Poncho Votivo Staff evaluation and review report APP202077 Hearing - - PowerPoint PPT Presentation

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

Recommendation Overall Risk Additional Controls Risk Assessment Default Controls Hazard Classification

General approach

Human Health & Environmental Risk

Quantitative assessment except human 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

Risk Assessment

Cultural Risk

Impact on Māori culture and traditions 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

Risk 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

• perator 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)

Use scenario Pollen consumption (g/day) EEC (ng ai/bee/day) Toxicity endpoint value RQ Trigger value /Presumption Acute / Adult honey bees - oral Clothianidin / Maize seed treatment 0.000041 – 0.012 0.00015 – 0.0432 LD50 = 2.5 ng ai/bee 0.00006 – 0.02 < 0.4 / low concerns Acute / Adult bumble bees - oral Clothianidin / Maize seed treatment 0.0266 – 0.0303 0.098 – 0.108 LD50 = 1.943 ng ai/bee 0.05 – 0.06 < 0.4 / low concerns Acute / honey bee larvae – oral* Clothianidin / Maize seed treatment

• Residues in

pollen: 3.6 µg/kg NOEC > 40 µg ai/kg diet < 0.09 < 0.4 / low concerns Chronic / Adult honey bee - oral Clothianidin / Maize seed treatment 0.000041 – 0.012 0.00015 – 0.0432 NOEC = 0.38 ng ai/bee/day 0.0004 – 0.11 < 1 / low concerns

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

E3 – no spraying on flowering plants

Not applicable to a seed treatment

TR – Tracking

Commonly deleted as it does not add to risk management

Deleted Controls

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

Additional controls - labelling

Substance Seed

• PPE requirements
• Maximum application rate
• Application in a purpose build

seed treatment machine

• Treatment facility to have

ventilation

• PPE requirements
• Seeds must not be left in

areas accessible to birds

• Seeds must be completely

covered in soil when sown

Blank Slide

Recommendations

A maximum application rate for this substance is 120 mL of this substance per 80 000 seeds This substance may only be applied as a seed treatment Seeds treated with this substance must be film coated to minimise the amount of dust being generated during handling and sowing Seeds treated with this substance must be dyed to distinguish them from untreated seed