Public Release Summary
on the evaluation of the new active Bacillus amyloliquefaciens strain QST 713 in the product Serenade Opti Biofungicide
APVMA product number 82242
December 2017
© Australian Pesticides and Veterinary Medicines Authority 2017
ISBN: 978-1-925390-94-0
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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.
December 2017
Contents iii
Contents
Preface vi
About this document vi
Making a submission vii
Further information viii
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 2
2 Chemistry and manufacture 3
2.1 Active constituent 3
2.2 Formulated product 4
2.3 Recommendations 4
3 Toxicological assessment 5
3.1 Evaluation of toxicology 5
3.2 Public health standards 6
4 Residues assessment 7
4.1 Metabolism 7
4.2 Residues in foods and animal feeds 7
4.3 Animal commodity MRLs 7
4.4 Dietary risk assessment 7
4.5 Recommendations 8
5 Assessment of overseas trade aspects of residues in food 9
6 Occupational health and safety assessment 10
6.1 Use pattern 10
6.2 Exposure during use 10
6.3 Exposure during re-entry 10
6.4 Recommendations for safe use 10
6.5 Conclusion 11
7 Environmental assessment 12
7.1 Introduction 12
7.2 Fate and environmental concentrations 12
7.3 Environmental effects 12
7.4 Risk assessment 13
7.5 Conclusions 14
8 Efficacy and safety assessment 16
8.1 Proposed product use pattern 16
8.2 Summary of evaluation of efficacy and crop safety 16
8.3 Conclusions 18
9 Labelling requirements 19
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 the Environment and Energy 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 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 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.
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 Serenade Opti Biofungicide 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 9 January 2018 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: www.apvma.gov.au
Introduction 1
1 Introduction
1.1 Applicant
Bayer Cropscience PTY LTD.
1.2 Purpose of application
Bayer Cropscience Pty Ltd has applied to the APVMA for registration of the new product Serenade Opti Biofungicide containing not less than 1.3 x 1010 colony forming units (CFU) per gram of the new active constituent Bacillus amyloliquefaciens strain QST 713 as a wettable powder formulation. Serenade Opti Biofungicide contains a strain of bacterium originally identified as B. subtilis strain QST 713 as the active constituent. Recent publications and advances based on phylogenetic analysis and new taxonomic studies (Riboprinter system) have established the bacterium to be more accurately characterised as
B. amyloliquefaciens strain QST 713. For registration purposes the APVMA proposes to register Serenade Opti Biofungicide containing not less than 1.3 x 1010 CFU/g of the new active constituent
B. amyloliquefaciens strain QST 713.
This publication provides a summary of the information reviewed and an outline of the regulatory considerations for the proposed registration of Serenade Opti Biofungicide, and approval of the new active constituent, B. amyloliquefaciens strain QST 713.
1.3 Product claims and use pattern
Serenade Opti Biofungicide is a biological fungicide intended for use as a preventative treatment in the control of botrytis bunch rot in grapevines. It is applied at a rate of 250 g/100 L with applications made at flowering, pre bunch closure and veraison through to harvest.
1.4 Mode of action
The bacterium, B. amyloliquefaciens, is prevalent in soils and has been found in a variety of habitats worldwide. The QST 713 strain of B. amyloliquefaciens is known to be antagonistic toward fungal plant pathogens. This antagonism may be achieved in several ways including nutrient competition, site exclusion, colonisation, and attachment of the bacteria to the fungal pathogen.
The Fungicide Resistance Action Committee (FRAC), has designated B. amyloliquefaciens strain QST 713 (synonym B. subtilis strain QST 713) as a Group 44 fungicide, the mode of action has been defined as being a microbial disrupter of pathogen cell membranes.
Introduction 1
1.5 Overseas registrations
The active constituent B. amyloliquefaciens strain QST 713 was first registered with the United States Environmental Protection Authority (US EPA) in June 2000 as B. subtilis strain QST 713.
The original registration of Serenade Opti refers to the active constituent Bacillus subtilis strain QST 713 as it was originally characterised. Serenade Opti containing the active constituent B. subtilis strain QST 713 is currently registered in the US, Canada, New Zealand and Mexico for a host of crops including brassica vegetables, bulb vegetables, berries, citrus, pome fruit, stone fruit, cucurbits, fruiting vegetables, leafy vegetables, grapes and many other crop types. Serenade Opti is registered as a broad spectrum, preventative product for the control or suppression of many important plant diseases including Sclerotinia sp., Botrytis sp., Alternaria sp., Venturia sp. and various other pathogens of economic importance.
chemistry and manufacture 3
2 Chemistry and manufacture
2.1 Active constituent
Bacillus amyloliquefaciens QST 713 is a bio-fungicide for agricultural use.
B. amyloliquefaciens QST 713 is a Gram-positive, motile rod measuring 1.0 µm × 3-5 µm with peritrichous flagella, and is differentiated from other Bacillus species using ribotyping. The strain B. amyloliquefaciens QST 713 was originally isolated from soil in a private peach tree orchard in Fresno County, California (USA) in 1995.
The active constituent is identified as below:
Common Name: / Bacillus amyloliquefaciens QST 713SPECIES Name: / Bacillus amyloliquefaciens (previously known as Bacillus subtilis)
STRAIN Name: / QST 713
GENUS NAME: / Bacillus
FAMILY NAME: / Bacillaceae
GROUP: / Gram-positive eubacteria
KINGDOM: / Bacteria
Bacillus amyloliquefaciens QST 713 is not isolated as an active constituent during production of the agricultural product Serenade Opti Biofungicide. The microorganism is fermented and formulated into the product in a continuous process. However, the whole broth, at the time-point at which QC samples are taken, prior to concentration of the whole broth (if required) and/or addition of other ingredients to create formulated products (in this case Serenade Opti Biofungicide) is defined as an active constituent for assessment purposes.
The APVMA has evaluated the chemistry aspects of B. amyloliquefaciens QST 713 (identification, stability, manufacturing process, quality control procedures, batch analysis results and analytical methods) and found them to be acceptable.
Based on a review of the data provided by the applicant, the APVMA is satisfied that the chemistry and manufacturing details of B. amyloliquefaciens QST 713 are acceptable.
toxicological assessment 5
2.2 Formulated product
The product Serenade Opti Biofungicide will be manufactured overseas and imported into Australia in
0.1 kg – 100 kg polypropylene bottles and multilayer bags (including polypropylene or polyethylene bags).
The APVMA has evaluated the chemistry aspects of Serenade Opti Biofungicide (stability, formulation, manufacturing process, quality control procedures, specifications, batch analysis results, stability, analytical methods, packaging, and the chemistry aspects of the proposed label) and found them to be acceptable.
Serenade opti biofungicide
distinguishing Name: / Serenade Opti Biofungicideformulation type: / Wettable Powder (WP)
active constituent concentration: / 1.3 x 1010 CFU/g Bacillus amyloliquefaciens strain QST 713
Physical and chemical properties of the formulated product
Physical form: / Solid powdercolour: / Light brown
Odour: / Yeast-like
pH (1% solution): / 6.38
Pack sizes and materials: / 100 g – 100 kg polypropylene bottles and multilayer bags (including polypropylene or polyethylene bags)
product stability: / Product will remain stable for 36 months when stored at ambient conditions
(17–27°C) and 30 months when stored at 40°C
2.3 Recommendations
Based on a review of the chemistry and manufacturing details provided by the applicant, the registration of Serenade Opti Biofungicide, and approval of the active constituent B. amyloliquefaciens QST 713, are supported from a chemistry perspective.
3 Toxicological assessment
3.1 Evaluation of toxicology
The toxicological database for B. amyloliquefaciens QST 713 and the product Serenade Opti Biofungicide, containing 1.3 x 1010 CFU/g B. amyloliquefaciens QST 713, was considered adequate to determine its toxicology profile and to characterise the risk to humans.
The toxicological database for B. amyloliquefaciens QST 713 consisted of toxicity tests conducted in laboratory animals. 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. Where possible, considerations of the species-specific mechanisms of adverse reactions weigh heavily in the extrapolation of animal data to likely human hazard. Equally, consideration of the risks to human health must take into account the likely human exposure levels compared with those, usually many times higher, which produce effects in animal studies. Toxicity tests should also indicate dose levels at which the specific toxic effects are unlikely to occur.