This consultation closed on 4 November 2015
Consultation period4 September 2015 to 4 November 2015
The United States Environmental Protection Agency, the Canadian Pest Management Regulatory Agency and the California Department of Pesticide Regulation have developed a tiered process for evaluating potential adverse effects on pollinating bees from exposure to pesticides. The final version of the North American pollinator risk assessment guidance was published on 19 June 2014.
A detailed European Food Safety Authority (EFSA) guidance on conducting assessments of the risk from plant protection products (PPPs) to bees was published in July 2013 (updated on 4 July 2014).
An APVMA regulatory workshop on ‘Pesticides and the health of insect pollinators’, held on 24 July 2013, discussed the available assessment frameworks for insect pollinators and decided that the North American approach was the most suitable for adoption in Australia. Nevertheless, the APVMA and its primary environmental advisory agency, the Department of the Environment, considered that there are elements of European guidance which could be combined with the North American approach to develop a risk assessment methodology suitable for Australia’s agricultural and regulatory environment.
Proposed new framework for insect pollinator risk assessment
The APVMA has developed a document, Roadmap for insect pollinator risk assessment in Australia, which outlines a tiered approach to risk assessment. The first tier of assessment involves the traditional assessment approach of calculating risk quotients. Methods for refinement at this tier are described, relying on data and approaches from both Europe and North America.
At higher tiers of assessment, increasingly complex studies pertaining to exposure and effects (semi-field and full-field studies at colony level) are considered. These studies allow for refinements in exposure and/or effects estimations using an increasing level of realism. Importantly, and as noted in the North American guidance document, the different levels of refinement are not intended to be prescriptive. The specific set of data used in assessing potential risks of a pesticide to bees ultimately depends on multiple lines of evidence and risk management objectives.
Risk mitigation—pollinator protection statements
This guidance proposes that recommendations for label statements are built into the risk assessment framework. Section 10 of the document addresses hazard-based label statements (ie statements which provide an indication of how toxic the product might be to bees), risk-based statements (even though a substance may be toxic to bees, a particular use may be acceptable if exposure is unlikely to reach hazardous levels after that use), and risk management statements (if both a hazard and a potential risk to bees—adults and/or colony—have been identified, risk management statements will be required).
The APVMA recognises that ecotoxicity test methods are still being developed and that pollinator risk assessment methodology is likely to be further extended and refined over the next several years. This guidance will be updated as new test protocols to better assess effects (hazard) of pesticides on bees and the exposure of bees to pesticides become available. For more information see: Overview report on neonicotinoids and honeybee health in Australia released.
Call for public comment
Comment is sought on:
- the risk assessment guidance outlined in the document Roadmap for insect pollinator risk assessment in Australia
- the proposed pollinator protection statements for product labels.
The APVMA will review responses from the consultation and make appropriate amendments. Further advice on the formal introduction of the framework as a guide for conducting pollinator risk assessments in Australia will follow.
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