Results of the REBECA Policy Support Action

IOBC/WPRS Alés 2007Regulation of Microbial Agents inEurope: Results of the REBECAPolicy Support ActionRalf-Udo Ehlersehlers@biotec.uni-kiel.de1

REBECA 2006+2007Why REBECA ?To provide environmentally safe,sustainable and cost-effectivecontrolproducts to EU agricultureTo produce more residue-freefoodTo promote SMEs2

REBECA StakeholderRegulators: We are hired to regulate, not to havevisions on innovative BCA regulationSANCO: Innovative new regulation. But were BCAsconsidered in the proposal?Academia Weed Control: We follow the highest ethicalstandards in our risk assessment. Realistic or lack ofunderstanding?Companies with registered products: We have done it,you can also do it!Small SMEs: : No expertise3

Some stories going onLIDL-Relation toSuppliers:„For all fresh fruit andvegetables we accept only1/3 of the allowablemaximum residue levelsaccording to German law “4

Growers under pressure• Pesticide resistance: Many pests, like white flies and thrips,have developed resistance against all available insecticides• Growers spray every two days without much effect on pest,but phytotoxic effects and extinction of natural enemies• Major problems to meet levels requested by retailers5

What about this guy ? Wouldn´t he prefer therisk related with biocontrol agents?6

How many tones of illegal pesticides areconfiscated every year in the EU ?7

EconomicsVolume doubled to2% of PPPsB. thuringiensis from 95%to 25%Now 55% IBCAs, with10%-20% yearly increase> 90 antagonist speciesmarketed, 40% exoticsMicrobials of lessimportance – consequenceof regulation?8

Growers damand BCABiocontrol Market1985 to 2004Problems with insecticide resistance and residues increaseBut hardly any BCAs on the marketWe need accelerated regulation to produce completeportofolios for each crop, integrating chemicalsThat is my understanding of IPM9

General problems with regulation• Unpredictable: guidelines and proposals for waivers ondata requirements are not binding, a newcomer can askfor the complete data package• No harmonisation on procedures, countries have theirown interpretation, mutual recognition???• Guidelines not set up for BCAs• Requirements not appropriate for micro-organisms• Regulation authorities have little or no experience go for precautionary principle• High fees, time consuming• Major obstacle: two level registrations - active substanceat EU and PPP in all member states10

History of Regulation: A long story of failures• Pesticide regulation has gradually become more stringent• Development in close interaction with multinationalagrochemical companies• Regulation based on scientific reports of damages• DDT – Data requirements on persistence• OPAs – Due to impact on non-targets now banned• Pesticide regulation and its failures were among mainstimuli for the emergence of the Precautionay Principle11

History of Biocontrol Regulation• Regulation was not a gradual evolution involving industry• Regulation was not based on scientific reports of damages• BCAs have no evolution of regulation rules• Rules for chemical pesticides were copied and pasted• More adapted and more balanced approaches were (andcurrently are) rolled back with the introduction of 91/414• What was the motivation to just use rules developed forchemical control agents on BCAs?• Which pressure groups have been successful implementingexaggerating regulation and thus managed to stop thedevelopment of safe control measures?12

The Precautionary Principle• Rio Declaration: “in order to protect the environment, theprecautionary approach shall be widely applied. Where thereare threats of serious or irreversible damage, lack of fullscientific certainty shall not be used as a reason forpostponing cost-effective measures to prevent environmentaldegradation”• The COM considers that the EU has the right to establish thelevel of protection –particularly of the environment, human,animal and plant health, - that it deems appropriate• (Communication of the COM on the PP (COM2000/1)13

The Precautionary Principle• Where the levels of uncertainty are high, where potentialimpacts are very large, and/or where those impacts may beirreversible, there are grounds for adopting a precautionaryapproach until such time as we have sufficient scientificknowledge to make a risk-based decision. (Communication ofthe COM on the PP (COM2000/1)• Does this apply to biological control?• EU and MS regulatory approach is now the PP: We have toconsider any possible risk• But they do not comply with EU COM rules !!!14

COMMISSION COMMUNICATION ON THEPRECAUTIONARY PRINCIPLE (COM(2000)1• PP is relevant only in the event of a potential risk• Before invoked, scientific data relevant to the risks must first beevaluated. However, one factor logically and chronologically precedes thisevaluation, namely identification of the potentially negative effects of aphenomenon.• Scientific evaluation of the potential adverse effects should be undertakenbased on the available data when considering whether measures arenecessary• These general principles include:- proportionality- non discrimination- consistency- examination of the benefits and costs of action or lack of action- examination of scientific developments15

Registration keeps safe products off the market• Dir91/414: Time consuming (8 years)• National registration has to follow (2 years)• High costs (> than 2 million €)• Knowledge resources required• BCAs are specific – market is small• Market size does not always provide return of investment• Registration is a blackbox: no investment• Barrier of entry for SMEs• BCAs sit on the shelf of the scientists• Technical progress is not introduced into the market• BCAs suffer from introduction of PP• Regulation serves as a justification for disguised protectionism• Political agenda (EU CAP and pesticide reductionprogramme) not achieved16

Political objectives:• Authorities should not regulate trivial risks• We need less and not more regulation (OECD)• We need Cost-Benefit-Analysis of Regulation and Risk-Tradeoff-Analysis prior to introduction of new regulations• Weigh costs of regulation - benefits and tradeoffs• Then develop balanced regulation rules• REBECA is calling for public-private partnership to developinnovative balanced approaches for regulation of BCAs17

Achievements:Initiate discussion in the EU and connect stakeholdersBiocontrol is now highly political (SANCO and Head of DGResearch at medium term report meeting in Brussels)EU parliament considering to stop new regulation if notmore emphasis is given to biocontrol situationComparison of EU and Non-EU regulationProposal to put baculoviruses on Annex 1Statement on contamination levelsDiscussion paper on „relevant“ metabolites„Lesson learn exercise“ from list 4 processProposals for innovative regulation approach18

Final Meeting Brussels SAS Radission HotelSeptember 20 + 21, 2007Register now: www.rebeca-net.deThanks for your attention19

www.rebeca-net.deYou find lots ofinformationincluding this talk20