Key Benefits:
Chapter 1 Area
Chapter 2 Evaluation of safety and health
Chapter 3 Classification of laboratories, laboratory areas and plant for storm retries and production
Chapter 4 Notification and approval of research projects and other laboratory tasks
Chapter 5 Notification and approval of storm-scale trials and production
Chapter 6 Substitution
Chapter 7 General provisions
Chapter 8 Pensation and appeal
Chapter 9 Punishment
Chapter 10 Entry into force and transitional provisions
Publication of genetic engineering and working environment 1)
Purline of section 17 (2). 3, section 22, paragraph. One, paragraph 35, section 39, paragraph. One and two, section 40, section 41, paragraph. 1, section 43, section 44, § 46, § 49, § 49a (2). 1 and 2, section 49c, section 73, section 75 (5). 1 and Article 84 of the Work Environment Act, cf.. Law Order no. 268 by 18. In March 2005, as well as the authority of the Minister for the Environment, pursuant to section 7, section 20 (4). 2, section 27 and section 36 (3). 4, in the area of the environment and gene technology, cf. Law Order no. 811 of 21. June 2007 shall be determined :
Chapter 1
Area
§ 1. The announcement includes work, including development work, with genetically modified organisms, cf. in Annex 1, in :
1) laboratories and laboratory areas, including animal stables, greenhouses, aquarium and other such,
2) systems for large-scale use and production.
Paragraph 2. The announcement shall apply regardless of whether the work is carried out for an employer.
§ 2. Exemptions from the notice are exhibition, other information dissemination, etc., as the Environment Minister, pursuant to the law on the environment and gene technology, can certainly take place outside classified laboratories and laboratories.
Paragraph 2. The Director of the Health Safety Board may decide to work with the genetically modified organisms that the Environment Minister is exempt under the law on the environment and gene technology, also exempts from the notice.
§ 3. In addition to the rules of this notice, the general rules of the working environment shall apply to the rules of the working environment and rules which, pursuant to other legislation, may be fixed on genetic engineering.
Paragraph 2. In the case of genetically modified micro-organisms, the rules shall also apply in respect of biological agents and the working environment of the duty to keep lists of employees exposed to biological agents at risk groups 3 or 4 as well as the duty to : ensure access for the employees to have a medical examination carried out.
Definitions
§ 4. In the case of genetically modified organisms, the meaning of this notice shall mean plants, animals, micro-organisms, cell cultures and viruses which present new composition of the genetic material which does not occur naturally, cf. Annex 1.
§ 5. In the case of application of the provisions of this notice, the following definitions shall be :
1) For the purposes of research projects and other laboratory tasks, work on genetically modified animals and plants, as well as work on genetically modified micro-organisms or cell cultures, with a volume per volume ; retains not more than 15 litres of the liquid.
2) In the case of large-scale shell-scale tests, work on genetically modified micro-organisms or cellular cultures means that there is no real production, but which takes place in similar installations. Work with genetically modified plants and animals is not covered by the definition.
3) The donor shall mean the organism or cell / cell stock from which the genetic material used is derived.
4) By host means the cell or organism in which the genetic material is introduced.
5) A vector means the biological material used to introduce genetic material in a host.
6) In the case of biological active material, donors, hosts, genetically modified cells and organisms, or tissues thereof, viruses and genetically modified animals and plants capable of replicating themselves.
7) Laboratories and laboratory areas shall mean the work space in which bioactive material is handled. That is, rooms where work is carried out under some kind of biological active material. In the case of a laboratory area, it is believed to be rooms such as animal stables, greenhouses and aquarium.
8) For the purpose of enclosed application, in Annex 2, Part B, any activity where micro-organisms are modified genetically, or where such genetically modified micro-organisms are grown, stored, transported, destroyed, disposed of, or used in any other manner, and where there is : specific containment measures shall be used in order to limit their contact with people and the environment.
9) In the event of accident, any incident involving a significant and unintended release of genetically modified micro-organisms under its enclosed use and which may result in immediate or consequent risk to human health or the environment.
10) In the case of an imprest situation, any incident involving accidents in accordance with the following conditions : § 5, nr. 9, as well as events that lead to an accident.
Chapter 2
Evaluation of safety and health
§ 6. The notification of work shall be carried out as a general assessment of the possible dangers to human safety and health or to the external environment of biological systems.
Paragraph 2. In the case of work on genetically modified micro-organisms, the assessment must include at least the assessment elements and the procedure shown in Appendix 3a, Part A, and Annex 3b. In accordance with the said assessment, the assessment shall be assessed in which class the work is to be carried out, cf. Annex 3a, Part B.
Paragraph 3. In the case of work on genetically modified animals, the assessment shall include the principles set out in Annex 3a, Part A, and Annex 3b.
Paragraph 4. A written statement shall be kept for the assessment to be made available to the Board of Work.
Paragraph 5. The assessment must be updated when changes are made to work, working methods, work processes, etc., which are relevant to the business environment of the establishment and the external environment, if :
1) the protective measures which are used are no longer adequate or the class in which the activity is carried out is no longer the correct one ; or
2) there is reason to assume that the evaluation will no longer be adequate on the basis of the latest scientific or technical knowledge.
Chapter 3
Classification of laboratories, laboratory areas and plant for storm retries and production
§ 7. Laboratories, laboratory testing and storage facilities for large-scale use and production in which work must be carried out with genetically modified organisms must be classified by the Board of Work. For classification, the approval of the worker ' s approval means that a field satisfies the requirements laid down for the territory.
Paragraph 2. The classification is valid until the Work is notified otherwise.
§ 8. Classification of laboratories and laboratory areas, including greenhouses, animal stables, aquarium and other similar situations shall be done in 4 classes in accordance with Annex 2, Parts A and B, cf. however, paragraph 1 2.
Paragraph 2. Laboratories and laboratory areas in which non-GM micro-organisms are not to be worked on but work with genetically modified plants and animals alone shall not be classified in 4 classes, but only after a specific assessment.
Paragraph 3. Classification of laboratories in which genetically modified plants and animals are to be worked on, as well as the classification of laboratory areas, after negotiation with the Environmental Management Board.
§ 9. Classification of installations for large-scale reproduction and production shall be done in 4 classes in accordance with Appendix 2, Parts A and C, cf. however, paragraph 1 2. Facilities for large-scale escalation shall be classified in accordance with the Environmental Management Board.
Paragraph 2. Installations for the production which are not to be worked on genetically modified micro-organisms, but must be worked on genetically modified plants and animals, not classified in 4 classes, but only after a specific assessment.
§ 10. The Director of the Health Safety Board may lay down rules for or decide that certain experiments in the training exercise with genetically modified organisms may be carried out outside classified laboratories and laboratory areas.
§ 11. Notification of classification in accordance with section 7 (4). 1 shall be submitted to the Board of Work and shall include information on the conditions set out in Annex 2, in addition to the technical means of processing aids and descriptions of the building conditions.
§ 12. Where there are already classified laboratories, laboratory areas, storage facilities and production are classified in a lower class or classification no longer wishes to be maintained, this must be reported to the Health Safety before notifying the claim.
§ 13. Work in classified laboratories, laboratory areas, storage facilities and production must always be carried out in accordance with the requirements of the class in question, cf. Annex 2, as well as in accordance with the specific terms and conditions laid down in the classification.
§ 14. Classification in accordance with section 7 (4). 1 shall be notified in writing within 45 days of the submission of the notification.
Paragraph 2. The classification of laboratories, laboratory areas and plant for high-scale and class 3 and 4 shall be notified in writing within 90 days of the submission of the notification.
Paragraph 3. For the calculation of the time limit in paragraph 1 1 and 2 shall not include the period during which the Work for Work is pending further information to which the Board of Work asked the notifier.
Chapter 4
Notification and approval of research projects and other laboratory tasks
§ 15. Research projects and other laboratory tasks incorporating work on genetically modified organisms must be approved prior to the approval of the Board of Work.
Paragraph 2. In the case of category 1, subsequent research projects and other laboratory tasks in the same legal entity may commence without further approval.
§ 16. Work with genetically modified micro-organisms must be carried out only in laboratories and laboratory areas that are at least classified for the work of the relevant nature.
Paragraph 2. If there is any doubt as to the class that is sufficient for the work in question, the higher class is selected.
§ 17. Notification of research projects and other laboratory tasks shall include the information referred to in Annex 4, Part A, cf. however, paragraph 1 2, and shall be submitted to the Labor Board.
Paragraph 2. Notification of research projects and other laboratory tasks referred to in Annex 5 shall include :
1) the information referred to in Annex 4, Part A and B,
2) identification of the health risks, as well as in normal working conditions, as in the event of accidents ; and
3) statement of the measures planned in addition to those resulting from the classification of the laboratory.
Paragraph 3. Notification of subsequent research projects and other laboratory tasks in class 1 shall be made out of the assessment after section 6 and the classification of the local work in which the work is to be carried out.
§ 18. The Commission shall submit notifications of research projects and other laboratory tasks for the Environmental Management Board where :
1) incorporating work on genetically modified reproductive plants, genetically modified animals or genetically modified organisms in animal stables, greenhouses, aquarium and other similar, or
2) an assessment according to section 6 shows that there is an environmental hazard.
§ 19. The notification and approval shall lapses after 5 years, unless it is renewed, cf. however, paragraph 1 2.
Paragraph 2. The approval of research projects and other laboratory tasks referred to in Annex 5 shall apply until the Work is notified otherwise.
20. The Board of Work shall provide approvals after paragraph 15 (1). 1 in writing no later than 45 days after notification of the notification. The time limit for calculating the time limit shall not be counted as to which Work is pending further information that the Work may have requested the notifier.
Paragraph 2. However, research projects and other laboratory tasks not covered by Annex 5 may, however, save 45 days after notification of the notification, without the notice of the notification, in accordance with the notification, in 45 days after notification. however, section 15 (3). 2.
Paragraph 3. The Director of the Health Safety Board may provide that work with certain genetically modified organisms may be implemented when the notification has been submitted.
Chapter 5
Notification and approval of storm-scale trials and production
§ 21. High-scale trials and production which are involved in the work of genetically modified organisms must be approved prior to the approval of the Employment Board.
Paragraph 2. As far as class 1 is concerned, the retrograde and production of the same legal unit may be initiated without further approval.
§ 22. Work with genetically modified micro-organisms must be carried out only in installations for high-scale tests and production which are at least classified for the work of the relevant nature.
Paragraph 2. If there is any doubt as to the class that is sufficient for the work in question, the higher class is selected.
-23. The notification of large-scale use and production shall contain the information listed in Annex 4, part A and B and shall be submitted to the Board of Work.
Paragraph 2. Enrollment of subsequent major-scale trials and the production of Class 1 shall be made out of the evaluation according to section 6 and the reference to the classification of the plant to be carried out in the work.
§ 24. The Board of Work shall submit to the Environmental Management Scrub trials in class 2 or higher for the Environmental Management Board.
§ 25. The arrest of a Class 1 class lapses after five years, unless it is renewed.
Paragraph 2. The approval of a class 2 or higher scale in class or higher and production shall be valid until the Work is notified otherwise.
SECTION 26. The Commission shall notify approvals in accordance with section 21 (1). 1 in writing no later than 45 days after notification of the notification. The time limit for calculating the time limit shall not be counted as to which Work is pending further information that the Work may have requested the notifier.
Paragraph 2. However, high-scale testing in Class 1 may, however, unless the Work has notified the second message, a 45-day period after notification of the notification, cf. however, section 21 (1). 2.
Paragraph 3. The Director of the Health Safety Board may lay down rules on a system of notification for the production of genetically modified organisms in category 1.
Chapter 6
Substitution
§ 27. A donor and a host vector system shall not be used if the donor or host vector system can be replaced by less dangerous donors and host vector systems.
Paragraph 2. Where the use of a replacement donor or a replacement value vector system will not result in insignificant differences in the technical characteristics or expenditure, a total weighing of the technical and economic consequences to the security-safety- and health concerns.
Paragraph 3. The Board of Employment may require the documents to be provided for in paragraph 1. 1 and 2 conditions.
Chapter 7
General provisions
§ 28. The employer shall ensure that the instructions for the staff and safety notices are given in writing and, where necessary, in the form of a lookup.
Paragraph 2. A contingency plan must be prepared for work on genetically modified organisms when the loss of containment measures immediately or later could result in particular danger to people outside of the premises and / or for the environment, except when : such contingency plans have already been drawn up in accordance with other legislation.
Paragraph 3. Any contingency plans shall be prepared before the work on genetically modified organisms will commence, and shall be accompanied by the notification for classification after Article 11.
§ 29. The Director of the Health Safety Board may require notification of the notifications after paragraph 11, section 17 (4). Paragraph 1, and section 23 (1). 1, shall be made in particular schemas that are requested in the Work with the Board of Work.
-$30. Any significant change in the information provided for in section 11, 17 and 23 of the importance of safety and health shall be notified to the Health Safety Board.
Paragraph 2. Approval of the amendments shall be notified in writing within 45 days of the submission of the notification. The time limit for calculating the time limit shall not be counted as to which Work is pending further information that the Work may have requested the notifier.
Paragraph 3. However, change of information after Section 17 (3) shall be amended. 3, and section 23 (4). Two, do not be approved.
§ 31. To the extent that it may be deemed necessary to assess the safety of the genetic engineering work or, where appropriate, conditions may require additional information in the Commission. The Board of Work may require the information to be assessed by a special expert, cf. the section 21 of the work environment.
§ 32. The company ' s security organisation shall be included in the preparation of the assessment after section 6 and internal emergency plan after section 28. In establishments in which no safety organisation is to be established, employees must be involved in a similar manner.
§ 33. A classification in accordance with section 7 (2). 1 and an approval after paragraph 15 (3). Paragraph 1, or Article 21 (1). 1 may be conditional upon specified terms and conditions, as well as a classification or approval may be made time limited.
Paragraph 2. The Board of Work may revoke a classification in accordance with section 7 (2). 1, and an approval after paragraph 15 (3). Paragraph 1, or Article 21 (1). 1 if the terms and conditions of safety and health are not respected or new information which are essential to safety and health, make it necessary.
§ 34. The Board of Work is investigating notifications after sections 11, 17 and 23, for
1) compliance with the requirements of this notice ;
2) the accuracy and completeness of the information provided,
3) the correctness of the assessment after section 6 and of the enclosed uses of the applicability, and
4) where necessary, on the containment measures and other protective measures and measures relating to waste management and preparedness are adequate.
Chapter 8
Pensation and appeal
$35. The Director of the Health Safety Board may, where special conditions are available, authorise deviations from the provisions of this notice, where it is deemed reasonable and fully justified, and to the extent that it is compatible with Directive 90 /219/EEC, relating to the confinalisation of the provisions of this Regulation ; the use of genetically modified micro-organisms as amended by Directive 98 /81/EC.
§ 36. The decisions of the labor force following this notice may be subject to Article 81 of the Work Environment Act.
Chapter 9
Punishment
§ 37. Unless the law on working life or other legislation is to be punished with a fine or penitentiance for up to 2 years, the penalty shall be punished by fine or penitentian until two years :
1) is in violation of section 6, section 7 (4). 1, sections 11, section 12, section 13, section 15, section 15. Paragraph 1, section 16, paragraph 1. One, section 17, section 21, paragraph. One, section 23, section 27, paragraph. 1 and 2, section 28, section 30 and section 32,
2) overrides terms associated with a classification after paragraph 7 (3). 1 or approvals after paragraph 15 (3). Paragraph 21 (1) or 9. 1 or
3) shall not be imposed or prohibitions issued pursuant to the provisions of the notice of the notice.
Paragraph 2. For violation of section 7 (4). 1, section 15, paragraph 1. Paragraph 21 (1) and section 21 (1). 1, even if the offence cannot be attributing to him as deliberate or negligent, an employer may be charged to the responsibility of one employer. No conversion penalty shall be fixed for the responsibility of the boatman.
Paragraph 3. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.
Chapter 10
Entry into force and transitional provisions
§ 38. The announcement will enter into force on the 171. September 2008.
Paragraph 2. At the same time, notice No 642 of 28. June 2001 on genetic engineering and working environment.
§ 39. Classifications, approvals and derogations given by the Director of the Health Safety before the 17. September 2008 will remain in effect, cf. however, section 19 (1). Paragraph 25, paragraph 25. 1 and 30.
Paragraph 2. In the case of significant changes to information in relation to classifications, approvals or derogations given by the Director of the Safety Board, in accordance with the Order of the Ministry of Work, 578 of 1. September 1987 or no. 684 of 11. In October 1991 on genetic engineering and working environment as amended by announcement No 1 705 of 22. In July 1996 a new notification shall be made in accordance with the provisions of this notice.
Paragraph 3. previously notified classifications of installations for the large-scale remission and production of Group 1 shall apply, in accordance with the entry into force of this notice, as well as installations for high-scale experiments and production in category 1.
The labor vision, the 11th. September 2008
Jens Jensen
/ Jeanne Borgqvist
Appendix 1
Techniques for genetic modification, cf. § § 1 and 4
Part A
Within the framework of the definition of genetically modified organisms in section 4, genetic modification occurs at least by the use of the following techniques :
1) Combinant nucleic techniques, which include the formation of new combinations of genetic material by the introduction of nucleic coasts produced in any way outside of an organism, in a virus, bacterial placards or other the vector system and their incorporation into a host body in which they do not occur naturally, but in which they are capable of continuing propagation.
2) Technical techniques for direct entry into an organism of genetic material that has been prepared outside the organism, including microinjection, macro injection and microencapsulation.
3) Cell merger (including protoplagers) or hybridization techniques, where live cells with new combinations of genetic material are formed by fusion of two or more cells by means of methods that do not occur naturally.
Part B
The following techniques are not considered to be a leading to genetic modification, insofar as they do not involve the use of combinant nucleic acid molecules or genetically modified organisms :
1) In vitro fertilization,
2) natural processes, such as conjugation, transduction, transformation, and
3) Polyploidiinduction.
Part C
The notice shall not apply to organisms manufactured using the following genetic modification techniques, provided that they do not involve the use of genetically modified organisms, such as recipient or parenogenic organisms :
1) mutagenesis,
2) cell fusion (including protoplagers) of prokaryote species which exchange genetic material at known physiological processes ;
3) cell fusion (including protoplafusion) of cells from all of the eeukaryote species, including the production of hybrids and plant-plant-plant mergers, and
4) traditional processing techniques.
Appendix 2
Notification and classification of laboratories, laboratory areas, storm-scale experiments and production, cf. Section 7 (2). 1
Part A
General
The classification shall be carried out in 4 classes in relation to :
1) the direction of the area,
2) plans for the execution of the work, including contingency plans,
3) the technical means of the area ; and
4) internal supervision and control.
Notification of classification :
Information required for the purpose of the section in section 7 (3). 1 declaration of notification :
-WHAT? the name of user / users and persons responsible for the supervision and security ;
-WHAT? information on training and qualifications in respect of persons responsible for the supervision and security ;
-WHAT? security organization information
-WHAT? the address and general description of the buildings ;
-WHAT? a description of the nature of the work which will be carried out ;
-WHAT? the class of enclosed use,
-WHAT? information on the management of waste.
-WHAT? any contingency plans,
Schema 1a, 1b, 1c, and 2 show the normal minimum requirements and measures necessary for each containment level.
The end is also guaranteed by the use of good working practices, training, containment equipment and, in particular, civil engineering design. For all activities involving genetically modified micro-organisms, the principles of good microbiological practices and the following principles of safety and hygiene in the workplace are :
i) the protective measures and the protective equipment shall be reviewed in an appropriate manner and maintained ;
(ii) to be tested, as necessary, for the presence of viable organisms from the outside of the primary physical containment ;
(iii) the staff shall be provided for the appropriate training of staff,
(iv) drawing up and implementing local guidelines as required for the safety of staff ;
(v) a suitable registration must be carried out,
We) in the interests of security, written working instructions shall be drawn up as required.
The Skemations ' headlines are indicative.
Table 1a indicates the minimum requirements for laboratories and laboratory areas in which genetically modified organisms are worked.
Table 1b lists additions to and changes to Schema 1a for greenhouse gases and similar ones where genetically modified micro-organisms are worked.
Table 1c lists additions to and changes to the schema 1a of animal stables and similar where genetically modified micro-organisms are worked.
Table 2 shows the minimum requirements for large-scale scale-scale experiments and production where genetically modified organisms are worked.
In some cases, it may be necessary to use a combination of measures from schema 1a and schema 2 at the same level.
In some cases, the user may not use a specification from a given containment-level or combining specifications from two different levels.
In the Schema, the "optionally" means that the user may carry out these measures on the basis of the evaluation in section 6 in each case. The Board of Work may, by means of a concrete assessment, make demands that the measures set out in the Schema as "possible" should be used.
Definitions :
Auto-Clapping :
For autoclapping, a saturated water vapour treatment is understood by 121 ºC for 20 minutes or other combinations of temperature and time, having at least the same inactivation power on biological material.
Disinfection :
In the case of disinfection, a reduction in the number of harmful micro-organisms in such a degree means that the spread of safety or health implications will not occur. Disinfection is mostly carried out by heat exposure or chemical exposure.
Part B
Contain and other safeguard measures for laboratories and laboratory areas, cf. § 3 and § 8.
In this Annex, both ' laboratory ` and ' laboratory territory ` shall be referred to as a laboratory.
The requirements of categories 2, 3 and 4 shall, in addition to the requirements referred to in the current class, also include the requirements referred to in the previous classes. For the classification of a class 3 or 4 laboratory, in addition to the general requirements set out in the Annex, specific requirements may be made subject to the specific project to be carried out in the laboratory.
A horizontal line means that the lower class requirement should not be transferred to the higher class, as it would be contrary to other requirements of this class.
Schema 1a. Laboratory and other safeguard measures for laboratories and laboratories.
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Table 1b. Confining and other protective measures for greenhouses and similar
The printing houses and similar references are to a structure with walls, a roof and a floor that is designed and essentially used for the propulsion of plants in a controlled and protected environment.
All provisions of the Schema 1a are applicable with the following additions / changes :
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Schema 1c. Indexing and other protective measures for animal stalkers and similar.
All provisions of the Schema 1a are applicable with the following additions / changes :
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Part C
Confining and other protective measures for large-scale scale trials and production, cf. § 9
The notification shall, where necessary, contain information on the protective measures planned for the protection against the risks associated with the use of the installation, including ;
-WHAT? the expected cultural volume,
-WHAT? the quantities, nature and consumption of raw materials, formulants, etc., to be used ;
-WHAT? the processes used, including the formation of between-and waste products, as well as by-products of safety and health care ;
-WHAT? the projected emissions at the workplace from installations and equipment of gaseous, liquid and solid substances and materials in connection with operations and accidents.
The requirements for the containment measures for organisms are shown in the categories listed below, depending on the organism concerned and the work concerned.
Each operation in the process must be assessed. Each operations characteristic is essential to the physical containment to be used. This will make it possible to select and organise the process and the plant and operational procedures which are best suited to ensuring adequate and secure containment. Two important factors which must be taken into account in the selection of containment equipment are the risk and the impact of failure of the equipment used. The more serious the consequences of a possible failure are, after all, the stricter requirements for manufacturing practices to be put in order to reduce the risk of failure.
Table 2.
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Appendix 3a
Evaluation after section 6 of the biological systems
Part A
This Annex contains a general description of the elements to be taken into account and the procedure to be followed in the assessment referred to in this Annex. The F.s.v.Amongst the detailed guidelines for the assessment are referred to Annex 3b.
The assessment shall take particular account of the issue of the release of waste and waste water.
A. Items for the Assessment referred to in section 6 :
1. The following should be considered to be potentially harmful effects :
-WHAT? disease in humans, including allergenic or toxic effects ;
-WHAT? disease in animals and plants ;
-WHAT? harmful effects caused by the impossibility of treating a disease or to offer an efficient prophylax ;
-WHAT? adverse effects resulting from the establishment in or diversification into the environment ;
-WHAT? harmful effects resulting from the natural transfer of inmate genetic material to other organisms.
2. in assessing possible hazards for safety and health at the biological systems, the following parameters must be taken into consideration in the extent that they are relevant :
a) Identification of all potentially harmful effects, especially those related to
i) donor, host, or (if any) the parental (s) organism (s) (as long as the organism is used in the activity)
(ii) the inserted genetic material (from the donor organism),
(iii) vector,
(iv) the resulting genetically modified organism.
b) The characteristic properties of the activity.
c) The extent of the potentially harmful effects, including the health of the health.
d) The probability that the potentially harmful effects occur.
(e) Surveillance techniques.
B. Procedure
3. The first phase of the evaluation process should be to identify harmful properties in the recipient organism and, where appropriate, in the donor organism and harmful properties associated with the vector or the inserted material, including any modification of the phase ; The existing properties of the recipient.
In general, it is only genetically modified organisms with the following characteristics, which will be considered suitable for the inclusion in class 1 :
i) Recipientorganism or the parenous organism is expected not to be able to cause diseases in humans, animals or plants ; 6)
(ii) the vector or the inserted material is of such a kind, that they do not give the genetically modified organism a faecal type which is expected to cause diseases in humans, animals and plants ; 6) or to have environmentally harmful effects ;
(iii) the genetically modified organism is expected not to be able to provoke diseases in humans, animals and plants ; 6) , and are not expected to have environmentally harmful effects.
In order to obtain knowledge of the information necessary for the implementation of this process, the notifier shall not be able to include relevant legislation, in particular the Agency ' s notice on biological agents and the working environment.
International or national classification systems (e.g. WHO, NIH), and their adaptations to scientific and technical progress may also be taken into account.
6. The fortification process to be carried out in accordance with section 3-5 shall lead to the identification of the degree of risk associated with the genetically modified organisms.
7. The selection of the containment and other protective measures shall then be taken on the basis of the level of risk associated with genetically modified organisms, as well as in the light of :
i) characteristic properties of the environment likely to be exposed (for example, in the environment likely to be subjected to genetically modified organisms, known biota, which may be adversely affected by the organisms used in the activity which has been involved in the enclosed application,
(ii) characteristic characteristics of the activity (such as its scope and species) ;
(iii) all non-standard operations (e.g., non-cogeneration of genetically modified micro-organisms in animals ; equipment likely causing aerosol formation).
On the grounds of paragraph 1 In accordance with point 6, the degree of risk that the genetically modified organism may be associated with the genetically modified organism may be increased or remain unchanged under point 6.
8. When the analysis is complete as described above, the activity is classified in one of the classes described below. The 4-class division shall not apply to genetically modified animals and plants.
9. The final classification of the enclosed use shall be verified following a review of the completed assessment as referred to in section 6.
Part B
Criteria for the selection of class.
The assessment in Annex 3a, Part A, shall result in a final classification of the enclosed uses in four classes, and this classification is in accordance with section 6 (4). 2 determinant of the containment level :
Class 1 : work which does not present any risk or only insignificant risk, i.e. work where the class 1 containment is sufficient to protect human health and the environment.
Class 2 : work which involves low risk, i.e. work where the class 2 containment is sufficient to protect human health and the environment.
Class 3 : work that involves moderate risk, i.e. work where the class 3 containment is sufficient to protect human health and the environment.
Group 4 : work that involves high risk, that is to say. work where class 4-containment is sufficient to protect human health and the environment.
Appendix 3b
Guidelines for risk assessment
1. Introduction
The elements to be taken into consideration in Annex 3a, part A, points 1 and 2 shall be drawn up in the assessment of potentially harmful effects on human health and the environment. Potential harmful effects are defined as : effects resulting from disease or the impact of prophylax or processing ineffective ; harmful effects on organisms or natural populations resulting from the establishment and / or dissipation of the environment ; or harmful effects resulting from retransmission to other organisms. The risk of these potentially harmful effects must be examined for each operation, which shall be classified in a given class, taking into account the nature and scope of the operation in order to determine the necessary containment measures. The risk of the use of genetically modified organisms (GMOs) and the construction of such organisms shall be determined by examining the seriousness of the potential harmful effects on health or environmental effects, and of the likelihood ; for these effects to take place. In the case of risk assessment, the exposure of humans or the environment to GMOs shall be assessed as a result of the operation of a plant for contained use or as a result of possible leakage from one such plant. The level of classification determined by the risk assessment determines which account requirements are in force for activities involving GMOs.
2. Risk Assessment
A complete risk assessment process includes the following two procedures :
2.1 Procedure 1
Identification of potential harmful properties (danger) of the GMO and location of the GMO in a provisional class (Class 1-Class 4) on the basis of the seriousness of the potential adverse effects
AND
estimation of the likelihood of harmful effects, based on an assessment of possible exposure (both people and the environment), taking into account the nature and extent of the activity and to : the containment measures for the initial class in which the activity is located.
2.2 Procedure 2
Finally, the classification and final determination of containment measures.
The definitive classification and final containment measures shall be confirmed by restating the procedure 1.
3. Procedure 1
3.1 Identification of harmful properties (danger) on the GMO.
The risk assessment process shall include identification of any harmful characteristics of the GMO as a result of the genetic modification or any changes in the properties of the recipient properties. The potentially harmful properties associated with the GMO must be determined by examining the recipients of the recipient organism, the donor organism, the properties and placement of the inmate material and the location and possible vector of the material. It is important to take into account that genetic modification of an organism can influence its ability to harm health and the environment, as it can be reduced, increases or remain unchanged.
3.2 Aspects that should be taken into account if appropriate :
3.2.1 Recipientorganism
-WHAT? the name, designation and origin,
-WHAT? information on the parental organism (s), or, where appropriate, of the reproductive cycle of the host body (gender / gender) ;
-WHAT? characterisation of pathogenicity and virulence, infectiveness, allergenicity, toxicity, and vectors for disease transfer
-WHAT? characterizing the inmates and the following agents, if they are to be able to mobilise the input material, and the frequency of such mobilisation ;
-WHAT? the nature and stability of any inactivation mutations,
-WHAT? the parental organism (s) or the stability of the host body with regard to the relevant genetic traits ;
-WHAT? any prior genetic modification ;
-WHAT? the host spectrum (if applicable),
-WHAT? important physiological features which may be modified in the final GMO and their stability, if applicable ;
-WHAT? natural habitat and geographical distribution ;
-WHAT? significant participation in environmental processes (such as asphyxia or pH regulation) ;
-WHAT? interaction with and interact with other organisms in the environment (including probable competitive, pathogenic or symbiotic properties),
-WHAT? ability to form survival structures (such as spores or sclerotier).
3.2.2 Donororganisme
-WHAT? the name, designation and origin,
-WHAT? the degree of affinity with the host organism ;
-WHAT? characterisation of pathogenicity and virulence, infectious toxicity, toxicity, and vectors for disease transfer
-WHAT? characterisation of the inals vectors :
-WHAT? sequence
-WHAT? frequency of mobilisation and specificity ;
-WHAT? presence of genes resistant to antimicrobial agents, such as antibiotics,
-WHAT? host spectrum,
-WHAT? other relevant physiological features,
3.2.3 Insert
-WHAT? description of the modification, including the method of the vector inautation in the host organism or the method used to produce the genetic modification in question ;
-WHAT? specific identity and operation of the insert (genes) ;
-WHAT? the Excussion level and rate of the inmate rematerialates. Mealey method and sensitivity
-WHAT? the identity and characteristics of the donor body, the identity and characteristics of the donor organism ;
-WHAT? previous genetic modifications, if relevant ;
-WHAT? the localization of the inserted material (the enabling / inactivation of the host genes as a result of the insertion).
3.2.4 Vektor
-WHAT? characterisation of the vector, its origin ;
-WHAT? the structure and quantity of nucleic acids from vector and / or donor, which may remain in the final construction of the modified micro-organism,
-WHAT? if the inserted vector is present in the final GMO : mobility frequency and / or potential transfer of genetic material.
3.2.5 The final GMO
-WHAT? the stability of the organism in relation to genetic traits ;
-WHAT? characterisation of substances which are formed or may be formed as a result of genetic manipulation ;
-WHAT? the activities of the proteins,
-WHAT? factors which may affect the survival, propagation and dissemination of the modified organism outside the cultural fluid ;
3.2.5.1 Sundance aspects
-WHAT? anticipated toxic or allergenic effects of the GMO and / or its metabolites,
-WHAT? product risk, including the formation of toxins or biologically high-active substances ;
-WHAT? comparison between the modified micro-organism and recipientorganism or (if applicable) the parental organism with regard to pathogenicity ;
-WHAT? expected colonial capacity
-WHAT? known and expected habitats,
-WHAT? if the micro-organism is the pathogen of immunocompetent people :
-WHAT? caused diseases and the transfer method, including the invasions and virulence ;
-WHAT? infectivity
-WHAT? contagious dose,
-WHAT? possible alteration of infection path or tissue specificity ;
-WHAT? the possibility of survival outside of human host,
-WHAT? presence of vectors or other common procedures,
-WHAT? biological stability,
-WHAT? antibiotic-resistant patterns
-WHAT? allergenicity,
-WHAT? the possibility of appropriate disease treatment and prophylax.
3.2.5.2 Environmental considerations
-WHAT? ecosystems for which the organism will be able to extract from the enclosed use ;
-WHAT? the anticipated survival skills, propagation and dissemination of the modified organism in the identified ecosystems ;
-WHAT? the expected result of interaction between the modified organism and the organisms or micro-organisms, which may be exposed in the event of a release in the environment ;
-WHAT? known or prestigious effects on plants and animals such as pathogenicity, toxicity, allergenicity, carrier pathogen, modified antibiotic resistance patterns, modified tropism or host specificity, colonisation ;
-WHAT? known or foreseen cooperation in biogeochemical processes.
3.2.5.3 Monitoring Technician
-WHAT? the identification, identification and monitoring of the modified organism ;
-WHAT? the detection of transfer of the new genetic material to other organisms ;
-WHAT? possible means of decontamination of the area in the event of a leak.
3.3 Tentative classification of the GMO
In Annex 3a, part A, point 3-5, it is stated that the first stage of the risk assessment of a GMO is to identify the potential harmful characteristics of the GMO so that a provisional classification can be made for a provisional classification. This is done by identifying the hazards that may be associated with the recipient of recipient cod, donor organism, vector and insert. The evaluation may take into account the general characteristics of Class 1, as described in Annex 3a, part A, point 4, and appropriate up to date national and international classification schemes (including the notice of biological agents and work environment and changes thereto). The corresponding set of the containment and other protective measures referred to in Annex 2 serves as a basis for assessing whether stricter containment and control measures are required to check the harmful effects of the impending.
The risk of harmful effects resulting from any harmful characteristics of the GMO shall be assessed by examining the seriousness of the damage and any biological properties (e.g. inactivation mutations) which limit the probability of entry ; damage. The seriousness of the harmful effects is assessed independently of the likelihood of their actual entry. The seriousness of any damage shall be assessed by examining the impact of the consequences thereof and not the likelihood of the injury to be taken in the case in question. For example, for a pathogen, it has to be assessed how serious the disease would be if a sensitive species is infected. In the case of the placement of a GMO in a provisional class, the seriousness of the damage shall also be taken into account. In the various classification schemes, such as the publication of biological agents and the working environment, the seriousness of the damage is due to the seriousness of the damage. However, many of these systems are based only on either health or environmental considerations. It is important to ensure that the seriousness of the harmful health and environmental impact of the GMO in question is fully taken into account.
3.4 Evaluation of the probability of harmful effects.
The likelihood of the occurrence of a harmful event depends first and foremost on the level and nature of the exposure of human or environmental exposure to a given GMO. The exposure aspect is, in most cases, of primary importance for the risk assessment, since it is often the case that it is crucial to whether a harmful effect will be taken. The likelihood of the human or environment being exposed to a GMO depends on the operations carried out (e.g. and on what scale) and what containment measures have been taken on the basis of the provisional classification in : in accordance with paragraphs 5 and 6.
Purset to paragraph 7 (no. (ii) and (iii) of Annex 3a, the definitive classification and choice of controls shall be taken into account in the operation of the characteristic characteristics and controls. The nature and extent of the activity shall be taken into account in order to assess the likelihood of exposure to human and environmental exposure, and this will also have implications for the choice of appropriate risk management procedures.
The characteristics of the operation, which may be of relevance to the risk assessment and which must therefore be taken into account, may refer to the activity itself, working routines, the extent of activity and of the containment measures used.
The evaluation shall take into account, in particular, of how waste and waste water are intended to be disposed of. Where appropriate, safety measures shall be taken to protect health and the environment.
3.4.1. The nature of the activities envisaged.
The level of risk and application of control measures to reduce this risk from the GMO to an appropriate level depend on the nature of the activities, since these will have an impact on the exposure of people and the environment and, therefore, to the likelihood of the environment ; for harmful effects.
The nature of the work will also determine the form in Annex 2 which contains the most appropriate containment and control measures.
In the case of work in laboratory escalation where the effects of the standard laboratory procedures on exposure are well known, a detailed risk assessment of each procedure will not be necessary unless a very dangerous organism is used. However, a more detailed assessment may be necessary for non-routine procedures or procedures which may have significant impact on the level of risk, such as procedures, resulting in aerosols.
3.4.2 Concentration and Scope
Large cell density may result in exposure to large concentrations of the GMO, in particular in downstream processing operations. The significance of the concentration on the likelihood of a harmful event is to be investigated.
The extent of an activity must also be taken into consideration at risk assessment, both the extent of a single operation, or in the form of frequent repetition of a process, because both may result in an exposure to the end-of-and-and-the-ending basis ; the control measures are failing and thus increase the likelihood of a harmful event.
Although operations of a large scale do not necessarily mean considerable risk, greater exposure may lead to exposure both as regards the number of people and the extent of the exposure of the environment in the event of failure in the containment measures.
The extent of the work will also be of relevance to the extent to which the scheme in Annex 2, which contains the most appropriate containment and control measures, will also be relevant.
3.4.3 Check-out conditions
For many activities with the enclosed application, the cultivation of animals is subject to strict containment conditions, but also the design and the nature of the reactors and other cultivated equipment will be of relevance to the health and environmental risks. Exposure to and thus the risk of a GMO can be significantly reduced by means of high-tech and close-closed ginger-barking. It is important to examine the reliability of this equipment and the possibility of operating disturbances where operational disturbances may result in large-scale exposure to harmful GMOs. Where such discharges are reasonably foreseeable, additional containment measures may be required. The standard working routines of persons working with cultivated GMOs, such as centrifugation or sonification, are of great importance to the effectiveness of the containment measures.
In addition to the physical cultivation conditions which act as a containment measures, biological and chemical measures which serve to protect the operation may contribute significantly to the containment measures. For example, by way of biological inference, auxotrophic mutants can be mentioned, which require the supply of specific growth factors in order to develop. Like chemical containment measures, disinfectants may be mentioned in the wiring systems.
In point 7 of Annex 3a, it states that assessing the likelihood of harmful effects and of their seriousness must be taken into account in the characteristics of the environment which could be exposed and to the effects of the effects, For real.
Certain aspects of these environmental considerations are important, such as the extent and the nature of the exposure of the environment and to the extent to which the presence of biota may be damaged by the GMO in the exposed area.
The following factors should, if necessary, be taken into account when evaluating the characteristics of the recipient environment will have the likelihood of the potential harmful effects of potentially harmful effects and, therefore, on the level of risk and the choice of : control measures.
3.4.3.1 The environment that will be exposed
The environment likely to be exposed may, in the majority of cases, be expected to be limited to the workplace and the area immediately around the plant, but, depending on the specific features of the enclosed use and plant, it is also necessary to : take account of the environment in further importance. The scope of the environmental exposure may depend on the nature and extent of the activity, but any conceivable form of transfer in the wider environment, such as a sewer, water, waste disposal, wind and biological vectors (such as through infected animals, and insects shall be taken into account.
3.4.3.2 The presence of sensitive species
The likelihood of damaging effects will depend on the availability of sensitive species, including humans, animals and plants, in the environment which may be exposed in the environment which may be exposed.
3.4.3.3 The possibility of the environment being able to promote the survival of GMOs
One important aspect of the risk assessment is the question of how wide the GMO can be able to survive and persistfully in the environment. The likelihood of harmful effects will be much less if a GMO cannot survive in the environment in which it will be able to escape.
3.4.3.4 Effects on the physical environment
In addition to the direct detrimental effects of a GMO, the adverse effects of indirect adverse effects resulting from significant changes in the physico-chemical properties of and / or the ecological balance in the environmental media soil and water are also taken into account.
4. Procedure 2
4.1 Determination of final classification and final containment measures. When the seriousness of all potentially harmful characteristics of the GMO and the likelihood of damage resulting from it has been examined taking into account the end-end and control arrangements that the provisional classification entails, the final classification of the product may be : the classification and final containment measures for the GMO shall be fixed. In the assessment of the final classification and final containment measures, the provisional classification should be reviewed to see whether it was properly taking into account the activities envisaged and operations. A comparison between the provisional classification and the associated containment measures with the final class and the associated containment requirements may result in three outcomes :
-WHAT? Whereas the provisional classification has not taken due account of certain harmful effects, so the provisional containment under procedure 1 is insufficient ; therefore, further containment measures are required, and the classification of the activity in question may be subject to revision ;
-WHAT? Whereas the provisional classification was appropriate and the related intake measures to prevent or minimise health and environmental damage ;
-WHAT? the provisional classification is more stringent than necessary for the activity, and therefore a lower classification should be chosen with the associated containment measures.
4.2 Confirmation of the appropriateness of final containment measures.
When the final classification and final containment conditions are laid down, the level of exposure of human and environmental exposure should be re-evaluated (procedure 1). In this respect, it must be confirmed that the likelihood of harmful effects is acceptable, taking into account the nature and extent of the work and the proposed containment conditions. Once this is done, the risk assessment process is complete.
in section 6 (4). 5, it states that the assessment must be updated when changes are made to work, working methods, work processes, etc., which are relevant to the business environment of the establishment and the external environment, if :
1) the protective measures which are used are no longer adequate or the class in which the activity is carried out is no longer the correct one ; or
2) there is reason to assume that the evaluation will no longer be adequate on the basis of the latest scientific or technical knowledge.
Any changes to the containment conditions as a result of the review of the risk assessment shall be implemented without delay in the interests of adequate protection of health and the environment.
The enclosed applications are classified in Class 1-4 on the basis of the classification and the containment and control measures that are required for the risk assessment to be sufficient for the sufficient containment of the GMO in connection with the intended activities. In Annex 2, the end-use and control measures for each class shall be described.
The administrative requirements shall be determined on the basis of the classification of the contained applications of GMO.
If there is uncertainty regarding the final classification and the final containment conditions, the Board of Director should be contacted.
Appendix 4
Notification and approval of research projects, other laboratory tasks, measly-scale experiments and production in which genetically modified organisms are subject to the subject matter in accordance with the procedure for the subject matter of genetically modified organisms. Section 15 (3). Paragraph 21 (1) and 21 (1) 1.
Part A
Generally.
Information required in connection with the one in section 15 (1). Paragraph 21 (1) and 21 (1) 1 declaration of notification :
1) date of the section in section 7 (3). 1 classification or submission of notification,
2) the names of persons responsible for the supervision and security, together with information on their training and qualifications ;
3) the recipients, donors and / or pareno-organisms employed, or, where appropriate, the host-vector system (s) used ;
4) the origin of the genetic material involved in the gene splicing modifications and the intended function of this material ;
5) the identity and characteristics of genetically modified organisms ;
6) the purpose of the enclosed application, including the expected results ;
7) the extent to which cultural activities are carried out with micro-organisms,
8) description of the planned containment and other protective measures, including information on the management of the waste generated, its treatment, final form and provision ;
9) a copy of the assessment referred to in Section 6,
10) the information to be carried out by the Board of Work with a view to evaluating the contingency plans drawn up in accordance with section 28 (1). Two and three.
Part B
Notification of research projects in categories 3 and 4, as well as large scale experiments and production.
The notification shall contain information as specified in Annex 4, part A.
The following points also need to be reported :
-WHAT? the extent to which the culture of culture will be used,
-WHAT? description of the containment and other protective measures that will be used, including the information on waste management, including the type and waste of waste which will be produced, its treatment, final form and provision
-WHAT? description of the parts of the plant
-WHAT? information on accident prevention and any contingency plans ;
-WHAT? specific risks arising from the location of the installation,
-WHAT? the preventive measures used, such as safety equipment, alarm systems and containment methods ;
-WHAT? the procedures and plans for the control of the containment measures, to continue to be effective ;
-WHAT? a description of the information supplied to the workers, including safety requirements ;
If it is not technically possible or deemed not necessary to provide some of the information, the reasons for this must be indicated.
In the case of products, the level of detail required for the response to each of the items will vary according to the nature and extent of the proposed production. In particular, it would normally not be necessary to provide detailed biological information on host organisms previously recognised as Class 1.
If some of the information requested previously submitted for the Employment Board may refer to such information, the notification may refer to such information.
Appendix 5
Approval of research projects and other laboratory tasks, cf. Section 20 (2). 2.
The following research projects and other laboratory tasks must be approved before commencement of the following ;
1) Research projects and other laboratory tasks to be carried out in laboratory lasse 3 or 4, cf. Annex 3a, Part B.
2) Whereas research projects and other laboratory tasks entailing the transfer of resistant markings to organisms, which are not known to be naturally possessed naturally if this transfer may bring the use of antibiotics to control pathogenic agents ; Agents are in danger.
1) The declaration contains provisions implementing Council Directive no. ECU 90 /219/EEC, EC Official Journal 1990 L 117. 1 as amended by Council Directive no. 98 /81/EC, EC Official Journal 1998 L 330 s. 13.
6) This is only about animals and plants in the exposed environment.
