Pesticide Registration Toolkit

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)

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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

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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.

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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.

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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:

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:

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

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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:

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.