Staff Presentation - Cadet APP202170 Hearing: 27 November 2015
2 Outline Introduction to application and process Application process Submissions Classifications, Risks, Controls Benefits Recommendations
3 Introduction Herbicide – broadleaf weed control 100 g/L Fluthiacet-methyl as an emulsifiable concentrate (new active ingredient to NZ) Registered in US, Japan, China
4 Use pattern Control of broadleaf weeds in production of Maize silage Maize grain Applied using ground-based boom spraying between growth stages 9 (emergence) to 33 (stem elongation – 3 nodes). Applied at rates of upto 80 mL Cadet (8 g a.i.) / ha, once per crop cycle
5 Application Process
6 Application Timeline 1 October – 5 June 17 September 13 November 13 November 2014 2014 2015 2014 Application Formally Staff Report Submission lodged Received Released Period 17 November 2014 – 19 September 2015 Further Information Requested and Received
7 Māori Consultation Prior to formal receipt, the EPA sent out a summary of information on Cadet to Te Herenga* The purpose of this consultation was to request feedback on the draft application. No specific information on this application was received. * T he EPA’s national network of Māori resource managers, practitioners and experts on the environment
8 Reason for public notification The application was publically notified because Cadet contains an active ingredient that is new to New Zealand
9 Submissions
10 Submissions 3 submissions were received: Opposed to approval • Te Rūnanga o Ngāi Tahu • Tau Iho I Te Po Trust In support of approval • Federated Farmers of New Zealand (Incorporated)
11 Key issues raised by submitters Availability of data provided in application Effects on taonga species Possibility of synergistic effects with other tank- mixed pesticides Impacts on waterbodies (from spray drift, run-off, leaching)
12 Staff response (1) Data, native species assessment addressed in previous applications and processes implemented Acknowledge lack of information on synergism Tank mixing is common practice No information to determine whether this is of concern Assessment looking at effects of Cadet Use of other substances is subject to compliance with controls for other substances Issues associated with tank mixes broader than scope of this application
13 Staff response (2) Staff R/A assessed risks to aquatic systems from spray drift, run-off and leaching Some acute risks to aquatic organisms Managed through additional controls
14 Classifications and Risks
15 Classifications Hazard Endpoint EPA classification Flammability 3.1D Acute Toxicity 6.1E (oral, aspiration) Eye corrosivity 8.3A Carcinogenicity 6.7B Repro./dev. toxicity 6.8A Target organ systemic toxicity 6.9A Aquatic ecotoxicity 9.1A Soil ecotoxicity 9.2A Vertebrate ecotoxicity 9.3C
16 Risks to human health Assessment valid for specified application conditions Negligible risks to human health During mixing / loading / application (specific PPE required) Re-entry workers Bystander (child)
17 Risks to the environment High acute risk for threatened algae High acute risks for threatened aquatic plants Protect through additional controls and application restrictions Currently no list of threatened freshwater algae so this conclusion is only theoretical No chronic risks are expected for fish and aquatic invertebrates
18 Identified uncertainties Synergistic effects [tank mix] Ecotoxicity of metabolites Environmental fate of metabolites Any significant uncertainties are considered to been addressed through the risk assessment
19 Ecotoxicity of metabolites Metabolites of significance Metabolites of significance Ecotoxicity of key metabolite CGA-300403 Ecotoxicity of key metabolite CGA-300403 Sediment toxicity Sediment toxicity
20 Environmental Fate Sediment, soil, water degradation Sediment, soil, water degradation Degradation of CGA-300403 in soil and water Degradation of CGA-300403 in soil and water Nitrogen/carbon transformation in soil Nitrogen/carbon transformation in soil Bioaccumulation/bioconcentration of key Bioaccumulation/bioconcentration of key metabolites metabolites These data gaps are adequately addressed by These data gaps are adequately addressed by the TTR approach the TTR approach
21 Total Toxic Residues (TTR) approach TTR assumes that all metabolites are as toxic as the parent molecule Degradation rates have been recalculated on the basis of the amounts of the parent compound and the 9 metabolites A conservative approach when metabolite information is not available
22 Additional information provided Applicant provided adsorption/desorption study for metabolite CGA-300403 (23/11/15) Study reviewed and summarised No other ecotoxicity or environmental fate information provided to support application Consider that TTR approach remains most appropriate No change to conclusion of R/A
Relationship of Māori to the 23 Environment With the controls proposed in this report, the staff consider that any potential impact to the relationship of Māori to the environment will be adequately managed Approval of application is not likely to be inconsistent with the principles of the Treaty of Waitangi
24 Key Controls
25 Maximum application rate Maximum application rate = 40 mL Cadet (4 g a.i.) / ha proposed. Maximum number of applications = once in any 365 day period
26 Protection of aquatic environment Not onto/into water Ground-based application only Coarse droplet size 10m Buffer Zone for downwind waterbodies
27 Labelling controls Label statements to communicate additional controls to users
28 Benefits
29 Benefits If applicant’s described benefits are realised New active ingredient with different mode of action to common herbicides Control of resistant weeds Avoid increasing application rates of common herbicide products Non-negligible benefits
30 Recommendation
31 Recommendation Despite identified uncertainties, adequate assessment of Cadet was completed The risks assessed risks of use of Cadet are adequately managed EPA staff propose that the import or manufacture of Cadet is approved, subject to the proposed controls
32 Questions
33 Supplementary Slides
34 Native species testing (1) Current practice relies on data for surrogate species and uncertainty factors Laboratory tests used for regulatory purposes are: • standardised (OECD guidelines) • of high quality (Good Laboratory Practices) Tests performed on species • with well known sensitivity • bred in laboratory in order to minimise interferences (e.g. diseases, parasites etc), aid reproducibility Results are reliable (only related to the test substance), reproducible, and accepted worldwide by regulatory bodies .
35 Native species testing (2) Complications regarding native species testing • Cost, particularly with respect to the marginal NZ market • Lack of NZ labs to produce GLP studies adhering to OECD protocols – only one such lab in Australasia, and it is in Australia – only certified for aquatic testing • No established framework for what such a regime might look like EPA continue to work towards a solution with the aim to both complement the current approach and more effectively address the concerns of Ngāi Tahu and others in this regard Also exploring options for mahinga kai
36 Confidential Information Confidential information We encourage applicants with notified applications to consider providing more detailed and technical information for submitters
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