Ministry of the Environment Environmental Risks Department

The Decision came into force on 121 April 2009.

Prague, April 3, 2009 To Reference Number: 93849/ENV/08

D e c i s i o n

The Ministry of the Environment of the as the administrative body competent according to § 5 of the Act No.78/2004 Coll., on the use of genetically modified organisms and genetic products as amended by the Act No. 346/2005 Coll. (hereinafter the „Act“) and in § 10 of the Act No. 500/2004 Coll., the Administration Code, as later amended,

has decided on the basis of a request of the company BASF spol. s r.o. located in Šafránkova 3, 155 00 Praha 5, for granting consent for the deliberate release into the environment in the Czech Republic of genetically modified (GM) potatoes with modified composition, transformation event EH92-527-1 (Amflora) pursuant to § 5 par. 8 of the Act:

the company BASF spol. s r.o. Šafránkova 3, 155 00 Praha 5

i s g r a n t e d c o n s e n t for the deliberate release

of genetically modified potatoes with modified starch composition,

transformation event EH92-527-1 (Amflora)

into the environment in the Czech Republic.

Requirements of the consent according to § 18 par. 6 of the Act:

Authorised person

1 Name: BASF spol. s r.o., Šafránkova 3, 155 00 Praha 5

Identification Number (I ČO): 41195469

Specification of the genetically modified organism

The genetically modified clone EH92-527-1, of commercial name Amflora derived from the clone P107 with inserted fragment of a gene gbss starch synthase bound on the starch grain in antisense orientation, which causes in the interaction with the promotor of gbss gene the decrease of amylase content and the increase of the amount of in potato tuber starch. Therefore its starch differs from the starch produced by recipient variety only with regard to amylose/amylopectin content. The selective gene for neomycine phosphotransferase II ( nptII or APH(3´)II) from a mobile element (transposon) Tn5 of Escherichia coli inducing the resistance to the antibiotics kanamycin and neomycin during the selection of transformed plant tissue. The transformation was made in a standard way by using the construct tumefaciens in a binary vector system. The genetically modified potato EH92-527-1 (Amflora) differs from conventional potato varieties only with regard to starch quality, and the presence of nptII gene. Agronomic characteristics are within the range corresponding to conventional potato varieties. No differences in interactions with non-target organisms are expected.

Specification of the genetic modification

To transform a potato the strain Agrobacterium tumefaciens LBA4404 with the content of Ti- plasmid pAL4404 was used. The inserted material (insert) is composed of the starch synthase promotor sequence bound with potato granule (990 bp, gbss ) and polyadenyl sequence of nopalin synthase gene (253 bp). The gbss gene segment in the inverted orientation to the promotor was inserted between these two DNA segments. The selective gene nptII (neomycin phosphotransferase II) with the nos (nopalin synthase from Agrobacterium tumefaciens) promotor and the polyadenyl sequence on the line sides were inserted. The insertion of a fragment of starch synthase gene ( gbss) bound with the starch granule (in antisense orientation to the fragment gbss potato promotor causes the reduction of amylase content in the potato tuber starch. It evokes the increase of amylopectin content in potatoes. The selective gene for neomycine phosphotransferase II induces the resistance to the antibiotic kanamycin during the selection of transformed plant tissue.

Risk assessment results

In respect of the manner of propagation, absence of wild compatible varieties in the Central Europe, and no-possibility of running wild, a potato has been considered as a relatively safe plant variety the spreading of which can be kept controlled. In this case the risk for its introduction into the environment lies more likely in the presence of active selective genes. Nevertheless, the gene nptII has been approved generally as safe for GMOs and food prepared from them (see the statement of the European Food Safety Authority – EFSA - of 13 th April 2007.

2 The current potato varieties are very demanding with regard to the agrotechnical conditions. There is no case of long-term survival of the plants in open air. In cold and low temperature conditions the potato plants are immediately contested by many fungal or viral diseases. Both the potato leaves and tubers serving for vegetative propagation are susceptible to frost damage. Due to an absolute absence of the blooming or defoliation of buds, the generative reproduction of the most of varieties is impossible. In many cases the varieties produce a small amount of pollen with the low fertility, often totally sterile. The plant is self-pollinating, and although it is pollinated almost entirely by insect, the flowers are not visited by main pollinators (bees). The creating of fruitages (berries) through the self-pollinating is not very common, and the berries after the earing early defoliate before the grains get matured or in consequence of the harvesting. It causes a significant decrease of the possibility that seeds could survive in soil. The seeds eventually survived loose the ability for germinating when ploughing under the soil into the depths of 0.5 cm. Potato seeds are not spread by birds. Relative species do not occur by nature in the Czech Republic with the exception of S. nigrum and S. dulcamara, with which a potato is not sexually compatible. An occurrence of potato plants run wild has not been observed as well. Not any difference has been observed concerning the survival and persistence in agricultural locations or the agressivity of penetration into the natural environment when compared to conventional potato varieties. A selective advantage or disadvantage does not exist in nature not even in consequence of the decrease of amylase content and the insert of nptII gene for the resistance of plants to the antibiotic kanamycin and other aminoglycoside antibiotics because of none-existence of a selective pressure which could give advantage to the virus carrier. The system can be used only for the selections in vitro conditions. Other selection advantage does not arise of this gene manipulation for potato plants. The both antibiotics have limited or none clinical importance because of the toxicity thereof. The resistance to the both antibiotics occurs in nature much frequently, and the genes of resistance are present in natural populations of microorganisms. The safety of APH(3´)II with regard to human and animal health has been evaluated in the publication series, and it has been also confirmed by quite a few standpoints of the Scientific Committee on Plants and the European Food Safety Authority (EFSA) (FDA, 1998; VIB, 2001; EFSA, 2004). The EFSA Scientific Committee has carried out a detailed risk assessment, and stated that there is no harmful effect caused by genetically modified event EH92-527-1 (EFSA, 2006a; EFSA, 2006b). Tubers are the useful part of the plant. The rigorous control of the content of harmful substances in tubers is carried out in the used varieties, and the limit values for the variety authorisation are determined. The genetic modification above mentioned is not intended to influence the content of harmful substances, and so any changes in the amount thereof are not awaited. Moreover, the tested genetically modified line is not intended for the use as food or feed, and therefore the input of inserted genes into food chains is decreasing to minimum. Agronomic characteristics represent a range of common potato varieties. No changes in the interactions with non-target organisms are awaited. It is expected that possible interactions of genetically modified potato clones with the non-living environmental elements will be comparable with common starch potatoes. The material from field experiments for EH92- 527-1 (Amflora) has been analysed, and it is proved that a starch modification had been stabile during several tuber generations. No other differences between EH92-527-1 (Amflora) clone and common used starch potatoes in the agronomic characteristics in relation to the introduction of potatoes into the environment. Because no changes in the agronomic characteristics are introduced, the lines of genetically modified potatoes show the same properties relative to the environment during cultivation as the comparable commonly used starch potatoes.

3 The request for the marketing of EH92-527-1 (Amflora) clone including the cultivation, has been in the EU submitted under both the Directive 2001/18/EC (request No. C/SE/96/3501) and the Regulation 1829/2003 (request EFSA-GMO-UK-2005-14). In both cases the European Food Safety Authority (EFSA) stated its positive opinion on the supposed use. Field trials with Amflora potatoes under given conditions will have the same impact on the environment as the cultivation of any other potatoes.

Conditions for the use

Genetically modified organisms above mentioned shall be used only in the way described in the request BASF spol. s r.o. located in Šafránkova 3, 155 00 Praha 5, Ref. No. MŽP 93849/ENV/08) submitted to the Ministry of the Environment on December 23, 2008, and supplemented by the submission delivered to MoE on March 10, 2009 (this request relates to the request of the company PROAGRO Radešínská Svratka, a.s., located in Radešínská Svratka 134, 592 33 Radešínská Svratka, Ref. No. MŽP 94262/ENV/08, and only when keeping all given conditions as follows: - The field trials shall not been carried out on the plot in location Svrate čka (a certified planting region). The data on this location are given only in the Annex to the request “Havarijní plán” (Emergency Plan) under point b). - Every handling with the genetically modified organism shall be under conditions minimising a possibility of release into the environment. - The measures taken to set, keep and harvest the field trials, and to use harvested genetically modified potatoes in other way if appropriate, agree with the common precaution rules, and the observance thereof shall fully ensure the safety within the introduction of the genetically modified potato into the environment. - When releasing into the environment the genetically modified potatoes shall not be intended for feeding, and must not be delivered to trespassers and non-trained persons. - In December 2008 the statement of the company Proagro on contained use was submitted. The submission was reasoned by the storage of potato tubers of Amflora harvested in 2008 in the storehouse Pikárec. These tubers were transferred to by the end of March 2009. All the tubers for planting in 2009 will be transported from Germany until the concurrent decision of MoE comes into legal force. Only such imported material can be used which has a certificate of health state of the planting granted by the competent authority. - If the permission for deliberate release of the GM potato event EH92-527-1 (Amflora) into the circulation under the part C of the Directive 2001/18/EC (see the request C/SE/96/3501) is granted before the harvest in the autumn 2009, the field trials shall be carried out just as they are described in that request. In the incoming period the company BASF is free to use the harvested material for the purpose of commercial production of starch in the Czech Republic or seed potatoes in the EU. - In case that in contrary to expectation the permission for the deliberate release of the potato event EH92-527-1 (Amflora) into the circulation is not granted by the autumn 2009, the potatoes harvested in 2009 will be stored in the storehouse of the farm of Pikárec being owned by the firm PROAGRO Radešínská Svratka, a.s. or transported into the starch factory for the purpose of the experimental production of starch or transported back to Germany. The notification of the starch factory on the contained use of GMOs will be submitted even before harvesting. - If the permission is not granted by the spring of 2010, the planting of potatoes shall carry out under the Directive 2001/18/EC, part B, it means the deliberate release into the environment according to law.

4 - Approximately 130 t of tubers will be used, with the seeding density approximately of 40,000 to 80,000 pieces/ha under the common farming praxis according to the size of planting tubers. Thus the total planted area of genetically modified potatoes EH92-527-1 (Amflora) will be every year about 40 ha at maximum. - If a variety Amflora is released into the environment pursuant to the consent issued in the EU, the further planting shall relate to the Act No. 219/2003 Coll. on the marketing of seed and planting material (the full wording of the Act No. 316/2006 Coll. of July 14, 2006). According to this Act the varieties which had not been registered in the Czech or EU Catalogue should not be planted commercially. In such case an applicant shall negotiate with the Department for Seed and Planting Material of the Central Institute for Supervising and Testing in Agriculture (OOS ÚKZÚZ) on the consent for the planting, and on the further development of the testing. - If a variety Amflora is not authorised for the marketing in the EU early in 2010, an applicant shall specify in advance within minimum 60 days before the date of planting, and after discussion with MoE and ÚKZÚZ how will the introduction into the environment go on, and provide information on the experimental plots intended for the planting of GM potatoes in the next years (in the best way in form of the updated part of a request under the Decree No. 209/2004 Coll., part C, point 4: “workplaces and plots, where the introduction into the environment will proceed”, including the enclosed map with a layout of the experimental plot). - The preparation and maintenance of a plot after finishing the experiment shall be in compliance with the common farming practice. - The potato planting material brought by the trained driver accompanied the staff of the company BASF by a camion in the transport sacks of the content of about 1 t, the integrity of which shall be checked during unloading of the vehicle, shall be loaded in the lockable storehouse on the farm Pikárec being owned by the firm PROAGRO, where will be built a special separate building box for GM potatoes (No. 1). - Not any other potatoes can be stored in this storehouse. The entry to the storehouse shall be equipped with the warning board “Trespassers will be prosecuted”, and labelled “GMOs”. The storehouse above mentioned shall be accessible for the control of the stored planting material on request of the seed inspection of ÚKZÚZ and ČIŽP (Czech Environmental Inspection). Amflora potatoes shall be stored in packaging labelled “Genetically modified organism”, “EH92-527.1” and “Not determined for food or feed”. - All the transport shall be realised so that the transport of planting potatoes to given experimental site and the transport of harvested potatoes will be carried out separately from conventional potatoes. The transport shall be timely synchronized so that the time of storage of tubers in the object of potato farm Pikárec before planting would be minimised. - The transfer from the potato storehouse onto the field shall be carried out by truck semitrailer tightly covered with tarp. The truck semitrailer shall be labelled with the boards “Genetically modified organism”, “EH92-527-1” and “Not determined for food and feed”. - The cup planter will be used for planting. On the plot the planting potatoes shall be filled directly into the storage hopper of the cup planter. All the amount of planting potatoes shall be planted directly on given plot. - The used machinery equipment must not leave the place of the experiment until the absence of tubers is checked. - The above-ground green parts shall be destroyed before harvesting either chemically by desiccation or mechanically. The remaining tubers intended for liquidation on the experimental plot shall be mechanically destroyed before shallow embedding into soil, and then treated with nitrogen fertilizer to speed up biological degradation thereof.

5 - The tubers will be harvested using a standard potato harvester. It must be rigorously safeguarded that harvested GM tubers will not be mixed with other harvested tubers. - The tubers of transgenic potatoes shall be immediately after harvesting transported by vehicles signed and covered with tarps into the storehouse of Pikárec. - The agricultural machinery for planting and harvesting shall be after finishing of activities on the plot checked and cleaned from all remaining parts of GMOs. - Every staff member shall clean his working clothes or protective means after finishing work. - The staff will be instructed not to use GM potatoes as food or feed. - The place where the field trial is carried out shall be labelled with sufficient number of warning boards visible throughout the whole periphery of the area planted in order to prevent entry for trespassers. At the every corner of the plot during all the vegetation period the warning board shall be installed with a notice: ATTENTION! GENETICALLY MODIFIED ORGANISM! NO ENTRANCE! TREATED WITH POISON! - In case of the escape of tubers into the environment the affected place must be signed, and the entry of trespassers prevented. All the tubers shall be gathered, placed into labelled lockable packaging, and transferred to the place of disposal. After the disposal of tubers by gathering into packages labelled with a notice:”Genetically modified organism” the place shall be located, and a layout of the place drawn, in order to check possible potato plants arisen on the plot affected like that. - In case of the escape onto the agricultural soil the place must be regularly monitored in order to prevent possible potato plants arisen. If potato plants are arisen, they must be removed using a suitable method (mechanically or spraying with suitable herbicides) under local conditions. The event and measures taken shall be reported, and a local competent environmental authority shall be informed immediately. - When transferring the empty sacks must be always available for emergencies to gather tubers. - For the sake of fire the subjects affected may be considered as depleted of genetically modified organisms. If a part of stored tubers is not affected by fire, it should be carried out and stored in the other lockable space. The management of the company BASF or a professional advisor will decide on further use of the tubers (including transportation for disposal to Germany if appropriate). Further, the management of the fire or accident must follow the Fire Control Regulations of the workplace and the Emergency Regulations. - If potato plants occur at the area where subsequent crop will be cultivated, they must be plucked and liquidated by spraying with herbicide (Reglone). - On the given plot not any potatoes can be cultivated during the period of three years after finishing field trials in order to ensure the monitoring of weedy potato plants and the monitoring of individuals arisen from seeds. The plants which eventually arise should be liquidated by conventional farming practice. To destroy potato plants in subsequent crop the herbicides will be used. It is supposed the method of crop rotation. Every staff member when using GMOs must follow all provisions described in the Operation Rules including the prohibition of consumption and feeding of GM potatoes. - There must be kept exact records on field trials with genetically modified potato in form of a day-book (a separate Vegetation Book) delivered by the company BASF (for example a record concerning all the working operations, state of vegetation and other variances which can have an effect on the environment, all emergencies, measures taken, and subsequent control will be kept and immediately notified to a local competent environmental body). - According to § 19 letter h) of the Act the applicant shall co-operate with the administrative bodies (Ministry of the Environment and laboratories if appropriate) under § 28 and § 31 to § 33 in the monitoring of plots, spaces and facilities intended for the use of genetically modified organisms or plots, spaces and facilities where the use proceeds or may proceed, including the

6 provision of written documents, and whenever during the use enable free of charge sampling of above mentioned genetically modified organisms or the genetic material thereof for control purposes.

Other conditions on the use of GMOs stipulated under § 5 par. 10 of the Act

- The planting proceeds every year in April or May, while the harvesting is supposed in the period from September to November. - To prevent from spreading pollen and tubers when cultivating GM potatoes the minimum isolation distance of 20 m shall be kept from commercially cultivated non-modified potatoes in every phase of the field trial. The place of the experimental release into the environment will be surrounded by agricultural soil. - The applicant is obliged to provide MoE or a dedicated accredited laboratory at any time with requested potato samples from field trials. - According to § 19 letter c) of the Act the applicant shall every year submit data on GM potato production and on the method of use thereof in the preceding calendar year to the Ministry in the written and electronic form always by 15 February of the subsequent calendar year, and according to § 19 letter d) of the Act to forward to the Ministry within 60 days from the termination of the use of genetically modified organisms a final report on the course and consequences of such use, particularly in relation to any risk of hazards to human health and the environment. - Moreover, we draw attention to the obligation of keeping record on planting according to the Act No. 219/2003 Coll. on the marketing of seed and planting material as subsequently amended.

Purpose of the use

The aim of the field trials is to obtain specific experience with agronomic characteristics of genetically modified potato event EH92-527-1 (Amflora) in the Czech Republic, and to evaluate the content and composition of starch in tubers after extraction in the starch factory in both extents the small and large enough so as a sufficient amount of amylopectin starch is gained for an experimental use in the industry. In the field trial the potato plants will be cultivated using common agronomic methods in order to obtain the knowledge about the cultivation in a large extent in the environment of the Czech Republic. There will be pursued characteristics like as the growth of plants, healthy condition, maturity, reactivity to fertilizers and protective spraying, and then the yield and quality of tubers. The contracting partner PROAGRO Radešínská Svratka (see the request 94262/ENV/08) will perform those activities.

Other requirements for labelling

The use of GMO follows common requirements for labelling of genetically modified organism which have been laid down by law. According to the Regulation (EC) No. 65/2004 the unique identification code has been assigned to genetically modified potatoes (Solanum tuberosum L.), event EH92-527-1 (Amflora) as follows: BPS-25271-9. During the whole field trial including storage and transportation all the packaged GM potato materials including transport shall be labelled with the notice „Genetically modified organism”, “EH92-527-1 (Amflora)”, and “Not determined for consumption or feeding either”.

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Place of the deliberate release into the environment

Region – Vyso čina, cadastral territory of municipality Moravec, Cadastral territory Podhorníky (1) Identification No. of the land block 620-1120-9901/6, and cadastral territory Podhorníky (2), Identification No. of the land block 620-1130-9004/21. Cadastral territory Podhorníky (1), the field area of 34.90 ha, the area planted with Amflora is about 34 ha, the cadastral territory Podhorníky (2), the field area of 28.74 ha, the area planted with Amflora is about 10 ha. The total experimental area is 63.64 ha, and the total area planted with genetically modified potato EH92-527-1 (Amflora) will be every year at maximum of 40 ha. The plots are used by the company PROAGRO, a.s., Radešínská Svratka.

Requirements for monitoring and reporting of monitoring results

The monitoring plan has been based on the results of risk assessment related to the environment, and its objective is to observe early and identify the events, which can have expected or non-expected consequences following the deliberate release of modified potato plants into the environment. The monitoring shall be carried out on the site of the experimental release into the environment, and at the same time the non-specific environmental monitoring shall proceed in the vicinity of the experimental areas. Common plant characteristics (UPOV) relating to agronomic behaviour of the event EH92- 527-1, any soil effects and climatic effect (tolerance to frost) shall be pursued under common farming practice, and continuously registered. The occurrence of pests and diseases shall be kept by traditional farming methods, at minimum possible level. In case of an exceptional attack from pests and diseases the variations in behaviour of GMOs shall be reported if occurred. The diaries recording field trials shall be supplemented during the whole period of the deliberate release into the environment. Information concerning unexpected consequential events (for example possible harmful effects on the environment and human health closely related to the line of genetically modified potato) shall be immediately forwarded to competent authorities, and suitable measures taken according to circumstances. The report summarising results of the observation performed during the field trial shall be submitted every year.

Monitoring during deliberate release into the environment Monitoring shall be carried out by a project leader or by trained personnel at minimum in monthly time intervals during the vegetation season, and that is from the beginning of vegetation period (approximately from April to October).

Surveillance after finishing the field trial After the field trial has been finished the project leader or trained personnel shall perform monitoring of the region in monthly time intervals during the vegetation season. The plots shall be after finishing the field trial observed for two years following the last year of the deliberate release into the environment. Then the report on the process of the field trial and results thereof shall be elaborated, and this report shall be sent to the Ministry of the Environment within 60 days from the termination of the monitoring in written and electronic form. Not any potatoes can be planted in the period of three subsequent years on sites where the field trials with the deliberate release of GM potatoes into the environment were running.

8 There can be cultivated only such crops those enable to pursue the occurrence of the individuals arisen from seeds and tubers (corn).

Consent validity time

The validity period of the consent is from 2009 to the end of 2010 .

I n s t r u c t i o n s

Within 15 days from the date of the notice of this Decision there is an opportunity by the submission to the Ministry of the Environment, Vršovická 65, 100 10, Praha 10, to remonstrate against this Decision according to § 152, par. 1 of the Act No. 500/2004 Coll., on administrative proceedings (Administrative Code), whereupon the Minister for the Environment shall decide.

Ing. Pavel Forint Department Director

This decision shall be received by:

A. Participant in the proceedings for personal delivery: BASF spol. s r.o., Šafránkova 3, 155 00 Praha 5

B. For information: 1. Ministry of Health 2. Ministry of Agriculture

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