Decree of the Ministry of Environment No. 374 / 2000 Coll.
Ordinance of the Ministry of the Environment on closer conditions for the management of genetically modified organisms and products
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Effective from 01.01.2001
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01.01.2001
26.10.2000
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374
DECLARATION
Ministry of Environment
of 6 October 2000
on closer conditions for the management of genetically modified organisms and products
In agreement with the Ministry of Health and the Ministry of Agriculture, the Ministry of the Environment provides, pursuant to § 24 (b) to (f) and (h) to (j) of Act No. 153 / 2000 Coll., on the treatment of genetically modified organisms and products and on the amendment of certain related laws, hereinafter referred to as "the Act ':
For the purposes of this decree:
(a) recipient - the organism in whose hereditary material foreign hereditary material is introduced by genetic modification,
(b) the donor organism - the organism from which the hereditary material originates from the hereditary material introduced into the genetic material of the recipient;
(c) parent organism - an organism from which a part of the hereditary material has been excluded by genetic modification;
(d) vector - a non-cellular body containing hereditary material and capable of carrying such hereditary material together with the embedded foreign hereditary material into the recipient's cells,
(e) insert - foreign inheritance material inserted into the recipient's inheritance material,
(f) by design - an artificially modified nucleic acid molecule,
(g) signal gene - the gene contained in the structure and determining the easily detectable property of the cells or organism containing the functional structure,
(h) the selection gene - the gene contained in the structure and determining the insensitivity to a particular substance or to the effect preventing the proliferation of cells that do not contain it;
(i) stage - the period during which the activity or system of activities in the course of the management of the genetically modified organism or product is carried out to a certain conclusion, to obtain data or to another partial result;
(j) primary data - all laboratory and work records and documents or certified copies thereof resulting from initial observations, measurements and registration of quantities.
Further conditions of professional competence
[K § 3 (7) (a) of the Act]
(1) The condition for the designation of a natural person by a professional consultant is duly completed by higher education (1).
(a) medicine, veterinary medicine, biochemistry or microbiology for the management of genetically modified micro-organisms;
(b) natural sciences, agriculture or forestry for the management of genetically modified plants; or
(c) natural sciences, agriculture or veterinary medicine for the management of genetically modified animals.
(2) The period of postgraduate or doctoral studies in the relevant field and in the field of the management of genetically modified organisms is counted against the period of two years required for the management of genetically modified organisms. 2)
(3) The expert consultant referred to in paragraph 1 shall also comply with the qualification conditions under specific legislation in the case of the supervision of animal testing and further management of genetically modified animals.
Further details on applications for entry in the lists
(Articles 6 (1), 7 (2) and 7, 8 (3) and 9 (3) of the Act)
(1) As part of the application for entry in the lists referred to in Article 3 (3) of the Act, the user may submit the required data on the characteristics of the genetically modified organism processed for another legal person or a natural person authorised to do business, provided that he also provides a certified copy of the consent of that person using the data submitted by the user.
(2) The supporting documents required by this decree, which are translation from foreign languages, are to be submitted in an officially certified translation and at the same time in the original. The user can attach additional information materials in English together with their brief content in Czech.
(3) The model of the application for registration in the List of Users for the contained use of genetically modified organisms (hereinafter referred to as "contained use") is set out in Annex 1, the model of the application for registration in the List of Users for the placing into the environment of genetically modified organisms (hereinafter referred to as "placing into the environment") is set out in Annex 2, the model of the application for registration in the List of Users for the placing into circulation of genetically modified organisms and products (hereinafter referred to as "putting into circulation") is set out in Annex 3.
(4) If the application for registration in the User List is submitted in accordance with Article 6 (3) of the Act, all data for each genetically modified organism must be provided separately in the application; This does not apply to the case referred to in Section 7 (3) of the Act.
(5) The model application for the entry of a genetically modified organism in the list of genetically modified organisms approved for restricted use is set out in Annex 4.
(6) The models for applications for the entry of a genetically modified organism in the list of genetically modified organisms approved for placing in the environment are set out
(a) Annex 5, if the genetically modified organism is a micro-organism;
(b) in Annex 6, if the genetically modified organism is a higher plant; or
(c) in Annex 7, where the genetically modified organism is an animal.
(7) Where an application for registration in the list of genetically modified organisms approved for placing in the environment is submitted in accordance with Section 8 (4) of the Act, the application shall contain all the particulars for each genetically modified organism separately.
(8) The models for applications for the registration of a genetically modified organism or product in the list of genetically modified organisms and products approved for circulation in the Czech Republic are given
(a) Annex 8, if the genetically modified organism is a organism other than a higher plant; or
(b) Annex 9, if the genetically modified organism is a higher plant.
Risk assessment
(K § 4 of the Act)
(1) The purpose of the risk assessment carried out under Article 4 of the Act is to identify and evaluate the possible adverse effects of the proposed treatment of a genetically modified organism or product on human and animal health, the environment or biodiversity. The risk assessment shall take into account any potential harmful effects, regardless of the likelihood with which they may occur, and shall be compared with the harmful effects of the treatment of the recipient or, where appropriate, the parent or related organisms.
(2) The effects of the management of a genetically modified organism or product may be:
(a) direct, that is the primary effect on human and animal health, the environment and biodiversity directly associated with the genetically modified organism or product;
(b) indirect effects on human and animal health, the environment and biodiversity resulting from the causal consequences of events such as interaction with other organisms, transfer of inherited material or changes in the way they are handled; indirect effects may be delayed,
(c) immediate, this is the one observed during the treatment of a genetically modified organism or product; immediate effects may be direct and indirect;
(d) delayed, this is one which may not be observed during the treatment of a genetically modified organism or product but may be identified as direct or indirect effects after the end of the treatment of a genetically modified organism or product.
(3) Possible harmful effects include:
(a) harmful effects on humans, including diseases, allergenic and toxic effects;
(b) harmful effects on animals and plants, including diseases, toxic or allergenic effects,
(c) the impact on the dynamics of species populations in the receiving environment and on the genetic diversity of each of those populations;
(d) limiting the possibilities of prophylaxis or treatment in the field of medical, veterinary or plant health, such as the transfer of pathogens, virulence or toxicities of organisms or genes causing resistance to antibiotics used in medicine or veterinary medicine;
(e) effects on biochemical processes, in particular the circulation of carbon and nitrogen, through changes in the degradation of organic substances in soil.
(4) Harmful effects on human and animal health, the environment and biodiversity may occur
(a) the establishment and spread of genetically modified organisms in the environment;
(b) by the natural transfer of the inherited material to other organisms;
(c) phenotypic and genetic instability,
(d) by interaction with other organisms;
(e) changes in the management of organisms or products, including any changes in agri-technical procedures.
(5) In the risk assessment, the occurrence of potential harmful effects on the management of a genetically modified organism or product in conjunction with:
(a) the beneficiary;
(b) inherited material (originating from the donor organism),
(c) by a vector,
(d) a donor organism (if the donor organism is used during genetic modification),
(e) by inserting a structure,
(f) signal and selection genes;
(g) insert;
(h) the removal of part of the inherited material (if the genetic modification involves it),
(i) the resulting genetically modified organism,
(j) the place and extent of handling of the genetically modified organism or product;
(k) environment at the place of disposal;
(l) possible interactions between the genetically modified organism or product and the environment at the place of disposal.
(6) The risk assessment shall include an assessment of the severity of any potential harmful effect and the likelihood of such harmful effect occurring, in the manner of handling in the workplace or place of introduction in the environment, and under conditions to be used or likely to occur. The risk assessment shall also take into account the characteristics of the activity and the hazards arising therefrom.
(7) Risk assessment procedure
(a) the identification of all potential harmful effects referred to in paragraphs 2 to 5 and the assessment of their severity;
(b) an evaluation of the consequences of each harmful effect, if any;
(c) an assessment of the likelihood of a harmful effect under the conditions;
(d) an estimate of the risk to human and animal health, the environment and biodiversity posed by each of the identified harmful effects on the basis of an assessment of the likelihood of such an effect occurring and the severity of that effect, if any,
(e) a comparison of the data obtained with the corresponding data for the donor organism, the recipient or, where appropriate, the parental organism under comparable conditions;
(f) the inclusion of the activity in the relevant risk category as set out in Annex 1 to the Act on the basis of the results obtained.
(8) All steps of the procedure referred to in paragraph 7 shall be documented in writing and, where possible, documented by references to scientific literature, protocols from experimental studies or documentation of previous handling. This written analysis must be kept together with the other documentation provided for in Section 3 (7) (b) of the Act.
(9) The risk assessment shall be reviewed without delay if a change occurs.
(a) scientific or technical knowledge concerning the effects of the management of the genetically modified organism or product referred to in paragraphs 1 to 6; or
(b) the management of the genetically modified organism or product.
(10) The risk assessment in the case of contained use shall take into account the facts referred to in paragraphs 1 to 6, and
(a) the characteristics of the environment likely to be affected by the release of the genetically modified organism from a enclosed area;
(b) the nature and extent of the contained use;
(c) any non-standard activities carried out during the contained use.
This may affect the inclusion of the management of a genetically modified organism in the relevant risk category referred to in paragraph 7 (f).
(11) The risk assessment in case of placing into the environment for genetically modified organisms other than higher plants shall include:
(a) the likelihood of a genetically modified organism becoming more resistant or invasive under conditions of introduction into the environment than the recipient or the parental organism in its natural habitat;
(b) any selective advantage or disadvantage resulting from genetic modification and the likelihood that such an advantage or disadvantage will manifest itself under conditions of introduction into the environment;
(c) the possibility of transferring the material to other species under conditions of introduction into the environment and any selective advantage or disadvantage which may be transferred in such a way;
(d) possible immediate or consequential environmental effects caused by direct or indirect interactions between the genetically modified organism and the target organism (if the target organism exists);
(e) possible immediate or consequential environmental effects caused by direct or indirect interactions between the genetically modified organism and non-target organisms, including impact on the level of populations of competitors, prey, symbiotes, predators, parasites and pathogens;
(f) the possible immediate or delayed effects on human health resulting from possible direct or indirect interactions between the genetically modified organism and persons in contact with it;
(g) the possible immediate or delayed effects on animal health and the consequences on food chains resulting from the consumption of a genetically modified organism or product intended for use as feed;
(h) possible immediate or delayed effects on biochemical processes resulting from possible direct and indirect interactions between the genetically modified organism and the target and non-target organisms in the environment, and
(i) possible immediate or delayed direct and indirect effects on the environment as a result of the use of specific techniques for the management of genetically modified organisms where such techniques differ from those normally used.
(12) The risk assessment in the case of the introduction into the environment of genetically modified higher plants, where appropriate, where genetically modified higher plants are put into circulation as seed or seed, (4) shall contain the following results:
(a) the likelihood that genetically modified higher plants become more resistant to the environment under conditions of introduction into the environment than the recipient or parental organism in the agricultural environment or more invasive in the natural environment;
(b) any selective advantage or disadvantage resulting from genetic modification;
(c) the possibility of transferring the material to the same or sexually compatible species under conditions of cultivation of genetically modified higher plants and any selective advantage or disadvantage which may be transferred in such a way;
(d) possible immediate or consequential environmental effects caused by direct or indirect interactions between the genetically modified higher plant and the target organism (if the target organism exists);
(e) possible immediate or consequential environmental effects caused by direct or indirect interactions between genetically modified higher plants and non-target organisms, including impact on the level of populations of competitors, herbivores, or symbiotes, parasites and pathogens;
(f) possible immediate or delayed effects on human health resulting from possible direct or indirect interactions between a genetically modified higher plant and persons in contact with it;
(g) the possible immediate or delayed effects on animal health and the consequences on food chains resulting from the consumption of a genetically modified higher plant or product intended for use as feed;
(h) possible immediate or delayed effects on biochemical processes resulting from possible direct and indirect interactions of genetically modified higher plants and target and non-target organisms around the cultivation of genetically modified higher plants; and
(i) possible immediate or delayed direct and indirect effects on the environment as a result of the use of specific cultivation, harvesting and processing techniques for genetically modified plants where such techniques differ from those normally used.
(13) The risk assessment of a product containing several different genetically modified organisms shall include an assessment of the relevant data for each of those organisms.
Emergency plan
(K § 5 of the Act)
The emergency plan shall include:
(a) the name, surname, permanent residence, nationality, place of business, birth number or date of birth, and, where applicable, user identification number, as provided for in Article 2 (g) of the Act, if it is a natural person authorised to do business;
(b) the name (trade name), legal form, registered office and user identification number referred to in Article 2 (g) of the Act, the name, surname and permanent residence of the statutory authority of the user, if any,
(c) the name, surname, permanent residence, telephone number and, where appropriate, fax number and e-mail address of the expert consultant;
(d) persons responsible for the destruction of the accident, the way in which they are connected and the organisational arrangements for the occurrence of the accident;
(e) a precise description of the land (5) or of the premises and facilities where the treatment of genetically modified organisms or products is being carried out, where they are stored and where accidents may occur, indicating the location (address) of those parcels or premises and facilities; a description of the route when exporting, importing or transit;
(f) a work plan identifying sites relevant for the reduction of the consequences of the accident (main controls of energy supply and auxiliary media, storage sites for genetically modified organisms or products, safety features of the closure of the premises in terms of contained handling, etc.); a description of the protection of genetically modified organisms or of the release products when exported, imported or transported;
(g) a description of the accident which may occur at the premises or places where the genetically modified organisms and products are being handled;
(h) an overview of the possible consequences of the accident on human, animal and environmental health and biodiversity, including ways to detect and protect effectively against these consequences;
(i) procedures for detecting the presence of genetically modified organisms or products;
(j) the methods and procedures applicable to the destruction of the GMOs or products concerned and the decontamination of the affected area;
(k) methods for the isolation of areas and installations affected by accidents, including methods for checking the effectiveness of isolation;
(l) a description and diagram of the storage of the means of rendering applicable to the disposal of the GMOs or products concerned and the decontamination of the affected area;
(m) procedures for the protection of human and animal health and the protection of the environment in the event of adverse effects on the accident; where applicable, methods for the disposal or remediation of plants and animals present in the area at the time of the accident, in accordance with specific legislation, 6)
(n) the municipalities or persons to whom the emergency plan is submitted pursuant to Article 5 (3) of the Act; and
(o) the administrative authorities referred to in Article 13 of the Act and the way in which they are informed in the event of an accident and, where appropriate, the way in which citizens are warned, depending on the place of the accident and its possible consequences.
Management and storage of documentation
[K § 3 (7) (b) of the Act]
(1) The documentation on the management of genetically modified organisms and products (hereinafter referred to as "the dossier") under Section 3 (7) (b) of the Act is:
(a) a copy of the application submitted pursuant to Article 3 (4) of the Act;
(b) a decision pursuant to Article 3 (5) of the Act or an officially certified copy thereof;
(c) an assessment of the risk of the management of a genetically modified organism or product under Article 4 of the Act;
(d) an assessment of the premises and facilities referred to in Article 7 (2) (b) of the Act in the case of contained use;
(e) the operating rules of the workplace;
(f) an emergency plan drawn up pursuant to Article 5 of the Act;
(g) operational diaries of each stage;
(h) final reports of each phase;
(i) records of checks carried out under Section 7 (10) of the Act in the case of contained use; and
(j) the final report pursuant to § 3 (7) (d) of the Act.
(2) The documentation shall be established, maintained and kept in written and electronic form in such a way as to prevent the loss, damage or theft of the documents and to ensure its clear layout and accessibility, where appropriate. Access to documentation must be limited to persons designated by the user or, where appropriate, by administrative authorities pursuant to § 3 (7) (i) of the Act.
(3) A stage plan shall be drawn up before the start of the stage, which shall include:
(a) the purpose of handling the genetically modified organism or product;
(b) particulars of the genetically modified organism,
(c) the indication of the stage and its objective;
(d) the name, surname and address of the manager of the stage;
(e) the name, surname and address of the expert adviser;
(f) the address of the workplace and, where appropriate, the location and description of the parcels where the stage will take place;
(g) the date of commencement and the estimated end of the stage;
(h) the list of organisms to be handled during the stage;
(i) a list of the isolated hereditary material to be handled during the stage;
(j) possible stage risks, including in the event of an accident;
(k) the risk category for the management of the genetically modified organism during the stage;
(l) the procedure for the management of genetically modified organisms and products during the stage, including the mandatory working procedures to be applied during the stage;
(m) monitoring system, in particular methods for the identification and monitoring of the genetically modified organism or product and its possible effects on human and animal health, the environment and biodiversity;
(n) the type and quantity of waste generated during the stage and the handling thereof in accordance with specific legislation, 7)
(o) the method of further management of the genetically modified organism or product after completion of the stage following the following stage, where appropriate, the method of disposal of the genetically modified organism or product and subsequent controls on the effectiveness of disposal; and
(p) the expert advisor's comments on the stage plan.
(4) The operating log to be kept during the stage contains:
(a) the stage plan;
(b) a description of the progress of the stage, in particular any difference between the progress of the stage and the plan of the stage;
(c) primary data obtained during the stage;
(d) records of any inspections and inspections carried out; and
(e) records of any incidents and accidents.
(5) Where the information referred to in paragraph 3 is changed during the stage, the reason for the change and the date on which the change was decided or occurred shall be indicated. The expert advisor shall confirm in the documentation that the change has been notified to him. In the event of a deliberate change, the expert consultant shall also confirm a positive assessment of the change in the dossier.
(6) All details of the course of the stage shall be recorded immediately, accurately and legibly by the person recording them. The alert shall state its name, surname and date of entry. Any changes in the primary data shall be recorded in such a way that the original record can be read. If necessary, the reason for the change, the name and surname of the person who made the change, and the date or time of the change, if any, shall be attached.
(7) Data stored in electronic form shall be backed up. Amendments and corrections to these data shall be made separately. Records on photosensitive paper or other materials with limited durability shall be transferred to a durable record.
(8) The stage documentation shall be completed by a final report positively assessed by the expert consultant. The final report shall include in particular:
(a) the purpose of handling the genetically modified organism or product;
(b) the indication of the stage and its objective;
(c) the name, surname and address of the head of the stage;
(d) the name, surname and address of the expert adviser;
(e) the address of the workplace and, where appropriate, the location and description of the land where the stage took place;
(f) the date on which the stage begins and ends;
(g) data on the genetically modified organism which was handled during the stage;
(h) isolated hereditary material which has been handled during the stage and, where appropriate, methods of genetic modification, if carried out during the stage,
(i) a description of the handling of the genetically modified organism or product during the stage, including incidents and accidents;
(j) results obtained during the stage and their evaluation.
(9) For the period laid down in Paragraph 3 (7) (b) of the Act, they shall also be maintained:
(a) records of staff training, training and familiarisation with the operating rules of the workplace pursuant to § 3 (7) (g) of the Act; and
(b) records of controls on the presence of genetically modified organisms outside the enclosed area or the land on which the genetically modified organisms or products are being handled, where appropriate.
(10) The documentation provided under this Decree does not apply to the medicinal products listed in Section 1 (2) of the Act.
(11) Without prejudice to specific legislation8) on documentation management.
Efficacy
This decree shall take effect on 1 January 2001.
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Regulation Information
| Citation | Decree of the Ministry of the Environment No. 374 / 2000 Coll., on closer conditions for the management of genetically modified organisms and products |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 26.10.2000 |
|---|---|
| Effective from | 01.01.2001 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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