Poncho Votivo Staff evaluation and review report APP202077 Hearing 3 December 2015
Scope of this hearing The decision-making committee (DMC) are asked to make a decision on Poncho Votivo They are not able to: Ban or alter the approval of any approved substance Revoke or recall any approved substance Re-evaluate or reassess neonicotinoids in general The DMC may choose to make recommendations about broader issues in their decision
Scope of the application It is a seed treatment The active ingredients are: 508 g/L of Clothianidin 102 g/L Bacillus firmus I-1582 B. firmus I-1582 is a new pesticide active ingredient to New Zealand It is intended to be used on maize seeds only It is for commercial/ workplace use only
Overall recommendation Approve with controls Evaluation of up-to-date (to 2014) test data for this substance and for the specific use proposed by the applicant Poncho Votivo used as seed treatment for maize
Overview General overview of the assessment approach Human health risks Environmental risks Cultural risks Questions
Assessment Approach
General approach Recommendation Hazard Default Additional Overall Risk Controls Controls Classification Risk Assessment
Human Health & Environmental Risk Risk Quantitative assessment except human Assessment health assessment for B. firmus I-1582 – which was qualitative Internationally accepted and validated regulatory models mainly from the US and EU We use studies that are • Done to Good Laboratory Practice (GLP) standards • Follow test guidelines and standard methods where available
Cultural Risk Risk Impact on Māori culture and traditions Assessment Qualitative assessment Social Risk Impacts on public health, social disruption Qualitative assessment Economic risk Impacts on employment, viability of businesses, local and national economies Qualitative assessment
Human Health Assessment
Exposed populations This substance is only expected to be used in workplaces Exposure to workers during seed treatment and sowing was evaluated quantitatively Exposure to bystanders and re-entry workers was considered negligible due to the use pattern
Potential exposure pathways Inhalation e.g. breathing in dust or mist Seeds treatment and at the seed treatment facility Handling, sowing and cleaning equipment Skin and eye contact Handling the substance Dusts during seed treatment, handling and sowing seeds, and cleaning equipment
Clothianidin Exposure studies and quantitative modelling Worker exposure is below the acceptable operator exposure level (AOEL) when appropriate PPE is worn Recommended controls Require long trousers, long-sleeved shirt and gloves during mixing, loading, or calibrating equipment, and handling treated seed or contaminated equipment Require long trousers, long-sleeved shirt, gloves and disposable coveralls when cleaning equipment
Bacillus firmus I-1582 Qualitative assessment of studies No pathogenic No toxicological effects observed in studies Microbial biopesticides are considered skin and respiratory sensitisers Recommended controls Require eye and respiratory protection (PPE)
Seed treatment process Workers may be exposed to dust or mists containing Poncho Votivo Recommended controls Seeds must be treated in a purpose build seed-treatment machine In a treatment plant with local exhaust ventilation
Recommendations The human health risks can be reduced to negligible with controls We recommend Varying the T5 control to specify the level of PPE that is required Applying additional controls to specify the required seed treatment practices (e.g. ventilation)
Environmental Assessment
Risk assessment approach Quantitative assessment ( i.e. using models) We use a mixture of validated and peer reviewed models from the US and EU Assessment made for maize crops only The applicant limited the use pattern of the substance to maize only during the risk assessment
Threatened natives species approach All study data is based on standard test species Threatened native species may be more sensitive than test species, or the loss of an individual may adversely affect the population Safety factor is used to account for uncertainty about native species sensitivity This approach is applied to the assessment of aquatic and soil organisms, plants and birds
Spray drift and dust drift Spray drift is not relevant because this is a seed treatment Dust drift occurs during seed sowing, can be reduced by film coating seeds Dust generated from maize seeds treated with Poncho Votivo were below the level of concern Recommended controls Require seeds to be film coated
Overview Risks were below the level of concern for Aquatic organisms Soil organisms Plants Bees Non-target arthropods There are chronic risk from clothianidin to threatened birds that consume treated shoots as their only food source
Assessment of risks to birds (clothianidin) Acute risk From eating seeds and shoots Short term (1-3 days) and long term (21 day) exposure Chronic risk From eating seeds and shoots during the reproduction period Key assumption 100% of the birds’ diet is treated seeds
Risks to birds There are borderline chronic (reproduction) risks to threatened birds only when the birds only eat shoots from treated seeds Threatened bird species do not tend to be found in agricultural areas, or to feed on solely on maize during the reproductive cycle The assessment scenario is more conservative than what actually occurs
Risks to birds The risks can be mitigated by additional controls Recommended controls Seeds must not be left in areas accessible to birds Seeds must be covered in soil when sown
Assessment of risk to bees Assessment covered Short and long term exposure Lab, semi-field and field tests Acute effects Mortality Chronic effects Behaviour, mortality, hive condition Bumble bees Adults Honey bee Adults and larvae
Bee RA methodology US EPA (2014) bee risk assessment methodology Addresses the current scientific knowledge Uses the available standardised methods for the bee risk assessment The RQ (risk quotient) values are calculated for individual bees, therefore they are applicable to solitary as well as social bees
Results of the risk assessment (RA) Pollen EEC Toxicity Trigger value Use scenario consumption (ng endpoint RQ /Presumption (g/day) ai/bee/day) value Acute / Adult honey bees - oral Clothianidin / 0.00015 – 0.00006 – LD 50 = 2.5 ng < 0.4 / low 0.000041 – 0.012 Maize seed 0.0432 ai/bee 0.02 concerns treatment Acute / Adult bumble bees - oral Clothianidin / LD 50 = 1.943 < 0.4 / low 0.0266 – 0.0303 0.098 – 0.108 0.05 – 0.06 Maize seed ng ai/bee concerns treatment Acute / honey bee larvae – oral* Clothianidin / Residues in NOEC > 40 < 0.4 / low Maize seed - pollen: 3.6 < 0.09 µg ai/kg diet concerns treatment µg/kg Chronic / Adult honey bee - oral Clothianidin / 0.00015 – NOEC = 0.38 < 1 / low 0.000041 – 0.012 0.0004 – 0.11 Maize seed 0.0432 ng ai/bee/day concerns treatment
Conclusions of the RA for bees There were no concerns for adult and larvae of honey bees from acute or chronic exposure to residues of clothianidin in the pollen of maize. There is no concerns for adult bumble bees from acute exposure. Higher tier studies (tunnel or field tests), for exposure to maize pollen or guttation fluid, showed that there were no effects on mortality, behaviour, hive condition for seeds treated at the rate proposed for Poncho Votivo
Cultural Assessment
Overall Recommendation
Approve with controls We have proposed several variations, deletions and additions to the default controls These are presented in the staff evaluation and review report and n discussed here
Questions for the Staff
Supplementary Slides
Summary of proposed varied, delted and additional controls
Varied Controls T5 – PPE control Varied to specify the type of PPE required in different situations EM12 – secondary containment systems Standard variation to clarify requirements Deleted Controls E3 – no spraying on flowering plants Not applicable to a seed treatment TR – Tracking Commonly deleted as it does not add to risk management
Additional controls – general Stationary Container Systems Standard additional control to manage liquids stored in tanks Water control Standard additional control to prevent pesticides being applied to water unless assessed for that use
Additional controls – seed treatment Use limited to a seed treatment only Seed treated in a purpose build seed treatment machine Seeds must be film coated Seeds must be dyed
Additional controls – treated seed Apply disposal requirements to treated seeds Labelling requirements applied to packages containing treated seeds to identify what they have been treated with.
Additional controls – use Treated seeds must not be used for human or animal consumption Maximum application rate 120 mL / 80 000 seeds Seeds must not be left in areas accessible to birds Seeds must be covered in soil when sown
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