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Country's Decision or any other Communication
Record information and status
Record ID
115918
Status
Published
Date of creation
2021-02-26 14:59 UTC (hana.jirakova@mzp.cz)
Date of publication
2021-02-26 15:00 UTC (hana.jirakova@mzp.cz)

General information
Country submitting the decision or communication
  • Czech Republic
Competent National Authority(ies) responsible for the decision or communication
Ministry of the Environment
Vrsovicka 65
Prague
Czech Republic, 10010
Phone:+420 267 122 066
Fax:+420 267 310 013
Email:gmo@mzp.cz
Url:Ministry of the Environment of the Czech Republic
Title / Reference number of the decision or communication
Decision on the deliberate release into the environment of genetically modified soya with the LTB gene
Date of the decision
2016-06-22
Is the decision taken prior to entry into force of the Protocol?
No
Jurisdiction
  • Czech Republic
Is this an amendment to a previous decision / communication?
No
Decision or communication details
Subject(s) of the decision
  • Decision on LMOs for intentional introduction into the environment (according to Article 10 or domestic regulatory framework)
Was the decision triggered by a request for a transboundary movement of LMOs into the country?
No
Does the decision apply to transboundary movements of LMO(s) into the country?
No
Importer’s or Applicant’s contact details
Dr. Oldrich Navratil
senior scientist
Institute of Experimental Botany, AS CR (IEB)
Prague
Czech Republic
Phone:+ 420 225 106 455
Email:ueb@ueb.cas.cz
Url:Institute of Experimental Botany, AS CR
Result of the decision
  • Approval of the import and/or use of the LMO(s) with conditions
Conditions
The above mentioned genetically modified organisms shall be used only in the way described in the application Ref. No. 23920/ENV/16 submitted to the Ministry of the Environment on April 6, 2016, and supplemented with the submission to the Ministry of the Environment on May 20, 2016, provided that all given conditions have been met, particularly as follows:
- All handling with the genetically modified material shall be under conditions minimizing a possibility of transgene escape into the environment.
- The principles of good agricultural practice shall be kept and the principles of good experimental practice shall be applied.
- GM soya shall be handled only in line with binding procedures, and must not be delivered to any persons who are not trained about the rules for use of GMOs.
- The field trials shall be carried out by staff trained for the use of GMO at the experienced workplace specialized for GMO trials, according to the unified methodology. Trials shall be conducted under the supervision of the professional consultant.
- The staff that will get into contact with seed or green plants when assessing or harvesting them shall be trained about rules for the use of genetically modified organisms, shall be equipped with protective tools and warned of the prohibition of consumption and use as feed of any type of the experimental material. The staff shall become acquainted with the Emergency Plan and the Operational Rules to be able to solve problems, if appropriate, and shall be informed on their duty to report on any health problem that can relate to the deliberate release to the environment. The written records shall be kept on all handling with the experimental material.
- The trained staff shall ensure the preparation of the plot before setting up the field trial as well as the agro-technical measures concerning standard treatment of the spring barley. They shall carry out ancillary works in connection with the setting up of the field trial, sampling, assessments and manual harvesting in the presence of the professional consultant.
- GM plants pre-cultivated in a cultivation room (higher temperature and a short- day) will be prepared for the cultivation season 2016. Plants will represent generations T7 and T13, respectively. This procedure will be applied also in the

next vegetation seasons. The number of plants released to the environment may vary every year depending on results of the glasshouse experiments and field trials.
- The plot is located in the fenced area of the Academy of Sciences. During the period approved in the Decision the trial shall be conducted at the same plot and properly labelled with warning signs
- Grass and original soil shall be removed from the plot before GM soya planting, then digging shall be performed, a mixed potting soil (brown soil and pearlite) shall be brought and the basic NPK fertilisation shall be applied.
- Following procedures will be applied: planting and plant lashing, watering, fertilisation, biological protection application, chemical treatment commonly used for the Institute's greenhouses. The plot will be irrigated.
- No buffer zone will be set around the trial plot. The trial shall be located in the part of grassed plot neighbouring the B4 greenhouse. No crops are cultivated in the vicinity, only a built-up area occurs nearby.
- Plant seeds intended for the release into the environment shall be stored in the refrigerator in the B2 building, the Institute of Experimental Botany ASCR. Seeds will be sprouted, plants put in the pots and pre-cultivated in the cultivating room and the B4 greenhouse (a workplace is secured from the entry of non-authorised persons).
- Control plants intended for the next vegetation season shall be obtained from seeds harvested from plants being isolated in the greenhouse. The amount of produced sub-unit protein per seeds weight shall be analysed using the Western blot and the antiFLAG specific antibody.
- With regard to soya plant biology and small size of the trial, particularly correct outplanting of GM soya plants and their labelling on the plot shall be controlled.
- GM plants of required size pre-cultivated in the cultivation room and the greenhouse shall be taken out on the plot in closed containers labelled "GMO" and planted out manually. All plants shall be planted out on the plot, and the control of completeness in line with the list shall be done.
- At least two-line distance shall be kept between lines with transgenic plants and 'Jack' original variety serving as control plants.
- With regard to the limited space to be used it is expected that totally 50 GM plants of the line No. 157 and control plants shall be released into the environment in the vegetation season 2016.
- It is not expected that the number of released GM plants will increase as the capacity of rooms suitable for plants pre-cultivation is limited.

- Plants may be planted in density 9 - 12 individuals / m2; it is approximately 10 individuals / m2 after planting out.
- The total planned area of the trial with GM soya deliberately released into the environment shall be ca 10 m2.
- Plants on the plot shall be bound to a supporting bean-pole, and a protective net against pest shall be fasten onto them and protect the whole field. Plants will be irrigated and fertilized. In case insect pest occurrence (spider mites and thrips), biological   protection   using   predaceous   mites   (Phytoseiulus    permisilis   and Ambyseiulus cucumeris) shall be applied. Occurrence of diseases is not expected.
- The trial plot with the GM soya shall be secured from the entry of non-authorised persons during vegetation season using a spatial separation and labelled with two visible warning sings "GMO - NO ENTRY".
- The trial plot with the GM soya shall be secured from animals using a fence around the area of the Academy of Sciences and an upper net placed above cultivated plants. Neither pods nor seeds are attractive to animals and therefore no risks for animal health are in place.
- Harvested GM soya shall not enter the food chain or feed chain. Harvest shall be realized by trained staff of the Institute of Experimental Botany ASCR, under the supervision of a professional consultant.
- Harvesting shall be carried out manually plant by plant. All plants shall be harvested simultaneously. Harvesting shall be performed repeatedly according to the gradual pods maturation.
- Every plant shall be harvested individually and pods shall be put into paper sacks, clearly labelled with codes so as to prevent their replacement, and ensured against the material loss; these sacks shall be put into the labelled lockable plastic container.
- Containers labelled with the text "Genetically modified organism - not for food or feed" shall be transported to the B2 building, and pods shall be left to dry by air in a lockable room.
- GM soya pods shall be transported separately from control plants pods. Before their storage the hulled seeds shall be dried by air and stored separately in the contained labelled boxes in the refrigerator.
- Required number of hulled seeds shall be homogenized in the laboratory and a soluble protein shall be extracted. Individual samples shall be prepared from three seeds originated from the same plant. Seeds from 5 - 8 individual plants shall be used for the analysis. The remaining seeds shall be stored in refrigerators for further plant cultivation except of 'Jack' non-transgenic variety.

- Seeds from Jack control variety shall be harvested as well, and used for the protein content analysis. However, they shall not be planted out repeatedly in the next vegetation season in order to avoid possible outcrossing of these plants.
- Measures to decrease or prevent pollen/seeds escape are not necessary to take. Although the outcrossing between 'Jack' control variety plants and plants from the line No.157 may happen, harvested seeds from control plants shall not be used for the pre-cultivation of new control plant following years.
- With regard the fact that no wild sexually compatible species occur in the Czech Republic, and soya is not cultivated near the Institute area, no measures will be taken.
- Plants and their remains shall be burnt on the plot after their partial desiccation. Remaining unused seeds, incl. those from 'Jack' control variety shall be inactivated using an autoclave.
- Written records on handling with the harvested experimental material as well as the waste shall be kept.
- Guidelines shall be changed according to the source material and the goals of the trials, and shall be amended regularly. Maps of the trial shall be integral part of the documentation at the Virology department, and shall be submitted to the Ministry of the Environment.
- Written records shall be kept on all handling with the GM material incl. transport and shall be also a part of the separate field Diary.
- An accident may happen during transportation of plants or pods on / from the plot (for example due to person's falling down); in such the plant material case may drop out on the lawn or flagstone. The material can be easily picked up and further used. If the original package is damaged and seeds are dropped out, the place of accident would be decontaminated immediately by manual collecting into the new package.
- If necessary, the trial is possible to treat with a non-selective herbicide (e.g. Roundup), its effectiveness shall be verified and the occurrence of escaped transgenic plants on the plot shall be monitored the next year. The procedure can be repeated. The herbicide shall be stored together with plant protection chemicals in the B3 greenhouse neighbouring with B2 building.
- During the storage of seeds in the B2 building fire may be marginally expected. GMOs affected by fire can be considered liquidated. If plant material is possible to save, transgenic plants and harvested seeds shall be saved first in order to prevent uncontrolled contamination of the building with GMOs. Director or the professional consultant shall decide about their further use. In other points, fire shall be eliminated in line with the Fire and Emergency Plan.

- Institute of the Experimental Botany ASCR shall in accordance with § 19 letter c) of the Act submit to the Ministry data on the amount of GM soya and on handling with it in written and electronic form annually, always by 15 February in the calendar year, and pursuant to § 19 letter d) of the Act submit within 60 days from termination of the use of genetically modified organisms a final report on the course and consequences of this activity, particularly with regard to any risk for human health and the environment. The final report shall be submitted in English as well pursuant to the Annex to the Decision of the European Commission 2003/701/EC.

- Every year no later than 30 days after the sowing of GM soya, the Institute of Experimental Botany ASCR shall provide to the Ministry of the Environment written information on the deliberate release into the environment and on the area of GM soya, and the map with the precise location of the trial incl. GPS lines as well as the map of the trial.
- The Institute of Experimental Botany must on request of the Ministry of the Environment or the laboratory according to § 28 par. 1 letter f) of the Act provide samples of the tested GM soya or its genetic material at any time in the course of its use.
- The Institute of Experimental Botany ASCR must according to § 28 and § 31 - 33 of the Act cooperate with the authorities (the Ministry of the Environment, the Czech Environmental Inspectorate, the Central Institute for Supervising and Testing in Agriculture) during the control of plots, premises and facilities intended for the use of GMOs, or the plots, premises and facilities in which GMO may be used, including written records, at any time in the course of its use.
- The Institute of Experimental Botany ASCR must on request of the Ministry of the Environment or the laboratory according to § 28 par. 1 letter f) of the Act provide samples of the tested GM soyas or its genetic material at any time in the course of its use.
Reasons
To comply with the Czech Act on the Use of GMOs and Genetic Products
Does the decision involve field trials?
Yes
Does the decision involve commercial release?
No
LMO identification
Soy modified for the expression of heat-labile enterotoxin, B subunit
Dr. Oldrich Navratil Production of medical or pharmaceutical compounds (human or animal) - Vaccines Resistance to antibiotics - Hygromycin Selectable marker genes and reporter genes
Risk assessment
Deliberate release into the environment of genetically modified soya with the LTB gene (2016-2021)
Soy modified for the expression of heat-labile enterotoxin, B subunit
Dr. Oldrich Navratil

Production of medical or pharmaceutical compounds (human or animal) - Vaccines
Resistance to antibiotics - Hygromycin
Selectable marker genes and reporter genes
Decision document