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Outcome-focussed approach
Problem formulation
Dr Maria Trainer PhD
Executive Director, Registration Management
26 February 2024
About the APVMA
• The Australian Pesticides and Veterinary Medicines Authority
(APVMA) is the independent authority responsible for assessing
and registering agricultural and veterinary (agvet) chemicals
proposed for supply and use in Australia, with control up to – and
including – the point of retail sale. Individual states and territories are
responsible for regulating agvet chemicals after sale (control of use)
• We work under legislative requirements and must be satisfied of
safety, efficacy, trade and labelling prior to registration, and we
undertake scientific risk assessments against these criteria
• We take a risk-based, outcome-focused approach to regulation
Our key assessment areas
Chemistry Toxicology Residues
and trade
Worker
safety
Environment
Efficacy and
target safety
Legislative criteria
Safety
5A
Efficacy
5B
Trade
5C
Labelling
5D
Agvet chemicals scope
• In determining satisfaction against criteria, the APVMA takes
an “outcome-based” approach
• Level of assessment is tied to both hazard and exposure
• Certain classes of compounds may be considered of lower risk
– however individual compounds may require additional
assessment on a case-by-case basis
• Ability to rely on previous assessments (subject to data
protection) to determine satisfaction against criteria
Biological
agricultural
products Group 3: microbial agents (bacteria,
fungi, viruses, protozoa)
Group 1: biological chemicals
(pheromones, hormones, growth
regulators, enzymes and vitamins)
Group 2: plant and other extracts
(plant extracts, oils)
Group 4: other living organisms
(microscopic insects, plants and
animals plus some organisms that
have been genetically modified)
Focus on determining active and
product is not, or would not be:
• an undue hazard to the safety
of people exposed to the
product during its handling or
people using anything
containing its residues
• likely to have an effect that is
harmful to human beings.
No ‘hard and fast’ rules about
how this must be determined.
Key outcomes
• Assess against statutory criteria
oSafety
oEfficacy
oTrade
• Risk assessment
oCharacterisation of hazard
oQuantification of exposure
Outcome-based approach
• Where minimal exposure occurs, assessment may be very
limited
• Example: pheromone at low levels in sealed device
o Environment: Specificity of the pheromone? Will it interact with any
other species?
o Health: Likely to be limited. Focussed on accidental poisoning
unless refilling of device is possible (this will require OHS
assessment)
o Residues: If unlikely to be present in food may not be required
o Efficacy, Chemistry: Assessment required
Exposure Quantification
• Each area will have different considerations
• If the organism is comparable to Australian isolate:
o Residues: MRL may not be needed if indistinguishable from natural
occurrence
o Environment: may not need detailed assessment if organism similar to
naturally occurring strain
o Health: may need WHS assessment if exposure occurs during application
o Chemistry: will assess composition and stability of formulation
o Efficacy: will need to be demonstrated
Problem formulation: how do we do it?
• If the organism is novel to the Australian environment:
o Residues: may still determine no assessment is required, depending on
action of the organism
o Environment: will require an assessment to determine potential impacts on
native ecosystems
o Health: may need WHS assessment if exposure occurs during application
o Chemistry: will assess composition and stability of formulation
o Efficacy: will need to be demonstrated
• Applicants are encouraged to apply for Pre-application assistance
Problem formulation: how do we do it?
• Applicant can present the product, show
available data and discuss possible scientific
arguments
• APVMA provides advice on suitability of
arguments/suggested data (without
assessment), as well as timeframes and fees
• Fee-based process with fees offset against application
fees
• Technical assessments on specific assessment areas can
also be done to provide advice (i.e. health advice may
contribute to whether residue assessment is required)
Pre-application assistance
Thank you for listening.
Maria Trainer, Ph.D.
Executive Director, Registration Management
Australian Pesticides and Veterinary Medicines Authority
Maria.Trainer@apvma.gov.au
apvma.gov.au

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APVMA outcome-focussed approach to data requirements to support registration decisions for biopesticides Maria TRAINER

  • 1. Outcome-focussed approach Problem formulation Dr Maria Trainer PhD Executive Director, Registration Management 26 February 2024
  • 2. About the APVMA • The Australian Pesticides and Veterinary Medicines Authority (APVMA) is the independent authority responsible for assessing and registering agricultural and veterinary (agvet) chemicals proposed for supply and use in Australia, with control up to – and including – the point of retail sale. Individual states and territories are responsible for regulating agvet chemicals after sale (control of use) • We work under legislative requirements and must be satisfied of safety, efficacy, trade and labelling prior to registration, and we undertake scientific risk assessments against these criteria • We take a risk-based, outcome-focused approach to regulation
  • 3. Our key assessment areas Chemistry Toxicology Residues and trade Worker safety Environment Efficacy and target safety Legislative criteria Safety 5A Efficacy 5B Trade 5C Labelling 5D
  • 4. Agvet chemicals scope • In determining satisfaction against criteria, the APVMA takes an “outcome-based” approach • Level of assessment is tied to both hazard and exposure • Certain classes of compounds may be considered of lower risk – however individual compounds may require additional assessment on a case-by-case basis • Ability to rely on previous assessments (subject to data protection) to determine satisfaction against criteria
  • 5. Biological agricultural products Group 3: microbial agents (bacteria, fungi, viruses, protozoa) Group 1: biological chemicals (pheromones, hormones, growth regulators, enzymes and vitamins) Group 2: plant and other extracts (plant extracts, oils) Group 4: other living organisms (microscopic insects, plants and animals plus some organisms that have been genetically modified)
  • 6. Focus on determining active and product is not, or would not be: • an undue hazard to the safety of people exposed to the product during its handling or people using anything containing its residues • likely to have an effect that is harmful to human beings. No ‘hard and fast’ rules about how this must be determined. Key outcomes
  • 7. • Assess against statutory criteria oSafety oEfficacy oTrade • Risk assessment oCharacterisation of hazard oQuantification of exposure Outcome-based approach
  • 8. • Where minimal exposure occurs, assessment may be very limited • Example: pheromone at low levels in sealed device o Environment: Specificity of the pheromone? Will it interact with any other species? o Health: Likely to be limited. Focussed on accidental poisoning unless refilling of device is possible (this will require OHS assessment) o Residues: If unlikely to be present in food may not be required o Efficacy, Chemistry: Assessment required Exposure Quantification
  • 9. • Each area will have different considerations • If the organism is comparable to Australian isolate: o Residues: MRL may not be needed if indistinguishable from natural occurrence o Environment: may not need detailed assessment if organism similar to naturally occurring strain o Health: may need WHS assessment if exposure occurs during application o Chemistry: will assess composition and stability of formulation o Efficacy: will need to be demonstrated Problem formulation: how do we do it?
  • 10. • If the organism is novel to the Australian environment: o Residues: may still determine no assessment is required, depending on action of the organism o Environment: will require an assessment to determine potential impacts on native ecosystems o Health: may need WHS assessment if exposure occurs during application o Chemistry: will assess composition and stability of formulation o Efficacy: will need to be demonstrated • Applicants are encouraged to apply for Pre-application assistance Problem formulation: how do we do it?
  • 11. • Applicant can present the product, show available data and discuss possible scientific arguments • APVMA provides advice on suitability of arguments/suggested data (without assessment), as well as timeframes and fees • Fee-based process with fees offset against application fees • Technical assessments on specific assessment areas can also be done to provide advice (i.e. health advice may contribute to whether residue assessment is required) Pre-application assistance
  • 12. Thank you for listening. Maria Trainer, Ph.D. Executive Director, Registration Management Australian Pesticides and Veterinary Medicines Authority Maria.Trainer@apvma.gov.au