Evaluation of the Active Constituent Novaluron in the Product Cormoran Insecticide

Public Release Summary

on the evaluation of the active constituent novaluron in the product Cormoran Insecticide

november 2016

© Australian Pesticides and Veterinary Medicines Authority 2016

ISSN: 1443-1335 (electronic)
ISBN: 978-1-925390-55-1 (electronic)

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Director Public Affairs and Communication

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

KINGSTON ACT 2604 Australia

Telephone: +61 2 6210 4988

Email:

This publication is available from the APVMA website: www.apvma.gov.au.

november 2016

Contents iii

Contents

Preface vi

About this document vi

Making a submission vi

Further information vii

1 Introduction 1

1.1 Applicant 1

1.2 Details of the product 1

1.3 Overseas registrations 1

2 Chemistry and manufacture 2

2.1 Active constituent 2

2.2 Formulated product 3

2.3 Recommendations 4

3 Toxicological assessment 5

3.1 Evaluation of toxicology 5

3.2 Public health standards 9

4 Residues assessment 11

4.1 Introduction 11

4.2 Metabolism 11

4.3 Analytical methods 13

4.4 Stability of the pesticide in stored analytical samples 13

4.5 Residue definition 13

4.6 Residue trials 13

4.7 Animal feeds 14

4.8 Animal commodity MRLs 14

4.9 Bioaccumulation potential 15

4.10 Spray drift 15

4.11 Residues in rotational crops 16

4.12 Estimated dietary intake 16

4.13 Recommendations 17

5 Assessment of overseas trade aspects of residues in food 19

5.1 Commodities exported 19

5.2 Destination and value of exports 19

5.3 Proposed Australian use pattern 19

5.4 Overseas registration 22

5.5 Comparison of Australian MRLs with codex and international MRLs 23

5.6 Potential risk to trade 26

6 Occupational Health and Safety assessment 29

6.1 Health hazards 29

6.2 Formulation, packaging, transport, storage and retailing 29

6.3 Use pattern 29

6.4 Exposure during use 30

6.5 Exposure during re-entry 30

6.6 Recommendations for safe use 31

6.7 Conclusion 31

7 Environmental assessment 32

7.1 Introduction 32

7.2 Environmental fate and behaviour 32

7.3 Environmental effects 34

7.4 Risk assessment 38

7.5 Conclusions 39

8 Efficacy and safety assessment 40

8.1 Proposed product use pattern 40

8.2 Summary of evaluation of efficacy and crop safety 40

8.3 Conclusions 41

9 Labelling requirements 42

Abbreviations 50

Glossary 54

References 55

List of tables

Table 1: Nomenclature, chemistry and key identifiers of the active constituent novaluron 2

Table 2: Summary of key physio-chemical properties of the active constituent Novaluron 3

Table 3: Key aspects of the identity of the product Cormoran Insecticide 4

Table 4: Summary of key physico-chemical parameters of the Cormoran Insecticide 4

Table 5: Proposed amendments to MRL Standard Table 1–MRLs of agricultural and veterinary chemicals and associated substances in food commodities 17

Table 6: Proposed amendments to MRL Standard Table 4–MRLs for pesticides in animal feed commodities 18

Table 7: Current and proposed Australian and overseas MRLs/tolerances for novaluron 23

Table 8: Current and proposed Australian and overseas MRLs/tolerances for acetamiprid 24

Table 9: Toxicity of active constituent novaluron and the product Cormoran Insecticide for various organisms 34

Preface vii

Preface

The Australian Pesticides and Veterinary Medicines Authority (APVMA) is the Australian Government regulator responsible for assessing and approving agricultural and veterinary chemical products prior to their sale and use in Australia.

In undertaking this task, the APVMA works in close cooperation with advisory agencies, including the Department of Health, Office of Chemical Safety (OCS), Department of Environment (DoE), and State Departments of Primary Industries.

The APVMA has a policy of encouraging transparency in its activities and seeking community involvement in decision making. Part of that process is the publication of Public Release Summaries for products containing new active constituents.

The information and technical data required by the APVMA to assess the safety of new chemical products, and the methods of assessment, must be consistent with accepted scientific principles and processes. Details are outlined on the APVMA website.

This Public Release Summary is intended as a brief overview of the assessment that has been conducted by the APVMA and of the specialist advice received from its advisory agencies. It has been deliberately presented in a manner that is likely to be informative to the widest possible audience to encourage public comment.

About this document

This is a Public Release Summary.

It indicates that the APVMA is considering an application for registration of an agricultural or veterinary chemical. It provides a summary of the APVMA’s assessment, which may include details of:

·  the toxicology of both the active constituent and product

·  the residues and trade assessment

·  occupational exposure aspects

·  environmental fate, toxicity, potential exposure and hazard

·  efficacy and target crop or animal safety.

Comment is sought from interested stakeholders on the information contained within this document.

Making a submission

In accordance with section 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether the application for registration of Cormoran Insecticide should be granted. Submissions should relate only to matters that the APVMA is required, by legislation, to take into account in deciding whether to grant the application. These matters include aspects of public health, occupational health and safety, chemistry and manufacture, residues in food, environmental safety, trade, and efficacy and target crop or animal safety. Submissions should state the grounds on which they are based. Comments received that address issues outside the relevant matters cannot be considered by the APVMA.

Submissions must be received by the APVMA by close of business on Tuesday 13 December 2016 and be directed to the contact listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.

Relevant comments will be taken into account by the APVMA in deciding whether the product should be registered and in determining appropriate conditions of registration and product labelling.

When making a submission please include:

·  contact name

·  company or group name (if relevant)

·  email or postal address (if available)

·  the date you made the submission.

All personal information, and confidential information judged by the APVMA to be confidential commercial information (CCI)[1] contained in submissions will be treated confidentially.

Written submissions on the APVMA’s proposal to grant the application for registration that relate to the grounds for registration should be addressed in writing to:

Case Management and Administration Unit

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

Kingston ACT 2604

Phone: +61 2 6210 4701

Fax: +61 2 6210 4721

Email:

Further information

Further information can be obtained via the contact details provided above.

Further information on Public Release Summaries can be found on the APVMA website at www.apvma.gov.au.

Introduction 1

1  Introduction

1.1  Applicant

Adama Australia Pty Limited.

1.2  Details of the product

It is proposed to register Cormoran Insecticide, containing 100 g/L novaluron and 80 g/L acetamiprid, as an emulsifiable concentrate for the control of apple dimpling bug (campylomma leibknechti) and plague thrips (thrips imaginis) in apples and longtailed mealybug (pseudococcus longispinus), Tuber Mealy bug (pseudococcus viburni), light brown apple moth (epiphyas postvittana) and codling moth (cydia pomonella) in apples and pears.

One application of Cormoran Insecticide be made to apples and two applications to pears, at a maximum concentration of 70 ml product/100 L (7 g novaluron/100 L and 5.6 g acetamiprid/100 L), or a maximum application rate of 1.4 L product/ha (140 g novaluron/ha and 112 g acetamiprid/ha).

Acetamiprid is an existing active constituent and is currently included in 9 registered products in Australia.

While there are existing approvals for the active constituent novaluron, Cormoran Insecticide is the first product containing novaluron to be introduced to the Australian market. This public release summary will focus on the evaluation of novaluron in the product Cormoran Insecticide. This publication provides a summary of the data reviewed and an outline of the regulatory considerations for the proposed registration.

The active constituent novaluron belongs to the benzoyl urea insect growth regulator chemical family (group 15 insecticides), which inhibit chitin biosynthesis. There are currently 40 other insecticides with active constituents from this chemical family registered in Australia.

Both novaluron and Cormoran Insecticide will be manufactured and formulated overseas. Cormoran Insecticide will be available in 1 L to 110 L high density polyethylene (HDPE) containers.

1.3  Overseas registrations

Novaluron 100 g/L as a combination emulsifiable concentrate formulation with 80 g/L acetamiprid is currently registered for use in Argentina, Chile, Colombia, Ecuador, Honduras, Indonesia, Israel, South Korea, Panama, Peru, Dominican Republic, South Africa, Turkey and Uruguay.

Chemistry and manufacture 3

2  Chemistry and manufacture

2.1  Active constituent

Table 1 and 2 summarise key properties of the chemical novaluron.

Table 1: Nomenclature, chemistry and key identifiers of the active constituent novaluron

Common Name (ISO): / Novaluron
IUPAC Name: / (±)-1-[3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)
phenyl]-3-(2,6-difluorobenzoyl)urea
CAS Registry Number: / (±)-N-[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)
ethoxy]phenyl]amino]-carbonyl]-2,6-difluorobenzamide
MOLECuLAR Formula: / C17H9ClF8N2O4
Molecular Weight: / 492.77
Structural Formula: /
CHEMICAL FAMILY: / Benzoyl urea insect growth regulator

Physico-chemical properties of active constituent

Table 2: Summary of key physio-chemical properties of the active constituent Novaluron

PHYSICAL FORM: / Solid with pale pink to white colour
Odour: / None detectable
Melting Point: / 176.5 to 178 °C
RELATIVE Density at 22oC: / 1.56
Vapour pressure: / 1.6 × 10-5 Pa at 25 °C
Octanol-water partition coefficient: / Log POW = 4.3
solubility in water: / 3 µg/L at 20 °C
Solubility in solvents: / n-Heptane 8.39 mg/L
Xylene 1.88 g/L
1,2-Dichloroethane 2.85 g/L
Methanol 14.5 g/L
Acetone 198 g/L
Ethyl acetate 113 g/L
n-Octanol 0.98 g/L
stability: / Stable at 54°C for 2 weeks

2.2  Formulated product

The product Cormoran Insecticide will be manufactured and formulated overseas and imported into Australia in HDPE containers.

Table 3: Key aspects of the identity of the product Cormoran Insecticide

[Product name] distinguishing name: / Cormoran Insecticide
formulation type: / Emulsifiable Concentrate (EC)
active constituent concentrations: / Novaluron at 100 g/L
Acetamiprid at 80 g/L

Physical and chemical properties of product

Table 4: Summary of key physico-chemical parameters of the Cormoran Insecticide

physical form: / Yellowish brown liquid
odour: / Pungent odour
pH value: / 2.8 at 21°C
specific gravity: / 1.10 at 22°C
VISCOSITY: / 73.2 cP at 21°C
FlasH Point: / 110°C
Oxidising properties: / Not oxidising
Explosive properties: / Not explosive
flammability: / Flammable at 110°C
corrosive hazard: / Non corrosive to aluminium and polyethylene;
Slightly corrosive to zinc and copper

2.3  Recommendations

The APVMA has previously evaluated the chemistry aspects of novaluron active constituent and found them to be acceptable. The established standard for novaluron active constituent can be viewed on the APVMA website at apvma.gov.au/node/2566.

The APVMA has reviewed the chemistry and manufacturing details provided under this current application (manufacturing process, quality control procedures, stability, batch analysis results and analytical methods) and registration of the product Cormoran Insecticide is supported.

Toxicological assessment 9

3  Toxicological assessment

3.1  Evaluation of toxicology

The product Cormoran Insecticide contains two active constituents, novaluron (100 g/L) and acetamiprid (80g/L). The following summary focuses on the toxicity of novaluron with additional information on the toxicity of Cormoran Insecticide.

The toxicology of novaluron has been previously considered by the APVMA when the active constituent was first submitted for approval in Australia in 2000. The toxicity database for novaluron is extensive and consists primarily of toxicity studies conducted in laboratory animals.

It should be noted that toxicity tests generally use doses that are high compared with likely human exposures. The use of high doses increases the likelihood that potentially significant toxic effects will be identified. Findings of adverse effects in any one species do not necessarily indicate such effects might be generated in humans. From a conservative risk assessment perspective however, adverse findings in animal species are assumed to represent potential effects in humans, unless convincing evidence of species specificity is available.