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ERMA200692: Application for re-evaluation Quintozene Page 7 of 134 Table E.3: Interpretation of TER in reproductive phase-specific assessment 88 Table E.4: Environmental risk quotients for aquatic organisms 90. ERMA200692: Application for re-assessment Quintozene Page 9 of 134 Table ES1: Summary of classifications of quintozene „ water dispersible granule or.

Revised controls

-entry workers Turf, Seedlings, Soil Health risks of re-entry workers from use of quintosene on turf and seedbeds in the field, both from quintosene and its dioxin contamination. Bystanders Turf, Seedlings, Soil Health risks of bystanders are high for use of quintosene on turf and seedbeds in the field due to exposure to quintosene and dioxin.

Preliminary recommendation

ERMA200692: Quintozene Reassessment Application Page 11 of 134 Non-negligible area. refer to section ) Details of non-negligible risks from dioxin long after application. No potentially significant positive effects were identified from the use of quintozene (with its contaminant dioxin) in relation to human health or the environment.

Submissions

Submissions must state the reasons for making the submission and indicate whether the submitter wishes to be heard at a public hearing.

SECTION ONE – THE APPLICATION

  • Background to the application
  • Preparation of the application
  • Notification and consultation
  • Substance(s) covered by the application

However, during this assessment ERMA New Zealand considered publicly available sources of toxicological and ecotoxicological data, including environmental fate data for quintocene, in order to check whether the ERMA New Zealand classifications for quintocene are generally consistent with internationally available data. For the dioxin impurity, a well-established human exposure criterion established by the New Zealand Ministry of Health was used to quantify the risk to human health.

Table 1:   Quintozene-containing substance covered by this application 1
Table 1: Quintozene-containing substance covered by this application 1

SECTION TWO – THE RISK MANAGEMENT CONTEXT

  • Risk management context
  • Consideration of risk management scenarios
  • Identification and assessment process
  • Consideration of uncertainty
  • Ethical considerations
  • Principles of the Treaty of Waitangi (Te Tiriti ō Waitangi)

When a scientific or technical uncertainty remains unresolved, the Authority must take into account the need for caution in managing the adverse effects of the substance (clause 30). When ethical dilemmas arise, ERMA New Zealand has described them in terms of the framework.

SECTION THREE – THE SUBSTANCE AND ITS LIFECYCLE

  • Quintozene technical grade active ingredient
  • Regulatory History in New Zealand
  • Overseas Usage and Regulatory History
  • Mode of action
  • Review of hazardous properties
  • Classification
  • Lifecycle

Residues of quintozene have been found in US locations where it is not used. The classification of quintozene is the same as that of the mixture in Table 3, because the quintozene component drives all classifications.

Table 3:   Hazard classification of „water dispersible granule or wettable powder  containing 750 g/kg quintozene‟
Table 3: Hazard classification of „water dispersible granule or wettable powder containing 750 g/kg quintozene‟

Manufacture, importation, transport and storage

New Zealand Usage of quintozene

Incidents

New Zealand Incidents

Overseas Reports

Uses

Application Method of application Application amount (product) Application amount (quintocene)* Frequency Grass area Low tube is assumed to be 30 g/10 m2 in 5 litres. No deposition rate for the dioxin impurity is given here, as the dioxin deposition rate was derived from the quintocene deposition rate using the dioxin contaminant concentration.

Current Controls

SECTION FOUR – IDENTIFICATION AND ASSESSMENT OF ADVERSE AND POSITIVE

Introduction

Environment Introduction

Identification of adverse effects (risks and costs)

Assessment of potentially significant adverse effects (risks and costs)

Acute risks: ERMA New Zealand considers the probability of acute mortality among birds to be low for all 3 uses modelled: peat, seedlings (post-plant) and soil (pre-sow). Quantitative assessment indicates that the use of quintosene poses a high acute and chronic risk to fish in the aquatic environment.

Table 8:   Summary of environmental risk assessment for use of quintozene (with its  dioxin contaminant) with current controls
Table 8: Summary of environmental risk assessment for use of quintozene (with its dioxin contaminant) with current controls

Identification of positive effects (benefits)

ERMA New Zealand also notes that the potential for long-distance transport of quintozene contributes to environmental risks that are not taken into account when modeling risk quotients. Quantitative assessment indicates that quintozene use poses a low probability of acute mortality in birds for all modeled use scenarios.

Overall evaluation of risks and benefits to the environment

Human health and safety

Additionally, due to the nature of the dioxin contamination, particularly its persistence, ERMA New Zealand notes that use of quintozen in a workplace over time may result in a build-up of residues. Bystander risks from dioxin following application of quintozen to grass from two applications 30 days apart are considered by ERMA New Zealand to be.

Overall evaluation of risks and benefits to human health

Society and communities

Identification of adverse effects on society and communities

Identification of positive effects on society and communities

The market economy

And address how the application will affect the market economy, as opposed to health, social, ecological and amenity impacts. This will include impacts on the supply of goods through their production, distribution and marketing, and on the domestic and export demand for those goods.

Identification of adverse effects on the market economy

Although it is accepted that there are significant overlaps between these areas, the intention is to provide information to support an understanding of how costs and benefits arise in the traded sector. The effects associated with risk management scenario (b) or a set of modified controls are expected to result in reduced adverse effects and reduced benefits.

Identification of positive effects (benefits) on the market economy

The New Zealand Sports Turf Institute (NZSTI) notes that while Terraclor 75WP is only one of a range of products, some of the others. Although the value of crop at risk is high (estimated at $100,000), ERMA New Zealand does not believe that this represents an accurate threshold value for the positive effect of the availability of Terraclor 75WP and concludes that the positive effect over a number of years is not potentially significant.

Overall evaluation of effects on the market economy

Māori interests and concerns Relationship of Māori to the environment

Treaty of Waitangi

International obligations

Persistent organic pollutants, to which New Zealand is a signatory, are relevant to the continued use of quintocene in New Zealand. ERMA New Zealand believes that the national commitment to the Stockholm Convention, to reduce dioxin emissions and introduce good management of other POPs, such as HCB and.

SECTION FIVE – LIKELY EFFECTS OF QUINTOZENE BEING UNAVAILABLE

Introduction

Availability of alternative pesticides

SECTION SIX – PROPOSALS TO MANAGE RISKS

Evaluation of risk management options

ERMA New Zealand notes that, given the intended use in seedling crops and on grass, bees are not expected to be exposed to quintocene from the use of the approved substance. Decision on additional control options to address risks to human health 6.1.20 ERMA New Zealand notes that for many risks to the operator re-entry.

Table 12:   Risks and proposed risk management measures
Table 12: Risks and proposed risk management measures

SECTION SEVEN – OVERALL EVALUATION

Introduction

Overall Evaluation

Preliminary Recommendation

ERMA New Zealand notes that the registrant has already stopped importing the product pending the outcome of this re-evaluation. ERMA New Zealand suggests allowing stockholders a period of 6 months to use up the product.

APPENDICES

Appendix A: Chemical and physical properties of the active ingredient and methods of analysis

DT50 ≤ 2.5 days (pH 5, 25 oC) Photodegradation is expected to be a significant route of distribution of quintocene in the environment when the substance is present in clear shallow surface water in non-adsorbed state. ERMA200692: Application for reassessment of Quintosene Page 70 of 134 Table B.3 Fate and behavior of quintosene in air.

Table B.1:  Terrestrial fate and behaviour of quintozene
Table B.1: Terrestrial fate and behaviour of quintozene

Appendix C: Environmental Exposure Modelling

Concentrations in surface water

The results of the modeling are summarized in Table C.3 and the model output is shown in Table C.3. ERMA200692: Application for re-evaluation of quintozene Page 73 of 134 FIELD AND STANDARD POND HALF-LIFE VALUES (DAYS).

Table C.3:  Scenarios used in exposure modelling and aquatic estimated environmental concentrations for quintozene
Table C.3: Scenarios used in exposure modelling and aquatic estimated environmental concentrations for quintozene

Concentrations in groundwater

Terrestrial exposure

Exposure

ERMA200692: Application for reassessment of quintozene Page 79 of 134 Table C.5: Exposure of birds for acute assessment. ERMA200692: Request reassessment Quintozene Page 81 of 134 Table C.6: Exposure of birds for reproductive assessment.

1  Crop type (EFSA, 2008, Table I.1 & I.3)
1 Crop type (EFSA, 2008, Table I.1 & I.3)

Appendix D: Ecotoxicity of quintozene

Environmental classification

Aquatic organisms

Terrestrial organisms

ERMA200692: Quintozene re-evaluation application Page 88 of 134 Table E.2: Exposure and toxicity measures used in the reproduction assessment. One possibility is to determine whether the effects are the result of short-term exposure.

Table E.3:  Interpretation of TER in reproduction phase-specific assessment  Assessment outcome
Table E.3: Interpretation of TER in reproduction phase-specific assessment Assessment outcome

Risk assessment

The results of the risk assessment are shown in table E.6 (acute risk) and table E.7 (reproduction risks). ERMA New Zealand considers the identified chronic environmental risks of quintozene use to be an underestimation of the risk.

Table E.5:  Toxicity values used in risk assessment
Table E.5: Toxicity values used in risk assessment

Bulb dipping

HQ values ​​that exceed levels of concern can be refined using higher-level test results, such as half court and field trials. Due to a lack of toxicity data for earthworms, plants and terrestrial invertebrates (except bees), ERMA New Zealand was unable to perform a risk assessment for those species.

Long-range transport

Conclusions environmental risks

A buffer zone of 200 m or more is required for multiple applications on turf and the pre-planting. A buffer zone of 30 meters will be sufficient to protect the aquatic environment after one application with a coarse droplet size on turf.

Appendix F: Classification of Quintozene (Class 6), Derivation of AOEL for Quintozene and the Tolerable

F1 Quintozene

ERMA New Zealand has not proposed a classification of quintozene for carcinogenicity based on these data. ERMA New Zealand does not consider the effects on thyroid in rodents to be toxicologically relevant to humans.

Table F.2:  Class 6 classification of quintozene technical active ingredient
Table F.2: Class 6 classification of quintozene technical active ingredient

F2 A brief summary of the toxicological effects of dioxin and adoption of the tolerable monthly intake (TMI)

In the proposed re-evaluation document of the PMRA from 2009 [which is not a final document but is available on the PMRA website (PMRA, 2009)] reference is made to the use of "33% of the orals". The core data for deriving the TMI for dioxin is that of the WHO which leads to the tolerable daily intake (TDI) of 1 – 4 pg/kg body weight/day.

Table F.5:   Key studies used in the derivation of human health criteria.
Table F.5: Key studies used in the derivation of human health criteria.

Appendix G: Human Exposure and Risk Assessment for Quintozene

G1 Introduction

G2 Operator Exposure Modelling for Quintozene

Estimated exposure to quintocene for 70 kg operator under five different exposure scenarios as predicted from the UK PSD's interpretation of the BBA model and associated RQ estimates from the use of Terraclor 75 WP for grass. The operator exposure estimates for both application methods for quintocene application to turf are unacceptable with any of the available levels of personal protective equipment (PPE).

Table G.4:    Operator exposure and risk estimates for quintozene from seed bed uses at  90 kg quintozene/ha
Table G.4: Operator exposure and risk estimates for quintozene from seed bed uses at 90 kg quintozene/ha

G3 Re-entry exposures to quintozene

Re-entry worker exposure is calculated by estimating the exposure of workers entering a crop that has been sprayed and comparing it to the AOEL. Re-entry exposure was estimated using a modified version of the approach used by the UK Chemical Regulation Directorate (CRD, 2010b).

G4 Bystander exposures to quintozene

ERMA New Zealand notes that using 35 days, the default value, for a relatively stable material such as quintocene is not tentative. ERMA200692: Quintozene reassessment application Page 117 of 134 Table G.6: Estimated exposure to quintozene of 15 kg child exposed through contact.

G5 Conclusions of Human Health Exposure and Risk Assessment for quintozene

Buffer zone required to reduce exposure of young children to RfD Turf (2 applications at 30 day intervals) 90000 kg a.i./ha. For applications to turf and seedbeds (at the highest rate) with a low boom, fine droplet sprays, which is most likely for the fungicide, the risk estimates for the toddler are high, even at a distance of 8m away.

Appendix H: Qualitative Descriptors for Risk/Benefit Assessment

Qualitative descriptors for risk/benefit assessment

Measurable beneficial effect on GDP, creating some long term (more than five years) significant social benefit to the surrounding community and individuals in the wider community. Significant ongoing effect, beneficial to GDP, long-term job creation on a national basis Major social benefits affecting the wider community.

Table H.2:  Magnitude of beneficial effect (benefits)  Descriptor  Examples of descriptions – BENEFICIAL
Table H.2: Magnitude of beneficial effect (benefits) Descriptor Examples of descriptions – BENEFICIAL

Examples of alternatives for quintozene use

Appendix J: Current Controls HSNO Act controls

Code D4 Reg 8 Disposal requirements for toxic and corrosive substances Code D5 Reg 9 Disposal requirements for ecotoxic substances. Code EM6 Reg 8(e) Information requirements for toxic substances Code EM7 Reg 8(f) Information requirements for ecotoxic substances Code EM8 Regs 12- 16,.

Non-HSNO Act controls

ERMA200692: Quintozene Review Application Page 128 of 134 Hazardous Substances (Tank Wagon and Transportable Containers) Regulations 2004. Adverse reactions seriously affecting the continued use of the product must be reported immediately.

Appendix K: Parties involved during the preparation of the application

Appendix L: References

See this page: http://www.hc-sc.gc.ca/cps-spc/pest/part/consultations/_prvd2009- 02/quintozene-eng.php#impurities. USEPA, Reregistration Eligibility Decision for Oxadiazon Available online at http://www.epa.gov/oppsrrd1/REDs/oxadiazon_red.pdf Accessed 3.12.10a.

Confidential Appendix M: Dioxin content of Terraclor 75WP

Confidential Appendix N: Human Exposure and Risk Assessment for Dioxin

Figure

Table 2:   Identity of quintozene technical grade active ingredient  Summary Information   Active substance (ISO Common Name)  Quintozene
Table 3:   Hazard classification of „water dispersible granule or wettable powder  containing 750 g/kg quintozene‟
Table 8:   Summary of environmental risk assessment for use of quintozene (with its  dioxin contaminant) with current controls
Table 11:   Summary of risks to be addressed  Area of non-negligible
+7

References

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