It is the EPA and the Danish Working Environment Authority who are responsible for approving production with GMOs. The EPA will, in cooperation with the local municipalities look into the environmental aspects of the application. Whereas the Danish Working Environment Authority look into the working environment related aspects of the application. Each authority must receive an application and each issue an approval.
Regulation
The EPA administrates the environmental regulation regarding contained use of genetically modified organisms (GMOs) in research, production and transport.
Application Guide for Production
The meaning of "Production with GMO" is that the production has a commercial purpose. An example is the use of a genetically modified bacteria used to produce enzymes which can be applied as detergents or foodstuffs. It could also be cultivation of plants which produce a growth factor which can be purified and used in medication. Common for the two different productions is that both productions must be risk assessed and approved before they can start-up.
The EPA have worked out an application form for approval of production with and of GMOs.
Approval of production with and of GMOs
And an application form for application of a new production in already approved production facilities.
New production in already approved production facilities
Risk Assessment
If there are any risks to the surrounding environment associated to the production with GMO, an emergency response plan has to be made for the emergency services to be aware of the hazards and informed thereof in writing. A risk assessment must be attached to the application for approval. The EPA have worked out a form for the risk assessment.
Criteria for Classification
Contained use of production with GMOs (e.g. microorganisms or cell-cultures) are classified into four risks groups depending on the risks associated to the activity.
Production with genetically modified animals or plants are divided into either risk group animals or risk group plants.
Emergency Plan
An emergency plan has to be for the protection of human health and the environment outside the installation in the event of an accident and the emergency services to be aware of the hazards and informed thereof in writing.
Inspection
The EPA has supervisory duties of the facilities in regard to:
- General provision in the law of environment and gene technology.
Prerequisites for terms of approvals of the law.
- Compliance of injunctions and prohibitions of the law
Procedural Service Charge
When the EPA works on approvals and inspections in relation to contained use of GMO a fee is charged.