Human toxicology

Risk envelope parameters

A risk envelope check for human toxicology is performed for the operator, bystander /local resident and worker.

Operator

The following parameters are relevant for the operator:

• Usage scenario
  For spraying, a list of usage scenarios is available in the Netherlands. For each crop, how the spraying can take place is indicated (machine vs. manual, downward vs. upward).
• Dose
• Spray volume
  The spray volume influences the risk assessment. A larger spray volume (i.e. a less concentrated spray solution) generally results in a higher dermal absorption percentage, resulting in greater operator exposure. However, for applications where the UK POEM model is relevant based on the assessment framework, a smaller spray volume is the worst case because this results in the greatest exposure.

Bystander/local resident

The following parameters are relevant to the bystander/local resident:

• Usage scenario
• Dose
• Spray volume
  The spray volume influences the risk assessment. A larger spray volume (i.e. a less concentrated spray solution) generally results in a higher dermal absorption percentage, resulting in greater exposure of the bystander/local resident. However, for applications where the UK model of the EFSA OPEX is relevant based on the assessment framework, a smaller spray volume is the worst case because this results in the greatest exposure.
• Specific DFR and/or DT50 (if used)

Worker

The following parameters are relevant for the worker:

• Type of activity/exposure time
• Dose
• Number of uses/interval between uses (if relevant based on the assessment framework)
• Transfer Coefficient (TC)
  If the EFSA model is relevant based on the assessment framework and PPE (gloves) is needed for safe use, then the TCs must also be compared with the use of PPE.
• Specific DFR and/or DT50 (if used)

Example: for grapes there is no TC with PPE in the EFSA model and therefore this situation can never fall under a risk envelope.

Risk envelope assessment

General

In principle, the newly requested field uses are compared with previously authorised field uses; the newly requested greenhouse uses are usually compared with previously authorised greenhouse uses.

Operator

The new application falls under the risk envelope of the existing authorisation if:

• the requested uses concern the same usage scenarios;
• the dose of the requested uses is equal or lower; and
• the spray volume of the requested uses is comparable: the maximum spray volume for the dermal absorption and the minimum spray volume in case UK POEM must be used for the assessment.

Bystander/local resident

The new application falls under the risk envelope of the existing authorisation if:

• the requested uses concern the same usage scenarios;
• the dose of the requested uses is equal or lower; and
• the spray volume of the requested uses is comparable: the maximum spray volume for the dermal absorption and the minimum spray volume in case the UK model or the EFSA OPEX model is to be used for the assessment; and
• in the event that a specific DFR and/or DT50 was used in the assessment of the existing authorisation, this DFR and/or DT50 also applies to the requested uses;

Worker

The new application falls under the risk envelope of the existing authorisation if:

• the type of activity is the same and the exposure time is the same or less;
• the dose of the requested uses is the same or lower;
• the number of uses is the same or fewer and the interval between uses is the same or longer;
• in the event that a specific DFR and/or DT50 was used in the assessment of the existing authorisation, this DFR and/or DT50 also applies to the requested uses; and
• the TC of the requested uses is equal or lower (even if it concerns a TC with PPE).

See below the table used for the risk envelope check.