SANCO/10159PPP Regulation rev.0 06.04.2005

Dear Sir,
as chairman of COST Action 850 "Biocontrol Symbiosis", a European network organizing the scientific cooperation in the field of nematode use for biological plant protection, I would like to express our sincere opposition to the attempts of the EU SANCO to regulate the use of nematodes in plant protection under Directive 91/414. In the draft amendment of the Directive it is mentioned: "For the purposes of this regulation, nematodes used in or as plant protection products will be assimilated to micro-organisms". We would like to object to this decision and ask to remove the sentence from the draft proposal.

The activities of COST Action 850 and preceeding Action 819 "Entomopathogenic Nematodes" have included evaluattions of potential risks related with the use of nematodes in plant protection. In 1995 a committee of the Organisation for Economic Cooperation and Development (OECD), Cooperative Research Programme “Biological Resource Management for Sustainable Agriculture Systems” and the European Cooperation in the Field of Science and Technical Research (COST), Action 819 “Entomopathogenic Nematodes” discussed potential risks related with the use of entomopathogenic nematodes (EPN) in biological control. The conclusions and results of the risk assessment of the committee members were as follows (Ehlers and Hokkanen,1996):
 
1. The use of EPN is safe for the user and the environment.
2. Biocontrol nematodes are certainly more specific and are less of a threat to the environment than chemical insecticides.
3. EPN cause no detrimental effect to mammals or plants.
4. The expert group could not identify any risk for the general public related to the use of EPN.
5. A remote risk was identified for production and application personnel. Due to unprofessional production procedures, contaminating micro-organisms (this does not include the symbionts) might be present in nematode products which could cause some harm. A slight risk exists that production personnel develops an allergic reaction against antigens originating from nematode-bacterium material.
6. Long-term effects on non-target organisms (NTOs) or other environmental impacts following the application of indigenous or exotic EPN have not been reported.
7. The possible short-term environmental risks of using EPN were discussed and rated. The list of rating refers to the likelihood of any adverse impact occurring, while, for all cases, the magnitude of any hazard was estimated to be practically zero.

In 2002 members of the Management Committee of the COST Action 850 “Biocontrol Symbiosis”, supported the conclusions and recommendations summarized by Ehlers and Hokkanen (Biocontrol Science and Technology 6, 1996) in all points.
 
I have the impression that we are dealing with a misunderstanding. It might have been considered that the symbiotic bacteria of entomopathogenic nematodes are the control agent rather than the animal. Entomopathogenic nematodes are symbiotically associated with entomopathogenic bacteria of the genera Xenorhabdus and Photorhabdus. Each of the free-living stages of the nematodes carry few cells of these symbionts in their gut and release them into the blood of their host insects after invasion. The role of the bacteria is to overcome the insects´s immune system and support establishment of the nematode. The bacteria also supply food for the reproduction of the nematodes. Tests with the symbiotic bacteria have shown that they cause no harm to homoiothermic species. In nature nematodes without their symbiotic bacteria can kill the insect. The association with the bacteria only accelerate the killing. In contrast, the symbiotic bacteria could never survive and infect an insect host without the nematode. Thus they are symbionts rather than single-standing pathogenic micro-organismsm. The user never gets into contact with these bacteria as they are inside the nematodes´s gut. For the simple reason that the nematodes are animals and function as such, we cannot identify any reason why they should now be considered to be assimilated to micro-organisms.

All animals carry bacterial symbionts, including humans. Aphids have bacteria of the genus Buchneria. Many insects and also nematodes are associated with bacteria of the genus Wolbachia. Parasitic wasp carry symbiotic viruses which are released during egg laying into the insect host. These viruses block the immune response of the insect host and thus enable successful establishment of the parasite. Would we now cover parasitic wasps under Directive 91/414 as well?

The scientific community is not against regulation. If risks are identified, risks assessment procedures must be implemented to manage possible hazards. Possible risks scientists identified with the use of nematodes are those related with the introduction of exotic species and their possible impact on non-target organisms. The risks of damage were classified as being remote, however, regulation was recommended. In the USA the EPA has exempted nematodes from registration requirements. But the import of exotic species is regulated by the USDA APHIS organization. But by no means have scientists ever thought that these possible risks to the environment would justify a registration process following rules developed for micro-organisms.

We would like to recommend a precise analysis of the risk related with the use of nematodes and are confident that afterwards SANCO will share our view on the risks of nematodes. This analysis should include an evaluation of possible tradeoff effects for farmers, industry and the environment. Prior to inclusion into the Directive 91/414 we should try to identify the benefits for society related with an introduction of  registration for nematodes. We should also ask the question whether the rules laid down for micro-organisms are the appropriate way of regulating nematodes. Governments should attempt to use effective and inexpensive tools for risk management. If we take costly steps to address all risks, however improbable or small they are, we will quickly impoverish ourselves. The search for cheaper and more effective tools to achieve the basic goal is of major importance and will produce creative solutions for risk assessment other than regulation following Directive 91/414. Markets are too small to justify costly production of dossiers. Our societies demand more biological control. To promote biological control costs related with regulation should be minimized and bureaucratic hurdles be avoided.

Scientists organized within COST 850 have been intensively working on the safety of nematodes for plant protection. A summary of the results is published on the internet page of COST Action 850: www.cost850.ch (click upper right corner "legal & safety). All of my colleagues in the Action 850 will be more than happy to help with information should further question arise. Please do not hesitate to contact me for inquiries.

Yours sincerely,

Prof. Dr. Ralf-Udo Ehlers
Institute for Phytopathology
Christian-Albrechts-University
Dept. Biotechnology & Biol. Control
Klausdorfer Str. 28-36
24223 Raisdorf, Germany

Tel.: ..49-4307-839833
Fax.: ..49-4307-829514
E-Mail: ehlers(a)biotec.uni-kiel.de


Homepage: http://www.uni-kiel.de/phytomed/
COST Action 850 "Biocontrol Symbiosis": http://www.cost850.ch

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