Explanation: Human Health - 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 to human health). Some legislative frameworks refer to the protection goals as ‘safety criteria’.
Some legislative frameworks emphasise and elaborate on certain aspects of the protection goal (eg no harm to humans also means no harm to vulnerable groups or future generations).
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 human health are acceptable)
Abbreviations:
- ADI - Acceptable Daily Intake
- ARfD - Acute Reference Dose
- AOEL - Acceptable Operator Exposure Limit
Decision-making principles
A pesticide is registered if scientific evaluation of the submitted data determines 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.
Explanation: Human Health - Occupational risks
Hazard assessment and end-point selection
The assessment of the toxicological 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:
- NOAEL - No Observed Adverse 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 intra- and inter-species sensitivity.
Assessment factors may be set through legislation or they may be set through national science policy.
Assessment factors can also be referred to as uncertainty factors or safety factors.
Abbreviations:
Exposure assessment
The exposure assessment involves understanding the different ways that operators or workers may be exposed (exposure scenarios), assessing the likelihood of exposure and measuring or modelling the extent of exposure.
Risk assessment and acceptability criteria
The risk assessment considers the outcomes of the hazard assessment in conjunction with the exposure expected when the product is used in accordance with the label instructions (including engineering controls, personal protective equipment and/or re-entry interval as relevant).
The criteria for acceptable risk may be based on a margin of exposure approach or by comparing the exposure with a relevant toxicological reference value.
Abbreviations:
- MOE - Margin of Exposure
Explanation: Human Health - Dietary risks
Hazard assessment and end-point selection
The assessment of the toxicological 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:
- NOAEL - No Observed Adverse 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 intra- and inter-species sensitivity.
Assessment factors may be set through legislation or they may be set through national science policy.
Assessment factors can also be referred to as uncertainty factors or safety factors.
Abbreviations:
- ADI - Acceptable Daily Intake
- ARfD -Acute Reference Dose
- LOAEL - Lowest Observed Adverse Effect Level
- NOAEL - No Observed Ad-verse Effect Level
- aPAD - acute population adjusted dose
- cPAD - chronic population adjusted dose
Residue evaluation and the setting of maximum residue limits
The residue evaluation and the setting of maximum residue limits involves the evaluation of metabolism data, analytical methods and residue studies to:
- establish a residue definition
- evaluate the residue analytical methods
- setting maximum residue limits
Abbreviations:
- MRL - Maximum Residue Limit
- GAP - Good Agricultural Practice
Dietary risk assessment
Dietary risk is considered the risk from either short-term (acute) or longer-term (chronic) exposure taking into account the toxicity of the pesticide and the amount of pesticide an individual to which an individual may be exposed
Abbreviations:
- CSFII - Continuing Survey of Food Intake by Individuals (US)
- IEDI - International Estimated Daily Intake (WHO)
- NEDI - National Estimated Daily Intake (Australia)
- IESTI - International Estimated Short-Term Intake (Australia)
- JMPR - Joint Meeting on Pesticide Residues (FAO/WHO)
- NESTI - National Estimated Short Term Intake (Australia)
Risk assessment and acceptability criteria
Risk resulting from pesticide residues in food (from acute or chronic expo-sure) is calculated by combining food exposure data and toxicity to produce a risk value. This risk value is compared to the toxicological reference value.