The APVMA’s Regulatory Action
First published 12 April 2010
What regulatory action has the APVMA taken?
The APVMA has suspended all quintozene approvals and quitozene product registrations for 12 months while further consideration takes place to determine a longer-term outcome.
Has the APVMA acted in a timely manner?
The APVMA acted quickly after it was advised in June 2009 of dioxin contamination in several pesticide products by university scientists who had conducted independent testing. The APVMA completed its own testing in August/September 2009 to determine whether the reported results were accurate; dioxin analysis requires significant amounts of time. When the reported dioxin levels were verified, an expedited human health risk assessment was commissioned in October and received in mid-November. Regulatory action was initiated in early December. The suspension of quintozene approvals and associated product registrations will continue until April 2012 to allow a comprehensive assessment of any new quintozene data that is provided.
Why hasn’t it banned these chemicals outright?
The APVMA has the power to de-register a product if it concludes that the risks it presents cannot be reduced or successfully managed. The APVMA legislation provides the manufacturer of a pesticide with the opportunity to demonstrate that some or all of the risks a pesticide may present can be successfully mitigated. In the case of quintozene, the manufacturer has supplied information which has not satisfied the APVMA, and unacceptable risks remain. Therefore the APVMA has stopped all use of quintozene products until further consideration can take place under the provisions of Australia’s Agricultural and Veterinary Chemicals legislation.
Who is at risk from exposure to dioxins in quintozene products and what is the risk?
The contemporary human health risk assessment the APVMA commissioned from the Office of Chemical Safety and Environmental Health in the Department of health and Ageing identified that there may be a risk that workers who regularly apply quintozene products may exceed safe exposure levels for dioxins, based on a health standard called the tolerable monthly intake (TMI). The value Australian health authorities have adopted for its TMI is identical to the international TMI set by the World Health Organization (WHO) for dioxins.
Risks from dioxins are related to long exposure periods and accumulation in the body. While everyone is exposed to small amounts of dioxins every day from food, air and water, it is important to minimise as much as possible any additional exposures that can be controlled. According to the best available scientific information, keeping exposure at or below the tolerable monthly intake for dioxins over the long term will not result in significant health risk.
What is happening in other countries?
Both the American and Canadian regulators have reviewed quintozene and published draft review reports. The United States Environmental Protection Agency published a quintozene re-registration document (external PDF, 2.77MB) in 2006 but to date no regulatory decision has been made with regard to re-registration. On 12 August 2010 the US EPA issued a Stop Sale, Use or Removal Order to the American manufacturer of quintozene, due to differences between the declared composition of quintozene and its actual composition. This decision has been subject to legal challenge but remains in effect.
The Canadian Pest Management Regulatory Agency also published a quintozene review document (external site) in February 2009 and a final document on 24 June 2010, limiting the use of products containing quintozene to bulb dip treatments and cole cropping only.
The Environmental Risk Management Authority New Zealand (ERMANZ) announced in May 2011 the revocation of existing approvals for quintozene products based on human health concerns for workers applying the fungicide.