[F2When measuring exposure to a plant protection product in the air within the breathing area of operators, bystanders or workers the requirements for measuring procedures described in Annex II A to Council Directive 80/1107/EEC of 27 November 1980 on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work (1) have to be taken into account.]
Textual Amendments
The risks for those using plant protection products depend on the physical, chemical and toxicological properties of the plant protection product as well as the type of the product (undiluted/diluted), and on the route, the degree and duration of exposure. Sufficient information and data must be generated and reported to permit an assessment of the extent of exposure to the active substance(s) and/or toxicologically relevant compounds in the plant protection product likely to occur under the proposed conditions of use. It must also provide a basis for the selection of the appropriate protective measures including personal protective equipment to be used by operators and to be specified on the label.
An estimation shall be made, using where available a suitable calculation model, in order to permit an evaluation of the operator exposure likely to arise under the proposed conditions of use.
An estimation of operator exposure must always be completed.
An estimation shall be made for each type of application method and application equipment proposed for use of the plant protection product taking account of the requirements resulting from the implementation of the classification and labelling provisions of Directive 78/631/EEC for handling the undiluted or diluted product as well as the different types and sizes of containers to be used, mixing, loading operations, application of the plant protection product, the climatic conditions and cleaning and routine maintenance of application equipment.
At first an estimation shall be made with the assumption that the operator is not using any personal protective equipment.
Where appropriate, a second estimation shall be made with the assumption that the operator is using effective and readily obtainable protective equipment which is feasible to be used by the operator. Where protective measures are specified on the label, the estimation will take these into account.
The test shall provide sufficient data to permit an evaluation of the operator exposure likely to arise under the proposed conditions of use.
Actual exposure data for the relevant exposure route(s) must be reported where the risk assessment indicates that a health-based limit value is exceeded. This will, for example, be the case when the results of the estimation of operator exposure provided for under point 7.2.1.1 indicate that:
the Acceptable Operator Exposure Level(s) (AOEL) established in the context of inclusion of the active substance(s) in Annex I, and/or
the Limit Values established for the active substance and/or toxicologically relevant compound(s) of the plant protection product in accordance with Council Directive 80/1107/EEC and Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens at work (2) ,
may be exceeded.
Actual exposure data must also be reported when no appropriate calculation model or no appropriate data are available to do the estimation provided for under point 7.2.1.1.
In cases where dermal exposure is the most important exposure route, a dermal absorption test or the results of a sub-acute dermal study, if not already available, may be a useful alternative test to provide data in order to refine the estimate provided for under point 7.2.1.1.
The test must be done under realistic exposure conditions taking into account the proposed conditions of use.
Bystanders can be exposed during the application of plant protection products. Sufficient information and data must be reported to provide a basis for the selection of appropriate conditions of use, including the exclusion of bystanders from treatment areas and separation distances.
An estimation shall be made, using where available a suitable calculation model in order to permit an evaluation of the bystander exposure likely to arise under the proposed conditions of use.
An estimation of bystander exposure must always be completed.
An estimation of bystander exposure must be made for each type of application method. The estimation shall be made with the assumption that bystanders do not use any personal protective equipment.
Measurement of bystander exposure may be required when estimates indicate a cause for concern.
Workers can be exposed following application of plant protection products, when entering treated fields or premises or handling treated plants or plant products on which residues remain. Sufficient information and data must be reported to provide a basis for the selection of appropriate protective measures, including waiting and re-entry periods.
An estimation shall be made using where available a suitable calculation model, in order to permit an evaluation of the worker exposure likely to arise under the proposed conditions of use.
The estimation of worker exposure must always be completed.
An estimation of worker exposure must be made for each crop and task to be carried out.
At first the estimation shall be made using available data on the exposure to be expected with the assumption that the worker is not using any personal protective equipment.
Where appropriate, a second estimation shall be made with the assumption that the worker is using effective and readily obtainable protective equipment which is feasible to be used.
Where appropriate, a further estimation shall be made using data generated on the amount of dislodgeable residues under the proposed conditions of use.
The test shall provide sufficient data to permit an evaluation of the worker exposure likely to arise under the proposed conditions of use.
Actual exposure data for the relevant exposure route(s) must be reported where the risk assessment indicates that a health-based limit value is exceeded. This will, for example, be the case where the results of the estimation of worker exposure provided for under point 7.2.3.1 indicate that:
the AOEL(s) established in the context of inclusion of the active substance(s) in Annex I,
and/or
the Limit Values established for the active substance and/or toxicologically relevant compound(s) of the plant protection product in accordance with Council Directives 80/1107/EEC and 90/394/EEC,
may be exceeded.
Actual exposure data must also be reported when no appropriate calculation model or no appropriate data are available to do the estimation provided for under point 7.2.3.1.
Where dermal exposure is the most important exposure route, a dermal absorption test, if not already available, may be a useful alternative test to provide data in order to refine the estimate provided for under point 7.1.3.1.
The test must be done under realistic exposure conditions taking into account the proposed conditions of use.]
Textual Amendments