EuropaBio. As there are other authorisation holders for GM oilseed rape it is essential to develop an industry wide approach because the shipments entering the European harbours could be co-mingled. First, the information on the GM product will be made available to the operators before the initial placing on the market (first import) on the EuropaBio website. Besides the product briefings and technical literature to the operators, the website of EuropaBio can also be used to give specific information (for example not to apply a glufosinate ammonium herbicide when oilseed rape populations are found in harbours or around processing facilities). Secondly, in addition to the distribution of information to operators, EuropaBio also plays the crucial role in collection the information recorded by the operators in relation to monitoring. In order to get an efficient and coordinated feedback from all involved operators a centralized approach is essential. The biotech industry has worked with the operators, responsible for placing agricultural commodities on the EU market, to develop a workable system for implementing general surveillance; operators have formally agreed to report to the authorisation holder any observed adverse effect of GMOs on human health and the environment. EuropaBio is responsible for the coordination of the system, which ensures that authorisation holders are provided with the information requested to compile monitoring reports, as foreseen by the GMO legislation. 2. Ongoing record keeping of reported potential adverse effects and other relevant information received via direct contacts with the authorisation holder. The authorisation holder shall be in the position to give evidence to the Commission and the competent authorities of the Member States: That the monitoring networks as specified in the monitoring plan collect the information relevant for the monitoring of T45 oilseed rape; That the members of these networks have agreed to make available that information to the authorisation holder before the date of the submission of the monitoring report. Evaluation of potential adverse effects Where scientific evaluation of the observation confirms the possibility of an unanticipated adverse effect, this would be investigated further to establish a correlation, if present, between the use of the GM crop and the observed effect. The analysis should consider the consequence of the observed effect and remedial action, if necessary, should be proportionate to the significance of the observed effect. 6. Reporting the results of monitoring Responsibility The authorisation holder is responsible, under the Regulation, to inform the Commission on the results of the surveillance effort and on the results of the monitoring concerning the presence of T45 oilseed rape.
7 This report shall clearly state which parts of the report is considered to be confidential, together with a verifiable justification for confidentiality in accordance with Article 30 of Regulation (EC) No 1829/2003. Confidential parts of such report shall be submitted in separate documents. Information that does not change the risk assessment. Frequency Direct and immediate effects refer to primary effects on human health and the environment that, if they occur, are likely to be observed during the period of authorisation of the GM crop. Therefore, it is proposed to submit a general surveillance report on an annual basis, following the initial placing on the market (first import). A final report will be made at the end of the authorisation. Indirect effects refer to a causal chain of events with an effect on human health and the environment. Observations of indirect effects might, in some cases, be delayed. Since surveillance will also include the observation of potential indirect and/or delayed effects, a report covering potential indirect or delayed effects, if any, should be included on a yearly basis as it is proposed for the direct/immediate effects, following the initial placing on the market (first import). A final report will be made at the end of the authorisation. Results concerning the monitoring on the presence of T45 oilseed rape will be submitted on an annual basis and included in the general surveillance report. Content The authorisation holder will submit a General Surveillance Report containing information primarily obtained via the reporting of the operators by EuropaBio, not excluding information obtained from key external networks. In addition, the report shall include the results of the monitoring concerning the presence of T45 oilseed rape in shipments of oilseed rape imported in the EU. Confirmed potential unanticipated adverse effects Frequency If information becomes available from users or other sources, that clearly indicates an adverse effect that alters the existing risk assessment, the authorisation holder shall immediately inform the Commission in accordance with the terms of the authorization and, if necessary, take proportional measures to protect human or livestock health and/or the environment. Content The authorisation holder will submit a Report, consisting of a scientific evaluation of the potential adverse effect and a conclusion on the safety of the product. The report will also include, where appropriate, the measures that were taken to ensure the
8 safety of human or livestock health and/or the environment. These procedural steps are summarised in Figure 1. Surveillance by different networks Observation and confirmation Notification of the Commission and, where a risk is identified, adoption of measures to protect the environment, or human and/or animal health Report preparation Possible adaptation of the environmental risk assessment and the management plan in collaboration with the Commission Figure 1: Summary of procedures for the observation, analysis, reporting and management of an unanticipated adverse effect
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