Development of the UK Biopesticide Scheme Richard Davis Pesticides Safety Directorate Richard Davis Pesticides Safety Directorate

Overview Background imperative UK Pilot Project Challenges of the project Lessons learned Biopesticide scheme Continuing developments Background imperative UK Pilot Project Challenges of the project Lessons learned Biopesticide scheme Continuing developments

Background imperative Concern over the lack of alternative control options, especially biologicals. Market size Regulatory requirements and associated fees considered inhibitory to market development Concern over the lack of alternative control options, especially biologicals. Market size Regulatory requirements and associated fees considered inhibitory to market development

Political Objective Agency “Aims and Objectives” agreed with UK Ministers in spring 2003 –reduce the negative impact of pesticides by encouraging reductions in their use, taking account of best practice, and developing and introducing alternative control measures Agency “Aims and Objectives” agreed with UK Ministers in spring 2003 –reduce the negative impact of pesticides by encouraging reductions in their use, taking account of best practice, and developing and introducing alternative control measures

Pilot Project Pilot Project introduced June 2003 Aim to increase availability of biological pesticides in UK –Improve knowledge in PSD –Raise awareness of requirements and how to meet them –Pre- submission meetings –Reduced fees Pilot Project introduced June 2003 Aim to increase availability of biological pesticides in UK –Improve knowledge in PSD –Raise awareness of requirements and how to meet them –Pre- submission meetings –Reduced fees

Challenges Reaching out to non-traditional ‘customer’ –IBMA –Academic/research Support at early stages in development Fee structure and success rate dependent on quality of submission Reaching out to non-traditional ‘customer’ –IBMA –Academic/research Support at early stages in development Fee structure and success rate dependent on quality of submission

PSD’s Pilot Scheme success ‘Exosex CM’ - Codling moth pheromone ‘Curbit’ - ZYMV (Zucchini Yellow Mosaic Virus - weak strain) ‘Contans WG’ - Fungal agent for control of Sclerotinia Several pre-submission meetings held ‘Exosex CM’ - Codling moth pheromone ‘Curbit’ - ZYMV (Zucchini Yellow Mosaic Virus - weak strain) ‘Contans WG’ - Fungal agent for control of Sclerotinia Several pre-submission meetings held

Lessons learned Early pre-submission support and liaison with PSD is essential! –Establish contacts and build confidence –Applicants encouraged to provide good general information –Ensure awareness of regulatory process and data requirements at the outset –Use public domain data and relevant cases –Ensure arguments are consistent throughout –Encourage applicants to keep initial applications simple Early pre-submission support and liaison with PSD is essential! –Establish contacts and build confidence –Applicants encouraged to provide good general information –Ensure awareness of regulatory process and data requirements at the outset –Use public domain data and relevant cases –Ensure arguments are consistent throughout –Encourage applicants to keep initial applications simple

Biopesticide Scheme Launched on 1 st April 2006 Four categories: –Semiochemicals –Micro-organisms (bacteria, fungi, protozoa, virus) –natural plant extracts –‘other’ novel products on case by case basis Launched on 1 st April 2006 Four categories: –Semiochemicals –Micro-organisms (bacteria, fungi, protozoa, virus) –natural plant extracts –‘other’ novel products on case by case basis

Biopesticide Scheme Fees –£22,500 biological/plant extracts –£13,500 semiochemicals –plus £ 7,500 for EU consideration of brand new active to Europe (Annex I listing) Fees –£22,500 biological/plant extracts –£13,500 semiochemicals –plus £ 7,500 for EU consideration of brand new active to Europe (Annex I listing)

Biopesticide Scheme Free pre-submission support and advice –Early in product development –e.g. prior to efficacy trials programme Internal biopesticides group Assigned ‘Biopesticide Champion’ Free pre-submission support and advice –Early in product development –e.g. prior to efficacy trials programme Internal biopesticides group Assigned ‘Biopesticide Champion’

Continuing development Biopesticides - dedicated area on PSD website (link from home page) – Continuing to develop guidance Biopesticides seminar –“An introduction to the Biopesticides scheme” 28 March 2007, York Biopesticides - dedicated area on PSD website (link from home page) – Continuing to develop guidance Biopesticides seminar –“An introduction to the Biopesticides scheme” 28 March 2007, York

Continuing development Participation in “Rebeca Project” Collaboration with RELU project including specialist training Participation in “Rebeca Project” Collaboration with RELU project including specialist training

Working with RELU Biopesticides have presented a fantastic challenge to both regulators and those developing alternative control measures, working with the RELU team has helped people over that hurdle. Our Biopesticides scheme is now a pathfinder in Europe Biopesticides have presented a fantastic challenge to both regulators and those developing alternative control measures, working with the RELU team has helped people over that hurdle. Our Biopesticides scheme is now a pathfinder in Europe

Please come and discuss your biopesticide development programme with us