Executive Order on Genetic Engineering and Work Environment

THE CONSOLIDATION covers Executive Orders

No. 910 of 11 September 2008, which entered into force on 17 September 2008

No. 88 of 22 January 2010, which entered into force on 30 January 2010

No. 1707 of 15 December 2010, which entered into force on 1 January 2011

Pursuant to Section 17, Subsection 3, Section 22, Subsection 1, Section 35, Section 39, Subsections 1 and 2, Section 40, Section 41, Subsection 1, Section 43, Section 44, Section  46, Section 49, Section 49 a, Subsections 1 and 2, Section 49 c, Section 73, Section 75, Subsection 1, and Section 84 of the Danish Working Environment Act, cf. Executive Order No. 268 of 18 March 2005 as well as by authorisation from the Danish Ministry of the Environment pursuant to Section 7, Section 13, Subsection 3, Section 17 a, Subsection 1, Section 20, Subsection 2, Section 27, and Section 36, Subsection 4 in the Danish Environmental and Genetic Engineering Act, cf. Executive Order No. 811 of 21 June 2007, as amended by Act No. 1270 of 16 December 2009, the following is hereby stipulated:

Chapter 1 – Area

Section 1. The Executive Order covers activities, including development activities, involving genetically modified organisms, cf. Annex 1, in:

1. laboratories and laboratory areas, including animal units, glasshouses/growth-rooms, aquariums and the like;
2. facilities for large-scale testing and production.

Subsection 2. The Executive Order applies regardless of whether the activities are carried out for an employer.

Section 2. Excluded from the Executive Order are exhibitions, other dissemination of information, etc., which, pursuant to the Environmental and Genetic Engineering Act, the Minister of the Environment has determined may take place outside classified laboratories and laboratory areas.

Subsection 2. The Director of the Danish Working Environment Authority may decide that activities involving genetically modified organisms, which the Minister of the Environment exempts pursuant to the Environmental and Genetic Engineering Act shall also be exempted from the Executive Order.

Section 3. In addition to the rules in this Executive Order, the general rules of the working environment legislation apply, as well as rules that may have been stipulated on genetic engineering in other legislation.

Subsection 2. For genetically modified micro-organisms, the rules in the Executive Order on Biological Agents and the Workplace also apply to the obligation to keep lists of employees who are exposed to biological agents in Risk Class 3 or 4, as well as the obligation to ensure access for employees to undergo an occupational health assessment.

Definitions

Section 4. Pursuant to this Executive Order, genetically modified organisms mean plants, animals, micro-organisms, cell cultures and viruses in which new compositions of the genetic material occur which do not occur naturally, cf. Annex 1.

Section 5. Pursuant to the stipulations of this Executive Order, the following definitions shall be used:

1. Research projects and other laboratory tasks mean activities involving genetically modified animals and plants, as well as activities involving genetically modified micro-organisms or cell cultures with a volume per container of max. 15 litres of nutrient broth.
2. Large-scale testing means activities involving genetically modified micro-organisms or cell cultures that are not actual production, but which take place in similar facilities. Activities involving genetically modified plants and animals are not covered by the definition.
3. Donor means the organism or cell/cell material from which the genetic material used originates.
4. Host means the cell or organism into which the genetic material is introduced.
5. Vector means the biological material used to introduce genetic material into a host.
6. Biologically active material means donors, hosts, genetically modified cells and organisms, or tissue thereof, viruses as well as genetically modified animals and plants that are capable of replicating themselves.
7. Laboratories and laboratory areas mean the workspace in which biologically active material is handled, i.e. rooms in which activities take place in one form or another with biologically active material. Laboratory area means rooms such as animal units, glasshouses/growth-rooms and aquariums.
8. Pursuant to Annex A, Part B, contained activity means any activity in which micro-organisms are genetically modified, or in which such genetically modified micro-organisms are grown, stored, transported, destroyed, disposed of or used in any other way, and where specific containment measures to limit their contact with people and the environment are applied.
9. Accident means any incident involving a significant and unintended release of genetically modified micro-organisms in the course of their contained use which present an immediate or delayed hazard to human health or the environment.
10. An accident means any incident which involves an accident, cf. Section 5, No. 9, as well as incidents which involve near misses.

Chapter 2 – Assessment of Safety and Human Health

Section 6. Prior to the notification of activities, an overall assessment must be made of the potential dangers to human safety and health or to the external environment of the biological systems.

Subsection 2. For activities involving genetically modified micro-organisms, the assessment must include at least the assessment elements and the procedure set out in Annex 3a, Part A and Annex 3b. Based on the assessment mentioned, it is assessed in which class the work is to be carried out, cf. Annex 3a, Part B.

Subsection 3. For activities involving genetically modified animals, plants, etc. the assessment must include the principles set out in Annex 3a, Part A and Annex 3b.

Subsection 4. A written account of the assessment must be kept and made available to the Danish Working Environment Authority.

Subsection 5. The assessment must be updated with any changes in the activities, working methods, work processes, etc., which are important for the company's working environment and for the external environment:

1. If the protective measures applied are no longer adequate or the class in which the activity takes place is no longer the right class; or
2. If there is reason to believe that the assessment is no longer adequate in the light of the latest scientific or technical knowledge.

Chapter 3 – Classification of Laboratories, Laboratory Areas and Facilities for Large-Scale Testing and Production

Section 7. Laboratories, laboratory areas and facilities for large-scale testing and production involving activities with genetically modified organisms must be classified by the Danish Working Environment Authority before use. Classification means the Danish Working Environment Authority's approval that an area meets the requirements stipulated for the area.

Subsection 2. The classification applies until the Danish Working Environment Authority announces otherwise.

Section 8. Laboratories and laboratory areas, including glasshouses/growth-rooms, animal units, aquariums and the like are classified into four groups in accordance with Annex 2, Parts A and B, subject to Subsection 2.

Subsection 2. Laboratories and laboratory areas that do not involve activities with genetically modified micro-organisms but only work with genetically modified plants and animals are not classified into four groups but only upon a concrete assessment.

Subsection 3. Classification of laboratories that carry out activities involving genetically modified plants and animals, as well as laboratory areas are classified upon negotiation with the Danish Environmental Protection Agency.

Section 9. Facilities for large-scale testing and production are classified into four groups in accordance with Annex 2, Parts A and C, subject to Subsection 2. Facilities for large-scale testing are classified upon negotiation with the Danish Environmental Protection Agency.

Subsection 2. Facilities for production that does not include activities involving genetically modified micro-organisms but only work with genetically modified plants and animals are not classified into four groups but only upon a concrete assessment.

Section 10. The Director of the Danish Working Environment Authority may lay down rules on or decide that certain testing for teaching purposes with genetically modified organisms may be carried out outside classified laboratories and laboratory areas.

Section 11. Notification for classification pursuant to Section 7, Subsection 1 must be submitted to the Danish Working Environment Authority and must contain information on the conditions mentioned in Annex 2. In addition, the Danish Working Environment Authority may require information about the technical aids and descriptions of the structural conditions.

Section 12. If already classified laboratories, laboratory areas, facilities for large-scale testing and production are to be classified into a lower class or there is no longer a desire to maintain the classification, this must be notified to the Danish Working Environment Authority in advance.

Section 13. Work in classified laboratories, laboratory areas, facilities for large-scale testing and production must always be carried out in accordance with the requirements for the class in question, cf. Annex 2, and in accordance with the specific conditions stipulated in connection with the classification.

Section 14. Classification according to Section 7, Subsection 1 must be notified in writing no later than 45 days after submission of the notification.

Subsection 2. However, classification of laboratories, laboratory areas and facilities for large-scale testing and production in Classes 3 and 4 must be notified in writing no later than 90 days after submission of the notification.

Subsection 3. When calculating the deadline in Subsections 1 and 2, the time during which the Danish Working Environment Authority awaits further information, which the Danish Working Environment Authority may have requested from the notifier, should not be included.

Chapter 4 – Notification and Approval of Research Projects and Other Laboratory Tasks

Section 15. Research projects and other laboratory tasks, which include activities involving genetically modified organisms, must be approved by the Danish Working Environment Authority prior to implementation.

Subsection 2. As for Class 1, subsequent research projects and other laboratory tasks within the same legal entity may be initiated without further approval.

Section 16. Activities involving genetically modified micro-organisms may only be carried out in laboratories and laboratory areas that are, as a minimum, classified for work of that nature.

Subsection 2. In event of any uncertainty, the appropriate containment and other protective measures for the higher classification should be applied.

Section 17. Notification of research projects and other laboratory tasks must contain the information mentioned in Annex 4, Part A, subject to Subsection 2, and must be submitted to the Danish Working Environment Authority.

Subsection 2. Notification of research projects and other laboratory tasks covered by Annex 5 must include:
1) the information listed in Annex 4, Parts A and B;

1. identification of the health risks both under normal working conditions and in the event of an accident; and
2. an account of the planned safety measures in addition to those resulting from the laboratory classification.

Subsection 3. Notification of subsequent research projects and other laboratory tasks in Class 1 consists of the assessment pursuant to Section 6, as well as a reference to the classification of the room in which the work is to take place.

Section 18. The Danish Working Environment Authority shall submit notifications of research projects and other laboratory tasks to the Danish Environmental Protection Agency if:

1. the activities involve genetically modified reproducing plants, genetically modified animals or genetically modified organisms in animal units, glasshouses/growth-rooms, aquariums and the like; or
2. an assessment pursuant to Section 6 shows that there is an environmental risk.

Section 19. The notification and approval lapse after five years, unless it is renewed, subject to Subsection 2.

Subsection 2. The approval of research projects and other laboratory tasks covered by Annex 5 are valid until the Danish Working Environment Authority announces otherwise.

Section 20. The Danish Working Environment Authority shall issue approvals pursuant to Section 15, Subsection 1 in writing no later than 45 days after submission of the notification. When calculating the deadline, the time during which the Danish Working Environment Authority awaits further information, which the Danish Working Environment Authority may have requested from the notifier, should not be included.

Subsection 2. However, research projects and other laboratory tasks that are not covered by Annex 5 may be initiated 45 days after submission of the notification, unless the Danish Working Environment Authority has given a different notice, subject to Section 15, Subsection 2.

Subsection 3. The Director of the Danish Working Environment Authority may decide that activities involving certain genetically modified organisms may be initiated once the notification has been submitted.

Chapter 5 – Notification and Approval of Large-Scale Testing and Production

Section 21. Large-scale testing and production, which includes activities involving genetically modified organisms, must be approved by the Danish Working Environment Authority prior to initiation.

Subsection 2. As for Class 1, subsequent large-scale testing and production within the same legal entity may be initiated without further approval.

Section 22. Activities involving genetically modified micro-organisms may only be carried out in facilities for large-scale testing and production that are, as a minimum, classified for work of the nature in question.

Subsection 2. In event of any uncertainty, the appropriate containment and other protective measures for the higher classification should be applied.

Section 23. Notification of large-scale testing and production must contain the information mentioned in Annex 4, Parts A and B and must be submitted to the Danish Working Environment Authority.

Subsection 2. Notification of subsequent large-scale testing and production at Class 1 consists of the assessment pursuant to Section 6, as well as a reference to the classification of the facility in which the work is to take place.

Section 24. The Danish Working Environment Authority shall submit notifications of large-scale testing at Class 2 or higher to the Danish Environmental Protection Agency.

Section 25. The notification of large-scale testing at Class 1 lapses after five years unless it is renewed.

Subsection 2. The approval of large-scale testing at Class 2 or higher as well as production is valid until the Danish Working Environment Authority announces otherwise.

Section 26. The Danish Working Environment Authority shall issue approvals pursuant to Section 21, Subsection 1 in writing no later than 45 days after submission of the notification. When calculating the deadline, the time during which the Danish Working Environment Authority awaits further information, which the Danish Working Environment Authority may have requested from the notifier, should not be included.

Subsection 2. However, large-scale testing at Class 1 may be initiated 45 days after submission of the notification, unless the Danish Working Environment Authority has announced otherwise, subject to Section 21, Subsection. 2.

Subsection 3. The Director of the Danish Working Environment Authority may lay down rules on a notification scheme for production, which includes genetically modified organisms at 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.

Subsection 2. When the use of a replacement donor or a replacement host-vector system will result in significant differences in technical characteristics or costs, the overall technical and economic implications must be weighed against safety and health considerations.

Subsection 3. The Danish Working Environment Authority may require documentation for the circumstances mentioned in Subsections 1 and 2.

Chapter 7 – General Provisions

Section 28. The employer must ensure that employee instructions and safety regulations are available in writing and, to the extent necessary, by posting of notices.

Section 28 a. An emergency response plan must be prepared for the work with genetically modified organisms when failing containment measures could immediately, or later on, pose a particular danger to people outside the rooms and/or to the environment, except when such a emergency response plan has already been prepared in accordance with other legislation.

Subsection 2. Any emergency response plans must be prepared and submitted to the Danish Working Environment Authority before work with genetically modified organisms is initiated and the notification must be attached to the classification pursuant to Section 11. The emergency response plans must be updated on a regular basis.

Subsection 3. The Danish Working Environment Authority shall forward the emergency response plans and their updates to the Danish Environmental Protection Agency with a view to ensuring that agencies and authorities, which may be affected by an accident, receive unsolicited notification of the emergency response plans in an appropriate manner, including the relevant safety measures. The Danish Environmental Protection Agency shall ensure that the above-mentioned agencies and authorities are notified of the updated information. The Danish Environmental Protection Agency shall also ensure that the information is made available to the public.

Section 28 b. The information on the contained use of genetically modified micro-organisms covered by Article 18, Subsection 2, subject to Subsection 4 of Directive 2009/41/EC of 6 May 2009 on the Contained Use of Genetically Modified Micro-organisms must always be disclosed if access to such information is requested. The information is reproduced in Annex 6.

Section 29. The Director of the Danish Working Environment Authority may demand that the notifications pursuant to Section 11, Section 17, Subsection 1, and Section 23, Subsection 1 be carried out using special tables, which may be requested from the Danish Working Environment Authority.

Section 30. Any significant change in the information pursuant to Sections 11, 17 and 23 of significance to safety and human health must be reported to the Danish Working Environment Authority.

Subsection 2. Approval of the changes must be notified in writing no later than 45 days after submission of the notification. When calculating the deadline, the time during which the Danish Working Environment Authority awaits further information, which the Danish Working Environment Authority may have requested from the notifier, should not be included.

Subsection 3. However, a change of information pursuant to Section 17, Subsection 3, and Section 23, Subsection 2, does not require approval.

Section 31. To the extent that it may be considered necessary for the assessment of the safety of the genetic engineering work, or when the circumstances otherwise give rise to it, the Danish Working Environment Authority may require additional information. The Danish Working Environment Authority may require the information assessed by experts, cf. Section 21 of the Danish Working Environment Act.

Section 32. The company's occupational health and safety organisation must be involved in the preparation of the assessment pursuant to Section 6 and the internal emergency response plan pursuant to Section 28. In companies where an occupational health and safety organisation does not need to be established, the employees must be involved in a similar way.

Section 33. A classification pursuant to Section 7, Subsection 1 and an approval pursuant to Section 15, Subsection 1, or Section 21, Subsection 1, may be subject to stipulated conditions, just as a classification or an approval may be temporary.

Subsection 2. The Danish Working Environment Authority may revoke a classification pursuant to Section 7, Subsection 1, and an approval pursuant to Section 15, Subsection 1, or Section 21, Subsection 1, if the conditions are not complied with or new information that is of significant importance for safety and human health makes it necessary.

Section 34. The Danish Working Environment Authority shall examine notifications pursuant to Sections 11, 17 and 23, for:

1. accordance with the requirements of this Executive Order;
2. the accuracy and completeness of the information provided;
3. the correctness of the assessment pursuant to Section 6 and of the class of the contained uses; and
4. if necessary, for the adequacy of containment measures and other protective measures as well as waste management and emergency preparedness measures.

Chapter 8 – Dispensation and Complaints

Section 35. The Director of the Danish Working Environment Authority may, where special circumstances exist, allow deviations from the provisions of this Executive Order when it is deemed reasonable and fully justifiable, and to the extent that it is compatible with Directive 90/219/EEC on the Contained Use of Genetically Modified Micro-organisms as amended by Directive 98/81/EC.

Section 36. The Danish Working Environment Authority's decisions pursuant to this Executive Order may be appealed in accordance with section 81 of the Danish Working Environment Act.

Chapter 9 – Punishment

Section 37. Unless a higher penalty is due under the Danish Working Environment Act or other legislation, anyone who violates:

1. Section 6, Section 7, Subsection 1, Section 11, Section 12, Section 13, Section 15, Subsection 1, Section 16, Subsection 1, Section 17, Section 21, Subsection 1, Section 23, Section 27, Subsections 1 and 2, Section 28, Sections 30 and 32;
2. disregards the conditions attached to a classification pursuant to Section 7, Subsection 1 or approvals pursuant to Section 15, Subsection 1 or Section 21, Subsection 1; or
3. does not comply with orders or prohibitions issued in accordance with the provisions of the Executive Order.

Subsection 2. For violation of Section 7, Subsection 1, Section 15, Subsection 1, and Section 21, Subsection 1, a fine may be imposed on an employer, even if the violation cannot be attributed to them as intentional or negligent. There shall be no alternative sentence imposable in lieu of a fine. It is a condition of the fine that the violation can be attributed to one or more persons associated with the company or the company as such.

Subsection 3. Companies etc. (legal persons) may be charged with criminal liability according to the rules in Chapter 5 of the Danish Penal Code.

Chapter 10 – Entry into Force and Transitional Provisions

Section 38. The Executive Order shall enter into force on 17 September 2008.

Subsection 2. At the same time, Executive Order No. 642 of 28 June 2001 on Genetic Engineering and the Working Environment shall be repealed.

Section 39. Classifications, approvals and exemptions granted by the Director of the Danish Working Environment Authority prior to 17 September 2008 remain valid, subject to Section 19, Subsection 1, Section 25, Subsection 1 and Section 30.

Subsection 2. In the event of significant changes to information in connection with classifications, approvals or exemptions granted by the Director of the Danish Working Environment Authority pursuant to the Danish Ministry of Labour's Executive Orders No. 578 of 1 September 1987 or No. 684 of 11 October 1991 on Genetic Engineering and Working Environment as amended by Executive Order No. 705 of 22 July 1996, a new notification must be made in accordance with the provisions of this Executive Order.

Subsection 3. Previously announced classifications of facilities for large-scale testing and production in Group 1 also apply to facilities for large-scale testing and production in Class 1 once this Executive Order enters into force.

Note: The Executive Order contains provisions that implement Council Directive 90/219 EEC, Official Journal 1990 L 117 p. 1 as amended by Council Directive 98/81/EC, Official Journal 1998 L 330 p. 13.