The above mentioned genetically modified organisms shall be used
only in the way described in the application Ref. No.
MZP/2018/750/2786 submitted to the Ministry of the Environment on
October 12, 2018, and supplemented with the submission to the
Ministry of the Environment on December 19, 2018, provided that all
given conditions have been met, particularly as follows:
- The workplace of ÚSOVSKO joint-stock company. fully complies with
current company standards for quality assurance of field
experiments. Suitable conditions are created for working with
transgenic materials.
- Legal liability for infringements of the law in the context of
deliberate release of GM barley into the environment lies with the
applicant - ÚSOVSKO joint-stock company, which is 100% owned by
ÚSOVSKO AGRO Ltd., located in Kopina 33, 78973, Kopina. ÚSOVSKO
AGRO Ltd., is engaged exclusively in agricultural production. The
employees of this subsidiary company will for the applicant ÚSOVSKO
joint-stock company provide and carry out part of the work
operations under the project" Optimisation of purification of LL-37
peptide produced by transgenic barley by the method indicated in
the publication Holásková et al., 2018 ".
- All handling with the genetically modified material will be
carried out under conditions minimising the possibility of
transgene leakage into the environment.
- The principles of good agricultural practice and good
experimental practice (GEP) will be respected. When carrying out a
field experiment with genetically modified barley producing LL-37
peptide, all statutory measures on the use of genetically modified
organisms and genetic products, as laid down by law, shall be
observed.
- The safe handling of seeds and plant material (harvesting,
storage, transport and disposal) shall be ensured in such a way
that no environmental risk arises.
- The plot with GM barley will be safely fenced with a mesh. The
entire area behind which the plot is located is protected against
the access of unauthorised persons (card entry). The experimental
plot can only be accessed from this secured area.
- GM warehouse is located in this secure area on the parcel number
2477, K.U. Mohelnice ( a built-up area and a courtyard). The
facility shall be intended exclusively for storage of GM seeds. The
grain of GM barley will be stored in two rooms with a total storage
area of 39 m2, the entrance to the storage is directly from the
outdoor area of the courtyard through a metal two-wing door secured
by a security hanging lock. The grain shall not be cleaned or
washed in the warehouse.
- Only three persons holding a valid licence shall enter the
warehouse. These persons shall be responsible for recording the
entries and activities in the GM warehouse. Access to the storage
shall be registered and restricted (locked), the warehouse shall be
duly marked and its windows shall be fitted with a net.
- Personnel who ensure the transport of plant material and who will
carry out sowing and handling of seed shall be regularly trained by
a professional consultant on the principles of handling GM
material. They will be equipped with mandatory protective work
equipment - working clothes (long trousers, blouse or cloak),
protective gloves for handling with GM seed (latex examination
gloves) and suitable footwear (boots or boots with a rigid sole).
All activities that do not comply with the experiment methodology
are prohibited on the plot. Workers will be notified of the
prohibition on the consumption and feeding of the product, and will
be familiar with the obligation to report any health problem
related to the deliberate release into the environment. They shall
comply with the trial methodology, the standard operating
procedures for field experiments according to the EPPO methodology
and the methodology for testing the use-value of field crops issued
by the Central Institute for Supervising and Testing in Agriculture
(CISTA).
- Persons qualified to conduct field experiments and persons
trained by CISTA to become competent for the use of plant
protection products shall be in the workplace. The application of
plant protection products will be carried out by a professionally
qualified person for handling plant protection products on the
basic level. The selection of plant protection products, their
accurate application, the term of application based on forecasting,
signalling and immediate need are ensured by a professionally
qualified person holding a valid certificate of professional
competence of persons for the handling plant protection products on
the second level.
- Persons working with plant protection products under field
conditions shall follow generally applicable principles for
pesticide application and the recommendations of the manufacturer
and a valid label for the product used. If plant protection
products are applied to GM barley, only the products with a valid
authorisation stated in the CISTA register shall be used.
- Authorised staff shall carry out (i) preparation of the plot
prior to the setting of the experiment, (ii) agro technical
procedures relating to the standard treatment of spring barley and
(iii) harvesting and post-harvest work.
- The experimental plots will be prepared according to the current
standard technological agro-technical practices for growing spring
barley in the given area (pesticides, fertilisers). Before sowing,
spraying with total herbicide will be performed, shallow processing
of the soil into the depth of the sowing bed together with the
application of basic fertilisers (N, P, K), settling the land and
crushing the lumps. GM crop will be secured by pest-strippers,
which generate a strong, usually ultrasound signal (inaudible to
humans) that protects outdoor areas from pests such as mice, rats,
moles, crows or birds.
- All handling of GM material shall be recorded and will also be
part of the field diary. Records on operation and sanitation of
equipment used for working with transgenic materials (sewing
machine, harvester) shall be kept in the workplace diary. The date
and time of the operation carried out and the method of sanitation
shall always be stated.
- Seed of transgenic barley will be obtained from the Faculty of
Science, University of Palacky (UP), Olomouc, Slechtitelu 27
(Department of molecular biology, building H, 2nd floor, and
laboratory No. 2.40). Legal liability for the violation of the law
in the context of the contained use is borne by the Faculty of
Science, UP in Olomouc, which is authorised to use GMOs under the
contained use regime (notification No. 4498/ENV/13). The use of
transgenic lines LL-37 to the department of molecular biology is
authorised on the basis of the notification of 20 June 2016, Ref.
No. 66915/ENV/16.
- GM material will be transported by trained personnel of ÚSOVSKO
joint stock company, and ÚSOVSKO AGRO Ltd. The grain of three
transgenic lines of spring barley with the production of LL-37
peptide intended for sowing shall be transported from UP Olomouc to
the farm Mohelnice (ÚSOVSKO joint stock company, and ÚSOVSKO AGRO
Ltd. before sowing in early April 2019 ), by a car (trained driver)
to a designated GM grains warehouse near the experimental field in
closing, clearly marked double plastic boxes, which will be marked
in a way to avoid confusion.
- She seed shall be transported from the warehouse to the
experimental field (plot No. 2502/4) on the day of sowing. The
transport shall also include an emergency plan, an autoclavable
Biohazard bag (for temporary storage and subsequent autoclaving of
the grains collected in the event of accident), as well as an
emergency plan, a broom, a shovel and an extra plastic container in
case of damage to the original transport boxes. Once delivered to
the plot, the packaging shall be checked for the completeness
according to the list before sowing.
- As regards good experimental practice, a three-year crop sequence
of experimental land is proposed. The exact area of the GM crop
will be designed each year according to the technological and
organisational needs of the research project to optimise the
purification of LL-37 peptide produced by transgenic barley,
- The seeds will be sown separately one by one, in rows, using a
one-line precision sowing machine. The machine works as a stainless
plant and shall be carefully cleaned before leaving the place of
sowing in order to avoid the uncontrolled spread of GM seeds
outside this place. The experiment shall be designed in such a way
that no seeds are left during sowing and the whole monitored
population transmitted to the site is always planted. However, if
any genetically modified seeds remain at the field trial site, they
shall be returned to the GMO warehouse without delay.
- Trained staff of the Usovsko Joint-stock company and Usovsko Ltd.
shall ensure the sowing of the GM barley. A record shall be made on
the transmission of seed for sowing and on the process of sowing in
the field. Once sowing has been carried out, the Ministry will be
supplied with a plan with the final shape of trial, accompanied by
GPS coordinates of its location.
- In the first year, the transgenic barley will be sown to about
400 m2. The area of cultivated transgenic barley with LL-37 peptide
in 2019: UBI line: LL-37 shall not exceed 100 m2, Bhor line: LL-37
shall not exceed 260 m2 and Bhor line: Mbp _ LL-37 shall not exceed
30 m2, - approximately 120 000 GM plants shall be planted: 30,000
plants line UBI: LL-37, 80,000 plants line Bhor: LL-37 and 10,000
plants line Bhor: Mbp _ LL-37. The plant density in each year shall
not exceed 300 plants / m2.
- Maximum number of plants deliberately released into the
environment will be 1.5 million per year. The number of plant
progeny released into the environment may vary from year to year
depending on the results of the experiments so that sufficient
grains are obtained to optimise the purification of LL-37
peptide.
- Total area required for experiments with GMO barley (experimental
field, including buffer zones) and the edges of the plot where no
other commercial barley can be grown shall not exceed 5000 m2
during the experiment.
- Trials will be finished by harvesting in the period of reaching
physiological maturity of barley grain. Part of the ears will be
taken in milky wax maturity.
- Harvest will be carried out by qualified and trained workers of
ÚSOVSKO joint-stock company and ÚSOVSKO AGRO Ltd. by hand and
mechanically using Harvester Combine Hege 160. This harvester,
owned by the Faculty of Science, UP in Olomouc, is specially
designed for experimental purposes and meets all the necessary
parameters for an accurate, seamless harvest. Harvesting bags of
10-25 kg will be used for harvesting purposes. The grains will be
stored in partially sealed pallets, ca 1 palette of 300 kg or the
possibility of storing freely on the storeroom floor. Production
will reach tonnes in a period of 3 years or more.
- The harvester shall be properly cleaned after harvesting on the
plot so that no grains or other plant material remain. Possible GM
waste (grains), will be put to properly marked autoclavable bags
and transferred to the UP Olomouc workplace for disposal by
autoclaving in the GMO laboratory, the Faculty of Science, the
University of Palacky, Olomouc, Slechtitelu 27, building H, level
II, the laboratory No. 2.39.
- The seeds will be harvested and transported in sealed, clearly
marked harvesting bags in a double transport box. A properly marked
transport box shall consist of an external and internal sealed
plastic container in order to prevent leakage of the transported GM
material.
- Transport from the field to the warehouse intended for storage of
GM seed shall be ensured by a four-wheeler.
- After the trial is completed, the unripe ears and harvested
grains used to optimise the purification of LL-37 peptide will be
transferred:
- all to Olomouc, Slechtitelu 27 (Department of molecular biology,
H-building, 2nd floor, the laboratory No. 2.40);
- in the event of more remaining grains, they will be further
stored in the GM grain warehouse of USOVSKO joint-stock company,
and processed gradually (in this case, the MoE shall be notified
about the amount of grains stored each year);
- if the experiment is completely finished, the grains shall be
transferred to the Palacky University in Olomouc, Slechtitelu
27 (Department of Molecular Biology, Building H, 2nd floor,
Laboratory No. 2.39), where the grains and all samples will be
disposed of by autoclaving.
- The use of GM material under the contained use regime (production
and storage of barley seed and analysis of samples) will be carried
out at the workplace of Palace University in Olomouc, Faculty of
Science, Department of Molecular Biology, Breeders 27, Building H,
2nd floor, Laboratory No. 2.40., and Building F, 2nd floor,
Laboratory No. 2.22. This institution is authorised to use GM
barley according to the notification Ref. No. 91997/ENV/10,
4498/ENV/13 and 66915/ENV/16, submitted to the MoE.
- Purification of peptide LL-37 (using a method by Holaskova et
al., 2018) will be carried out at the Faculty of Science, the
Palacky University in Olomouc.
- All packaging intended to handle GM plants shall be properly
marked with: "Contains genetically modified spring barley material
LL-37. Not for food and feed! Do not hand it over to unauthorized
persons!
- After the work has been completed, each worker shall clean his or
her work clothing or protective equipment. Workers who handle GM
material shall carefully carry out maintenance of all machinery and
techniques.
- After harvesting, any post-harvest plant remains, including
conventional spring barley cultivated in buffer zones, shall be
crushed immediately and cut up (crushing the straw with a crusher,
spraying it with total herbicide, and planting the crushed straw in
the soil by ploughing - heavy disk gates). The plant scrub shall be
evenly dispersed across the experimental plot and after application
of nitrogen fertilisation to accelerate decomposition ploughed
under the soil.
- Ploughing is also an effective protection against sprouting from
released mature seeds. If spring barley plants occur in a
subsequent crop (other than spring barley), they shall be destroyed
mechanically or by herbicide.
- For the next two years, no commercial spring barley or other
cereals shall be grown on the experimental area, and only such
crops that allow monitoring of volunteers and its effective
chemical disposal, if occur, shall be planted (e.g. winter
rape).
- Maize grown for silage, rapeseed, winter wheat and sugar beet
will be planted on surrounded plots in 2019.
- In subsequent years, the applicant shall submit a written
information to the MoE on what crops will be planted on the areas
and plots surrounding with planned GM barley trials, no later than
30 days from sowing.
- The GM barley detection method will be added to the Emergency
plan (point 9 - GMO detection).
- Written records shall be kept on all waste management, including
disposal of GM barley material. Official written records on
handling the harvested material shall be also kept.
- In case of the use of an unauthorised plant protection product or
unauthorised use of a plant protection product the request for
granting consent to carry out experiments for research or
development purposes according to the Regulation (EC) No.
1107/2009, Article 54, para 2 shall be submitted in advance, and
the testing of the product shall be realised only after granting
consent for the application by the Central Institute for
Supervising and Testing in Agriculture, Hroznová 2, 656 Brno. Where
appropriate, Regulation (EC) 1107/2009, Article 54, para 4, and the
Act No. 326/2004 Coll., on phytosanitary care, as amended, shall be
followed.
- Usovsko joint-stock company shall in accordance with § 19 letter
c) of the Act submit to the MoE data on the amount of barley and on
handling with it in written and electronic form annually, always by
February, 15 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 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.
Other conditions stipulated under § 5 par. 10 of the Act
- All possible measures shall be taken to ensure cultivation on
experimental plots: Possibly released pollen from GM barley plants
with peptide production LL-37 will be regulated with a 100 metre
isolation distance from all non-testing spring barley plants to
avoid any sexual species compatibility.
- The experiment site shall be protected by a 3 m wide buffer zone
of conventional spring barley of similar earliness (commonly grown
'Francin' variety). The buffer zone shall be treated as GM
plants.
- Plots No. 7908 and 8001/3, where USOVSKO joint-stock company
operates its agricultural activities, are located in the 100 m
isolation distance from the field trial.
- The trial with GM barley shall be safely fenced with a mesh
fence.
The entire area in which the trial plot is located is secure
against trespassing (card entry).
Access to the trial is only possible from this secure area.
The GM warehouse is located on parcel number 2477 in the above
mentioned secure area (built-up area and courtyard). The warehouse
is lockable with the key that is being placed in the locked office
of a authorised and trained person.
- Plot on which the field trial will be carried out shall be
labelled at all corners with visible warning signs as follows:
"Attention! GMO! No Entry! Not for Feed! Not For Food! Chemically
Treated! Delivery to non-authorised persons prohibited!" in order
to prevent the access to non-authorized persons. If necessary,
regarding the organisation of the field trial, more warning boards
shall be used so that notices can be seen from one to
another.
- Usovsko, joint-company, is required to conclude a contract on
crop rotation and keeping isolation distances from the trial plot
with the director of Palomo joint-stock company that has been
managing a plot No. 7001/8.
- Every year, after sowing the trial, the company shall notify to
the MoE no later than 30 days after sowing, information on setting
the trial, its area with buffer zone and provides a map of the
parcels with an accurate indication of its location, including GPS
coordinates, as well as an up-to-date trial scheme.
- Usovsko, joint-company must, upon request of the MoE or a
laboratory, if appropriate, as referred to in § 28(1f) of the Act,
provide at any time during the field trial duration samples
of the 3 GM barley lines or their genetic material.
- In accordance with § 19 (h) of the Act, Usovsko joint-stock
company must provide administrative authorities (Ministry of
Environment, Czech Environmental Inspectorate, Central Institute
for Supervising and Testing in Agriculture) according to the § 28
and 31 to 33 with synergies in controlling plots, premises and
equipment intended to use genetically modified organisms or plots,
premises and facilities in which such handling occurs or may occur,
including the provision of documents at any time during duration of
the field trial. For control purposes, free sampling of the above
GMOs or their genetic material must be allowed.
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