Public Release Summary
on the evaluation of the new active Beauveria bassiana strain PPRI 5339 in the product Broadband OD Insecticide
SEPTEMBER 2017
© Australian Pesticides and Veterinary Medicines Authority 2017
ISSN: 1443-1335 (electronic)
ISBN: 978-1-925390-87-2
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Australian Pesticides and Veterinary Medicines Authority
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KINGSTON ACT 2604 Australia
Telephone: +61 2 6210 4988
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This publication is available from the APVMA website: www.apvma.gov.au.
SEPTEMBER 2017
Contents iii
Contents
Preface v
About this document v
Making a submission vi
Further information vii
1 Introduction 1
1.1 Applicant 1
1.2 Purpose of application 1
1.3 Product claims and use pattern 1
1.4 Mode of action 1
1.5 Overseas registrations 1
2 Chemistry and manufacture 3
2.1 Active constituent 3
2.2 Formulated product 4
2.3 Recommendations 5
3 Toxicological assessment 6
3.1 Evaluation of toxicology 6
3.2 Public Health Standards 7
4 Residues assessment 9
4.1 Metabolism 9
4.2 Residues in food and animal feeds 9
4.3 Residues in animal commodities 9
4.4 Dietary risk assessment 9
4.5 Recommendations 9
5 Assessment of overseas trade aspects of residues in food 11
6 Occupational Health and Safety assessment 12
6.1 Use pattern 12
6.2 Occupational exposure 12
6.3 Public exposure 12
6.4 Recommendations for safe use 12
6.5 Conclusions 12
7 Environmental assessment 14
7.1 Introduction 14
7.2 Environment Fate and Behaviour 14
7.3 Environmental Effects 14
7.4 Risk Assessment 16
7.5 Conclusions 17
8 Efficacy and safety assessment 18
8.1 Proposed product use pattern 18
8.2 Summary of evaluation of efficacy and crop safety 18
8.3 Conclusions 19
9 Labelling requirements 20
abbreviations 23
Glossary 26
References 27
Preface vii
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 Environment 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.
Preface vii
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 approval of the new active constituent and registration of the product Broadband OD 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 applications. 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 3 October 2017 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: http://www.apvma.gov.au.
Introduction 1
1 Introduction
1.1 Applicant
BASF Australia Ltd.
1.2 Purpose of application
BASF Australia Ltd is seeking approval and registration of the oil dispersible product Broadband OD Insecticide, containing >4.0 × 109 colony forming units (CFU) per mL of the new active constituent Beauveria bassiana PPRI 5339.
This publication provides a summary of the data reviewed and an outline of the regulatory considerations for the proposed registration of Broadband OD Insecticide, and approval of the new active constituent, Beauveria bassiana, PPRI 5339.
1.3 Product claims and use pattern
Broadband OD Insecticide, is a biological insecticide intended for use for the suppression of thrips (Thrips tabaci and Frankliniella occidentalis), whitefly (Bemisia tabaci. B. argentifolii and Trialeurodes vaporariorum), aphids (Myzus persicae, Macrosiphum rosae and Macrosiphoniella sanborni) and mites (Tetranychus urticae) in protected horticulture.
The product is applied at a rate of 100 mL/100 L for thrips and whitefly and 180 ml/100 L for aphids and mites when pests are first detected or are above economic thresholds. Broadband OD Insecticide is to be applied as a foliar spray to the point of good coverage, but not to the point of run off.
Broadband OD Insecticide should be applied in a water volume ranging from 500 to 2500 L/ha. Repeat applications of the product are to be made as necessary at intervals of 3-14 days. The last application can be made up to harvest, with a withholding period not required when used as directed.
In higher pest situations, the product is best used within an integrated pest management program in conjunction with a chemical insecticide.
1.4 Mode of action
Beauveria bassiana is a naturally occurring soil fungus found throughout the world acting as a parasite on various arthropod species causing white muscardine disease. Different strains of Beauveria bassiana vary in their host range and specificity.
The Insecticide Resistance Action Committee (IRAC) does not currently have any Mode of Action Classifications for biological insecticides. IRAC guidelines recommend integration of other control methods (chemical, cultural, biological) into insect control programs. The use of additional control measures is also important to minimise the risk of resistance developing with repeated, ongoing use.
1.5 Overseas registrations
The product is currently registered in South Africa as BroadBand, a fungal contact insecticide, for the population reduction of target pests: diamond back moth, false codling moth, red scale, red spider mite, potato tuber moth, stinkbug, thrips and whitefly in horticultural crops.
.
Chemistry and manufacture 5
2 Chemistry and manufacture
2.1 Active constituent
The active constituent Beauveria bassiana strain PPRI 5339 is a fungal spore used as a contact insecticide, for the population reduction of target pests on crops. Beauveria bassiana strain PPRI 5339 is not listed in Food and Agriculture Organisation of the United Nations (FAO) specifications.
Beauveria bassiana strain PPRI 5339 has the following characteristics of identification:
Common Name (ISO): / Beauveria bassiana strain PPRI 5339species Name (binomial): / Beauveria bassiana (Balsamo) Vuillemin
Strain: / PPRI 5539
genus name: / Beauveria
family name: / Various names given by different authorities, including Cordycipitaceae and Clavicipitaceae
Description: / Strain PPRI 5339 was originally isolated by Dr Schalk Schoeman from the larva of a tortoise beetle, Conchyloctenia punctate (Coleoptera: Cassidinae) collected in Escombe, Queensburgh, KwaZulu Natal, South Africa
Biological properties of Beauveria bassiana (Balsamo) Vuillemin including its history, natural occurrence and geographical distribution, host range, mode of action and production of metabolites/toxins have been reviewed, confirming the identity of Beauveria bassiana strain PPRI 5339.
The APVMA has evaluated the chemistry aspects of Beauveria bassiana strain PPRI 5339 (identification, fermentation process, quality control procedures, batch analysis results and analytical methods) and found them to be acceptable. On the basis of the data provided, and the toxicological assessment, it is proposed that the following APVMA Active Constituent Standard be established for Beauveria bassiana strain PPRI 5339 active constituent:
Constituent / Specification / LevelBeauveria bassiana strain PPRI 5339 / Beauveria bassiana strain PPRI 5339 / × 1011 cfu/g minimum
Beauvericin / 0.5 µg/g maximum
The active constituent Beauveria bassiana strain PPRI 5339 will be manufactured overseas.
Based on a review of the data provided by the applicant, the APVMA is satisfied that the chemistry and manufacturing (fermentation) details of Beauveria bassiana strain PPRI 5339 are acceptable
2.2 Formulated product
The formulated product Broadband OD Insecticide will be manufactured overseas and in Australia in high density polyethylene containers with pack sizes of 0.25 L to 1000 L.
The APVMA has reviewed the chemistry and manufacturing aspects of the product and found them to be acceptable.
BROADBAND OD INSECTICIDE
distinguishing name: / Broadband OD Insecticideformulation type: / Oil-based suspension concentrate (OD)
active constituent concentration: / Beauveria bassiana strain PPRI 5339 (40 g/L, >4 × 109 colony-forming units per mL)
PHYSICAL AND CHEMICAL PROPERTIES OF THE FORMULATED PRODUCT
Appearance: / Yellow oil with light cream sediment that re-suspends with shakingph value: / Neat test item: 6.1
1% dilution of test item: 6.7
Surface tension: / 33.47 mN/m at 20 ºC
viscosity / When subjected to changes in shear rate;
average viscosity [mPa·s] at 20 ºC: 85.6
average viscosity [mPa·s] at 45 ºC: 39.0
Explosive properties: / No explosive properties
Oxidising properties: / No oxidizing properties
Flammability: / Not flammable
Corrosive hazard: / Not corrosive hazard
Pack sizes: / 0.25 L, 0.5 L, 1 L, 5 L, 1000 L
Packaging material: / High density polyethylene (HDPE)
Product stability: / As a product containing organisms, Broadband OD Insecticide is a date-controlled agricultural chemical product.
The available stability data supports a shelf life of 6 months, with storage below 25 ºC (air conditioning)
2.3 Recommendations
Based on a review of the chemistry and manufacturing details provided by the applicant, the registration of Broadband OD Insecticide is supported from a chemistry perspective.
Toxicological assessment 7
3 Toxicological assessment
3.1 Evaluation of toxicology
The following summary focuses on the toxicity of the active as well as that of the Broadband product.
The submitted data package included acute toxicity studies on Beauveria bassiana PPRI 5339, pathogenicity studies, and published human case studies on Beauveria bassiana generally. The acute toxicology studies were conducted in accordance with relevant test guidelines and were considered adequate for the assessment of the product toxicology profile.
In interpreting the data, 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.