Legislation
Protection goal
Legislation will set out the protection goals. These are usually described in general terms and require a high level of protection (eg no harm or unintended effect to the environment). Some legislative frame-works refer to the protection goals as ‘safety criteria’.
Some legislative frameworks emphasise and elaborate on certain aspects of the protection goal (eg the scope including surface waters, ground water, soil and air and impact on biodiversity and ecosystems).
Matters to be taken into account in making a decision
The legislative criteria may set out a number of technical matters that the decision-maker must have regard to in determining whether the protection goal is met (ie that the risks to the environment are acceptable)
Abbreviations:
- DT50 - Half-life
Decision-making principles
A pesticide is registered if scientific evaluation of the submitted data deter-mines that the legislative criteria are met. Conditions may apply, as deemed necessary.
In the EU legislation also sets out uniform principals to be followed by individual decision-makers when evaluating and registering a pesticide.
Abbreviations:
- ADI - Acceptable Daily Intake
- AOEL - Acceptable Operator Exposure Level
- DT90 - time taken for degradation of 90%
- LD50 - dose required to kill half of the members of a tested population after a specified test duration
Groundwater
Setting of toxicological reference values and the use of assessment factors
Abbreviations:
- ADI - Acceptable Daily Intake
- DWLOC - Drinking Water Level of Concern
- PAD - Population Adjusted Dose
- PNEC - Predicted No-Effect Concentration
Exposure assessment
Abbreviations:
- PEC- Predicted Environmental Concentration
- PWC - Pesticide in Water calculator
Risk assessment and acceptability criteria
Abbreviations:
- ADI - Acceptable Daily Intake
- EEC - Estimated Environmental Concentration (also PEC)
- DWLOC - Drinking Water Level of Concern
Surface water
Hazard assessment and end-point selection
The assessment of the ecotoxicological and other relevant data in line with the matters to be taken into account as set out in legislation, forms the basis for the hazard assessment
Abbreviations:
- EC10 - concentration that induces an effect to 10% of the test population
- EC50 - concentration that induces an effect to 50% of the test population
- LC50 - concentration that is lethal to 50% of the test population
- NOEC - No Observable Effect Concentration
Setting of toxicological reference values and the use of assessment factors
The toxicological reference values are derived by applying an assessment factor to the outcomes of the hazard assessment to account for potential differences in species sensitivity and, as relevant, specific protection goals.
Assessment factors can also be referred to as uncertainty factors or safety factors.
Abbreviations:
- RAC - Regulatory Acceptable Concentration, a toxicological reference value derived by applying an assessment factor to the relevant end-point
Exposure assessment
The exposure assessment involves estimating concentration of the pesticide in surface water based on a specific water body scenario and taking into consideration the application rate(s), chemical properties and environmental fate properties, including the dissipation of the pesticide between applications.
Abbreviations:
- EEC - Estimated Environmental Concentration
- PEC - Predicted Environmental Concentration
- PECsw - Predicted Environmental Concentration for surface water
Risk assessment and acceptability criteria
The risk assessment considers the outcomes of the hazard assessment as represented by the toxicological reference value in conjunction with the exposure expected when the product is used in accordance with the label instructions (including application equipment and methods, buffer zones and other risk mitigation methods).
The criteria for acceptable risk is where the estimated exposure is less than or equal to the relevant toxicological reference value. The criteria for acceptable risk is some-times expressed as the Risk Quotient being less than or equal to 1. It may also be expressed as 1 being the Level of Concern.
Abbreviations:
- RQ - Risk Quotient
- LOC - Level of Concern, the policy tool used to determine potential risk
Bees
Hazard assessment and end-point selection
The assessment of the ecotoxicological and other relevant data in line with the matters to be taken into account as set out in legislation, forms the basis for the hazard assessment
Abbreviations:
- LC50/LD50 - concentration/dose required to kill half the members of a tested population after a specified test duration
- NOAEL - No Observable Adverse Effect Level
- NOEL - No Observable Effect level
Setting of toxicological reference values and the use of assessment factors
The toxicological reference values are derived by applying an assessment factor to the outcomes of the hazard assessment to account for potential differences in species sensitivity and, as relevant, specific protection goals.
Assessment factors can also be referred to as uncertainty factors or safety factors.
Abbreviations:
- RAD - regulatory acceptable dose
Exposure assessment
The exposure assessment may use formula based on application rates or calculated using specifically developed modelling tools.
Abbreviations:
Risk assessment and acceptability criteria
The risk assessment considers the outcomes of the hazard assessment (where applicable represented by the toxicological reference value) in conjunction with the exposure expected when the product is used in accordance with the label instructions.
The criteria for acceptable risk may be expressed as the Risk Quotient, a Hazard Quotient or an Exposure Ratio. The Risk Quotient is expressed as the ratio: estimated exposure/the hazard end-point or, where applicable the ratio of the estimated exposure/toxicological reference value). The Hazard Quotient is expressed as the ratio: application rate/hazard end-point. The Exposure Ratio is expressed as the ratio: exposure/end-point.
The criteria for acceptable risk are based on the Risk Quotient, the Hazard Quotient or the Exposure Ratio (as applicable) being lower than a specified value (sometimes also referred as the Trigger Value or Level of Concern).
Abbreviations:
- ETR - Exposure Toxicity Ratio
- HQ - Hazard Quotient
- LOC - Level of Concern
- NOEC - No Observable Effect Concentration
- RQ - Risk Quotient
Soils
Hazard assessment and end-point selection
The assessment of the ecotoxicological and other relevant data in line with the matters to be taken into account as set out in legislation, forms the basis for the hazard assessment
Abbreviations:
- EC10 - concentration that induces an effect to 10% of the test population
- EC50 - concentration that induces an effect to 50% of the test population
- LC50 - concentration that is lethal to 50% of the test population
- NOEC - No Observable Effect Concentration
Setting of toxicological reference values and the use of assessment factors
The toxicological reference values are derived by applying an assessment factor to the outcomes of the hazard assessment to account for potential differences in species sensitivity and, as relevant, specific protection goals.
Assessment factors can also be referred to as uncertainty factors or safety factors.
Abbreviations:
- RAC - Regulatory Acceptable Concentration, a toxicological reference value derived by applying an assessment factor to the relevant end-point
Exposure assessment
The exposure assessment involves estimating concentration of the pesticide in surface water based on a specific water body scenario and taking into consideration the application rate(s), chemical properties and environmental fate properties, including the dissipation of the pesticide between applications.
Abbreviations:
- DT50 - Half-time
- EEC - Estimated Environmental Concentration
- PEC - Predicted Environmental Concentration
- PEWCsoil - Predicted Environmental Concentration in soil
Risk assessment and acceptability criteria
The risk assessment considers the outcomes of the hazard assessment as represented by the toxicological reference value in conjunction with the exposure expected when the product is used in accordance with the label instructions (including application equipment and methods, buffer zones and other risk mitigation methods).
The criteria for acceptable risk is where the estimated exposure is less than or equal to the relevant toxicological reference value. The criteria for acceptable risk is sometimes expressed as the Risk Quotient being less than or equal to 1.
Abbreviations:
- LOC - Level of Concern
- RQ - Risk Quotient
- TER - Toxicity to Exposure Ratio