The information provided, taken together with that for the active substance(s), must be sufficient to permit an assessment of the impact on non-target species (flora and fauna), of the plant protection product, when used as proposed. Impact can result from single, prolonged or repeated exposure, and can be reversible, or irreversible.
In particular, the information provided for the plant protection product, together with other relevant information, and that provided for the active substance, should be sufficient to:
specify the hazard symbols, the indications of danger, and relevant risk and safety phrases for the protection of the environment, to be mentioned on packaging (containers),
permit an evaluation of the short- and long-term risks for non-target species — populations, communities, and processes as appropriate,
permit an evaluation of whether special precautions are necessary for the protection of non-target species.
There is a need to report all potentially adverse effects found during routine ecotoxicological investigations and to undertake and report such additional studies which may be necessary to investigate the mechanisms involved and assess the significance of these effects.
In general, much of the data relating to impact on non-target species, required for authorization of plant protection products, will have been submitted and evaluated for the inclusion of the active substance(s) in Annex I. The information on fate and behaviour in the environment, generated and submitted in accordance with points 9.1 to 9.3, and on residue levels in plants generated and submitted in accordance with point 8 is central to the assessment of impact on non-target species, in that it provides information on the nature and extent of potential or actual exposure. The final PEC estimations are to be adapted according to the different groups of organisms taking in particular into consideration the biology of the most sensitive species.
The toxicological studies and information submitted in accordance with point 7.1 provide essential information as to toxicity to vertebrate species.
Where relevant, tests should be designed and data analysed using appropriate statistical methods. Full details of the statistical analysis should be reported (e.g. all point estimates should be given with confidence intervals, exact p-values should be given rather than stating significant/non significant).
Whenever a study implies the use of different doses, the relationship between dose and adverse effect must be reported.
Where exposure data are necessary to decide whether a study has to be performed, the data obtained in accordance with the provisions of Annex III, point 9 should be used.
For the estimation of exposure of organisms all relevant information on the plant protection product and on the active substance must be taken into account. A useful approach for these estimations is provided in the EPPO/Council of Europe schemes for environmental risk assessment (1) . Where relevant the parameters provided for in this section should be used. Where it appears from available data that the plant protection product is more toxic as the active substance, the toxicity data of the plant protection product have to be used for the calculation of relevant toxicity/exposure ratios.
In the context of the influence that impurities can have on ecotoxicological behaviour, it is essential that for each study submitted, a detailed description (specification) of the material used as provided for under point 1.4, be provided.
In order to facilitate the assessment of the significance of test results obtained the same strain of each relevant species should where possible be used in the various toxicity tests specified.
Possible effects on birds must be investigated except where the possibility that birds will be exposed, directly or indirectly, can be ruled out such as for use in enclosed spaces or wound healing treatments.
The acute toxicity/exposure ratio (TER a ), the short term dietary toxicity/exposure ratio (TER st ) and the long term dietary toxicity/exposure ratio (TER lt ) must be reported, where:
=
LD 50 (mg a.s./kg body weight) / ETE (mg a.s./kg body weight)
=
LC 50 (mg a.s./kg food) / ETE (mg a.s./kg food)
=
NOEC (mg a.s./kg food) / ETE (mg a.s./kg food)
where ETE = estimated theoretical exposure.
In the case of pellets, granules or treated seeds the amount of a.s. in each pellet, granule or seed must be reported as well as the proportion of the LD 50 for the a.s. in 100 particles and per gram of particles. The size and shape of pellets or granules must be reported.
In the case of baits the concentration of a.s. in the bait (mg/kg) must be reported.
The test should provide, where possible, LD 50 values, the lethal threshold dose, time courses of response and recovery, the NOEL, and must include relevant gross pathological findings.
The acute oral toxicity of preparations must be reported, where TER a or TER st for the active substance(s) in birds are between 10 and 100 or where results from mammal testing give evidence of a significantly higher toxicity of the prepration compared to the active substance unless it can be justified that it is not likely that birds are exposed to the plant protection product itself.
The study must be conducted on the most sensitive species identified in the studies provided for in Annex II, point 8.1.1 or 8.1.2.
The test will provide sufficient data to evaluate the nature and the extent of the risk in practical conditions of use.
Where the TER a and TER st are > 100 and when there is no evidence of risk from any further study on the active substance (e.g. reproduction study) no further testing is required. In the other cases, expert judgement is necessary to decide whether there is a need to carry out further studies. This expert judgement will take into account, where relevant, foraging behaviour, repellency, alternative food, actual residue content in the food, persistence of the compound in the vegetation, degradation of the formulated product or treated produce, the amount of predation of the food, acceptance of bait, granules or treated seed and the possibility for bioconcentration.
Where TER a and TER st ≤ 10 or TER lt ≤ 5, cage or field trials must be conducted and reported unless a final assessment is possible on the basis of studies according to point 10.1.3.
Before performing these studies the applicant should seek the agreement of the competent authorities on the type and conditions of the study to be performed.
The test will provide sufficient data to evaluate the possibility of consumption of the protection product or plant products treated with it.
In the case of seed dressings, pellets, baits and preparations which are granules and where TER a ≤ 10, acceptability (palatability) tests must be conducted.
Expert judgment is required to decide whether the effects of secondary poisoning should be investigated.
Possible effects on aquatic species must be investigated except where the possibility that aquatic species will be exposed can be ruled out.
TER a and TER lt must be reported, where:
=
acute LC 50 (mg a.s./l)/realistic worst case PEC sw (initial or short-term, in mg a.s./l)
=
chronic NOEC (mg a.s./l)/long term PEC sw (mg a.s./l)
In principle tests should be carried out on one species from each of the three groups of aquatic organisms as referred to in Annex II, point 8.2 (fish, aquatic invertebrates and algae) in case the plant protection product itself can contaminate water. However where the available information permits to conclude that one of these groups is clearly more sensitive, tests on only the most sensitive species of the relevant group have to be performed.
The test must be performed where:
the acute toxicity of the plant protection product can not be predicted on the basis of the data for the active substance which is especially the case if the formulation contains two or more active substances or formulants such as solvents, emulgators, surfactants, dispersants, fertilizers which are able to increase the toxicity in comparison with the active substance, or
the intended use includes direct application on water
unless suitable studies referred to under point 10.2.4 are available.
The relevant provisions as under the corresponding paragraphs of Annex II, points 8.2.1, 8.2.4 and 8.2.6 apply.
The tests must provide sufficient data to evaluate the essential impact on aquatic organisms under field conditions.
Where TER a ≤ 100 or where TER lt ≤ 10, expert judgment must be used to decide whether a microcosm or mesocom study is appropriate. This judgment will take into account the results of any additional data over and above those required by the provisions of Annex II, point 8.2 and of point 10.2.1.
Before performing these studies the applicant shall seek the agreement of the competent authorities on the specific aims of the study to be performed and consequently on the type and conditions of the study to be performed.
The study should include at least the highest likely exposure rate, whether from direct applicaiton, drift, drainage or run-off. The duration of the study must be sufficient to permit evaluation of all effects.
Appropriate guidelines are included in:
Setac — Guidance document on testing procedures for pesticides in freshwater mesocosms/Workshop Huntingdon, 3 and 4 July 1991
or
Freshwater field tests for hazard assessment of chemicals — European Workshop on Freshwater Field Tests (EWOFFT).
The test will provide sufficient data to evaluate the potential for occurrence of residues in fish.
In general data are available from bioconcentration studies in fish.
Where bioconcentration has been observed in the study performed in accordance with Annex II, point 8.2.3 expert judgement is required to decide whether a long-term microcosm or mesocosm study has to be carried out in order to establish the maximum residues likely to be encountered.
Setac — Guidance document on testing procedures for pesticides in freshwater mesocosms/Workshop Huntingdon, 3 and 4 July 1991 .
The studies referred to in Annex II, points 8.2.2 and 8.2.5 may be required for particular plant protection products where it is not possible to extrapolate from data obtained in the corresponding studies on the active substance.
Possible effects on wild vertebrate species must be investigated except where it can be justified that it is not likely that terrestrial vertebrates other than birds are exposed, directly or indirectly. TER a , TER st and TER lt must be reported, where:
=
LD 50 (mg a.s./kg body weight) / ETE (mg a.s./kg body weight)
=
subchronic NOEL (mg a.s./kg food) / ETE (mg a.s./kg food)
=
chronic NOEL (mg a.s./kg food) / ETE (mg a.s./kg food)
where ETE = estimated theoretical exposure.
In principle the evaluation sequence for the assessment of risks to such species is similar to that for birds. In practice it is not often necessary to perform further testing as the studies conducted in accordance with the requirements of Annex II, point 5 and Annex III, point 7 would provide the required information.
The test will provide sufficient information to evaluate the nature and the extent of risks for terrestrial vertebrates other than birds in practical conditions of use.
Where TER a and TER st > 100 and where there is no evidence of risk from any further study no further testing is required. In the other cases, expert judgment is necessary to decide whether there is a need to carry out further studies. This expert judgment will take into account, where relevant, foraging behaviour, repellency, alternative food, actual residue content in the food, persistence of the compound in the vegetation, degradation of the formulated product or treated produce, the amount of predation of the food, acceptance of bait, granules or treated seed and the possibility for bioconcentration.
Where TER a and TER st ≤ 10 or TER lt ≤ 5 cage or field trials or other appropriate studies must be reported.
Before performing these studies the applicant shall seek the agreement of the competent authorities on the type and conditions of the study to be performed and whether the effects of secondary poisoning should be investigated.
The possible effects on bees must be investigated except where the product is for exclusive use in situations where bees are not likely to be exposed such as:
food storage in enclosed spaces,
non-systemic seed dressings,
non-systemic preparations for application to soil,
non-systemic dipping treatments for transplanted crops and bulbs,
wound sealing and healing treatments,
rodenticidal baits,
use in glasshouses without pollinators.
The hazard quotients for oral and contact exposure (Q HO and Q HC ), must be reported:
=
dose/oral LD 50 (µg a.s. per bee)
=
dose/contact LD 50 (µg a.s. per bee)
where
=
the maximum application rate, for which authorization is sought, in g of active substance per hectare.
The test should provide the LD 50 values (by oral and contact exposure).
Testing is required if:
the product contains more than one active substance;
the toxicity of a new formulation cannot be reliably predicted to be either the same or lower than a formulation tested according to the provisions of Annex II, point 8.3.1.1 or of this point.
The test must be carried out according to EPPO Guideline 170.
The test should provide sufficient information to evaluate possible risks to foraging bees from residual traces of plant protection products remaining on crops.
Where Q HC ≥ 50, expert judgment is required to decide whether the effect of residues must be determined unless there is evidence that there are no significant residual traces remaining on crops which could affect foraging bees or unless sufficient information is available from cage, tunnel or field tests.
The median lethal time (LT 50 ) (in hours) following 24-hour exposure to residues on leaves aged during eight hours must be determined, and reported. Where LT 50 is more than eight hours, no further testing is required.
The test should provide sufficient information to evaluate possible risks from the plant protection product for bee survival and behaviour.
Where Q HO and Q HC are < 50, further testing is not required except if significant effects are observed in the bee brood feeding test or if there are indications for indirect effects such as delayed action or modification of bee behaviour, in those cases cage and/or field tests shall be carried out.
Where Q HO and Q HC are > 50, cage and/or field testing is required.
Where field testing is conducted and reported in accordance with point 10.4.4, it is not necessary to conduct cage tests. However, cage tests where conducted, must be reported.
The test should be carried out using healthy bees. If bees have been treated, e.g. with a varroacide, it is necessary to wait for four weeks before using the colony.
The tests must be conducted in accordance with EPPO Guideline 170.
The test should provide sufficient information to evaluate possible risks from the plant protection product on bee behaviour, colony survival and development.
Field tests must be conducted where on the basis of expert judgement, taking into account the proposed manner of use and the fate and behaviour of the active substance, significant effects are observed in cage testing.
The test should be carried out using healthy honeybee colonies of similar natural strength. If bees have been treated, e.g. with a varroacide, it is necessary to wait for four weeks before using the colony. The tests shall be conducted under conditions reasonably representative of the proposed use.
Special effects (larval toxicity, long residual effect, disorienting effects on bees) identified by the field tests may require further investigation using specific methods.
The tests must be conducted in accordance with EPPO Guideline 170.
The test should provide sufficient information to evaluate the impact on bees resulting from feeding on contaminated honey dew or flowers.
Where it is not possible to investigate certain effects in cage or field trials, a tunnel test should be carried out, e.g. in the case of plant protection products intended for control of aphids and other sucking insects.
The test should be carried out using healthy bees. If bees have been treated, e.g. with a varroacide, it is necessary to wait for four weeks before using the colony.
The test must be carried out in accordance with EPPO Guideline 170.
The effects of plant protection products on non-target terrestrial arthropods (e.g. predators or parasitoids of harmful organisms) must be investigated. The information obtained for these species can also be used to indicate the potential for toxicity to non-target species inhabiting the same environment.
The test should provide sufficient information to evaluate the toxicity of the plant protection product for selected arthropod species that are relevant to the intended use of the product.
Testing is not required where severe toxicity (> 99 % effect on the organisms compared to control) can be predicted from relevant available data or where the plant protection product is for exclusive use in situations where non-target arthropods are not exposed such as:
food storage in enclosed spaces,
wound sealing and healing treatments,
rodenticidal baits.
Testing is required when significant effects on the organisms in comparison with the control are reported in the laboratory tests at the maximum recommended dose, conducted in accordance with the requirements of Annex II, point 8.3.2. Effects on a particular test species are considered to be significant when they exceed the threshold values as defined in the EPPO schemes for the environmental risk assessment unless species-specific threshold values are defined in the respective test guidelines.
Testing is also required if:
the product contains more than one active substance,
the toxicity of a new formulation cannot be reliably predicted to be either the same or lower than a formulation tested according to the provisions of Annex II, point 8.3.2 or of this point,
on the basis of the proposed manner of use or on the basis of the fate and behaviour continued or repeated exposure can be anticipated,
there is a significant change in the proposed use, e.g. from arable crops to orchards, and species relevant to the new use have not previously been tested,
there is an increase in the recommended application rate, above that previously tested under Annex II.
Where significant effects were observed in the studies performed in accordance with the requirements of Annex II, point 8.3.2, or in the case of change of use such as arable crops to orchards, the toxicity of two additional relevant species must be investigated and reported. These must be different to the relevant species already tested under Annex II, point 8.3.2.
For a new mixture or formulation, the toxicity should initially be assessed using the two most sensitive species as identified in studies already performed for which the threshold values were exceeded but effects still remain below 99 %. This will enable a comparison to be made; if it significantly more toxic two species relevant to its proposed use must be tested.
Testing must be conducted at a rate equivalent to the maximum rate of application for which authorization is sought. A sequential testing approach should be adopted, i.e. laboratory, and if necessary extended laboratory and/or semi-field.
Where there will be more than one application per season, the product should be applied at twice the recommended application rate unless this information is already available from studies performed in accordance with Annex II, point 8.3.2.
Where on the basis of the proposed manner of use or on the basis of the fate and behaviour continued or repeated exposure can be anticipated (such as the product is to be applied more than three times per season with a re-application of 14 days or less), expert judgment is required to examine whether further testing is required, beyond initial laboratory testing, which will reflect the proposed use pattern. These tests may be performed in the laboratory or under semi-field conditions. When the test is done in the laboratory a realistic substrate such as plant material or a natural soil should be used. However it may be more appropriate to carry out field tests.
Where relevant testing should be done according to appropriate guidelines which satisfy as least the requirements for testing as included in Setac - Guidance document on regulatory testing procedures for pesticides with non-target arthropods.
The tests should provide sufficient information to evaluate the risk of the plant protection product for arthropods under field conditions.
Where significant effects are seen following laboratory and semi-field exposure, or where on the basis of the proposed manner of use or on the basis of the fate and behaviour continued or repeated exposure can be anticipated expert judgment is required to examine whether more extensive testing is necessary to permit an accurate risk assessment.
The tests must be conducted under representative agricultural conditions and in accordance with the proposed recommendations for use, resulting in a realistic worst case study.
A toxic standard should be included in all tests.
Where relevant testing should be done according to appropriate guidelines which satisfy at least the requirements for testing as included in Setac — Guidance document on regulatory testing procedures for pesticides with non-target arthropods.
The possible impact on earthworms must be reported except where it can be justified that it is not likely that earthworms are exposed, directly or indirectly.
TER a and TER lt must be reported where:
=
LC 50 (mg a.s./kg)/realistic worst case PEC s (initial or short-term, in mg a.s./kg)
=
NOEC (mg a.s./kg)/long term PECs (mg a.s./kg).
The test should provide the LC 50 , where possible the highest concentration causing no mortality and the lowest concentration causing 100 % mortality and must include observed morphological and behavioural effects.
These studies are only required where
the product contains more than one active substance,
the toxicity of a new formulation cannot be reliably predicted from the formulation tested according to the provisions of Annex II, point 8.4 or of this point.
The tests must be conducted in accordance to OECD Method 207.
The test should provide the NOEC and the effects on growth, reproduction and behaviour.
These studies are only required where
the product contains more than one active substance,
the toxicity of a new formulation cannot be reliably predicted from the formulation tested according to the provisions of Annex II, point 8.4 or of this point,
there is an increase in the recommended application rate, above that previously tested.
The same provisions as under the corresponding paragraphs of Annex II, point 8.4.2 apply.
The test should provide sufficient data to evaluate the effects on earthworms in field conditions.
Where TER lt < 5 a field study to determine effects under practical field conditions must be conducted and reported.
Expert judgment is required to decide whether residue contents of earthworms should be investigated.
Fields selected shall have a reasonable earthworm population.
The test must be carried out at the maximum proposed application rate. A toxic reference product must be included in the test.
The test should provide sufficient data to evaluate the impact of the plant protection product on macro-organisms that contribute to the breakdown of dead plant and animal organic matter.
Testing is not required where in accordance with Annex III, point 9.1, it is evident that DT 90 values are less than 100 days, or the nature and manner of use of the plant protection product are such that exposure does not occur or when data from studies on the active substance performed in accordance with the provisions of Annex II, points 8.3.2, 8.4 and 8.5 indicate that there is no risk for soil macrofauna, earthworms or soil microflora.
Impact on organic matter breakdown must be investigated and reported, where the DT 90f values determined in field dissipation studies (point 9.1) are > 365 days.
The test should provide sufficient data to evaluate the impact of the plant protection product on soil microbial activity in terms of nitrogen transformation and carbon mineralization.
Where the DT 90f values determined in field dissipation studies (point 9.1) are > 100 days, impact on soil non-target micro-organisms must be investigated through laboratory testing. Testing is, however, not required if in the studies performed in accordance with the provisions of Annex II, point 8.5 deviations from control values in terms of metabolic activity of the microbial biomass after 100 days is < 25 %, and such data are relevant to the uses, nature, and properties of the particular preparation to be authorized.
Setac — Procedures for assessing the environmental fate and ecotoxicity of pesticides.
The test should provide sufficient data to evaluate the impact of the plant protection product under field conditions on microbial activitiy.
Where at the end of 100 days, measured activity deviates by more than 25 % from the control, in the laboratory testing further testing in the laboratory, under glass and/or in the field may be necessary.
A summary of available data from preliminary tests used to assess the biological activity and dose range finding whether positive or negative, which provides information with respect to possible impact on non/target species, both flora and fauna, must be provided, together with a critical assessment as to its relevance to potential impact on non-target species.]
Textual Amendments
[F1OEPP/EPPO (1993). Decision-making schemes for the environmental risk assessment of plant protection products. Bulletin OEPP/EPPO Bulletin 23, 1-154 and Bulletin 24, 1-87.]