Decree No. 209 / 2004 Coll.
Ordonnance on closer conditions for the management of genetically modified organisms and genetic products
Valid
Order
Effective from 27.04.2004
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209
DECLARATION
of 15 April 2004
on closer conditions for the management of genetically modified organisms and genetic products
The Ministry of the Environment, in agreement with the Ministry of Health and the Ministry of Agriculture, provides pursuant to § 38 of Act No. 78 / 2004 Coll., on the treatment of genetically modified organisms and genetic products (hereinafter referred to as "the Act") for the implementation of § 5 (1) and (4), § 7 (7), § 11 (3), § 15 (2), § 16 (2) and (3), § 19 (b), § 20 (4) and § 24 (17):
Subject matter
This decree implements the relevant provisions of the European Union1) and regulates the detailed conditions for the management of genetically modified organisms and genetic products by establishing:
(a) the models of the application for authorisation for the contained use of the third or fourth risk category, the application for authorisation for placing in the environment and the application for registration in the Marketing List;
(b) the particulars of the summary of the content of the application for authorisation for placing in the environment and for registration in the Marketing List;
(c) the formalities and procedures for risk assessment;
(d) threshold for the occurrence of additives;
(e) requirements for enclosed space and protective measures in the case of contained use;
(f) models of the notification of the contained use of the first or second risk category;
(g) a model of risk assessment for the contained use of the first category of risk referred to in Article 16a (4) of the Act;
(h) the manner and extent of documentation management;
(i) the model of the emergency plan and the scope of the Ministry's published information on the emergency plan;
(j) the elements of the evaluation report.
Basic concepts
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) the target organism - an organism whose effects on the genetically modified organism are to be affected by genetic modification;
(e) vector - a non-cellular body containing hereditary material and capable of bringing such hereditary material together with the embedded foreign hereditary material into the recipient's cells,
(f) insert - foreign inheritance material inserted into the recipient's inheritance material,
(g) signal gene - the gene contained in the insert and indicating the easily detectable property of the cells or organism containing the functional insert;
(h) the selection gene - the gene contained in the insert and determining the insensitivity to a particular substance or to the effect preventing cell proliferation that does not contain the gene;
(i) a higher plant - plants of hoverseed (Gymnospermae) and cover seed (Angiospermae).
Models of notifications, requests and other documents
(Articles 5 (1) and 16 (2) and (3) of the Act)
(1) Model
(a) the notification of the contained use is given in Part A of Annex 1 to this Order
1. in Part 1, if the contained use of the first risk category is concerned,
2. in Part 3, if the contained use of the second risk category is concerned,
3. in Episode 4, if the contained use of the second risk category is presented under Section 16a (5) of the Act,
(b) the risk assessment for the contained use of the first category of risk submitted under Section 16a (4) of the Act is set out in Part A of Annex 1 to this Decree in Part 2,
(c) the applications for authorisation for the contained use of the third or fourth risk category are set out in Part B of Annex No 1 to this Regulation;
(d) the procedures for assessing the risk of contained use are set out in Part C of Annex 1 to this Regulation;
(e) the application for authorisation for placing in the environment is set out in Annex No 2 to this Decree.
1. in Part A, Part 1, if it is a genetically modified organism other than a higher plant;
2. in Part A, Part 2, if it is a genetically modified organism which is a higher plant,
3. in Part B, if it is a genetically modified organism introduced into the environment for the purpose of clinical trial of medicinal products,
(f) the applications for registration in the Marketing List are set out in Annex 3 to this Order.
1. in Part A, if it is a genetically modified organism other than a higher plant or a genetic product other than containing a genetically modified higher plant,
2. in Part B, if it is a genetically modified organism which is a higher plant, or a genetic product containing a genetically modified higher plant.
(2) The notification, risk assessment or application shall be made on the basis of the breakdown set out in Annexes 1 to 3 to this Regulation and, if the request is made on a technical medium or in electronic form, in the format "Rich Text Format," graphic documents (plans, map, scanned documents, etc.) in the JPEG format (JPG); The "Portable Document Format" format can be used for both cases.
(3) Where an application for authorisation is submitted for more than one genetically modified organism (Section 18 (3) of the Act), all the required data shall be provided separately for each genetically modified organism.
Forms of summary of the content of the application published
(K § 5 (4) of the Act)
The details of the summary of the content of the application for authorisation for placing in the environment and the application for registration in the Marketing List are set out in Annexes 2 and 3 to this Decree.
Requirements and risk assessment procedures
(Paragraph 7 (6) of the Law)
(1) The effects of the management of a genetically modified organism or genetic product may be:
(a) direct - primary effects on human, animal, plant or environmental health directly linked to a genetically modified organism or genetic product;
(b) indirect effects on the health of humans, animals, plants or the environment arising from the causal sequence of events, for example through interaction with other organisms, transfer of inherited material or changes in the manner of disposal; indirect effects may occur with delay,
(c) immediate - those observed during the treatment of a genetically modified organism or genetic product; immediate effects may be direct and indirect;
(d) late - those which may not be observed during the treatment of a genetically modified organism or genetic product but may be detected as direct or indirect effects after the end of the treatment of a genetically modified organism or genetic product; or
(e) cumulative long-term effects - the cumulative effects of the management of genetically modified organisms or genetic products on human, animal, plant and environment health.
(2) The placing on the market of genetically modified organisms or genetic products shall also take into account long-term effects - those resulting either from delayed reaction of organisms or their offspring to long-term or chronic exposure to the genetically modified organism or from the extensive use of genetically modified organisms over time and space.
(3) In identifying and evaluating the long-term adverse effects of GMOs on human health and the environment, account shall be taken of:
(a) long-term interactions between the genetically modified organism and the receiving environment;
(b) the characteristics of the genetically modified organism which will become significant in the long term;
(c) data obtained from the repeated placing on the environment or on the market of the genetically modified organism for a long time.
(4) The identification and evaluation of cumulative long-term effects shall also take into account genetically modified organisms put into the environment or on the market in the past.
(5) In the risk assessment, the intended and unintended changes resulting from genetic modification shall be identified and their potential adverse effects on human health and the environment evaluated. The intended change resulting from genetic modification is a change to be made that meets the original goal of genetic modification. The unintended change resulting from genetic modification is a consistent change that goes beyond the intended change. Intended and unintended changes may have direct or indirect effects on human health and the environment, either immediately or in time.
(6) The risk assessment shall take into account the characteristics of:
(a) the consignee or, where appropriate, the parent organism;
(b) the donor organism, if the donor organism is used during genetic modification;
(c) vector and embedded hereditary material, including signal and selection genes, if used;
(d) the resulting genetically modified organism,
(e) the location, manner and extent of handling of the genetically modified organism or genetic product;
(f) the environment at the place where the genetically modified organism or genetic product is handled; and
(g) the interaction of these elements.
(7) The risk assessment shall also take into account relevant information from previous placing of the same or similar genetically modified organisms and organisms with similar characteristics in the environment or on the market, their interactions with similar receiving environments, including information obtained through monitoring of those organisms.
(8) Harmful effects on human health, animals, plants or the environment may in particular include:
(a) effects on the dynamics of populations of species in the receiving environment and on the genetic diversity of those populations which could lead to a potential decrease in biodiversity;
(b) altered susceptibility to pathogens to facilitate the spread of infectious diseases;
(c) the limited effectiveness of prophylactic or therapeutic human or veterinary treatment, or, where appropriate, the effectiveness of plant treatment, for example, by transferring genes that cause resistance to antibiotics used in human or veterinary medicine;
(d) effects on soil biochemical processes, including carbon and nitrogen circulation, resulting in changes in the soil degradation process of organic materials;
(e) diseases affecting humans, including allergic or toxic reactions,
(f) diseases affecting animals or plants, including toxic and allergic reactions in animals.
(1) The risk assessment shall be carried out for each area referred to in Article 5b in the following successive steps:
(a) the definition of the problem, including the identification of a hazard for which any changes in the properties of the organism associated with genetic modification will be identified; any potential harmful effects associated with such changes shall be further identified, regardless of the likelihood with which they may occur,
(b) the characterisation of a hazard for which the scope of any potential harmful effect is assessed, provided that it occurs,
(c) a characterisation of the exposure for which the likelihood of each identified potential adverse effect is assessed;
(d) an estimate of the risk posed by each of the identified harmful effects on the basis of the assessment of the likelihood that this effect will occur and the severity of that effect, if any; for each identified risk, the level of uncertainty shall also be expressed;
(e) where risks have been identified requiring certain risk reduction or exposure measures, a risk management strategy shall be proposed; the proposed measures must be proportionate to the intended risk reduction, the extent and conditions of use and the level of uncertainty in the case in question,
(f) the overall risk assessment and conclusions made with regard to the risk estimation, the proposed risk management strategy and the associated uncertainty levels; specific requirements for the monitoring plan, including how to monitor the effectiveness of the proposed risk management measures, shall also be proposed in cases of environmental or marketing as part of the overall risk assessment.
(2) The risk assessment in the case of contained use also takes into account:
(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; and
(c) any non-standard activities carried out during the contained use, such as vaccination of animals with genetically modified micro-organisms or the operation of equipment which may generate aerosols.
(3) All steps of the procedure referred to in paragraph 1 shall be documented in writing and, where possible, documented by references to scientific literature, protocols from experimental studies and, where appropriate, documentation on the previous management of genetically modified organisms or genetic products. The relevant European Union legislation, guidelines issued by the European Food Safety Authority or the European Medicines Agency and international or national classification systems, including new scientific and technical knowledge, shall also be used for risk assessment.
(4) In the case of the contained treatment of genetically modified organisms, the classification of biological agents according to the specific legislation10) or classification systems applicable to plant and animal pathogens 1a may also be used for risk assessment.
(5) The outcome of the risk assessment of the contained use shall be the inclusion of such treatment in one of the risk categories listed in Annex 3 to the Act. Only genetically modified organisms for which only genetically modified organisms may be included in the first risk category of contained use
(a) it is unlikely that the recipient or the parental organism will cause disease to humans, animals or plants;
(b) the nature of the vector and insert is such that they cannot make the phenotype of the genetically modified organism subject to which it could cause human, animal or plant disease or which could have harmful effects on the environment;
(c) the genetically modified organism is unlikely to cause diseases in humans, animals or plants or to have harmful effects on the environment; and
(d) any non-standard activities carried out during the contained use, in particular the vaccination of animals with genetically modified micro-organisms or the operation of equipment which may generate aerosols.
(3) All steps in the procedure referred to in paragraph 1 shall be documented and documented in writing by references to scientific literature, if available, protocols from experimental studies, and, where appropriate, documentation on the previous management of genetically modified organisms or genetic products. The relevant European Union legislation, guidelines issued by the European Food Safety Authority or the European Medicines Agency and international or national classification systems, including new scientific and technical knowledge, shall also be used for risk assessment.
(1) The specific areas for which a risk assessment is carried out in cases where GMOs other than a higher plant are placed in the environment or on the market are:
(a) the likelihood of a genetically modified organism becoming more resistant or more invasive than the recipient or the parent organism in its natural habitat under conditions of introduction into the environment;
(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 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 delayed 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 delayed 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 genetic 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 commonly used in the management of the corresponding non-modified organisms.
(2) The risk assessment for placing genetically modified organisms in the environment for the purpose of the clinical trial of medicinal products also contains:
(a) a description of the ways in which the genetically modified organism or its functional parts can spread from the tested body (human or animal) to the environment;
(b) the indication of the inclusion and elimination criteria for the selection of clinical trial subjects and the environmental risk impact of those criteria; and
(c) the identification and evaluation of potential harmful effects in the event of an interaction of the genetically modified organism with humans not subject to a clinical trial.
(3) The specific areas for which a risk assessment is carried out in the case of the placing on the environment or on the market of a genetically modified higher plant are:
(a) persistence and invasiveness of a genetically modified higher plant, including the transfer of genes from plant to plant;
(b) the transfer of genes from a genetically modified higher plant to micro-organisms;
(c) interactions between genetically modified higher plants and target organisms;
(d) interactions between genetically modified higher plants and non-target organisms;
(e) the effects of specific cultivation, agrotechnology and harvesting methods;
(f) effects on biochemical processes; and
(g) effects on human and animal health.
(1) The applicant shall provide evidence of the application for registration in the Marketing List,
(a) where toxicological studies have been carried out to ensure that such studies have been carried out in establishments which comply with the requirements of another legislation2), or where toxicological studies have been carried out outside the European Union that the establishments comply with the principles of the Organisation for Economic Cooperation and Development for Good Laboratory Practice;
(b) where non-toxicological studies have been carried out, that such studies have been carried out in accordance with the principles of good laboratory practice laid down by other legislation (m2) or that they have been carried out by organisations accredited to the relevant International Organisation for Standardisation (ISO) standard or, in the absence of the relevant standard, that they have been carried out in accordance with internationally recognised standards.
(2) The information on the studies referred to in paragraph 1 shall include unprocessed data in an electronic format suitable for statistical or other analysis.
(3) In the case of an application for the placing on the market of a genetically modified organism containing a combined transformation event or a genetic product containing such an organism, it is necessary to carry out a risk assessment for each single transformation event or a reference must be made to previous marketing applications concerning the relevant simple transformation events. In assessing the risk of a genetically modified organism containing combined transformation events, it is necessary to assess:
(a) stability of transformation events;
(b) expression of transformation events; and
(c) potential additive, synergistic or antagonistic effects arising from a combination of transformation events.
(4) Where the progeny of that genetically modified organism may contain different sub-combinations of transformation events, the applicant shall be required to provide relevant experimental data for those sub-combinations, unless it is sufficiently justified that it is not necessary to provide experimental data for the sub-combinations concerned.
(5) The assessment of the risk of a genetic product containing several different genetically modified organisms must include an assessment of the relevant data for each of these organisms.
The threshold for the occurrence of additives
(Paragraph 11 (4) of the Law)
Genetic products which need not be labelled under Section 11 (4) of the Act shall mean genetic products intended for direct processing which do not contain more than 0,9% of the ingredients of genetically modified organisms authorised for placing on the market under Section 23 (1) of the Act, provided that they are random or cannot be technically prevented.
Requirements for closed space and protective measures for individual risk categories in closed handling
(Paragraph 15 (2) of the Law)
(1) The requirements for enclosed space and protective measures for contained use are set out in Annex 4 to this Decree according to the type of workplace and risk category in which the contained use was included (Section 15 (1) of the Act).
(2) Protection measures include compliance with workplace operating rules, principles of occupational hygiene and safety, as well as the provision of staff training and retraining [§ 19 (f) and (g) of the Act].
(3) The provisions of paragraphs 1 and 2 are without prejudice to specific legislation governing the correct procedure of the working and laboratory praxe.3)
Method and extent of documentation management
[K § 19 (b) of the Act]
(1) The documentation on the treatment of genetically modified organisms (hereinafter referred to as "the dossier") under Section 19 (b) of the Act includes:
(a) a copy of the application for authorisation for contained use, authorisation for placing in the environment or for registration in the Marketing List or for extension of the authorisation pursuant to Article 5 (1) of the Act, a copy of the notification submitted pursuant to Article 16 (3) or Article 16a (5) of the Act, or an assessment of the risk submitted pursuant to Article 16a (4) of the Act;
(b) decisions to grant authorisations for contained uses, authorisations for placing in the environment (Section 5 of the Act) and extensions (Sections 16c (4) and 18 (7) of the Act), amendment or cancellation (Section 12 of the Act) of such authorisations, decisions which have imposed on the notifier the implementation of an adjustment of the conditions of use set out in the Notice (Section 16b (1) of the Act), decisions pursuant to Section 34 of the Act, and decisions imposing a fine pursuant to § 35 or 35a of the Act or, where appropriate, an officially certified copy of those decisions;
(c) risk assessment of the management of genetically modified organisms (Section 7 of the Act);
(d) the operating rules of the Institute (§ 19 (f) of the Act);
(e) emergency plan (Section 20 of the Act),
(f) methodologies for activities related to the management of genetically modified organisms, where they are processed (e.g. standard operating procedures) and are not the content of the application or notification referred to in (a);
(g) operating journals;
(h) sub-reports (e.g. reports containing information pursuant to § 19 (c) of the Act and § 25 (5) of the Act);
(i) records of checks carried out pursuant to Article 15 (3) of the Act and their results;
(j) the final report pursuant to § 19 (d) of the Act;
(k) records of staff training, re-training and familiarisation with the working order of the workplace pursuant to § 19 (g) of the Act; and
(l) records of controls on the presence of genetically modified organisms outside the enclosed area or land on which the treatment of genetically modified organisms has been carried out, where appropriate, and their results and records of checks carried out by the administrative authorities, including control reports.
(2) The documentation shall be established, maintained and kept in paper and electronic form in such a way that the content cannot be lost, damaged or stolen, and that its clear layout and accessibility can be ensured, if necessary.
(3) The operating log to be kept during the treatment of genetically modified organisms contains:
(a) a description of the management of genetically modified organisms;
(b) data on the course of treatment of genetically modified organisms, in particular any difference from the description referred to in (a);
(c) primary data obtained during the treatment of genetically modified organisms;
(d) records of any inspections, inspections and results made;
(e) records of any incidents and accidents;
(f) the date of each alert, the name and signature of the person who carried it out.
(4) In the case of longer-term projects, the management of genetically modified organisms may, where appropriate, be divided into several stages, i.e. periods to obtain partial results. A separate operating log may be kept for each stage.
(5) If there is a change to the description of the treatment during the treatment of genetically modified organisms, the reason for the change and the date on which the change was decided or occurred shall be indicated in the operating log. The expert advisor shall confirm in the documentation that the change has been notified to him.
(6) All data on the course of the treatment of genetically modified organisms shall be entered immediately, accurately and legibly by the person recording them. The alert shall state the name and signature of the person making the alert and the date of the alert. Any changes in the original data on the results of the observations, measurements and registration of the variables shall be recorded in such a way that the original record is legible, in which case the reason for the change of the data, the name and signature of the person who decided to change and who made the change, and the date and, where applicable, the time of the change.
(7) Data stored in electronic form shall be backed up. The amendments and corrections to this information shall be marked with the name, names and receipt, where appropriate, of the person who made the changes and corrections. Records on photosensitive paper or other materials with limited durability shall be transferred to a durable record.
(8) The documentation of the management of genetically modified organisms shall be terminated by the final report [Paragraph 19 (d) of the Act], which has been positively assessed by the expert consultant. The final report shall include in particular:
(a) the objective of managing genetically modified organisms;
(b) the particulars given in the authorisation in force for the contained use or placing into the environment, the date and reference number of the authorisation and, where applicable, the date of the submission of the notification where the contained use of the first or second risk category is concerned;
(c) the address of the workplace and, where appropriate, the location and description of the parcels where the loading took place;
(d) the date of commencement and termination of the treatment of the genetically modified organism;
(e) data clearly identifying the genetically modified organisms with which they have been treated or placed in the environment;
(f) the isolated hereditary material which has been handled and, where appropriate, the methods of genetic modification, if any;
(g) a description of the management of genetically modified organisms, including date, description and evaluation of all incidents and accidents;
(h) the description and date of disposal of the genetically modified organisms used, as well as the verification of the effectiveness of the disposal, including the name (s) of the person authorised to dispose of the genetically modified organism, who carried out or verified its effectiveness, unless such activities were carried out by the authorised person himself;
(i) the results of the management and evaluation of genetically modified organisms, including the results of continuous monitoring;
(j) a description of the provision of subsequent monitoring of premises and parcels after the end of the treatment of genetically modified organisms and the name (name or business name) of the person carrying out the monitoring for the person authorised to carry out the treatment, unless it is carried out by the authorised person himself;
(k) the statement of the expert adviser, his signature and the date of signature.
(9) Specific legislation (4) on documentation management remains unaffected.
Model of the emergency plan and scope of the Ministry published information on the emergency plan
(K § 20 (4) and (5) of the Act)
(1) The model of the emergency plan is set out in Annex 5 to this Order
(a) in Part A, if there is an emergency plan for contained use;
(b) in Part B, if there is an emergency plan for placing into the environment.
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Regulation Information
| Citation | Decree No. 209 / 2004 Coll., on closer conditions for the management of genetically modified organisms and genetic products |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 27.04.2004 |
|---|---|
| Effective from | 27.04.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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