Key issues in biopesticide
regulation
Pesticides Safety Directorate
19 June 2007
Challenges
• Reaching out to non-traditional ‘customer’
– International Biological Manufacturers Association
(IBMA)
– Academic/research
• Support at early stages in development
• Fee structure and success rate dependent on
quality of submission
• Applicants understanding of regulatory ‘world’
Lessons learned from pilot scheme
• Awareness of regulatory process and data
requirements at the outset. e.g. GLP, GEP
• Establish contacts (Confidence)
• Pre-submission support and liaison with PSD
• Use public domain data and appropriate cases
– explain relevance
• Ensure arguments are consistent across
specialist areas
Preliminary Data/Supporting Evidence
• Laboratory/glasshouse studies
• Public domain (published papers)
– Mode of action, biological properties,
Reasoned cases, host specificity, natural
occurrence, identity (strain)
– Relevance
• Support all areas of risk assessment
Common areas for risk assessment
• Efficacy (biology specialists) can take lead
• Common issues in risk assessment
– Is it toxic ?
– Does it produce any toxins ?
– Can it infect humans ?
– Host specificity ?
– Will it infect native wild species (plants/organisms)?
– What happens to the virus/micro-organism in the
environment ?
– How do applied levels/populations compare to
natural ?
Efficacy issues
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More specific/unique mode of action
Variation in performance
Levels of control
Temperature/humidity/rainfall effects
Plot size/ trial design
Impact of application equipment
Use in conjunction with other pesticides
Pesticide Chemistry
• Identity –
– To strain/isolate level
– methods of analysis often non-conventional and these
need to be validated
– Demonstrate appropriateness and reliability
• Microbial contaminants?
• Residues data are required only where reasoned
cases cannot exclude the possibilities of residues
concern. Cases need to be robust
Mammalian Toxicology
• Substantial
differences from data
requirements for
chemical pesticides
• Less reliance on
traditional toxicology
studies
Mammalian toxicology
• Form of organism used in tests must be same
as form humans will be exposed to
• Applicant needs to establish whether the
organism can infect/reproduce in humans
• Information from humans exposed during
manufacturing and development, or on
background occurrence required
Mammalian Toxicology
• If related species are pathogenic,
harmful or produce exotoxins →
information to address those concerns
for the proposed organism is required
• If absence of significant hazard can be
demonstrated
• → an acceptable risk assessment
can be achieved
Operator exposure
• No endpoints for living organisms, difficult to
estimate levels of exposure
• Accepted op ex modelling used for
conventional chemicals is of limited use
• Most organisms considered potentially
sensitising, in absence of robust data PPE is
required
Operator exposure
• Metabolites
- possible difficulties determining levels present in a
formulation
- difficult to predict how levels vary during lifecycle of
organism
• Dynamic population – byproducts and their
safety to workers re-entering crops for harvest
Fate and Behaviour
• Information on natural occurrence is crucial
(microbe/substance/ toxin/metabolite etc).
• Information on related strains/similar naturally
occurring compounds can be useful
(Sanco/10754/2005 rev.5)
Fate and Behaviour
• Care needed in use of such arguments
• May not be appropriate if applied levels significantly
higher or more persistent than naturally occurring
range
• May not be appropriate if applied in areas where it is
not naturally occurring
• If appropriate comparisons cannot be drawn,
specific data on the organism/substance may be
needed to address Data Requirements
Ecotoxicology
The risks to the major wildlife groups must be
addressed. It may be possible to use published
information and reasoned cases. If effects data are
not available and exposure exists, dedicated studies
will be needed.
Data to enable the product to be correctly classified
with respect to aquatic life.(?)
Ecotoxicology
Information on concentrations in the environment,
persistence including potential for propagation,
and other behaviour
Natural occurrence in the situation in which it is to
be used.
If concentration not raised above the range of
normal levels, unlikely to be a problem.
Key points
• Key is well thought out explanation of product,
mode of action and central argument that can
cut across many areas of risk assessment
• Product developer knows their product best.
• Make use of information from other uses e.g.
food grade, cosmetic uses etc
Key points
• Applicant needs to come to PSD early in product
development
• Awareness of legislation and available guidance
• Address all the areas detailed in relevant legislation
– Could be data or a reasoned case if appropriate
• Not making best use of published information
– Inadequate explanation or relating results to their product
– Not stating which data requirements it is addressing