This consultation closed on 30 March 2018
Consultation period18 December 2017 to 30 March 2018
Submissions are invited from interested stakeholders on the draft proposal for spray drift risk assessment.
The purpose of the proposed spray drift management approach is to enable more reasonable buffer zones to be set; provide clearer label instructions and increased flexibility; and support the use of drift reducing technologies (DRT).
Documents and files
The following documents and files all form part of the spray drift management approach:
- Spray Drift Risk Assessment Manual (SDRAM): overarching document that describes the framework and its elements
- Spray Drift Risk Assessment Tool (SDRAT): used by the APVMA to conduct a risk assessment of the realistic worst-case scenario for the use of each product to generate buffers for different sensitive areas. The tool will generate the wording to appear on the product label. The tool will also be available to applicants to conduct self-assessments prior to submitting an application
- Spray Drift Management Tool (SDMT): used by the APVMA for assessing DRTs. In the future this may allow chemical users to refine these realistic worst-case risk assessments from SDRAT based on the specific equipment, application rate, weather conditions, etc. relevant to their own circumstances and can recalculate buffer zone distances accordingly
- Spray Drift Data Guideline (SDDG): describes how information and data related to spray drift management (spray drift data) may be generated and submitted
- Standard scenarios: AGDISP input files used for realistic worst case scenarios for boom sprayer, fixed wing and helicopter. Output from these scenarios is used in SDRAT
- Droplet Size Distributions (DSD): standard APVMA spectra used to determine boundaries for droplet size classification. These can be imported into AGDISP
- DSD converter: ensures that droplet size distributions from different testing facilities can be compared and be consistent relative to APVMA DSD.
Overview of the proposal
Under the proposed spray drift management approach, there are no changes proposed to the current items and modules for registration applications.
Applicants would continue to submit relevant information packages to allow the Regulatory Acceptable Levels (RAL) to be determined. The method used to determine the RAL is described in Chapter 3 of the Spray drift risk assessment manual (SDRAM).
Standard deposition curves (outlined in Chapter 4 of the SDRAM and scenario files) will be used to determine buffer zones based on realistic worst case scenarios. Applicants will also have an option to provide information to determine custom deposition curves. The Spray Drift Data Guideline describes how spray drift information and data may be generated and submitted.
The approved RAL and deposition curve would be entered into the Spray Drift Risk Assessment Tool (SDRAT) that is described in Chapter 6 of the SDRAM. The SDRAT contains approved label instructions (Chapter 5 of the SDRAM) and will be used to generate the label instructions, including buffer zones and spray drift restraints.
The Spray Drift Management Tool (SDMT) will initially be used by the APVMA to put buffers relevant to the use of DRTs on labels or permits. In the future its use may be expanded to allow users to reduce buffer zones where they are restricting the way the product is used to a greater extent than required by the approved label (or permit). Buffer zone and conditions are recalculated according to the chemical users’ specific equipment, application rate, weather conditions, etc. relevant to their own circumstances.
The proposed framework will initially only apply to new chemistries and chemical reviews.
A Spray Drift Management Tool (SDMT) that allows refinement of the realistic worst-case risk assessments that are used to develop label instructions has been proposed. In the future this may allow buffer zones and conditions to be recalculated according to their users own circumstances. However the use of instructions and conditions resulting from use of the SDMT that are not physically part of the approved label may require changes to state control of use legislation. Due to the time it may take to introduce changes to state legislation and time and cost to develop an interactive web-based tool, it is proposed to implement the new spray drift framework in 2 stages.
Stage 1: Chapters 1 to 6 of the SDRAM which covers all aspects up to the on-label instructions.
Stage 2: Chapter 7 of the SDRAM which is the Spray Drift Management Tool (SDMT).
Proposed interim measures prior to implementation of stage 2
Prior to implementation of stage 2, it is proposed that the following interim measures would apply:
- Applicants have the option to either include extra buffer zones for additional application techniques (DRTs) onto the label or refer to an off-label source (e.g. APVMA or company website) that provides a summary of approved alternate application options. In the short term any off-label information may need to be supported by a permit to meet control of use requirements.
- An excel version of the Spray Drift Risk Assessment Tool (SDRAT) would be used by the APVMA to set buffers and conditions for the label based on realistic worst case scenarios. This would be available to applicants to conduct self-assessments prior to making an application.
- An excel version of the Spray Drift Management Tool (SDMT) would be used by the APVMA to set buffers and conditions for alternate application parameters and drift reducing technologies. This would be available to applicants to conduct self-assessments prior to making an application.
Call for public comment
The APVMA is seeking stakeholder input on the draft proposal for spray drift risk assessment. In particular comment should address to the following topics:
- Methodology used to determine regulatory acceptable levels (RAL’s)
- Standard scenarios and deposition curves that define realistic worst case situations and are used to generate on-label spray drift buffers
- Spray drift data guidelines to support the generation of custom deposition curves
- On label spray drift instructions
- Spray drift risk assessment tool
- Spray drift management tool that allows chemical users to refine these realistic worst-case risk assessments based on their own circumstances and recalculate buffer zone distances accordingly
- Interim measures prior to an interactive web based tool being available (stage 2) and legislative requirements to enable off-label spray drift conditions set by the tool to be enforced.
The consultation period is open until close of business on 30 March 2018. Following consideration of comments received during the consultation period, stage 1 and interim measures will be finalised and made available on the APVMA website by 1 August 2018. Further consultation may be required prior to introduction of stage 2.
All submissions will be published unless you state in your submission that you do not want the submission to be published.
Please send your written submission by email, post or fax to:
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604
Phone: +61 2 6210 4701
Fax: +61 2 6210 4721
Email: email@example.com (link sends e-mail)