Division 2.6.1.1 Member States shall evaluate operator exposure to the micro-organism, and/or to toxicologically relevant compounds in the plant protection product (e.g. their metabolites/toxins, residual growth medium, contaminants and co-formulants), likely to occur under the proposed conditions of use (including in particular dose, application method and climatic conditions). Realistic data on exposure levels must be used and, if such data are not available, a suitable, validated calculation model. When available, a European harmonised generic exposure database for plant protection products should be used.

This evaluation will take into consideration the following information:

1. (i)

   the medical data and the toxicity, infectivity and pathogenicity studies as provided for in Annex IIB, and the results of the evaluation thereof. Tier 1 tests should permit an evaluation to be made of a micro-organism with respect to its ability to persist or grow in the host and its ability to cause effects/reactions in the host. Parameters that indicate the absence of ability to persist and multiply in the host, and the absence of ability to produce non-adverse or adverse effects in a host, include fast and complete clearance from the body, no activation of the immune system, no histopathological changes, and for replication temperatures far below or far above mammalian body temperatures. These parameters can in some cases be assessed using acute studies and existing human data, and sometimes can only be assessed using repeated dose studies.

   Evaluation based on relevant parameters of Tier 1 tests should lead to an assessment of the possible effects of occupational exposure, taking into account the intensity and duration of exposure including exposure due to repeated use during practical use.

   The toxicity of certain metabolites/toxins can only be assessed, if it has been demonstrated that the test animals are actually exposed to these metabolites/toxins;

2. (ii)

   other relevant information on the micro-organism, the metabolites/toxins, residual growth medium, contaminants and co-formulants in the plant protection product, such as their biological, physical and chemical properties (e.g. survival of the micro-organism at the body temperature of humans and animals, ecological niche, behaviour of the micro-organism and/or metabolites/toxins during application);

3. (iii)

   the toxicological studies provided for in Annex IIIB;

4. (iv)

   other relevant information provided for in Annex IIIB such as:

   • composition of the preparation,

   • nature of the preparation,

   • size, design and type of packaging,

   • field of use and nature of the crop or target,

   • method of application including handling, loading and mixing of the plant protection product,

   • exposure reduction measures recommended,

   • protective clothing recommendations,

   • maximum application rate,

   • minimum spray application volume stated on the label,

   • number and timing of applications.

On the basis of the information mentioned in (a) the following overall end-points should be established for single or repeated operator exposure following the intended use:

• persistence or growth of the micro-organism in the host,

• adverse effects observed,

• observed or expected effects of contaminants (including contaminating micro-organisms),

• observed or expected effects of relevant metabolites/toxins.

If there are indications of colonisation in the host and/or if any adverse effects, indicative of toxicity/infectivity are observed, taking into account the exposure scenario (i.e. acute or repeated exposure), further testing is indicated.

This evaluation shall be made for each type of application method and application equipment proposed for use of the plant protection product as well as for the different types and sizes of containers to be used, taking into account mixing, loading operations, application of the plant protection product and cleaning and routine maintenance of application equipment. Where relevant, other authorised uses of the plant protection product in the area of envisaged use containing the same active substance or which give rise to the same residues may also be taken into account. It should be taken into account that if replication of the micro-organism is expected, exposure assessment could be highly speculative.

The absence or presence of the potential for colonisation or the possibility of effects in operators at the tested dose levels as provided for in Annex IIB and IIIB should be assessed with regard to measured or estimated levels of human exposure. This risk assessment, preferably quantitative, should include consideration of e.g. mode of action, biological, physical and chemical properties of the micro-organism and other substances in the formulation.