23 January 2023

IBMA Webinar “Bacillus thuringiensis: How to promote microorganisms & biocontrol avoiding unnecessary regulatory hurdles?”

On 23 January 2023, the International Biocontrol Manufacturers Association (IBMA) organised a webinar on Bacillus thuringiensis trying to answer the question about how to promote microorganisms & biocontrol avoiding unnecessary regulatory hurdles.

Ms Jennifer Lewis, IBMA Executive Director, stressed in her welcoming remarks how Bacillus thuringiensis as the most used microbial product worldwide is essential for the EU Green Deal. Indeed, Bacillus is used to produce residue-free fruits and vegetables across the world.

The event was moderated by Mr Pascal Michaux, Managing Partner of EU Focus Group. In his introductory remarks he contextualised Bacillus as a key tool to deliver the Green Deal by increasing organic agriculture while maintaining similar levels of production. “Without Bacillus thuringiensis ”, Michaux stressed, “it is an illusion to believe that the 25% objective of organic farming by 2023 will ever be close to reach”.

Microorganisms like Bacillus thuringiensis and other natural solutions are not considered under the draft Sustainable Use Regulation as chemical substances of products, thereby escaping the volume reduction targets for not posing risks to humans or to the environment. Michaux questioned the need for maximum residues limit (MRL) or pre-harvest interval (PHI) by showing the misleading character of accepting an unproven causality link between Bacillus thuringiensis and some slight foodborne sickness symptoms.

Indeed, the notion of acceptable risk leads to contradictory scenarios in which food production and consumption are presented as higher risk activities than flying, driving, or consuming tobacco and alcohol. “The selectivity in our risk tolerance is surprising and, in this case, contradictory”, stated Michaux.

The salience of discussing Bacillus thuringiensis today is precisely due to the inconsistent management of risks. On the one hand, promoting biocontrol and natural solutions constitute core policy goals. On the other, the regulatory framework suggests that natural solutions are equivalent to synthetic ones and thus their volumes should be reduced. In doing so, replacing a granular scientific assessment of risks with emotional decisions may compromise innovation within the EU and comparatively with other regions.

The panel discussion opened with Prof Ben Raymond, Professor at the University of Exeter. He presented Bacillus thuringiensis as “the safest and most successful microbial insecticide available to humanity” and responded to EFSA’s misleading suppositions. He concluded, with scientific arguments, that B. cereus group is genetically and ecologically heterogeneous and therefore not the same as Bacillus thuringiensis. Similarly, he showed that associating Bacillus thuringiensis with acute human infection is “misleading if not actually wrong”, that doses of 107-108 Bacillus thuringiensis spores are 2 asymptomatic for vertebrates, and that the study associating Bacillus thuringiensis with diarrhoea lacks a control group and does not constitute evidence of causation.

The substance was also presented by three corporations: Ms Karine Grosbeau from CBC Biogard, Ms Maria Herrero from Sumitomo Chemical/Valent Biosciences, and Mr Jose Carvalho from Certis USA. They introduced Bacillus thuringiensis as the most important insecticide for organic agriculture, essential for the Farm-to-Fork objectives. They also discussed the importance of defining “biological control” in the context of the Sustainable Use Regulation and how Bacillus thuringiensis represents an essential and sustainable biological plant protection product for sustainable.

Bacillus thuringiensis constitutes a low-risk natural solution that is indigenous and ubiquitous and does not tend to germinate or increase in the environment or on fresh produce. Bacillus thuringiensis tends to behave as a non-competitive microorganism, even under conditions when B. cereus will grow.

The applicants responded persuasively to the deceptive attempt to link Bacillus thuringiensis with foodborne outbreaks. In particular, they reminded the audience of the fact that no cereulide gene is present in any commercial Bacillus thuringiensis, with no conclusively proven diarrheal event from Bacillus thuringiensis applications after more than fifty years of use.

Finally, the company representatives showed how PHIs should only be required when toxicity is established, not based on speculative data that does not prove a scientific causality link. With a comparative approach across Member States, the applicants showed that unnecessary PHIs would affect and reduce the availability of fresh fruits and vegetables treated with biocontrol solutions.

Mr Frank Volk from Biofa AG shared concrete cases in which the Member States authorities disregarded scientific evidence out of fear for food security scandals. He quantified the huge loss of use of Bacillus thuringiensis after introducing a PHI for greenhouse production in Germany, forcing growers to replace Bacillus thuringiensis with synthetic plant protection products that are indeed not equivalent from the point of view of toxicity. Volk said that in shifting to conventional products, we are losing the residue-free added value of Bacillus thuringiensis as a natural solution. He also mentioned that soil specifications are more relevant than periods of application when it comes to identifying differences.

Mr Jeroen Meeusseun closed the conversation by presenting IBMA’s adamant position that “setting MRLs for Bacillus thuringiensis, and for microbials in general, is not appropriate”. Indeed, biocontrol products ensure a high level of protection of both human health and the environment and at the same time safeguard the competitiveness of Community agriculture, following Regulation (EC) No 1107/2009. Meeusseun stressed that commercial Bacillus thuringiensis strains should be exempted from MRL tolerances, as well as PHIs, because they would be “inappropriate and not scientifically justified, while they would create considerable negative consequences for EU farmers and particularly for organic agriculture”.

Did you miss our webinar? Check out the recording posted here.