Development of the UK
Biopesticide Scheme
Richard Davis
Pesticides Safety Directorate
Overview
• 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
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
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
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
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
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
Biopesticide Scheme
• Launched on 1st 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)
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’
– Lisa.Moakes@psd.defra.gsi.gov.uk
Continuing development
• Biopesticides - dedicated area on PSD
website (link from home page)
– www.pesticides.gov.uk
• 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
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
Please come and discuss your
biopesticide development
programme with us