Application safety of plant protection products
BfRshort forGerman Federal Institute for Risk Assessment assesses whether the health of all persons, as well as pets and farm animals, who may come into contact with plant protection product (PPP) during its use can be ensured when the product is used as intended. This is a requirement for the authorisation of PPP.
The following groups of people are taken into consideration:
- Users who may be exposed to PPP or their components through e.g. the skin or through inhalation during the application process
- Workers who carry out follow-up work on the treated area
- People who live or work in the vicinity of the treated areas (residents)
- People who stay nearby the area during application (bystanders, e.g. people walking by), who can be exposed to PPP or their components through the skin, through inhalation or, in the case of small children, through ingestion
ExposureExposureTo glossary assessment for users, workers, residents and bystanders
In the course of the application safety assessment, BfRshort forGerman Federal Institute for Risk Assessment determines the maximum intake according to EU-harmonised Guidelines to be expected for each of these potential routes of exposure before the authorisation of a PPP. For this assessment, the intended conditions of use are taken as a basis.
Separate exposure assessments are carried out for the aforementioned groups of people.
BfRshort forGerman Federal Institute for Risk Assessment determines the exposure of users (generally farmers, but can also include horticultural workers or amateur users in home and allotment gardens) by model calculations. These models are based on measurements for each type of application.
Kinetic considerations (for instance, how much active substance can be absorbed through the skin) are included in the exposure assessment, but also possible protective measures with which the exposure can be reduced (e.g. protective gloves).
Exposure during follow-up work is calculated for operator (e.g. farmers), workers in horticultures and in processing plants as well as for non-professional users in home and allotment gardens.
When evaluating residents and bystanders, BfRshort forGerman Federal Institute for Risk Assessment not only accounts for adults, but also for small children (incl. toddler), as they often put their fingers in their mouths or swallow certain items (e.g. sand, parts of plants).
Models as a basis for exposure assessment
For the exposure assessment, BfRshort forGerman Federal Institute for Risk Assessment initially uses models with quite conservative assumptions.
The guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products guidelines is harmonised in the EU and has been published by the European Food Safety Authority (EFSAshort forEuropean Food Safety Authority, 2014/2022).
Risk assessment for operator, workers, bystanders and residents from plant protection products
Based on the exposure assessments described above and the toxicological evaluation of the PPP, BfRshort forGerman Federal Institute for Risk Assessment assesses whether PPP, when used as indented, pose a health risk to operators, workers, residents or bystanders.
To this end, exposure is compared with the harmful ("toxic") effects of the product or the active substances and other ingredients it contains. The limit values derived from a variety of toxicological studies serve as a measure of harmfulness. An unacceptable risk can only be ruled out if exposure is lower than the relevant toxicological limit value. If necessary, risk mitigation measures can be specified. Such measures may involve the wearing of protective gloves or a protective suit when handling the product. The use of warning signs or minimum waiting times before re-entering treated areas may also be required. If a potential risk of uninvolved persons during application of PPP cannot be ruled out based on these exposure assessments, the use of special, drift-reducing equipment, for example, may be required.
Only when a corresponding risk can be ruled out - if necessary taking risk reduction measures into account - will BfRshort forGerman Federal Institute for Risk Assessment consent to the authorisation of a PPP.
Result of the risk assessment
The risk, also from repeated exposure, is acceptable if the maximum expected exposure is below the corresponding toxicological limit value (e.g. Acceptable Operator Exposure Level - AOELshort forAcceptable Operator Exposure Level)
The result of the BfRshort forGerman Federal Institute for Risk Assessment risk assessment includes:
- Determination of proposals for the classification and labelling concerning toxicological aspects of the pesticide product according to the CLP regulation (Regulation (EC) 1272/2008);
- Stipulation of restrictions on use, personal protection measures or other risk mitigation requirements to ensure the safe handling and application of the products.
Additional information regarding the principles of risk assessment and the derivation of toxicological limit values such as the AOELshort forAcceptable Operator Exposure Level can be found External Link:here.
References
The literature cited above can be found in:
EFSAshort forEuropean Food Safety Authority 2014, Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products, EFSAshort forEuropean Food Safety Authority Journal 2014;12(10):3874, External Link:http://www.efsa.europa.eu/de/efsajournal/pub/3874
EFSAshort forEuropean Food Safety Authority 2022, Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products. EFSAshort forEuropean Food Safety Authority Journal 2022, 20(1), 7032,External Link:https://www.efsa.europa.eu/en/efsajournal/pub/7032