Endosulfan Statements
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APVMA's decision not to review endosulfan registrations - January 2009
The APVMA's decision not to review endosulfan registrations in the light of a decision by the New Zealand regulator to de-register the chemical has drawn comment from a number of commentators.
Some of this comment has been inaccurate. For example, it has been asserted that endosulfan is being considered for a global ban under the Stockholm Convention on Persistent Organic Pollutants. It is implied that this decision will be made in October 2009. However, according to the Convention's own processes, the earliest this could be done would be May 2011and then only if parties to the Convention supported the move.
Similarly, it has been implied that other countries have deregistered endosulfan because of adverse findings. This is not necessarily correct. In a number of countries other factors have been involved including lack of manufacturer support, high level policy decisions, and the absence of appropriate risk management systems.
A key premise of much of the debate - especially from environmental groups - has been that Australia should necessarily follow the regulatory decisions made in other countries and, indeed, is negligent if it does not so.
This is a premise that needs analysis. While there is significant dialogue between various international regulators including agreed processes and practices, there are many country-specific factors that might lead different national jurisdictions to make varying regulatory decisions. These include (but are not limited to) climate, soil type, crops that are grown, chemical use patterns, cultural practices, and environmental management arrangements.
On this basis, a decision by one country should not necessarily be seen as an imperative for others. Differences between jurisdictions may simply reflect country specific factors.
In Australia the APVMA bases its regulatory decisions on the best available scientific information and a thorough knowledge of Australian circumstances. While Australian decisions generally correlate with those of other countries there are cases where they will be different either in a conservative or progressive sense.
Regulatory action in New Zealand - December 2008
On December 15 2008, New Zealand's Environmental Risk Management Authority (ERMA) revoked the approvals for the insecticide endosulfan and prohibited its importation, manufacture and use in New Zealand.
Endosulfan is registered for use in Australia and is applied to a number of agricultural and horticultural crops for the control of a variety of insects and mites.
The Australian Pesticides and Veterinary Medicines Authority (APVMA) notes the New Zealand decision with interest.
The APVMA concluded a review of endosulfan in 2005. This review was prompted by concerns about possible risks to the public from short and long-term exposure to endosulfan residues, occupational health and safety, trade and the environment.
As a consequence of the review many uses of endosulfan products were restricted and conditions imposed on their use (see endosulfan review page). Four products are currently registered for use in Australia.
Does the NZ decision mean that the APVMA should similarly deregister endosulfan in Australia?
Endosulfan is used differently in Australia than in New Zealand. In New Zealand, for example, users can use agricultural chemical products at rates higher than the approved rates (providing the MRL is complied with) stated on the label. This is not the case in most of Australia where any off-label use needs to be scientifically assessed before a product can be approved for use under a permit.
It was also used in different situations in New Zealand than in Australia. A major New Zealand use was for earthworm control in turf (a NZ-specific problem due to the nature of their soils, rainfall, worms and sporting calendar), leading to concerns about exposure of children and adults playing on treated lawns, as well as occupational health and safety concerns. Endosulfan is not approved for a similar use in Australia. Such differences in use can generate a higher real and perceived risk profile.
There are also regulatory differences between New Zealand and Australia. ERMA does not have the power to call-in scientific data or request that additional data be provided to help it inform a regulatory decision. It must rely on publicly-available information and studies available at the time of review. In Australia the APVMA has wider powers and can request that chemical companies provide it with scientific information from their data holdings and/or generate new data to fill information gaps identified through the course of a review. The database of studies available to the APVMA is therefore likely to be different and may be more extensive than that available to ERMA.
The APVMA's current position is that endosulfan registrations in Australia remain appropriate given the scientific evidence and the controls that are in place. Endosulfan will therefore not be re-reviewed at this stage.
It should be noted that this position is evidence-based and may change if new studies emerge which clearly indicate that endosulfan poses risks that cannot be successfully managed.
Australian Government agencies will consider any new information to which ERMA may have had access when formulating the Australian position regarding the possible listing of endosulfan under the Stockholm Convention on Persistent Organic Pollutants.