Emergency plan according to the GenTNotfV and the BioStoffV

In genetic engineering law, the preparation of an emergency plan is regulated in Section 30 Paragraph 2 No. 16 of the Genetic Engineering Act (GenTG). This authorizes the federal government to determine the competent authority in the event of an accident in a genetic engineering facility based on documents to be provided by the operator, to prepare external emergency plans, to coordinate their preparation and implementation with the competent authorities of the Member States of the European Union and the other contracting states to the Agreement on the European Economic Area that may be affected by an accident, and to inform the public about safety measures. The operator can be required by the regulation to report the circumstances of the accident and the measures taken by the operator to the competent authority. The Genetic Engineering Emergency Ordinance (GenTNotfV) was enacted on this basis. The emergency plan is regulated in Section 3 of the GenTNotfV. This is an external emergency plan for cases in which an accident has occurred. An accident is any occurrence that results in a significant escape of GMOs from the genetic engineering facility that was not intended by the operator and that could lead to a danger to the protected legal interests (Section 2 GenTNotfV).
The emergency plan regulates official cooperation outside the facility in the event of a risk of infection with human-pathogenic GMOs of risk groups 3 and 4 in approved genetic engineering facilities of safety levels 3 and 4. The emergency plan serves as a basis and guideline for the responsible authorities and institutions to ensure rapid and effective responses to emergencies. It specifies the measures necessary to manage accidents involving GMOs and to protect the legal interests listed in Section 1 of the GenTG. The authorities are responsible for the preparation and continuation/updating of this emergency plan, as well as for ensuring compliance. The authorities are also responsible for the technical implementation of this emergency plan; this may be the local health authority.

Under the BioStoffV, an internal emergency plan must be drawn up to avert hazards in activities at protection level 3 or 4 in laboratories, animal husbandry, biotechnology, and at protection level 4 in healthcare facilities. Activities involving biological agents in risk group 3** are exempt from this. For activities at protection level 4, the plan must contain information on the scope of necessary safety drills and their regular implementation, provided these are required as a result of the risk assessment. The plan and the measures must be coordinated with the responsible rescue and safety services. Functional warning and communication systems for employees to alert the services must be established. Before activities begin, a procedure for accident reporting and investigations for serious accidents and needlestick injuries must be established, identifying possible organizational and technical causes of accidents to avoid individual blame. Employees must be informed immediately of operational disruptions and accidents if their safety or health is at risk.

The employer is responsible for drawing up the internal emergency plan. This is because the BioStoffV is a regulation governing internal occupational health and safety, and employers are responsible for ensuring occupational health and safety.

This publication can also be found on the website of the law firm Dr. Kauch .