Plant Protection Products
Risk assessment of the biological plant protection product Serenade ASO, with the organism Bacillus subtilis QST 713
Report no: 2016: 21
The Norwegian Scientific Committee for Food Safety (VKM) has on request by the Norwegian Food Safety Authority (NFSA) conducted a health and environmental risk assessment of the use of the bacterium Bacillus subtilis as a pesticide. VKM shares the opinion of the European Food Safety Authority (EFSA), in that the bacterium is a benign organism that does not cause disease in humans, animals or plants.
Bacillus subtilus QST713 is the active ingredient in the new plant protection product, Serenade ASO. Serenade ASO is applied for approval in Norway. The intended use is as biological fungicide in strawberry in greenhouse and plastic tunnels, carrot in field, lettuce in field and tomato, pepper, aubergine in greenhouse.
It is the opinion of EFSA and the US Environmental Protection Agency that Bacillus subtilis is a benign organism. The organism does not possess traits that cause disease. EFSA and the US Environmental Protection Agency considers that the bacterium is not pathogenic or toxic to humans, animals or plants. VKM has analyzed available test data for the bacterial strain Bacillus subtilis QST713 and VKM shares the opinion.
Important Product Control
The possible risk related to Bacillus subtilis is that the bacterium may be confused with a toxic variant of another Bacillus strain, for example Bacillus anthracis or Bacillus cereus. VKM emphasizes the importance of product control, to ensure and document the identity, purity and relevant content and property of each product batch prior to marketing and use.
Bacillus subtilis is not known to produce toxins, but it produces proteolytic enzymes. Inhalation studies show that proteolytic enzymes can cause irritation and allergic reactions in the airways. Thus, proper preventive equipment should be used.
VKM’s Panel on Plant Protection Products has approved the risk assessment.