PRODUCTION OF BIOCONTROL AGENTS USIG SOLID ... - REBECA

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PRODUCTION OF BIOCONTROL AGENTS USIG SOLID ... - REBECA

Structure of BCA markets and the burdenof regulation for a SMEPeter Lüth


Presentation• The Company• Structure of the BCA market• Burden of regulation


The Company


Sterilising of the fermenter121 °C20 minvacuumtechnology


Incubation of the fermenter


Formulation of the final productCONTANS ® WG(1 x 10 9 conidia per gram)


Contans ® WGActive ingredient: Coniothyrium minitansWater dispersible granuleCarrier: Glucose1 x 10 9 living conidia per gram productRate: 2 – 8 kg per hectareShelf life: 24 months at +4 °C and 5 yearsat –18 °CApplicable to control: Sclerotiniasclerotiorum on oilseed rape, sunflower,lettuce, beans and other cropsThe product is manufactured on a purebiological basis.


Registration obtainedStatus of RegistrationEuropean UnionUSA(Annex I listed)(US EPA registered)GermanyFranceItalyPoland (ornamentals + vegetables)AustriaCzech RepublicSwedenSwitzerlandDenmarkThe NetherlandsMexicoSpainBelgiumLuxembourgSpainUKRegistration expectedJapan (2007)Canada (2007)


BioAct ® WPActive ingredient: Paecilomyces lilacinusWettable powderCarrier: dried skimmed milk powder1 x 10 11 living conidia per gram productRate: 0.02 gram per plant, but not morethan 0.4 kg per hectareShelf life: 12 months at +4 °C and 24months at –18 °CApplicable to control: Root-knotnematodes, lesion nematodes, burrowingnematodes, citrus nematodesand othersThe product is manufactured on a purebiological basis.


Status of RegistrationThe product is currently registered in:•USA•Bulgaria• The Philippines• New Caledonia• Italy (provisional)•Mexico• Turkey• Macedonia


Key FiguresNumber of employees: 17Number of products:2 (but 1 not registered yet)Balance sheet total: 2.20 million €Annual turnover: 1.60 million €Annual profit: 0.00 million €Annual interests to be paid: 0.15 million €Annual depreciations: 0.21 million €Sold product:120,000 kg


Structure of the BCA marketIs there a specific BCA market?Is the market more national or international?How is the market organised?


High price marketDevelopment andRegistration costsProduct for the highprice segmentSmall production plantwhich causes high costsWill there be aprofit or not?Small but highvalue market toget the money backGreenhouse andorganic market


Low price marketDevelopment andRegistration costsAffordable product(low price)Big production plant toproduce the product ascheap as possibleWill there be aprofit or not?Big marketto get themoney backMarket for conventionalproducts


RequirementsIf the BCA get distributed into the conventionalmarket they must be:• as effective as the chemical products• as applicable as the chemical products• as cheap as the chemical productsNevertheless, we will never be able to sell as much as thechemical industry.Biocontrol companies have an additional problem:The reputation of our products is not good enough.


The current market for Contans WGWith only 1 % sold into the organic market.


Market organisationPriceNational distributor 33 %Sub-distributor 56 %Retailer 80 %Grower 100 %


Structure of the BCA marketIs there a specific BCA market?Yes, but companies must decide whether thismarket is big enough or not.Is the market more national or international?Companies by all means must concentrate onboth. Otherwise they never will get their moneyback.How is the market organised?Different levels (up to three) which all demand amargin. final price 300 %


The burden of registrationin the EUIn Cuba there are yearly close to 1,000,000 ha treated withbeneficials or BCA’s.Registered microbial plant protection agents:• Metarhizium anisopliae• Beauveria bassiana• Verticillium lecanii• Paecilomyces fumosoroseus• Trichoderma viride• Bacillus thuringiensis


Registration of BCA’s in the USAUSAEUContans WG 23 months 64 monthsBioAct WG21 monthsnot yet after54 months


Costs of the registration (€)Toxicology studies• acute oral tox 2000• acute inhalative tox / acute pulmonary tox 9200• acute dermal tox 2000• intraperitonial tox 15000• eye irritation 1100• skin irritation 1100• skin sensitization 4000• genotoxicity on S. typhimirium 380036,400


Costs of the registration (€)Ecotoxicology Studies• rainbow trout 3500• Daphnia magny 3800• Desmodesmus subspicatus 3500• earthworm (Eisenia fetida) 2500• Aphidius rhopalosiphi 5000• Typhhlodromus pyri 5000• Poecilus cupreus 5000• Aleochara bilineata 5000• soil micro-flora 600039,300


Costs of the registration (€)Other costs• 5 batch analysis 2000• influence of the temperature on microbial growth 2000• physical-chemical studies 31,400• preparation of the Annex I dossier 60,000• fee for the introduction in Annex I 0.00 - 42,000• efficacy test on 4 crops in 3 European regions 48,000• preparation of the Biological assessment dossier 6,000• preparation of 10 national dossiers 20,000• national registration fees in 10 countries 40,000209,400 - 251,400


Registration costs for a microbial BCAin the EU300,000 € - 350,000 €Costs which have to be spent additionally.


MicroorganismsConiothyrium minitans Paecilomyces lilacinus Gliocladium catenulatum• fungi are adapted to there hosts (co-evolution)


Nobody assumes that powdery mildew on wheat or a ruston wheat can cause any human diseases.It is simply unscientific!But, if I should intend to use such plant pathogens asbiological herbicides they had to go through all thedemanded toxicity/pathogenicity tests.Why?Because, the people who set the rules were not scientists(at least they didn’t deal scientifically), maybe they werechemists, but certainly not micro-biologists.


MicroorganismsConiothyrium minitans Paecilomyces lilacinus Gliocladium catenulatum• fungi are adapted to there hosts (co-evolution)• fungi are producing a very specific enzyme cutlery• fungi are terrestrial not aquatic


Costs of the registration (€)Toxicology studies• acute oral tox 2000• acute inhalative tox / acute pulmonary tox 9200• acute dermal tox 2000• intraperitonial tox 15000• eye irritation 1100• skin irritation 1100• skin sensitization 4000• genotoxicity on S. typhimirium 380036,400


Amatoxin (toxin of the death cup, Amanita phalloides)LD50 200 – 500 µg/kg mouse• 1000 g of ContansWG contain 53 g fungal biomass• assuming the biomass consists of 500 ppm of a toxic metabolite26.5 mg• further assumed the metabolite is as toxic as amatoxinA small person (50 kg) had to eat 350 g to 900 g of theproduct to reach the LD 50 level.But, nobody, not even accidentally, would even eat only 10 g of apesticide unless he intends to commit suicide.Why do we need the oral toxicity study?


Costs of the registration (€)Ecotoxicology Studies• rainbow trout 3500• Daphnia magny 3800• Desmodesmus subspicatus 3500• earthworm (Eisenia fetida) 2500• Aphidius rhopalosiphi 5000• Typhhlodromus pyri 5000• Poecilus cupreus 5000• Aleochara bilineata 5000• soil micro-flora 600039,300


Small pond: 10 m x 10 m x 1 m (100.000 litres)• assumed 2000 litres spraying solution with 40 kg (maximumrate) product (ContansWG) get into the pond• further assumed the fungal biomass consists of 500 ppm of atoxic compound40,000 g x 0.056 x 500 ppm = 1.12 g in 100,000 Liter11.2 µg/litre bound to the biomass (not dissolved in the water)Maximum acceptable level in food according to the German Food Law• aflotoxin B1• mixture of Aflatoxin B1, B2, G1, G2• patulin• zearalenon• deoxynivalenol2 µg/kg4 µg/kg25 µg/kg50 µ/kg500 µg/kg


Do we need this kind of registrationfor microbial BCA’s at all?


If there wouldn’t the the hurdle created bythe registration Prophyta would have atleast 3 more products in its portfolio:- Trichoderma- Beauveria- Metarrhizium. . . Which could replace some more orless hazardous synthetic pesticides.


Thank You

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