1. The impending challenges
Agrichemicals
The impending challenges
Kevin Bodnaruk

2. Agrichemicals - the impending challenges
Access
Retaining (Regulatory pressures)
Gaining (New chemistry)
Trade
MRLs
Regulatory risk assessment

3. Agrichemicals - the impending challenges
Regulatory pressures
Reconsiderations
National and International
APVMA, Codex, EFSA, PMRA, US EPA etc
Risk assessment methodologies
e.g., Shorter than lifetime, AMR

4. Agrichemicals - the impending challenges
Regulatory pressures
Data gaps
Old chemistry - Lack of data
Registrants - Little incentive to generate data
Cost can be prohibitive for industry to try and fill

5. Agrichemicals - the impending challenges
Example - Dithiocarbamates
Three subgroups
Dimethyl-dithiocarbamates
Ethylene bis-dithiocarbamates
Propylene bis-dithiocarbamates
Thiram and ziram
Mancozeb and metiram
Propineb

6. Agrichemicals - the impending challenges
Dithiocarbamates
Issues include:
Residue definitions
metabolites
HBGVs & dietary exposure
OH&S
Availability of data will be critical

7. Agrichemicals - the impending challenges
Dithiocarbamates
Status
Canada – metiram only one use retained; thiram all food uses cancelled; Ziram all uses cancelled mancozeb?
EU – thiram & propineb deregistered
Codex review scheduled for 2021
APVMA ~2021

8. Agrichemicals - the impending challenges
New chemistry
Australian market size
Fewer 1st registrations
Between 2008 – 2012
Longer development timeframes
Delayed access
Compounds
Australia
USA 26 56
149

9. Agrichemicals - the impending challenges
Trade
Lack of MRLs or MRL differences
Reference MRLs?
Codex MRLs & or Other jurisdictions
Import MRLs?
Lack of capacity
Costs

10. Agrichemicals - the impending challenges
Regulatory risk assessment prepared