Criteria for classifying GMOs into risk groups

The following summarizes the criteria for classifying biological agents into four risk groups according to their risk potential, somewhat more differentiated than those outlined in the GenTSV or the Biological Agents Ordinance. The classification of these groups is based on the classification scheme primarily proposed by the World Health Organization (WHO) and has been adopted as a summary by European and German legislation.

Criteria for classifying biological agents into risk groups 1:

• no known diseases documented in humans
• Humans (animals) are unsuitable as growth media
• or pathogenicity has been lost through mutation

Criteria for classifying biological agents into risk groups 2:

• harmless diseases are possible or serious diseases occur only rarely despite constant contact with humans
• Special transmission routes are necessary for infection
• a high infectious dose is essential to trigger disease
• an efficient prophylaxis option and treatability are the rule
• spread in the population is unlikely (high immunity, etc.)

Criteria for classifying biological agents into risk groups 3:

• serious illnesses are possible
• Infections can also be transmitted by air
• difficult treatment option
• low infectious dose
• rapid progression of the disease
• also fatal diseases with specific routes of infection
• the risk of spread in the population is present, but can usually be limited

Criteria for classifying biological agents into risk groups 4:

• fatal diseases are possible
• after infection, no effective therapy is possible
• high virulence
• high contagiousness
• high manifestation index (probability of becoming ill after infection)
• rapid transmission through air, insects or direct skin or mucous membrane contact with infected persons
• the risk of spread in the population is high