Transcript Chief Executive initiated reassessmentOrganophosphate and

Chief Executive initiated
reassessment
Organophosphate and Carbamate based insecticides
New reassessments approach
Moving from single substance to group reassessments
Older substances, often removed or restricted by other
jurisdictions
Engaging early – go out with early thinking
Aim:
Avoid perverse outcomes
Consistent controls to manage risk
Greater certainty about tools available for use in medium
term
More efficient use of resources
Consultation
Call for Information
To identify those that may have high risks
To obtain use information
Feasibility of possible controls or other controls to
mitigate risk
Hui
Northland, Bay of Plenty, Rotorua and Marlborough
Scope of the reassessment
acephate
carbarylc
chlorpyrifos
diazinon
dichlorvos
dimethoate
fenamiphos
fenitrothion
phoxim
c=carbamates
maldison
methamidophos
methomylc
phorate
pirimicarbc
pirimiphos-methyl
prothiofos
oxamylc
terbufos
pyrazophos
benomylc
carbofuranc
carbosulfanc
chlorpyrifos-methyl
dichlofenthion
ethion
famphur
isazofos
omethoate
HSNO
Process
May approve if the positive effects of the substance
outweigh the adverse effects
• If risks are negligible then the approvals should be retained
• If additional controls make the risks negligible, then the
approval should be retained with those additional controls.
• If the risks are non-negligible even with extra controls a
risk/benefit analysis is conducted and:
• If benefits are greater than the risks the approval is
recommended to be retained
• If risks are greater than benefits the approval is
recommended to be revoked either with or without a phaseout period
Evaluation
Risk vs Benefit
Qualitative descriptors allow a risk or a benefit to
be negligible, low, medium or high to focus
comparisons
Likelihood and magnitude for risks and benefits
Page 43 – 45 of the consultation report
Example
Diazinon
widely used
high risks and high benefits
effective alternatives not yet available
Analysis of risks
Risk is a function of exposure and hazard
Exposure estimated using models/measured
data
Use patterns established from product label and
stakeholder feedback
Hazard: Use threshold values derived by other
regulators
Risks assessed with and without additional
controls
Analysis of risks
Operators
Re-entry workers
Bystanders
Aquatic environment
Birds
Bees
Analysis of risks
Risk Quotient = Predicted exposure/threshold
value
Target Risk Quotient is <1
Risks - Qualitative Descriptors
Human health
Risk
Quotient
Risk Parameter
Operators
Re-Entry workers
Bystanders
<1
Overall
Negligible
Negligible
Negligible
Magnitude
Minor
Minor
Moderate
Likelihood
Likely
Very unlikely
Unlikely
Overall
Low
Negligible
Low
Magnitude
Moderate
Moderate
Moderate
Likelihood
Likely
Unlikely
Unlikely
Overall
Medium
Low
Low
Magnitude
Major
Major
Major
Likelihood
Highly likely
Likely
Unlikely
Overall
High
Medium
Medium
Risk
Quotient
Risk parameter
Aquatic
Birds
Bees
<1
Overall
Negligible
Negligible
Negligible
Magnitude
Minor
Minor
Minor
Likelihood
Very unlikely
Unlikely
Very unlikely
Overall
Negligible
Low
Negligible
Magnitude
Moderate
Minor
Minor
Likelihood
Unlikely
Highly likely
Very unlikely
Overall
Low
Medium
Negligible
Magnitude
Major
Major
Minor
Likelihood
Likely
Highly likely
Very unlikely
Overall
Medium
High
Negligible
>1-10
>10-100
>100
Environment
>1-10
>10-100
>100
Benefits - Qualitative Descriptors
Marginal cumulative benefits
Category
Criteria
Very
unlikely
No evidence provided of actual use
Possible
Used only rarely or when needed
Likely
Some current use across industry
Highly
likely
Significant and regular use across industry
Minor
Difficult to ascertain material impacts.
Moderate
Medium term regional effects with some national
implications for GDP - $0-$15 million
Major
Measurable beneficial effect on GDP - $15-$50
million
Massive
Significant on-going beneficial effect on GDP Above $50 million
Magnitude
Likelihood
Minor
Moderate
Major
Massive
Very unlikely
Negligible
Negligible
Negligible
Negligible
Possible
Negligible
Low
Medium
Medium
Likely
Negligible
Low
Medium
High
Highly likely
Negligible
Medium
High
High
Generic Benefits
Efficacy
Broad spectrum
Lower application rates
Cheaper
Short pre-harvest intervals
Short re-entry intervals
Maximum Residue Limits
Resistance management
Biosecurity
Specific Benefits
Many OPCs are particularly effective in
controlling specific pests. This makes them
beneficial on a number of crops where these
pests are difficult to control
Diazinon to control grass grub on pasture
Supports large industries = large contribution to GDP
Specific pest to NZ
No effective alternatives – ongoing research
Approach to controls
AIM: Reduce risk levels to, or close to, negligible
Controls are risk reduction measures, intended to reduce
exposure to human health / environment
Default controls (arising from hazardous properties – s77)
Additional controls (to manage risks not addressed by default
controls, reflect parameters of scenarios – s77A)
Risks identified to the receptors identified in the risk
assessment
Operators, re-entry workers, bystanders
Aquatic and terrestrial environment, birds, bees
Additional controls toolbox developed with stakeholders
Controls toolbox
Example controls
Operational
• prescriptive PPE requirements
• permitted application methods (e.g. ground-based application only),
maximum application rates and frequencies
• buffer zones and spray drift reduction measures (NZS:8409)
• restricted entry intervals (REI)
• notifications and signage
Obligations
• Approved Handlers only
• Authorised Person
• Labelling statements
Restrictions
• indoor use only
• phase out/revocation
Recommendations
Based on balance of risks and benefits
Controls selected to mitigate risks as far as
possible
Recommendations – Diazinon
Very high risks – but also very high benefits
Long phase-out period proposed to allow
development of alternatives – plus additional
controls e.g.
Maximum application rates
Semi-automated equipment for indoor application
No hand-held application of granules
Key issues raised in submissions
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Home garden uses
ADI/MRL relationship
Biosecurity uses
Information challenges/data gaps
UK COT
Updated recommendations
Retain dimethoate
Retain outdoor uses of pirimiphos-methyl & methomyl
Biosecurity – Authorised Person-only control for
fenamiphos after 5 years; Extend AP control to all OPCs
we’re retaining
Extend phase-in period to 2 years
Change definition of automated application in
greenhouses
Remove droplet size requirements for chlorpyrifos and
diazinon
Allow shorter buffer zones through COP
New label warning for bee risks