Executive Order On Genetic Engineering And Working Environment Reprinted Definitive Series

Original Language Title: Bekendtgørelse om genteknologi og arbejdsmiljø Omtryk

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now

Read the untranslated law here: https://www.retsinformation.dk/Forms/R0710.aspx?id=121099

Overview (table of contents) Chapter 1 Chapter 2 Assessment of Area safety and health Chapter 3 classification of laboratories, laboratory areas and installations for large-scale trials and production Chapter 4 Review and approval of research projects and other laboratory tasks Chapter 5 Review and approval of large-scale trials and production Chapter 6 Substitution Chapter 7 General provisions Chapter 8 waiver and appeal Chapter 9 Penalty Chapter 10 entry into force and transitional provisions Annex 1



Annex 2



Annex 3a



Annex 3b



Annex 4



Annex 5 The full text of the Executive order on genetic engineering and arbejdsmiljø1)

Under section 17, paragraph 3, article 22, paragraph 1, section 35, section 39, paragraphs 1 and 2, article 40, article 41, paragraph 1, article 43, § 44, § 46, § 49, § 49a, paragraphs 1 and 2, § 49c, § 73, article 75, paragraph 1, and section 84 of the Act on occupational safety and, see. lovbekendtgørelse nr. 268 of 18. March 2005, as well as under the authority of the Minister of the environment pursuant to § 7, § 20 (2), section 27 and section 36, paragraph 4, of the law on the environment and genetic engineering, see. lovbekendtgørelse nr. 811 of 21. June 2007, lays down: Chapter 1 Scope § 1. The notice includes work, including development work with genetically modified organisms, see. Annex 1, i: 1) laboratories and laboratory areas, including animal stables, greenhouses, aquariums and similar, 2) installations for large-scale trials and production.

(2). The notice applies, regardless of whether the work is done for an employer.

§ 2. Exempt from the Executive order's exhibition, other dissemination etc., as Minister of the environment pursuant to the law on the environment and genetic engineering have certainly can take place outside classified laboratories and laboratory areas.

(2). The Director of the Danish working environment authority can decide to work with genetically modified organisms, as the Minister exempts pursuant to the law on the environment and genetic engineering, also exempt from the Executive order.

§ 3. In addition to the rules laid down in this Ordinance applies to the occupational safety and health legislation general rules as well as rules under other legislation had to be fixed about genetic engineering.

(2). For genetically modified micro-organisms also applies to rules laid down in the Ordinance on biological agents and working environment concerning the duty to keep lists of employees who are exposed to biological agents in risk group 3 or 4, as well as a duty to ensure access for the employees to have a working medical study.

Definitions



§ 4. By genetically modified organisms be understood after this notice plants, animals, microorganisms, cell cultures and viruses, which seems new configurations of the genetic material, which does not occur in a natural way, without prejudice. Annex 1.

§ 5. For the purposes of the provisions of this order, the following definitions shall be used: 1) research projects and other laboratory tasks means working with genetically modified animals and plants, as well as work with genetically modified micro-organisms or cell cultures with a volume per container not exceeding 15 litres culture fluid.

2) By large scale trials means working with genetically modified micro-organisms or cell cultures, there is no actual production, but which take place in similar plants. Working with genetically modified plants and animals are not covered by the definition.

3) By donor understood the organism or cell/cell material, from which the genetic material used strains.

4) By host means the cell or organism in which the genetic material is introduced.

5) vector means the biological material used to introduce genetic material into a host.

6) By biological active material means donors, hosts, genetically modified cells and organisms or tissues therefrom, viruses and genetically modified animals and plants that are able to replicate itself.

7) By laboratories and laboratory fields means it or the workspace, which biologically active material is handled. That is, the premises in which the work is taking place under one form or another with biologically active material. When we are talking about a lab area meant premises such as animal stables, greenhouses and aquariums.

8) By contained use means, see. Annex 2, section B, any activity in which micro-organisms are genetically modified or in which such GMMs are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with people and the environment.

9) accidental shall mean any incident involving a significant and unintended release of GMMs in the course of the contained use, and which may result in immediate or subsequent harm to human health or to the environment.

10) By accident situation shall mean any incident involving accidents see. § 5, nr. 9, as well as events that involve the influent to the accident.

Chapter 2 Assessment of the health and safety section 6. There must be a prior review of work carried out a comprehensive assessment of the possible dangers to human health and safety or for the external environment by biological systems.

(2). For work with genetically modified micro-organisms shall include as a minimum the elements of assessment assessment and the procedure set out in annex 3a, section A and Annex 3b. Apart from the above mentioned assessment assessed, in which class work to be performed, see. Annex 3a, part B.

(3). For work with genetically modified animals, plants, etc. must be in the assessment included the principles set out in annex 3a, section A and Annex 3b.

(4). There shall be kept a written account of the assessment that must be made available to the Labour Inspectorate.

(5). The assessment must be updated when there are changes in the work, working methods, work processes, etc., which are important for the company's working environment and for the external environment, if: 1) the protective measures applied are no longer adequate or the class in which the activity takes place, no longer is the right one, or 2) there is reason to suspect that the assessment is no longer adequate in the light of the latest scientific and technical knowledge.

Chapter 3 classification of laboratories, laboratory areas and installations for large-scale trials and production section 7. Laboratories, laboratory areas and installations for large-scale trials and production, which must be carried out work with genetically modified organisms, prior use shall be classified by the Labour Inspectorate. By classification means the Danish working environment service's approval of that an area meets the requirements established for the area.

(2). Classification applies until the labour inspectorate shall communicate to the other.

§ 8. Classification of laboratories and laboratory areas, including animal stables, greenhouses, aquariums and similar, happening in 4 classes in accordance with Annex 2, section (A) and (B) of the basic regulation. However, paragraph 2.

(2). Laboratories and laboratory areas, where there is no working with genetically modified micro-organisms but only be worked with genetically modified plants and animals, not classified in 4 classes but only after a concrete assessment.

(3). Classification of laboratories, which must work with genetically modified plants and animals, as well as classification of laboratory areas is done after negotiating with the environmental protection agency.

§ 9. Classification of installations for large-scale trials and production is done in 4 classes in accordance with Annex 2, section (A) and (C) of the basic regulation. However, paragraph 2. Installations for large scale trials are classified according to negotiation with the environmental protection agency.

(2). Installations for the production, which should not be working with genetically modified micro-organisms but only be worked with genetically modified plants and animals, not classified in 4 classes but only after a concrete assessment.

§ 10. The Director of the labour inspectorate may impose rules on or provide that certain experiments in educational purposes with genetically modified organisms may be carried out outside classified laboratories and laboratory areas.

§ 11. Notification to the classification pursuant to section 7 (1) shall be lodged with the Labour Inspectorate and shall contain information on the conditions specified in annex 2. In addition, the labour inspectorate can require information about the technical AIDS and descriptions of the road works.

§ 12. If already classified laboratories, laboratory areas, installations for large-scale trials and production is sought classified in a lower grade or classification no longer desired maintained, this advance notification to the Labour Inspectorate.

§ 13. Work in classified laboratories, laboratory areas, installations for large-scale trials and production must always be carried out in accordance with the requirements for the class, see. Annex 2, and in accordance with the specific conditions laid down in the context of classification.

§ 14. Classification in accordance with § 7 paragraph 1 of this article shall be communicated in writing at the latest 45 days after submission of the notification.

(2). Classification of laboratories, laboratory areas and installations for large-scale trials and production in class 3 and 4 shall be notified in writing, however, no later than 90 days after submission of the notification.

(3). In the calculation of the time limit referred to in paragraphs 1 and 2 shall not be taken into account the time during which the Danish working environment authority is awaiting further information which the labour inspectorate may have prompted the notifier.

Chapter 4 Review and approval of research projects and other laboratory tasks


§ 15. Research projects and other laboratory tasks involving work with genetically modified organisms, must be approved by the Labour Inspectorate before implementation.

(2). In the case of class 1, subsequent research projects and other laboratory tasks in the same legal entity will commence without further approval.

§ 16. Working with genetically modified micro-organisms may only be carried out in laboratories and laboratory areas, which at least has been awarded for work of that nature.

(2). There is doubt as to which class that is adequate for the particular work, selected the higher class.

§ 17. Review of research projects and other tasks of the laboratory shall contain the information set out in annex 4, section A, of the basic regulation. However, paragraph 2, and shall be submitted to the Labour Inspectorate.

(2). Review of research projects and other laboratory tasks covered by Annex 5 should include: 1) the information referred to in annex 4, parts A and B, 2) identification of the health risks under normal working conditions as well as in the event of an accident, and 3) statement for the planned security measures in addition to those arising from the classification of the laboratory.

(3). Review of subsequent research projects and other laboratory tasks in class 1 consist of assessment under section 6, as well as reference to the classification of the premises to which the work must be in.

§ 18. The labour inspectorate shall submit reviews of research projects and other laboratory tasks for the environmental protection agency, if 1) included work with genetically modified reproducing plants, genetically modified animals or genetically modified organisms in animal stables, greenhouses, aquariums and similar, or 2) an assessment under section 6 shows that there is an environmental risk.

§ 19. Notification and approval will lapse after five years unless it is renewed, see. However, paragraph 2.

(2). Approval of research projects and other laboratory tasks covered by Annex 5, applies until the labour inspectorate shall communicate to the other.

§ 20. The labour inspectorate shall grant approvals under section 15 (1) in writing at the latest 45 days after submission of the notification. The deadline shall not be taken into account when calculating the time in which the Danish working environment authority is awaiting further information which the labour inspectorate may have prompted the notifier.

(2). Research projects and other laboratory tasks, which are not covered by Annex 5, however, unless the Danish working environment authority has given the second message, launched 45 days after submission of the notification referred to in article 6. However, section 15, paragraph 2.

(3). The Director of the Danish working environment authority can decide to work with certain genetically modified organisms may be initiated when the notification is submitted.

Chapter 5 Review and approval of large-scale trials and production section 21. Large-scale trials and production, incorporating work with genetically modified organisms, must be approved by the Labour Inspectorate before implementation.

(2). In the case of class 1, subsequent large-scale trials and production in the same legal entity will commence without further approval.

§ 22. Working with genetically modified micro-organisms may only be carried out in installations for large-scale trials and production, which at least has been awarded for work of that nature.

(2). There is doubt as to which class that is adequate for the particular work, selected the higher class.

§ 23. Review of large-scale trials and production shall contain the information referred to in annex 4, parts A and B, and must be submitted to the Labour Inspectorate.

(2). Review of subsequent large-scale trials and production of class 1 consist of assessment under section 6, as well as reference to the classification of the works to which the work must be in.

§ 24. The labour inspectorate shall submit reviews of large scale experiments in class 2 or higher for the environmental protection agency.

§ 25. Notification of large scale experiments in class 1 shall lapse after five years unless it is renewed.

(2). Approval of large scale experiments in class 2 or higher as well as the production applies until the labour inspectorate shall communicate to the other.

section 26. The labour inspectorate shall grant approvals under section 21 (1) in writing at the latest 45 days after submission of the notification. The deadline shall not be taken into account when calculating the time in which the Danish working environment authority is awaiting further information which the labour inspectorate may have prompted the notifier.

(2). Large scale experiments in class 1 may, however, unless the Danish working environment authority has given the second message, launched 45 days after submission of the notification referred to in article 6. However, article 21, paragraph 2.

(3). The Director of the labour inspectorate may impose rules on a review mechanism for the production, which included genetically modified organisms in class 1.

Chapter 6 Substitution section 27. A donor and a host-vector system must not be used if the donor or host-vector system can be replaced by less dangerous donors and host-vector systems.

(2). When the use of a replacement donor or a surrogate host-vector system will involve not insubstantial differences in technical characteristics or expenditure must be carried out an overall balancing of the technical and economic consequences to the safety and health concerns.

(3). The labour inspectorate may ask for documentation for those referred to in paragraphs 1 and 2 against.

Chapter 7 General provisions section 28. The employer must ensure that the instructions for the staff and security regulations are available in writing and, as necessary, by lookup.

(2). To be drawn up contingency plan for work with genetically modified organisms, when the failure of containment measures immediately or later is likely to involve particular risk to humans outside the premises and/or to the environment, except where such an emergency plan has already been drawn up in accordance with other legislation.

(3). Any contingency plans to be drawn up before work with genetically modified organisms will commence and shall be attached to the notification to the classification pursuant to section 11.

section 29. The Director of the labour inspectorate may require reviews under section 11, section 17, paragraph 1, and article 23, paragraph 1, shall be carried out in special schemas that are available on request from the Labour Inspectorate.

section 30. Any substantial modification of the contents according to § § 11, 17 and 23 of the importance of safety and health must be reported to the Labour Inspectorate.

(2). Approval of amendments shall be notified in writing at the latest 45 days after submission of the notification. The deadline shall not be taken into account when calculating the time in which the Danish working environment authority is awaiting further information which the labour inspectorate may have prompted the notifier.

(3). However, modification of information under section 17, paragraph 3, and article 23, paragraph 2, is not acceptable.

section 31. To the extent deemed necessary for the assessment of the safety of the genetic engineering work, or when conditions in fact gives rise thereto, the labour inspectorate may request additional information. The labour inspectorate may require the information evaluated by special experts, see. occupational health and Safety Act, section 21.

section 32. The company's security organization should be involved in the preparation of the assessment under section 6 and internal emergency plan in accordance with section 28. In companies where there is no need to create security organization, the staff similarly involved.

section 33. A classification under section 7 (1) and an approval under section 15 (1) or section 21, paragraph 1, shall be conditional on defined conditions, like a rating or an authorisation may be limited in time.

(2). The labour inspectorate may revoke a classification under section 7 (1), and an approval under section 15 (1) or section 21, paragraph 1, if the conditions are not complied with or new information, that have a significant impact on safety and health, makes it necessary.

§ 34. The Labour Inspectorate investigates notifications after §§ 11, 17 and 23, for 1) compliance with the requirements set out in this notice, 2) accuracy and completeness of the information given, the correctness of the assessment) 3 under section 6 and of the contained uses class, and 4), if necessary, on containment measures and other protective measures and measures on waste treatment and emergency response is sufficient.

Chapter 8 waiver and appeal section 35. The Director of the labour inspectorate may, where special circumstances exist, allow derogations from the provisions of this Ordinance, when it is deemed reasonable and justifiable, and in so far as it is compatible with Directive 90/219/EEC on the contained use of genetically modified micro-organisms, as amended by Directive 98/81/EC.

§ 36. The Danish working environment service's decisions in accordance with this Ordinance an appeal may be lodged under section 81 of the Act on occupational safety.

Chapter 9 Penalty section 37. With less higher penalty is inflicted by law OSH or other legislation are punishable by fine or imprisonment for up to 2 years the who: 1) violates section 6, section 7, paragraph 1, article 11, § 12, § 13, § 15, paragraph 1, article 16, paragraph 1, article 17, article 21, paragraph 1, article 23, section 27 (1) and (2), section 28, section 30 and section 32, 2) overrides the terms associated with a classification under section 7 (1) or approvals under section 15 (1) or section 21, paragraph 1 or 3) fails to comply with the injunction granted in accordance with the provisions of the Executive order.

(2). For violations of section 7, paragraph 1, article 15, paragraph 1, and article 21, paragraph 1, may be subject to an employer's responsibility, although the infringement fines not imputable to him as a wilful or negligent. For fine responsibility be determined no alternative custodial penalty.


(3). That can be imposed on companies, etc. (legal persons) criminal liability in accordance with the provisions of the criminal code 5. Chapter.

Chapter 10 entry into force and transitional provisions § 38. The notice shall enter into force on 17 December. September 2008.

(2). At the same time repealed Executive Order No. 642 of 28. June 2001 on genetic engineering and working environment.

§ 39. Classifications, approvals and waivers granted by the Director of the Labour Inspectorate in the 17. September 2008 will remain in force, without prejudice. However, section 19, paragraph 1, article 25, paragraph 1, and section 30.

(2). By substantial changes of information in connection with classifications, approvals or waivers granted by the Director of the Labour Inspectorate under the Ministry of Labour notices no. 578 of 1. September 1987 or nr. 684 of 11. October 1991 concerning genetic technology and the working environment, as amended by Decree No. 705 of 22. July 1996 new review must be conducted in accordance with the provisions of this Ordinance.

(3). Previously announced ratings of installations for large-scale trials and production of Group 1, after the entry into force of this Ordinance also applies for installations for large-scale trials and production in class 1.

The Labour Inspectorate, the 11. September 2008 Jens Jensen/Jeanne Borgqvist



Annex 1 techniques of genetic modification referred to in article 6. sections 1 and 4

Part A

Within the framework of the definition of genetically modified organisms in § 4 genetic modification occurs at least through the use of the following techniques: 1) Recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism which they do not naturally occur but in which they are able to continue to propagering.



2) techniques involving the direct introduction into an organism of heritable material prepared outside the organism including micro-injection, macro-injection and micro-encapsulation.



3) cell fusion (including protoplast fusion) or hybridisation techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally.

Part B

The following techniques shall not be considered as leading to genetic modification, in so far as they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms: 1) In vitro fertilisation,



2) natural processes such as: conjugation, transduction URf.eks., transformation, and



3) polyploidiinduktion.

Part C

The Ordinance shall not apply to organisms obtained through the use of the following techniques in genetic modification, on condition that they do not involve the use of genetically modified organisms as recipient or parental organisms: 1) mutagenesis,



2) cell fusion (including protoplast fusion) of prokaryotic species that exchange genetic material by known physiological processes,



3) cell fusion (including protoplast fusion) of cells of any eukaryotic species, including production of hybridomas and plant cell fusions, and



4) traditional processing methods.



Annex 2 review and classification of laboratories, laboratory areas, installations for large-scale trials and production, see. § 7 (1)

Part A General Classification shall be carried out in 4 classes in relation to: 1) areas of Interior design,



2) plans for activities, including contingency plans,



3) areas, technical AIDS, and



4) internal supervision and control.

Notification to the classification:

Information required in connection with the in section 7, paragraph 1 of this article review: – name of the user/users and the persons responsible for supervision and safety



– information on the training and qualifications in respect of the persons responsible for supervision and safety



– information about the security organization



– the installation's address and general description of the buildings



– a description of the nature of the work, which will be implemented



– the class of the contained use



– information on the management of waste.



– any contingency plans Forms 1a, 1b, 1 c and 2 shows the normal minimum requirements and measures necessary for each level of containment.

Containment is guaranteed also by the use of good work practices, training, containment equipment and special construction design. For all activities involving GMMs the principles of good microbiological practice, and the following principles of safety and hygiene in the workplace: in) protection measures and equipment shall be verified in an appropriate manner and maintained



II) as needed to be tested for the presence of viable process organisms outside the primary physical containment;



(iii)) shall be provided for adequate training of staff



(iv)) shall be drawn up and implemented local guidelines as required for staff safety



v) there must be an appropriate registration



vi) there must, for safety reasons, as appropriate shall be drawn up in writing work instructions.

-Scheme headings are indicative.

Schedule 1a presents minimum requirements for laboratories and laboratory areas, where work with genetically modified organisms.

Schedule 1b presents additions to and modifications of Table 1a for greenhouses and similar, working with genetically modified micro-organisms.

Schedule 1 c presents additions to and modifications of Table 1a of animal stables and the like, working with genetically modified micro-organisms.

Table 2 presents minimum requirements for installations for large-scale trials and production, working with genetically modified organisms.

In certain cases it may be necessary to apply a combination of measures from schedule 1a and table 2 at the same level.

In some cases, the user may, by agreement with the Labour Inspectorate need not apply a specification from a particular containment level or combine specifications from two different levels.

In the forms meaning ' possibly ', the user can implement these measures on the basis of the assessment referred to in section 6 in each case. The labour inspectorate may, in accordance with a specific assessment demand that the measures in the schemas are specified as ' any ' will be used.

Definitions: autoclaving: by autoclaving means a treatment with saturated water vapor at 121 ° C for 20 minutes, or other combinations of temperature and time having at least the same inaktiverende effect on biological material.

Disinfection disinfection means: by reducing the number of harmful microorganisms to such an extent that the proliferation of security or health significance will not occur. Disinfection is carried out usually by heat or chemical exposure.

Part B of the containment and other protective measures for laboratories and laboratory fields, see. § 3 and § 8.

Of this annex shall be referred to as both ' laboratory ' and ' laboratory ' area as laboratory.

Requirements of class 2, 3 and 4 shall include, in addition to the requirements mentioned in the current class also the requirements mentioned in the previous classes. By the classification of a class 3 or 4 laboratory may in addition to the General requirements set out in the annex, be made specific requirements depending on the specific project, to be carried out in the laboratory.

A horizontal line means that the requirement from the lower class not to be transferred to the higher class, as it would be in contradiction with other requirements in this class.

Schedule 1a. Containment and other protective measures for laboratories and laboratory areas.









Specifications





Containment level (class)





 



1





2





3





4







ADMINISTRATIVE

FORHOLD



 

 

 

 





Adgang og transport ind i laboratoriet.





Unauthorized persons access to the laboratory should be limited.





Only access for the staff, there is a need for activities, as well as persons who are appropriately directed.





Access only for specially designated staff, there is a need for activities.



 



 

 

 

 



A logbook must be kept above the staff stay.





 

 

 



Access should only be done through sluice with bathing and changing facilities.




 



 

 

 



All material must be brought in through a sluice-gate, decorated in accordance with the same principles as the inlet sluices.



 



 



Must be worn coat or other suitable clothing in the laboratory.



 



Special requirements for work clothing and personal protective equipment.



 



 

 



To use suitable footwear in the laboratory.

Gangtøj must not be stored in the laboratory.



 

 



 

 



Jewellery, wristwatches, handkerchiefs and the like are not permitted in the lab.



 

 



 

 



Extraneous material is not permitted in the lab.



 

 



 



Tobacco, food and beverage must not be enjoyed and cosmetics is not applied in the laboratory. They must, if they are allowed, must be kept in a special enclosure.

Foodstuffs must not, however, be kept in the laboratory.





Tobacco, food and beverages, and cosmetics are not permitted in the lab.



 

 



 

 



Animals and plants that are not involved in the work, may not be available.



 

 





Output transport out of the laboratory and the special working clothes removed before eating, as well as by the working hours.





The special workwear and footwear removed before leaving the laboratory.





Output may be through sluice with bathing and changing facilities. To be taken bad and spoon dressing at the end.



 



 

 



Hands must be washed before leaving the laboratory.



 

 



 

 

 



Material transport must be done through a sluice.



 



 



To be compiled procedure for transport of biologically active material out of the facility, and about how the labelling of transport containers must be carried out.



 

 



No material may be removed, unless it is autoklaveret.

Special equipment for that purpose must be found in the area.





 



All waste with a content of biologically active material must be collected in suitable containers and autoclaved or disinfected properly prior to disposal.





All waste with a content of biologically active material must be collected in suitable containers and autoclaved before disposal.





All waste must be autoclaved before disposal in the classified area.



 



 



If the waste with content of biologically active material to be transported outside the classified area to be autoklaveret or disinfected must be transported in leak-proof containers.





If the waste with content of biologically active material to be transported outside the classified area to be autoklaveret, it must be transported in leak-proof and sealed containers.





____________





____________





 



Where disinfection or autoclaving is impracticable, may waste transferred directly to sound destruction.

Transport shall be carried out in suitable, tightly closed packaging.





____________





____________





____________





 



Syringes, disposable syringes, sharp objects and similar are placed in sealed containers immediately after use and autoclaved or disinfected before disposal or cleaning.





Syringes, disposable syringes, sharp objects and similar are placed in sealed containers immediately after use and autoclaved before disposal or cleaning.





Syringes, disposable syringes, sharp objects and similar are placed in sealed containers immediately after use and autoclaved in the classified area before disposal or cleaning.



 



 



Utensilier, glassware and the like, contaminated with biological active material to be autoclaved or otherwise disinfected before cleaning.





Utensilier, glassware and the like, contaminated with biological active material, must be autoclaved before cleaning.





Utensilier, glassware and the like must be autoclaved in the classified area before cleaning.



 



 

 

 



Necessary help material must not be removed from the restricted area before it is autoklaveret.





____________





 

 



Clothing collected in a sealed container and autoclaved securely prior to, or in connection with a sink.





Clothing collected in a sealed container and autoclaved in the classified area before washing.



 



 

 



Exterior surfaces of transport containers must be disinfected properly, before the containers transferred out of the restricted area.



 

 





Training and instruction.



 



There must be special supervision of the work of a person with the necessary insight within that workspace.





Special requirements for the staff's professional skills.



 





Security regulations





If going on trials and the like without the presence of experts, it must be possible to call in a professional competent person.



 

 



There must be no trial and the like without the presence of a professional competent person.





 

 



To be placed on the log of all crash situations that have given rise to the risk to safety or health of persons or to the external environment.





To be placed on the log of all crash situations.



 



 

 

 



There must be controlled with autoklaveringens efficiency.



 



 

 

 



Major accident shall immediately be reported to the Labour Inspectorate.



 






ACTIVITIES the work to be performed, so the formation of aerosols is minimised.



 

 

 



 



Mouth pipetting is not allowed.



 

 

 



 

 



The work must be carried out in Cabinet equipped with its own ventilation system, when there is a danger of harmful air pollution, including when:

1) there is a danger of formation of aerosols with biologically active material,

2) working with large fluid volumes with biologically active material, or

3) working with large concentrations of biologically active material.





All work with biologically active material outside the closed systems must be carried out in Cabinet equipped with its own ventilation system.



 



 



Needles, syringes, sharp objects, and the like should be used as little as possible.



 

 

 





Cleanliness, etc.





Jobs in the laboratory must be cleaned and disinfected daily.





Jobs in the laboratory must be cleaned and disinfected daily in accordance with the special procedure.



 

 



 

 

 



The restricted area must be cleaned at least once a day.



 



 



There must be appropriate disinfectants in laboratory.



 

 

 



 



By waste of biologically active material must be immediately disinfected with an appropriate disinfectant.



 



By any spills must be immediately disinfected with an appropriate disinfectant.



 





Special workwear and personal protective equipment the special working clothes and footwear must not be outside the laboratory before it must to wash or destruction.



 

 



 



Suitable gloves must be used for contact with biological active material.





Suitable gloves must be used for the risk of contact with biologically active material and work with animals.



 

 



 

 



Footwear should be disinfected with an appropriate disinfectant in waste.



 

 





Personal hygiene.





Hands must be washed after contamination with biological material and waste, and contact with animals as well as in breaks in the work and in working hours.



 

 



Special washing procedure.







Doors/Windows.



 



Doors to the restricted area shall be closed when performing work.



 

 





The PLACE of WORK

GADGETS Windows must be either closed or equipped with mosquito net.





____________





____________







Signage.





There should be signs marked ' Genetically area grade 1 ' on the doors to the classified area.





There should be signs marked ' Genetically area, class 2 ' on the doors to the classified area.





There should be signs marked ' Genetically area, class 3 ' on the doors to the classified area.





There should be signs marked ' Genetically area, class 4 ' on the doors to the classified area.





 

 

 



The restricted area must be especially separated from the rest of the building.





The restricted area must be in separate or special isolated part of the building.







Interior design, technical AIDS and equipment.



 

 



The restricted area shall be arranged so that it is extremely easy to clean.





Particular requirements for cleaning procedure and personnel qualifications.





 

 



On jobs in the laboratory, where work with biologically active material, may there only exists the necessary technical AIDS.



 

 



 



Technical devices, which may come in the context of biological activity material in the laboratory, should as far as possible be designed so that they are easy to clean and disinfect.





Technical devices in the laboratory must be designed so that they are easy to sanitize and clean.



 

 



 



Work tables, chairs, etc. in the laboratory must have a smooth surface that is easy to clean.



 

 

 



 

 



Floors must be smooth and without cracks and to rounded transition into wall.



 

 



 

 



Wall surfaces in the laboratory must be smooth and easily washable. Transitions between fixtures and building parts must either be completely close or so open that effective cleaning is possible.



 

 



 



Laboratory fixtures and fittings and flooring surface must be able to withstand acids, alkalis, organic solvents, and moderately warm.



 

 

 



 



Finding decontamination and washing facilities, including easy access to the sink in the workspace.



 



Finding decontamination and washing facilities, including easy access to the sink in the workspace. A sink shall be placed near the end.



 



 

 

 



Taps must not be hand-operable.



 



 

 

 



Windows must be closed and sealed.





Windows must be unbreakable.





 

 

 




Locks must be fitted with self-closing doors and under pressure in relation to its surroundings and excess pressure in relation to the classified area.



 



 

 

 

 



There must be an observation window or similar to the area, so that those who are in the restricted area can be seen from the outside.





 

 

 

 



There must be self-locking doors by floodgate.





 

 

 

 



Special requirements to the décor in the lock.





 

 

 



The restricted area shall be sealable to permit fumigation.





The restricted area shall be sealable to permit fumigation.







PLUMBING



 

 

 



Special requirements for plumbing fixtures.







Ventilation systems



 



The exhaust air from the room ventilation may not be returned to the room or other premises. In special cases (URf.eks. sterilrum) can, however, be accepted.





Ventilation air must not be transferred to the room or other premises.



 



 

 



There must normally be enclosure with its own ventilation system in the lab. In special cases, however, it is accepted that the exhaust air is transferred to the room (URf.eks. sterile benches).





Particular requirements for ventilation systems.



 



 

 

 



Special requirements to the closed systems.



 



 

 



Off-gases from cabinets with its own ventilation system must be filtered through the absolute filters and filters must be autoclaved before disposal.





All off-gases to filter through absolute filters, and filters must be autoclaved before disposal.





All off-gases and intake must filter through absolute filters, and filters must be autoclaved before disposal.





 

 



There should be procedure for control and maintenance of the filters and for control of ventilation systems as well as for maintenance.





Special requirements for inspection and maintenance.



 





Sewage and drainage facilities are Biologically active material must not pour into drain/sewer.





There must be physical safeguards against spills of sewage from all drains. There must be opportunity for capture of emissions with biologically active material and autoclaving thereof. Drain from the wash, which alone are used for hand-washing, are exempt from this requirement.





There must be physical safeguards against spills of sewage from all drains including bathroom. All waste water must be collected and autoclaved.



 









Schedule 1b. Containment and other protective measures for greenhouses and similar

The terms greenhouse and the like refers to a structure with walls, a roof and a floor that is designed and used primarily for the propulsion of plants in a controlled and protected environment.

All the provisions in Schedule 1a shall apply with the following additions/changes: Specifications













Containment level (class)







1





2





3





4















Building



 

 

 

 





1





Greenhouse: permanent struktur1) No





Yes





Yes





Yes







Equipment



 

 

 

 





2





Access via a separate compartment with two interdependent doors





No





Where appropriate,





Yes





Yes







3





Control of contaminated waste water





Where appropriate,





Water runoff can be reduced most Repellence-muligt2)

currents

be prevented





Repellence-

currents

be prevented







Working system



 

 

 

 





4





Measures to control unwanted species such as insects and rodents, arthropods





Yes





Yes





Yes





Yes







5





Procedures for the transfer of live material between the greenhouse, protective structure and laboratory to prevent the spread of genetically modified micro-organisms Spread be reduced as much as possible





The spread is reduced as much as possible





The spread is prevented





The spread is prevented





 

 

 

 

 

 





1)





The greenhouse must consist of a permanent structure with a continuous waterproof covering, located in an area which slopes so that ingress of surface water run-off which have self-closing lockable doors.







2)






When that can be transmitted through the Earth





 

 

 

 

 

 









Schedule 1 c. Containment and other protective measures for animal barns and looked like.

All the provisions in Schedule 1a shall apply with the following additions/changes: Specifications













Containment level (class)







1





2





3





4















Facilities



 

 

 

 





1





Isolation of dyreenheder3), where appropriate





Yes





Yes





Yes







2





Animal facilities, 4) separated by lockable doors





Where appropriate,





Yes





Yes





Yes







3





Animal facility facility for decontamination (water resistant and easily washable material (cages, etc.))





Where appropriate,





Where appropriate,





Yes





Yes







4





Floor and/or walls easily washable





Where appropriate,





Yes (floor and walls)





Yes (floor and walls)





Yes (floor and walls)







5





Animals kept in appropriate containment facilities such as cages, pens or tanks





Where appropriate,





Where appropriate,





Where appropriate,





Particular requirements for cage and stable conditions for laboratory animals







6





Filters on isolators or isolated rum5) Possibly





Yes





Yes





Yes







7





Personal protective equipment



 

 



Suitable filtering respiratory protective devices to be used Suitable filtering respiratory protective devices should be used 3)





Animal barn: a building or a separate area within a building containing facilities and other areas such as changing rooms, showers, autoclaves, food storage rooms, etc.







4)





Animal facility: a facility normally used to house animals for propagation or experimentation or a facility, which is used for the implementation of minor surgical procedures.







5)





Isolators: Transparent boxes in which the animal is contained either within or outside a cage; for larger animals can soundproof room be more appropriate.





 

 

 

 

 

 









Part C of the containment and other protective measures for large-scale trials and production installations, see. § 9 notification shall contain information about the necessary protection measures planned established to safeguard against the risks associated with the use of the facility, including;



– the expected culture volume



– amounts, nature and consumption of raw materials, auxiliary materials, etc., to be used



– the operations employed, including formation of middle-and waste products and by-products of importance for safety and health



– the projected emissions in the workplace from the facilities and equipment of gaseous, liquid and solid substances and materials in connection with the operation and accident.

Requirements for containment measures for organisms, evidenced by the below listed categories, depending on the organism and the particular work.

Each operation in the process must be assessed. Each operation characteristics determine which physical containment to be used. This will make it possible to select and organize the process and the construction and operating procedures which best lends itself to secure a sufficient and safe containment. Two important factors that must be taken into account when selecting containment equipment, is the risk and the effects of a failure in the equipment used. The more serious the consequences of a possible failure becomes the more stringent requirements for manufacturing practices will be able to be made in order to reduce the risk of failure.

Table 2.









Specifications













Containment level (class)







1





2





3





4















GENERAL



 

 

 

 





1





Viable micro-organisms should be contained in a system which physically separates the process from the environment (closed system)





Where appropriate,





Yes





Yes





Yes







2





Control of exhaust gases from the closed system






No Yes, emissions are reduced as much as possible





Yes, leaks are prevented





Yes, leaks are prevented







3





Control of aerosols during sample collection, addition of material to a closed system or transfer of material to another closed system





Where appropriate,





Yes, emissions are reduced as much as possible





Yes, leaks are prevented





Yes, leaks are prevented







4





Inactivation of large quantities of culture fluids before removal from the closed system





Where appropriate,





Yes, by validated methods





Yes, by validated physical or chemical methods





Yes, by validated physical or chemical methods







5





Seals should be designed to minimize or prevent releases





No specific requirements





Emissions are reduced as much as possible





Spills are prevented





Spills are prevented







6





The controlled area should be designed so that the discharge can accommodate the entire contents of the closed system





Where appropriate,





Where appropriate,





Yes





Yes







7





The controlled area should be sealable to permit fumigation





No





Where appropriate,





Where appropriate,





Yes







EQUIPMENT



 

 

 

 





8





Access via Airlock





No





No





Where appropriate,





Yes







9





The surfaces must be resistant to acids, alkalis, solvents, disinfectants, decontamination agents and easy to clean Yes

(possibly table)





Yes

(possibly table, floor)





Yes

(possibly table, floor)





Yes

(possibly table, floor, ceiling, walls)







10





Special measures to ensure adequate ventilation of the controlled area, so air contamination is reduced as much as possible





Where appropriate,





Where appropriate,





Where appropriate,





Yes







11





The controlled area should be under pressure in relation to the immediate surroundings





No





No





Where appropriate,





Yes







12





Air water inlet and exhaust air from the controlled area should be HEPA filtered





No





No





Yes (air extraction system, optional for air intake)





Yes (extract-and-exhaust ventilation)







13





A closed systems should not be opened for maintenance, unless it is sterilized using recognized method





Where appropriate,





Yes





Yes





Yes







14





Closed systems must have monitoring-and feel devices that measure indeslutningens integrity during operation





Where appropriate,





Where appropriate,





Yes





Yes







15





Containment integrity of closed systems should be tested using the corresponding host organism before the system is put into use





Where appropriate,





Where appropriate,





Yes





Yes







WORKING SYSTEM



 

 

 

 





16





Closed systems should be located within a controlled area





No





Yes





Yes





Yes, designed for the purpose







17





Access only for specially designated staff





No





Yes





Yes





Yes, via Airlock







18





To place signs on the field area





Yes, class 1





Yes, class 2





Yes, class 3






Yes, class 4







19





Staff must take a shower before leaving the controlled area





No





No





Where appropriate,





Yes







20





Decontamination and washing shall be provided opportunities for staff





Yes





Yes





Yes





Yes







21





Personnel should wear protective clothing





Yes (workwear)





Yes (workwear)





Yes





Complete changing room before the exit and entrance







WASTE



 

 

 

 





22





Inactivation of GMMs in effluent from sinks and showers or similar effluents





No





No





Where appropriate,





Yes







23





Inactivation of GMMs in contaminated material and waste, including process waste water prior to final release





Where appropriate,





Yes, with validated methods





Yes, with validated physical or chemical methods





Yes, with validated physical methods













Annex 3a Assessment pursuant to section 6 of the biological systems

Part A

This annex describes in general terms the elements to be taken into consideration, and the procedure to be followed for the assessment referred to. F.s.v.a. the detailed guidelines for the assessment reference is made to Annex 3b.

The assessment shall be taken in particular of the question of the discharge of waste and waste water.

A. Elements of the assessment referred to in article 6:

1. The following should be considered as potentially harmful effects:-disease to humans including allergenic or toxic effects,



– disease in animals and plants



– harmful effects due to the impossibility of treating a disease or providing an effective prophylaxis



– harmful effects as a result of establishment in or spread to the environment



– harmful effects due to the natural transfer of inserted genetic material to other organisms.

2. for the assessment of possible risks to health and safety by the biological systems of the following parameters, in so far as they are relevant, should be taken into account: a) the identification of all potentially harmful effects, in particular those related to



I) donor, hosted or (where appropriate) parental organism (s) (s) (as long as the organism is used during the activity)



II) the inserted genetic material (from the donor organism)



III) vector



IV) the resulting genetically modified organism.



(b)) The characteristics of the activity.



(c)) the scope of the potentially harmful effects including sundshedshensyn.



(d)) the likelihood that the potentially harmful effects occur.



e) monitoring techniques.

B. Procedure

3. The first stage in the assessment process should be to identify the harmful properties of the recipient organism and, where relevant, in the donor organism and harmful properties associated with the vector or inserted material, including any alteration of the recipient's existing properties.

4. In general, only genetically modified organisms with the following characteristics will be considered appropriate for inclusion in class 1: i) Recipient organism or parental organisms is not expected to be able to cause disease in humans, animals or planter6)



II) the vector or inserted material is of such a nature that they do not provide the genetically-modifying organism a phenotype likely to cause disease to humans, animals and planter6) or to have negative environmental impacts



III) the genetically modified organism is not expected to cause diseases in humans, animals and planter6), and is not expected to have environmental impacts.

5. To gain knowledge of the information that is necessary for the implementation of this process, the notifier may only withdraw the relevant legislation, in particular the Danish working environment service's Ordinance on biological agents and working environment.

International or national classification systems (URf.eks. The who, NIH) and adjustments thereto to scientific and technical progress may also be taken into account.

6. The hazard identification process carried out in accordance with points 3 to 5, should lead to the identification of the level of risk associated with genetically modified organisms.

7. Selection of the containment and other protective measures taken then on the basis of the degree of risk associated with genetically modified organisms, as well as taking into account: (i) the characteristics of the environment, characteristic) that is likely to be exposed (there is URf.eks. in the environment likely to be exposed to the genetically modified organisms known biota which can be adversely affected by the organisms used in the activity concerned with the contained use)



II) characteristics of the activity (URf.eks. its extent and nature)



III) any non-standard operations (URf.eks. inoculation of genetically modified micro-organisms in animals; equipment which probably causes the aerosol formation).

Under the terms of nr. I-iii), it may, in accordance with point 6 identified the degree of risk that for the activity in question is connected with the genetically modified organism shall be increased, reduced or remain unchanged.

8. When the analysis is completed as described above, the activity is classified in one of the classes described below. The Division into 4 classes are not used for genetically modified animals and plants.

9. The final classification of the contained use is confirmed after a review of the completed assessment referred to in section 6.

Part B

Criteria for the election of class.

Assessment in annex 3a, part (A) results in a final classification of the contained uses in four classes, and this classification is in accordance with § 6 (2) determines the level of containment:

Class 1: work, as do not present any risk or only a negligible risk, IE. work, where class 1-containment is sufficient to protect human health and the environment.

Class 2: work, which involves low risk, IE. work, where class 2-containment is sufficient to protect human health and the environment.

Class 3: work involving moderate risk, IE. work, where class 3-containment is sufficient to protect human health and the environment.

Class 4: work, which involves high risk, IE. work, where class 4-containment is sufficient to protect human health and the environment.



Annex 3b guidelines for risk assessment

1. introduction


In annex 3a, part A, points 1 and 2 shall be established for the elements to be taken into account in the assessment of potential adverse effects to human health and the environment. Potentially harmful effects is defined as: effects that cause disease or makes prophylaxis or treatment ineffective; harmful effects to aquatic organisms or natural populations as a result of the establishment and/or distribution in the environment; or harmful effects arising from gene transfer to other organisms. The risk of these potentially harmful effects must be examined for each operation, which should be classified in a given class, taking account of the nature and scope of the operation with a view to defining the necessary containment measures. The risk of the contained use of genetically modified organisms (GMO) and in the construction of such organisms is determined by examining the seriousness of the potential adverse health or environmental effects will be, and of the likelihood of such effects occurring. In the risk assessment of Gmos on human or environmental exposure is assessed as a result of the operation of a facility for contained use or as a result of possible leaks from such a plant. The classification level to be determined by the risk assessment determines what containment requirements that make it applicable to 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 (hazard) of the GMO and the location of the GMO in a provisional class (class 1 to class 4) on the basis of the seriousness of the potential adverse effects

And

assessment of the likelihood that adverse effects will occur, based on an assessment of the potential exposure (both human and environmental) taking into account the nature and extent of the activity in question and the containment measures for the provisional class, the activity is located at.

2.2 Procedure 2

Final classification and finally fixing the containment measures.

To the final classification and containment measures are appropriate, be confirmed by repeating the procedure 1.

3. Procedure 1

3.1 identification of harmful properties (hazard) of the GMO.

The risk assessment process includes the identification of potential harmful characteristics of the GMO, as a result of the genetic modification or any changes in the recipient organisms ' existing properties. The potentially harmful properties associated with the GMO must be determined by examining the recipient organism, the donor organism, the inserted genetic material properties and location and any vector. It is important to take into account the fact that genetic modification of an organism can affect its ability to harm human health and the environment, since it can be reduced, increased or remain unchanged.

3.2 aspects that should be taken into account if they are relevant:

3.2.1 Recipient – name, description and origins



– information on the (n) parental organism (s) or, where applicable, by the host organism reproductive cycles (sexual/asexual)



-nature of pathogenicity and virulence, infectivity, allergenicity, toxicity and vectors of disease transmission



-nature of indigenous vectors and supplied agents if they could mobilise the inserted genetic material, and the frequency of such mobilisation



– the nature and stability of any inaktiverende mutations



– the (n) parental organism (s) or the host organism stability as regards the relevant genetic traits;



– any prior genetic modifications



-host range (if relevant)



– significant physiological traits which may be altered in the final GMO and their stability, if applicable



-natural habitat and geographic distribution



– significant involvement in environmental processes (such as nitrogen fixation or pH Regulation)



– interaction with and impact on other organisms in the environment (including likely competitive, pathogenic or symbiotic properties)



– ability to form survival structures (such as spores or sclerotia).

3.2.2 Donor financing – name, description and origins



– degree of similarity with the host organism



-nature of pathogenicity and virulence, infectivity, toxicity and vectors of disease transmission



-nature of indigenous vectors:



– sequence



– frequency of mobilisation and specificity



– presence of genes which confer resistance to antimicrobials, URf.eks. antibiotics



-host range



– other relevant physiological traits 3.2.3 Insert – description of the modification including the method of vector insertion into the host organism or the method used to generate the relevant genetic modification



– the specific identity and function (genes)



– the inserted genetic expression level and rate. Measurement method and sensitivity



– the source of origin of the donor (s) identity and characteristics where this is relevant



– previous genetic modifications if appropriate



– the inserted genetic material (possibility of activation/deactivation of host genes as a result of insertionen).

3.2.4 Vector – characteristics of the vector, its origin



– the structure and amount of nucleic acids from vector and/or donor that may remain in the final construction of the modified micro-organism;



– If the inserted vector is present in the final GMO: frequency of and/or transfer of genetic material.

3.2.5 the final GMO – stability of the organism in terms of genetic traits;



– characteristics of substances that are formed or can be formed as a result of the genetic manipulation



– the expressed protein's activities



– factors that may affect the modified organism survival, multiplication and dissemination outside the culture fluid 3.2.5.1 Health aspects – awaited toxic or allergenic effects of the GMO, and/or its metabolic products



– product risks, including the formation of toxins or biological-activity substances



– comparison of the modified micro-organism and recipient organism or (where appropriate) parental organism regarding pathogenicity



– expected colonisation ability



known and predicted habitats



– If the micro-organism is pathogenic to immunocompetent humans:



-diseases caused and the method of transmission including invasiveness and virulence,



– infectivity



– infectious dose



– the possible change of the route of infection or tissue specificity



– possibility of survival outside of human host



– presence of vectors or other distribution methods



-biological stability



– antibiotic resistance patterns



– allergenicity



– the possibility for appropriate medical care and prophylaxis.

3.2.5.2 environmental considerations – ecosystems to which the organism could be unintentionally released from the contained use



– the modified organism expected survivability, multiplication and spread in the identified ecosystems



– expected result of interaction between the modified organism and the organisms or micro-organisms which might be exposed in case of release to the environment



-known or predicted effects on plants and animals such as pathogenicity, toxicity, allergenicity, carrier of the pathogen, altered antibiotic resistance patterns, altered tropism or host specificity, colonisation



-known or predicted involvement in biogeochemical processes.

3.2.5.3 Monitoring technician – techniques for detection, identification and monitoring of the modified organism



– techniques for detecting transfer of the new genetic material to other organisms



– possible methods for the decontamination of the area in the event of a spill.

3.3 Preliminary classification of the GMO

Annex 3a, part A, paragraphs 3-5, it appears that the first stage of the risk assessment of a GMO is to identify the potential harmful characteristics of the GMO, so there can be an initial classification thereof. This is done by identifying the dangers that can be associated with the recipient, donor, vector and insert. The assessment may take account of the General characteristics of class 1, as described in annex 3a, part A, point 4, and appropriate up-to-date national and international classification systems (including the Ordinance on biological agents and working environment and amendments thereto). The corresponding set of containment and other protective measures set out in annex 2 serves as the starting point for the assessment of whether that required more stringent containment and control measures to control the identified adverse effects.


The risk of adverse effects resulting from any harmful characteristics of the GMO assessed by examining the seriousness of the damage and any biological properties (URf.eks. inaktiverende mutations) which limit the probability that damage will occur. Severity of the adverse effects be assessed independently of the likelihood that they actually occur. The severity of any damage shall be assessed by examining what the consequences might be, and not the likelihood that injury will occur in that case. For a pathogen to the URf.eks. assess the severity of the disease would be if a sensitive species is infected. Know the location of a GMO in a provisional class also takes account of the seriousness of the damage. In the various classification schemes, such as URf.eks. in the Ordinance on biological agents and the working environment, are taken into account the possible damage impact severity. Many of these schemes are, however, based only on either health or environmental considerations. It is important to ensure that fully take into account the severity of adverse health and environmental effects from the GMO.

3.4 Assessment of the probability of adverse effects occurring.

The probability of a harmful event occurring, depends primarily on the level and nature of human or environmental exposure for a given GMO. The exposure aspect is in most cases of primary significance for risk assessment, as it often determines whether an adverse effect will occur. The likelihood of people or the environment exposed to a GMO, depends on which operations are executed (URf.eks. and in the scale) and the containment measures taken for doing so, based on the provisional classification in accordance with paragraphs 5 and 6.

In accordance with point 7 (nr. ii and iii) in annex 3a, the final classification and selection of control measures taking into account the characteristics of the operation. Account should be taken of the nature and extent of the services in order to assess the likelihood of human and environmental exposure, and this will also have an impact on the selection of appropriate risk management procedures.

Of the characteristics of the operation, which may have implications for the risk assessment and, therefore, should be taken into account include actual activity, work routines, the activity's scope and used containment measures.

The assessment shall, in particular, be taken of how waste and waste water be disposed of. There must, where appropriate, be taken security measures for the protection of human health and the environment.

3.4.1. nature of the proposed activities.

The level of risk and the application of control measures to reduce that risk from the GMO to an appropriate level depends on the nature of the activities, since these will affect human and environmental exposure, and thus the probability of adverse effects occurring.

The nature of the work will also be used to determine which table in annex 2 which contains the most appropriate containment and control measures.

For work in laboratory scale, where the effects of standard laboratory procedures on exposure are well-known, there will hardly be a need for a detailed risk assessment of each procedure, unless using a very dangerous organism. A more detailed assessment can, however, be necessary for non-routine procedures or procedures which may have significant impact on the level of risk, URf.eks. procedures by which generated aerosols.

3.4.2 Concentration and scale

Large cell density increases the risk of exposure to high concentrations of the GMO, in particular in downstreamforarbejdningsoperationer. Concentration on the impact on the probability of a harmful event occurring, must be examined.

Also the scope of an activity must be taken into account in the risk assessment, both the level of a single operation or in the form of frequent repetition of a process, because both can lead to increased likelihood of exposure, if the containment and control measures fail and thus increases the probability of a harmful event occurring.

Although the operations of large scale does not necessarily mean high risk, can increased extent involve greater probability of exposure both in terms of numbers of people and the extent of the environmental exposed in the event of failure of the containment measures.

Allow the volume will also influence which table in annex 2, containing the most appropriate containment and control measures.

3.4.3 Cultivation conditions

Too many activities in contained use is growing severely containment conditions, but also of the reactors and other cultivation equipment design and art will have a bearing on health and environmental risks. Exposure to and thus the risk of a GMO can be reduced considerably by using high technology and tightly closed fermentation tanks. It is important to examine the reliability of this equipment, and the possibility of disruption in cases where disruption can lead to extensive exposure to harmful Gmos. Where reasonably foreseeable such spills, there may be a need for additional containment measures. Default arbejdsrutinerne for persons who work with cultivated Gmos, as URf.eks. centrifugation or sonikering, are of great importance for the effectiveness of containment.

In addition to the natural growing conditions that act as containment measures, can also biological and chemical measures that serves to protect the operation, contribute significantly to the containment measures. As an example of biological containment include auxotrofiske mutants that require entry of specific growth factors in order to be able to evolve. As an example of chemical containment measures include disinfectants in emission systems.

In paragraph 7 of annex 3a States that the assessment of the probability of adverse effects occurring, and their earnest must take into account the characteristics of the environment, which are likely to be exposed, and to assess the seriousness of the situation.

Certain aspects of these environmental concerns are important, such as the scope and nature of environmental exposure and whether in the exposed area are biota which may be damaged by the GMO.

The following factors should be taken into account in the assessment of the impact of the characteristics of the receiving environment will have on the likelihood of the potentially harmful effect will occur, and thus on the level of risk and on the choice of control measures.

3.4.3.1 The environment likely to be exposed

The environment likely to be exposed, can in most cases is expected to be limited to the work site and the area immediately around the plant, but depending on the specifics of the contained use and the facility, it is also necessary to take account of the environment in higher importance. The extent of environmental exposure may depend on the nature and scope of the activity, but all imaginable forms of transfer in the wider environment, URf.eks. physical paths (such as local drains, watercourses, waste disposal, wind) and biological vectors (such as through infected animals and insects) to be taken into account.

3.4.3.2 the presence of sensitive species

The probability of adverse effects occurring will depend on whether in the environment that can be exposed, are sensitive species, including humans, animals and plants.

3.4.3.3 the possibility that environment can promote the survival of the GMO

An important aspect of the risk assessment is the question of the extent to which the GMO can survive and persist in the environment. The probability of adverse effects occurring, will be far less if a GMO is unable to survive in the environment in which it will be able to gain.

3.4.3.4 Effects on the physical environment

In addition to the direct harmful effects of a GMO must also take into account indirect harmful effects as a result of significant changes in the physico-chemical properties of and/or the ecological balance in environmental compartments soil and water.

4. Procedure 2

4.1 determination of final classification and containment measures. When the seriousness of all potentially harmful characteristics of the GMO and the likelihood of injury as a result of this are explored, taking into account the containment and control measures, the provisional classification entails, can the final classification and containment measures for GMO is fixed. In assessing the final classification and containment measures should the provisional classification are reviewed to see if it was properly having regard to the proposed activities and operations. A comparison between the preliminary classification and associated containment measures with the final class and associated containment requirements can lead to three results: – there is in the provisional classification not taken due account of certain harmful effects, why the provisional containment in accordance with procedure 1 is inadequate; Therefore, additional containment measures are required, and the classification of the activity in question might need to be revised;



– the preliminary rating was appropriate and the related indslutningsforanstaltninger sufficient to prevent or minimize health and environmental damage;




– the preliminary classification is stricter than is necessary for the activity, why there should be chosen a lower classification with associated containment measures.

4.2 the Confirmation of final containment measures expediency.

When the final classification and containment conditions are laid down, the level of human and environmental exposure should be reassessed (procedure 1). In doing so, it must be confirmed that the probability of adverse effects occurring is acceptable, taking into account the nature and extent of and the proposed containment conditions. Once this is done, the risk assessment process is completed.

In article 6, paragraph 5, States that the assessment must be updated when there are changes in the work, working methods, work processes, etc., which are important for the company's working environment and for the external environment, if: 1) the protective measures applied are no longer adequate or the class in which the activity takes place, no longer is the right, or



2) there is reason to suspect that the assessment is no longer adequate in the light of the latest scientific and technical knowledge.

Any changes in the containment conditions as a result of the review of the risk assessment must immediately be put into practice in the interests of the adequate protection of human health and the environment.

The contained uses are classified in class 1-4 on the basis of the classification and the containment and control measures in the risk assessment are found to be necessary for an adequate containment of the GMO in the proposed activities. Annex 2 describes the containment and control measures for each class.

The administrative requirements to be established on the basis of the classification of the contained uses of GMOs.

There is uncertainty with respect to the final classification and containment conditions, labour inspection should be contacted.



Annex 4 Review and approval of research projects, other laboratory tasks, large-scale trials and production, involving genetically modified organisms, see. section 15 (1) and § 21 (1).

Part (A) In General.

Information required in connection with the in section 15 (1) and § 21 (1): 1) date of notification referred to in § 7 paragraph 1 referred to classification or submission of notification



2) name of the persons responsible for supervision and safety and information on their training and qualifications



3) or the used recipients, donors and/or parental organisms, or possibly it or the used host-vector systems



4) the origin of the genetic material involved in the modification (s) altered, and this material's intended function



5) the genetically modified organism's identity and characteristics



6) the purpose of the contained use including the expected results



7) approximate culture extent when working with microorganisms



8) description of the containment and other protective measures, including information on the management of the waste generated, their treatment, final form and destination



9) a copy of the assessment referred to in article 6



10) the Labour Inspectorate need information in order to evaluate the contingency plans drawn up in accordance with article 28, paragraphs 2 and 3.

Part b. Review of research projects in class 3 and 4 as well as large-scale trials and production.

The notification shall contain the information referred to in annex 4, section A.

There must also be informed about the following points: – the cultural scale, which will be used



– description of the containment and other protective measures will be applied, including information about waste management, including the type and form of wastes to be generated, their treatment, final form and destination



-description of the installation parts



– information about accident prevention and emergency response plans, if any



– specific risks due to the plant's location



-the preventive measures applied such as safety equipment, alarm systems and containment methods,



– procedures and plans for monitoring of the containment measures continue to be effective



– a description of the information provided to workers, including security requirements, it is not technically possible or it is not considered necessary to give some of the information, the reasons shall be indicated.

For productions, the level of detail required to reply to the individual points will vary according to the nature and extent of the proposed production. In particular, it will normally not be necessary to give detailed biological information on host organisms, previously recognized as class 1.

Are some of the required information previously submitted to the Labour Inspectorate, the notification can refer to this information.



Annex 5-approval of research projects and other laboratory tasks, see. Article 20, paragraph 2.

The following research projects and other laboratory tasks must be approved before they commence;



1) research projects and other laboratory tasks that must be performed in the laboratory of class 3 or 4 of the basic regulation. Annex 3a, part B.



2) research projects and other laboratory tasks involving the transfer of resistance markers to organisms, as far as is known not naturally possess such, if this transfer can bring the use of antibiotics to control disease-causing agents in danger.

Official notes 1) Ordinance contains provisions implementing Council Directive No. 90/219/EEC, official journal 1990 L 117 s. 1 as amended by Council Directive No. 98/81/EC, Official Journal L 330 of 1998 s. 13.

6) Who are here only to talk about animals and plants in the exposed environment.