Chapter 4 Implementation of the Act. Enforcement provisions
§ 12 Relationship to the Freedom of Information Act
The Freedom of Information Act applies to cases that are dealt with under the present Act. Notwithstanding the duty of secrecy, the following information shall, however, always be public, unless it comes within the scope of section 6, subsection 1, of the Freedom of Information Act:
- the description of the genetically modified organism, the user's name and address, the purpose of the use and the location of use
- methods and plans for monitoring and emergency response
- assessments of foreseeable effects.
§ 13 Public consultation
In cases where approval is required under the present Act, the competent authority may decide that a public consultation is to be held. The processing of applications for the deliberate release of genetically modified organisms shall always include public consultation. The public consultation shall be held well before a decision is made. It must be carried out in a way that ensures that the general public, and particularly interest groups who will be affected, are given access to relevant information and a real opportunity to make their opinions known. A decision to hold a public consultation shall be published.
§ 14 Labelling requirement
The King may issue regulations relating to the labelling of products that consist of or contain genetically modified organisms or products from cloned animals.
§ 15 Conditions laid down in approval
Conditions may be laid down in approval granted pursuant to sections 6, second paragraph, 7, or 10, or in an exemption granted pursuant to section 11b. These may include conditions relating to the choice of the technical procedures and other factor inputs that are best on the basis of health and environmental considerations, a duty to take out insurance or provide security for liability pursuant to sections 21 and 23, and measures for preventing and limiting possible adverse effects. Approval may be granted for a limited period of time.
§ 16 Alteration and withdrawal of approval
The conditions attached to an approval may be altered by the King, and if necessary the approval may be withdrawn if:
- the risk to health or the environment posed by the use in question proves to be greater than was foreseen when the use was approved, or
- new technology makes it possible to reduce the risk of adverse effects on health or the environment, or
- this otherwise follows from the rules for reversing decisions that are currently in force.
§ 17 Control and internal control systems
The King will decide which instance shall be responsible for ensuring compliance with this Act and any decisions made pursuant thereto.
The King may issue regulations relating to internal control and internal control systems to ensure compliance with requirements laid down in or pursuant to this Act.
§ 18 Right of inspection
The supervisory authority may inspect any place where activities that come within the scope of this Act are being carried out.. The supervisory authority may require documents and other material that may be of importance for the exercise of its duties pursuant to this Act to be submitted for its inspection.
§ 19 Duty to provide information
Any person that carries out activities that come within the scope of this Act has a duty on orders from the supervisory authority and notwithstanding any duty of secrecy, to provide the supervisory authority with any necessary information to enable it to carry out its duties pursuant to this Act. Information may also be required from other public authorities, notwithstanding any duty of secrecy that otherwise applies.
The supervisory authority shall be notified immediately in the event of an accident or other unforeseen circumstances that arise during the production and use of genetically modified organisms.
§ 20 Order to stop activities
The supervisory authority may give orders for any activity that is in conflict with the Act or any decision made pursuant thereto to be stopped immediately. The same applies if the production and use of genetically modified organisms pursuant to the Act or decisions made pursuant thereto prove to pose a risk of adverse effects on health or the environment. If necessary, an order to stop an activity may be implemented with the assistance of the police.
§ 21 Duty to avoid or limit damage
If genetically modified organisms have entered the environment in conflict with the Act or decisions pursuant thereto, the person responsible for the activity shall take reasonable measures to avoid or limit damage and nuisance. The same applies if the genetically modified organisms have been deliberately released into the environment in accordance with decisions pursuant to this Act, and their use proves to involve a greater risk to health or the environment than foreseen when the use was approved. The supervisory authority may order the person responsible to retrieve or take other measures to control the organisms within a specified time limit, including measures to restore the environment to its initial state as far as possible. Measures pursuant to this provision may also be implemented on another person's property.
If orders given pursuant to the first paragraph are not carried out within the time limit specified, the supervisory authority may arrange for the measures to be implemented at the expense of the person responsible. The same applies if giving an order pursuant to the first paragraph may mean that implementation of the necessary measures is delayed. The expenses incurred by the supervisory authority are enforceable by execution proceedings.
§ 22 Fees
The King may issue regulations relating to fees for processing applications for approval pursuant to this Act or regulations laid down pursuant thereto, and relating to supervisory measures implemented to ensure compliance with the Act or decisions pursuant thereto. Fees are enforceable by execution proceedings.
§ 23 Compensation
Any person responsible for activities pursuant to the present Act is liable to pay compensation regardless of any fault on his part if his activities cause damage, nuisance or loss through the deliberate or unintended release of genetically modified organisms into the environment.
Moreover, the provisions of Chapter 8 of the Pollution Control Act concerning compensation for pollution damage apply insofar as they are appropriate. The supervisory authority pursuant to the present Act takes the place of the pollution control authority pursuant to section 58 of the Pollution Control Act. The instance authorised to grant approval pursuant to the present Act takes the place of the pollution control authority pursuant to section 63, second and third paragraphs, of the Pollution Control Act.
§ 24 Coercive fines
In the event of contravention of conditions, orders or prohibitions issued pursuant to this Act, the King may impose a coercive fine that continues to be effective for as long as the contravention continues. A coercive fine is enforceable by execution proceedings.
§ 25 Penal measures
Any person who wilfully or through negligence contravenes provisions set out in or issued pursuant to this Act or decisions made pursuant to the said provisions is liable to fines or imprisonment for a term not exceeding one year.
If there are especially aggravating circumstances, imprisonment for a term not exceeding four years may be imposed.
An attempt to commit such an offences or aiding and abetting therein are subject to a penalty. Contravention of the first paragraph is considered to be a misdemeanour.