Staff Presentation - Ranman APP201941 Hearing: 24 February 2015
2 Outline Introduction Application process Classifications Risks Controls Benefits Recommendations
3 Introduction Fungicide – control late blight in potatoes and downy mildew in onions 421 g/kg cyazofamid (new active ingredient to NZ) Registered in Europe and USA
4 Use pattern Ranman is intended to be used on potatoes (to treat late blight) and onions (to treat downy mildew). Application form says in future, Ranman could be used to treat downy mildew and soil-borne diseases in other crops.
Application Process
6 Application Timeline 22 6 October – 11 February 24 April 2014 September 1 October 2014 18 November 2015 2014 2014 Maori Supplementary Submission E&R Consultation Formally info provided Period Released Received 27 November 2014 Further Information Requested
7 Further information request The staff asked for following further information: • ecotoxicity and environmental fate studies (including those requested by US EPA) • dermal absorption study for the formulation and information on test formulations • composition of proprietary components.
8 Māori Consultation In April 2014, the EPA sent out a summary of information on Ranman to Te Herenga*. The purpose of this consultation was to request enquires or feedback on the proposed application. The feedback received was used by the applicant to revise the application before it was formally received. * T he EPA’s national network of Māori resource managers, practitioners and experts on the environment
9 Public notification The application was publically notified because Ranman contains cyazofamid, an active ingredient that is new to New Zealand. One submission was received, from Te Rūnanga o Ngāi Tahu. It opposed the approval of Ranman.
10 Key issues in Ngāi Tahu’s submission Ngāi Tahu have concerns about information being kept confidential, whether the applicant’s cultural risk assessment was adequate and the lack of testing on native species. These issues have been raised in several previous submissions. The staff continue to address these concerns outside the application process. They also had concerns about the application form and the risks and benefits of Ranman. The EPA response to these issues is on pages 10-12 of the Evaluation and Review report.
11 Ngā Kaihautū * Ngā Kaihautū did not provide a report on this application but considers the issues and themes of relevance to Māori to be broadly similar to those identified in relation to the Mainman application. * The EPA’s Māori Advisory Committee
Classifications and Risks
13 Hazard classifications The staff determined the hazard classifications for Ranman using study data and mixture rules. The classification assigned: • 9.1A – very ecotoxic in the aquatic environment Ranman does not trigger any human toxicity classifications.
14 Risk assessment- human health The staff carried out a quantitative human health risk assessment for Ranman. This showed the exposure estimates are acceptable for: • operators • bystanders (member of the public), and • re-entry workers. The exposure estimates are below the acceptable operator exposure level (AOEL) for the proposed uses of Ranman.
15 Risk assessment - Environmental Aquatic organisms The acute risks for freshwater fish, crustacean and algae are low. However, there is a high acute risk to endangered/native species. The chronic risks were low. Soil organisms There was a high chronic risk for earthworms for cyazofamid and the metabolite CTCA in field (cultivation area). There were no acute risks. Terrestrial vertebrates (birds) No acute or reproductive risks to birds. Terrestrial invertebrates (bees) There were low risks to bees and other non-target arthropods
16 Relationship of Maōri to the Environment Native species could be exposed to Ranman by inaccurate or improper application or disposal. This could have an adverse impact on recreational or culturally significant food sources.
17 Relationship of Māori to the Environment (2) With the controls proposed in this report, the staff consider that any potential impact to the relationship of Māori to the environment will be negligible. The staff consider that the application is unlikely to be inconsistent with the principles of the Treaty of Waitangi.
Controls
19 Controls A set of default controls are triggered by the 9.1A hazard classification. The staff propose the following additional controls: Controls to manage risks to the aquatic and soil environment • Ranman cannot be applied into and onto water • the maximum application rate of this substance is 80 g cyazofamid/ ha • Ranman must not be applied to the same area more than six times per year • an interval of at least 7 days between applications of the substance must occur • the application of the substance is limited to ground based application methods only.
20 Controls 2 • when Ranman is applied in a wide dispersive manner, it must only be applied at high volume with a nozzle set to provide a coarse spray • a buffer zone of 4 metres between the application area and any downwind water body must be observed when applying Ranman. More additional controls: • WorkSafe New Zealand have set a WES (Workplace Exposure Standard) value for component B. This value applies to component B.
21 Controls 3 Controls which must be on label and safety data sheet The following statements (or words to this effect) must appear on the product label and safety data sheet: • “Do not allow entry into treated areas until the spray has dried, unless wearing cotton overalls buttoned to the neck and wrist (or equivalent clothing) and chemical resistant gloves. Clothing must be laundered after each day’s use” • “The maximum application rate of this substance is 80 g of cyazofamid/ ha” • “This substance must not be applied within 4 metres of a downwind water body”.
Benefits
23 Benefits • Ranman contains a new active ingredient, cyazofamid. This has a different mode of chemistry to currently available products. New actives with different modes of action that can be alternated with the older products are important for managing pest resistance. • Ranman has fewer hazards and lower hazard classifications than most other fungicides used for the same purpose. It can therefore be considered a safer alternative to some other active ingredients.
24 Benefits (2) • The staff consider that Ranman will provide benefits to growers and regional economic benefits to small organisations.
Conclusions and Recommendation
26 Overall Recommendation Provided there is compliance with the proposed set of controls identified in Appendix I, the staff have concluded there are: negligible risks to human health negligible risks to the environment negligible risks to the relationship of Māori to the environment, and significant benefits.
27 Recommendation That the Committee approval the import or manufacture of Ranman with the proposed controls
Any questions?
Recommend
More recommend
