French Biotech Withdraws US Application for its Living Biocide 

The US Environment Protection Agency (EPA) has stated it cannot grant registration to a biocide developed by Lyon-based company Amoéba for water treatment in cooling towers. Amoéba’s shares on Euronext Paris went down by 30% on Tuesday following the announcement.

The biocide treatment consists of a live strain of amoeba called Willaertia magna C2c Maky. This microorganism is able to kill pathogenic bacteria by ingesting them. 

“There is a need for new products for water treatment of cooling towers, where there are pathogens like Legionella. Current treatments are all chemicals and come with big drawbacks in terms of corrosion and environmental impact,” Fabrice Plasson, CEO of Amoéba, told me.   

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While the US EPA has not determined the product is dangerous for human health or the environment, the agency has stated that the standards for registration were not met. According to Plasson, one of the concerns was the possibility that some of the pathogenic bacteria might stay hidden within the amoeba without being digested. 

To address this, Amoéba changed the way the study and the data were structured. However, this happened too late in the process for the EPA to accept it. In response, the company has decided to withdraw the application and submit a new one early next year.

“The most logical choice is to withdraw our dossier and submit a new one with this new format of data,” explained Plasson. The review process typically takes 18 months, though Plasson hopes it could be shorter given that the EPA has previously reviewed most of the data.  

Amoéba already used this new format to submit an application to the European Union in July this year. The review process will take at least 12 months, after which the product would be first used in Malta for another year before it can be sold across all European countries. 

Currently, there are only two products available in Europe for water treatment in cooling towers. One is chlorine, which is also used in swimming pools. The other, monochloramine, is a similar but more aggressive product. A third class of chemicals called isothiozolones was banned by the EU in 2016 because it was found to be toxic to humans and the environment. 

“To give you an idea, chloride was made during the First World War. Monochloramine is from 1954. They are very old products,” remarked Plasson. 

While the EPA decision will delay the expected approval of its biocide in the US, other applications of the product that Amoéba is developing have not been affected. The company recently tested the use of its biocide as a fungicide to protect crops from infections.

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