Minor Use Alan Norden Manager Minor Use APVMA

Minor Use Alan Norden, Manager – Minor Use APVMA

Minor Use How APVMA handles minor uses & Some thoughts/perspectives………

How APVMA handles minor uses Background: l l l Provisions to issue ‘permits’ – approve off-label uses ‘Third Party’ applicants – growers / peak bodies Cost = $350/application Same requirements as registration – health & safety Other requirements (policies – reg. alternatives, cost, minor use classification) Assessment timeframes approx. 5 -8 months

How APVMA handles minor uses Some statistics: l l l 350 permit applications / annum Approx. 1000 current permits 75% for use on food crops generally national (25 nonfood – localised needs) 58% involve (minor) use on major crops 60% require residue assessment / MRL establishment

How APVMA handles minor uses

How APVMA handles minor uses Process & Outcomes: l l l Application lodgement Screening – determine review areas Reviewer(s) assessment (internal & external) Assessment & Decision (issue, amend or refuse) Outcome may be ‘temporary’ – confirmatory data Duration of permits 2 -3 yrs or 5 -10 yrs

Some thoughts & perspectives 1. The Fundamental Approach Required 2. Definitions 3. Regulatory Mechanisms, Incentives & Requirements 4. Expert knowledge

Some thoughts & perspectives The Fundamental Approach Required l l l The approach needed must be constructed in a way no dissimilar to that which applies to registration. Needs must be tackled in a similar way to how manufacturers pursue registrations. Regulators need to ensure they assess risks appropriately.

Some thoughts & perspectives Collaborate & agree on key objectives Re-prioritise Conduct R&D Conduct a gap & priority needs analysis Seek guidance/assisstanc e Make regulatory submissions Identify possible solutions Determine data availability Communicate outcomes

Some thoughts & perspectives Definitions l l Minor crops & Major Crops = Production volume/area = Risk assessment approach Minor Uses & Major Uses = Profitability = Economic return OECD Guidance Document on Defining Minor Uses

Some thoughts & perspectives Regulatory Mechanisms & Incentives l l l Require processes that allow third parties to participate Tailor data requirements to minimise costs – risk assessment based / not economic based Design incentives to encourage private investment in minor uses / registration OECD Guidance Document on Regulatory Incentives

Some thoughts & perspectives Expert knowledge l l l Extrapolation Acceptance of overseas data Minimum No. of trials Maximising coverage/outcomes of available data Temporary approvals

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