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Public Release Summary


on the Evaluation of the New Active CYDIA POMONELLA GRANULOSIS VIRUS STRAIN V22 in the Product GRANDEX BIOLOGICAL INSECTICIDE

APVMA Product Number P69674

© Australian Pesticides and Veterinary Medicines Authority 2015

ISSN: 1443-1335


ISBN: 978-1-922188-93-9

Ownership of intellectual property rights in this publication

Unless otherwise noted, copyright (and any other intellectual property rights, if any) in this publication is owned by the Australian Pesticides and Veterinary Medicines Authority (APVMA).



Creative Commons licence

With the exception of the Coat of Arms and other elements specifically identified, this publication is licensed under a Creative Commons Attribution 3.0 Australia Licence. This is a standard form agreement that allows you to copy, distribute, transmit and adapt this publication provided that you attribute the work.


A summary of the licence terms is available from www.creativecommons.org/licenses/by/3.0/au/deed.en. The full licence terms are available from www.creativecommons.org/licenses/by/3.0/au/legalcode.

The APVMA’s preference is that you attribute this publication (and any approved material sourced from it) using the following wording:



Source: Licensed from the Australian Pesticides and Veterinary Medicines Authority (APVMA) under a Creative Commons Attribution 3.0 Australia Licence.

In referencing this document the Australian Pesticides and Veterinary Medicines Authority should be cited as the author, publisher and copyright owner.



Use of the Coat of Arms

The terms under which the Coat of Arms can be used are set out on the Department of the Prime Minister and Cabinet website (see www.dpmc.gov.au/pmc/publication/commonwealth-coat-arms-information-and-guidelines).



Disclaimer

The material in or linking from this report may contain the views or recommendations of third parties. Third party material does not necessarily reflect the views of the APVMA, or indicate a commitment to a particular course of action.

There may be links in this document that will transfer you to external websites. The APVMA does not have responsibility for these websites, nor does linking to or from this document constitute any form of endorsement.

The APVMA is not responsible for any errors, omissions or matters of interpretation in any third-party information contained within this document.



Comments and enquiries regarding copyright:

Director Public Affairs and Communication

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

KINGSTON ACT 2604 Australia

Telephone: +61 2 6210 4701

Email: communications@apvma.gov.au

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


Contents


Preface iv

About this document iv

Making a submission v

Further information vi



Introduction 7

1.1 Purpose of Application 7

1.2 Mode of action 7

1.3 Product claim and use pattern 7

1.4 Overseas registration 7

Chemistry and manufacture 8

Toxicological assessment 10

Residues assessment 10

Occupational Health and Safety assessment 10

Environmental assessment 10

Efficacy and safety assessment 11

Labelling requirements 12

abbreviations 18

Glossary 20

Preface


The Australian Pesticides and Veterinary Medicines Authority (APVMA) is the Australian Government regulator with responsibility 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 and Ageing, Office of Chemical Safety (OCS), Department of Environment (DoE), and State Departments of Primary Industries.

The APVMA has a policy of encouraging openness and transparency in its activities and of 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 in the APVMA’s publications and Regulatory Guidelines.

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 it received from its advisory agencies. It has been deliberately presented in a manner that is likely to be informative to the widest possible audience thereby encouraging public comment.

About this document


This is a Public Release Summary.

It indicates that the Australian Pesticides and Veterinary Medicines Authority (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 sections 12 and 13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether the application for registration of GRANDEX BIOLOGICAL 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 11 August 2015 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 4741

Email: enquiries@apvma.gov.au

Further information


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

Copies of evaluation report covering environmental aspects are available from the APVMA on request.

Further information on public release summaries can be found on the APVMA website: www.apvma.gov.au

Introduction

1.1Purpose of Application


Andermatt Biocontrol AG has applied to the APVMA for registration of the new product GRANDEX BIOLOGICAL INSECTICIDE containing the new active constituent Cydia Pomonella Granulosis Virus Strain V22 in the form of a suspension concentrate (SC) formulation.

This publication provides a summary of the data reviewed and an outline of the regulatory considerations for the proposed registration of GRANDEX BIOLOGICAL INSECTICIDE containing the new active constituent Cydia Pomonella Granulosis Virus Strain V22 (CpGV- V22).


1.2Mode of action


The baculovirus CpGV-V22 acts as a biological stomach insecticide against larvae of codling moth (Cydia pomonella) and oriental fruit moth (Grapholita molesta).

Ingestion by susceptible larvae leads to the granules being dissolved in the midgut and free virions being released that invade midgut cells by fusion with the microvilli. As a polyorganotropic disease, other tissues are also invaded, eventually resulting in death of the larvae before pupation can occur. The body of the insect then liquefies.



While the virus is released into the environment once the host larva has liquefied and could infect other larvae, the rapid inactivation of the virus by sunlight results in the need for re-application of the product to ensure subsequent hatching larvae are controlled.

1.3Product claim and use pattern


GRANDEX BIOLOGICAL INSECTICIDE (the product) is intend for the control of codling moth and oriental fruit moth in pome and stone fruits. The product is intended to be used in all states.

1.4Overseas registration


GRANDEX is registered as Madex Twin in the EU and MADEX HP in the US.

Chemistry and manufacture


The active constituent Cydia pomonella granulosis virus strain V22 has the following properties:

Common Name (ISO):

Cydia Pomonella Granulosis Virus Strain V22 (CpGV-V22)

Chemical Name:

N/A

Product Name:

Grandex Biological Insecticide

CAS Registry Number:

N/A

Empirical Formula:

N/A

Molecular Weight:

N/A

Physical Form:

Grey-brown liquid (200C)

Colour:

Grey-brown

Density:

1100 kg/m3

Structural Formula:

N/A

The product Grandex Biological Insecticide will be manufactured overseas and imported into Australia in 100 mL to 20 L polyethylene terephthalate (PET) or high density polyethylene (HDPE) containers.

Physical and Chemical Properties of the Product

Property

Results

Appearance

Grey brown liquid with typical odour

Relative Density

1.16

Pourability

Residue: 1.05%

Rinsed Residue: 0.16%



Spontaneity of Dispersion

89–105%

Suspensibility

86–93%

Persistent Foam

0 mL

Foaming of Suspension Concentrates

0 mL

Kinematic Viscosity

39.0 mm2/s @ 20°C

25.0 mm2/s @ 30°C

17.1 mm2/s @ 40°C


Property

Results

Surface Tension

39.9 mN/m @ 20°C

pH

6.4 (1% w/v aqueous dilution)

Sieve Analysis

1.1% 140µm

1.2% 125µm

1.6% 100µm

2.5% 75µm





Toxicological assessment


The Office of Chemical Safety (OCS) in the Department of Health has advised that the proposed product Grandex Biological Insecticide containing a new strain of the Cydia Pomonella Granulosis Virus (CpGV-V22) is considered to have a similar public health risk profile to that of the currently approved strain (CpGV-M) present in the registered reference product Madex Biological Insecticide (63025). On this basis OCS has recommended that the proposed product would not be likely to have an effect that is harmful to human beings and that the existing First Aid Instructions and Safety Directions are adequate.

Residues assessment


An assessment of the application for Grandex Biological Insecticide was undertaken by the APVMA. The APVMA has determined that the proposed product Grandex Biological Insecticide containing a new strain of the Cydia Pomonella Granulosis Virus (CpGV-V22) for use on pome fruit and stone fruit is covered in the MRL Standard by the current Table 5 entry for Cydia Pomonella Granulosis Virus as an insecticide. Table 5 includes Uses of substances where MRLs are not necessary.

Occupational Health and Safety assessment


As for Toxicological Assessment above the Office of Chemical Safety (OCS) in the Department of Health has advised that the proposed product Grandex Biological Insecticide containing a new strain of the Cydia Pomonella Granulosis Virus (CpGV-V22) is considered to have a similar public health risk profile to that of the currently approved strain (CpGV-M) present in the registered reference product Madex Biological Insecticide (63025). On this basis OCS has recommended that the proposed product would not be likely to have an effect that is harmful to human beings and that the existing First Aid Instructions and Safety Directions are adequate.

Environmental assessment


The active constituent Cydia pomonella GV strain V22 (CpGV-V22) is a naturally occurring insect virus that is isolated from codling moth. CpGV-V22 was considered to be closely similar to the active constituent CpGV-M that is currently used in the nominated reference product Madex Biological Insecticide (product number 63025). Grandex and Madex Biological Insecticides are identical in their physical, chemical and technical properties; the only variation is that the virus isolate differs.

Due to small genetic difference as shown by REN (restriction-endonuclease), phylogenic analysis, and genome sequencing it was concluded that CpGV-V22 is almost identical to the active constituent CpGV- M.

CpGVs are granuloviruses (GVs) which is one of two genera taxonomically classified in the family Baculoviridae. Baculoviruses can persist in the environment from hours to days to years especially in the soil where they are immobile. The persistence is highly dependent on UV radiation and other factors such as temperature, humidity and precipitation. The limited lifetime of baculovirus insecticides in the environment, to a great extent caused by their sensitivity for sunlight (UV).

CpGVs are not known to be active to organisms other than the moth larvae of the family Tortricidae. Available data indicate that CpGVs are classified as harmless to predators or parasites, such as a predatory mite (Typhlodromus pyri), a ground beetle (Poecilus cupreus), other predator insects (i.e. fillips, clerids, pentatomids and minds), and parasitic wasps (Aphidius rhopalosiphi). In addition, CpGV treatment did not have any effect on San Jose scale (Aspidiotus perniciosus), mealybugs or woolly aphid (Eriosma lanigerum). As a result, it was concluded that the use of Grandex Biological Insecticide will not cause greater risk to non-target organisms than that posed by the nominated reference product, Madex Biological Insecticide.


Efficacy and safety assessment


The efficacy of Grandex Biological Insecticide was evaluated in three bioefficacy trials examining the control of Codling moth in pome fruit orchards and four bioefficacy trials for the control of Oriental fruit moth (OFM) in stone fruit orchards, covering a range of pest intensities.

For the pome fruit trials, Madex Biological Insecticide was used as a reference product, and in one case another industry standard product was included, Sumitomo Samurai Systemic Insecticide (clothianidin). For the stone fruit trials, efficacy was compared to the industry standard Calypso 480 SC Insecticide (thiacloprid). All the studies were conducted using replicated small plots (evaluating 1–2 trees per plot) on commercial orchards. Foliar application was by power operated hand lance, with dilute spraying to runoff. Efficacy was evaluated by inspection for damage to fallen fruit and fruit on the trees at 1–3 occasions during the season as well as at harvest, plus inspection for tip damage from OFM.

The outcome of the bioefficacy trials supports the label claims for similar efficacy to the reference product Madex Biological Insecticide for the control of Codling moth in pome fruit orchards. The outcome of the bioefficacy trials also supports the label claim for efficacy against OFM in stone fruits. However, for both pests, particularly under high pest pressure additional control measures may be needed to achieve adequate control. The draft label carries appropriate advice to assist users in achieving satisfactory control of both codling moth and OFM.

The crop safety of Grandex Biological Insecticide in pome and stone fruits was evaluated as part of the bioefficacy trials. These studies confirmed crop safety to pome and stone fruit under the proposed use regimes.

The label directions for Grandex closely follow those for the existing Madex label, with the addition of instructions dealing with OFM.

Labelling requirements


READ SAFETY DIRECTIONS BEFORE OPENING OR USING

Grandex®

Biological Insecticide


ACTIVE CONSTITUENT: 3x1013 granula /L CYDIA POMONELLA GRANULOSIS VIRUS
A biological agent to control codling moth and oriental fruit moth in pome and stone fruits

IMPORTANT: READ THE ATTACHED LEAFLET BEFORE USE.


CONTENTS: [100 mL – 20L]

APVMA APPROVAL No: xxxx/xxxxx

® Grandex is a Registered Trademark of Andermatt Biocontrol, Switzerland


Organic Crop Protectants

Unit 1/61, Turrella St, TURRELLA NSW 2205


STORAGE AND DISPOSAL:

Keep out of reach of children. Store in the closed, original container out of direct sunlight. The product can be stored for short periods (14 days) at room temperature. For long term storage (2 years) keep refrigerated at less than 5°C.

Triple rinse containers before disposal. Add rinsings to spray tank. Do not dispose of undiluted chemical on site. If not recycling, break, crush or puncture and deliver empty packaging to an approved waste management facility. DO NOT burn empty containers or product.
SAFETY DIRECTIONS:

May irritate the eyes and skin. Repeated exposure may cause allergic disorders. Avoid contact with the eyes and skin. When opening the container and preparing the spray, wear elbow-length chemical-resistant gloves and goggles or safety glasses. Wash hands after use.


FIRST AID:

If poisoning occurs, contact a doctor or Poisons information Centre (telephone 13 11 26).


MATERIAL SAFETY DATA SHEET:

Additional information is listed in the Material Safety Data Sheet available from the supplier.


Batch No:

DOM:


Expiry date: 2 years from DOM when stored at less than 5°C.

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

Grandex®

Biological Insecticide


ACTIVE CONSTITUENT: 3x1013 granula /L CYDIA POMONELLA GRANULOSIS VIRUS
A biological agent to control codling moth and oriental fruit moth in pome and stone fruits

IMPORTANT: READ THIS LEAFLET BEFORE USE.


APVMA APPROVAL No: xxxx/xxxx

® Grandex is a Registered Trademark of Andermatt Biocontrol, Switzerland

Organic Crop Protectants

Unit 1/61, Turrella St, TURRELLA NSW 2205
DIRECTIONS FOR USE
SPRAY DRIFT RESTRAINTS

DO NOT apply within 48 hours of expected precipitation or during heavy rainfall. DO NOT disturb soil for 48 hours after application.

ONLY APPLY with orchard application spray equipment.

DO NOT apply when wind speed is less than 3 or more than 20 km per hour as measured at the application site.

DO NOT apply during surface temperature inversion conditions at the application site.

Users of this product MUST make an accurate written record of the details of each spray application within 24 hours following application and KEEP this record for a minimum of 2 years. The spray application details that must be recorded are: (1) date with start and finish times of application; (2) location address and paddock/s sprayed; (3) full name of this product; (4) amount of product used per hectare and number of hectares applied to; (5) crop/situation and weed/pest; (6)

wind speed and direction during application; (7) air temperature and relative humidity during application; (8) nozzle brand, type, spray angle, nozzle capacity and spray system pressure measured during application; (9) name and address of person applying this product. (Additional record details may be required by the state or territory where this product is used.) DO NOT apply when there are native forests, aquatic and wetland areas including aquacultural ponds or

surface streams and rivers downwind from the application area and within the mandatory nospray zone shown below.


MANDATORY NO-SPRAY ZONE

DO NOT apply when there are native forests, aquatic and wetland areas including aquacultural ponds or surface streams and rivers within 40 m downwind from the application area.





Crop

Pest

Rate (L/ha)

Critical Comments

Pome fruit

Codling moth (Cydia pomonella)

Oriental fruit moth (Grapholita molesta)



7 mL / 100L

(100 mL/ha)



Use 100 mL Grandex in 1500–2000 litres of water per hectare. High volumes will be required in older orchards with large trees to obtain proper coverage of fruit. Apply as a dilute spray to the point of runoff. Grandex mixes readily with water.
Timing of applications is critical to ensure larvae are exposed to sufficient concentration of the virus. Make the first application from petal fall onwards when newly hatched codling moth and oriental fruit moth larvae are present in the orchard. This should be based on pheromone trap catches of codling moths in orchards. Larvae will be present within 4 weeks of moth catches.
Alternatively, use the appropriate amount of 'degree days' for your area to determine egg hatch as recommended by your local advisor.
Apply at 7 to 14 day intervals while codling moth larvae are present. Use the shorter interval during periods of high sunlight intensity (long sunny days). Most areas of Australia will have 3 or more generations per season and so it is important to monitor for each generation. For areas where there is considerable generational overlap, regular applications will be required for maximum effect.



Stone fruit

Oriental fruit moth (Grapholita molesta)

Use 100 mL Grandex in 1500–2000 litres of water per hectare. High volumes will be required in older orchards with large trees to obtain proper coverage of fruit. Apply as a dilute spray to the point of runoff. Grandex mixes readily with water.
Timing of applications is critical to ensure larvae are exposed to sufficient concentration of the virus. Make the first application when newly hatched Oriental fruit moth larvae are present in the orchard. This should be based on pheromone trap catches of Oriental fruit moths in orchards.
Apply at 7 to 14 day intervals while Oriental fruit moth larvae are present. Use the shorter interval during periods of high sunlight intensity (long sunny days).




NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY TO THIS LABEL UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION
WITHHOLDING PERIOD: NOT REQUIRED WHEN USED AS DIRECTED.
GENERAL INSTRUCTIONS

Correct application of Grandex will result in high mortality of larvae in even high density populations. If used to treat all generations in consecutive seasons, especially over large areas, large reductions in Codling moth and Oriental fruit moth will be achieved. However, where heavy infestations of Codling moth or Oriental fruit moth are present in orchards, young larvae can still cause considerable damage on the surface of fruits before being killed by the virus.


Grandex should therefore be used as part of an integrated pest management strategy. Other compatible methods such as pheromone mating disruption dispensers can be used to complement the control achieved by applications of Grandex. Particularly when heavy infestations are present, it is important to use such measures to reduce the population to levels where damage can be better managed by Grandex.
The use of additional control measures is also important to minimise the risk of resistance to Grandex developing with repeated, ongoing use.
To assist in reducing migration of mated female moths into the treated area, it is highly advisable to clean up any accessible areas where refuges of untreated moths may be harbouring, e.g. fruit trees not receiving any pesticide treatment to control larvae, packing sheds or any areas with fruit that could contain Codling moth or Oriental fruit moth larvae.
MIXING

Grandex mixes readily with water for application.



COMPATIBILITY

Do not mix with pesticides that have a pH of less than 5.0 or greater than 8.5 in solution as the virus may be deactivated.


PROTECTION OF WILDLIFE, FISH, CRUSTACEANS AND ENVIRONMENT

DO NOT contaminate streams, rivers or waterways with this product or used containers.


STORAGE AND DISPOSAL

Keep out of reach of children. Store in the closed, original container out of direct sunlight. The product can be stored for short periods (14 days) at room temperature. For long term storage (2 years) keep refrigerated at less than 5°C.


Triple rinse containers before disposal. Add rinsings to spray tank. Do not dispose of undiluted chemical on site. If not recycling, break, crush or puncture and deliver empty packaging to an approved waste management facility. DO NOT burn empty containers or product.
SAFETY DIRECTIONS

May irritate the eyes and skin. Repeated exposure may cause allergic disorders. Avoid contact with the eyes and skin. When opening the container and preparing the spray, wear elbow-length chemical resistant gloves and goggles or safety glasses. Wash hands after use.


FIRST AID:

If poisoning occurs, contact a doctor or Poisons Information Centre (telephone 13 11 26).


MATERIAL SAFETY DATA SHEET:

Additional information is listed in the Material Safety Data Sheet available from the supplier.

Batch No.

DOM


Expiry date: 2 years from DOM when stored at less than 5°C.

® Grandex is a Tradename of Andermatt Biocontrol, Switzerland.


APVMA Approval Number: xxxx/xxxx

abbreviations


ac

active constituent

ai

active ingredient

DAT

Days After Treatment

DT50

Time taken for 50% of the concentration to dissipate

EA

Environment Australia

EUP

End Use Product

Fo

original parent generation

g

gram

h

hour

ha

hectare

IPM

Integrated Pest Management

kg

kilogram

L

Litre

LC50

concentration that kills 50% of the test population of organisms

LD50

dosage of chemical that kills 50% of the test population of organisms

mg

milligram

mL

millilitre

MRL

Maximum Residue Limit

MSDS

Material Safety Data Sheet

NOEC/NOEL

No Observable Effect Concentration Level

ppb

parts per billion

PPE

Personal Protective Equipment

ppm

parts per million

Q-value

Quotient-value

s

second

REN

Restriction-endonuclease

SC

Suspension Concentrate

SUSDP

Standard for the Uniform Scheduling of Drugs and Poisons

TGAC

Technical grade active constituent

µg

microgram

vmd

volume median diameter

WHP

Withholding Period

Glossary


Active constituent

The substance that is primarily responsible for the effect produced by a chemical product

Acute

Having rapid onset and of short duration.

Carcinogenicity

The ability to cause cancer

Chronic

Of long duration

Codex MRL

Internationally published standard maximum residue limit

Desorption

Removal of a material from or through a surface

Efficacy

Production of the desired effect

Formulation

A combination of both active and inactive constituents to form the end use product

Genotoxicity

The ability to damage genetic material

Hydrophobic

repels water

Leaching

Removal of a compound by use of a solvent

Log Pow

Log to base 10 of octanol water partitioning co-efficient, synonym KOW

Metabolism

The chemical processes that maintain living organisms

Photodegradation

Breakdown of chemicals due to the action of light

Photolysis

Breakdown of chemicals due to the action of light

Subcutaneous

Under the skin

Toxicokinetics

The study of the movement of toxins through the body

Toxicology

The study of the nature and effects of poisons



1 A full definition of ‘confidential commercial information’ is contained in the Agvet Code

July 2015


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