Fipronil

Fipronil is a broad spectrum phenyl pyrazole insecticide that is used in both agricultural and veterinary situations. It controls insect pests in a wide range of agricultural crops, it is used as an insecticidal seed dressing, and it is used for the control of termites, cockroaches and ants in residential and commercial buildings.

In veterinary situations, fipronil products are used as spray or concentrated spot-on formulations to control fleas, ticks and other ectoparasites that live on the skin of dogs and cats, and the products are used for the treatment and control of flea allergy dermatitis.

Fipronil review

Status: review in progress; scope extended to include consideration of environmental concerns—submissions for the extended review scope are open until 31 August 2012

Fipronil was nominated for review following the receipt of a number of reports of adverse experiences in humans and animals. The APVMA commenced the review of fipronil in September 2003. The initial review considered concerns over toxicity, primarily related to skin irritation and induction of skin sensitisation, but also the potential for fipronil to form toxic photodegradation products, occupational health and safety issues, animal safety, and the adequacy of label instructions.

The APVMA released the Preliminary Review Findings for public comment in 2011.

The Preliminary Review Findings recommend that there should be no change to the approval status of fipronil or to the ongoing registration of existing fipronil products in Australia. However, amendments to instructions on labels would be required to address occupational safety and animal safety concerns.

At the commencement of the fipronil review in 2003, no environmental concerns were identified in Australia.

In 2007 the Department of Sustainability, Environment, Water, Population and Communities (DSEWPaC) nominated fipronil as a priority 1 chemical for environmental review. This followed the identification of new information, considered by international regulatory authorities (primarily the European Food Safety Authority in 2006), showing that fipronil and its metabolites are very highly toxic to organisms in the environment, particularly aquatic and terrestrial insects.

DSEWPaC has advised that previous Australian assessments, conducted for product registration or permit applications, that identified little risk to the environment from the use of fipronil products may not be an accurate reflection of the (now evident) environmental risks associated with fipronil use in Australia.

On this basis the APVMA has determined that consideration of environmental concerns is required and will be achieved through extension to the scope of the current review. The APVMA will review the following environmental aspects of product registrations for fipronil including, but not limited to:

  • aquatic degradation
  • persistence in environmental media (soil, water and sediment)
  • partitioning in the environment e.g. deposition, adsorption
  • toxicity to fish and aquatic invertebrates, sediment organisms, bees and non-target arthropods

The APVMA will also consider whether product labels carry adequate instructions and warning statements.

The APVMA’s detailed reasons for this reconsideration can be found in the APVMA’s Fipronil Review Scope Document, Part 2 Environmental Considerations and associated reports from DSEWPaC. The scope document also provides details on the data requirements for this review.

Please note that the extension of the review will not include household insecticide products, veterinary preparations, or products intended as baits or bait stations.

The APVMA will issue a final report once the assessment of all available data is completed.

Fipronil review archive


Title Date
Fipronil review - frequently asked questions August 2012
Fipronil Review Scope Document Part 2—Environmental considerations (PDF, 895kb) | (DOC, 475kb) July 2012
Fipronil Environmental Effects Assessment (PDF, 881kb) | (RTF, 1.6MB) July 2012
Fipronil Environmental Fate assessment (PDF, 821k) | (RTF, 1.3MB) July 2012
Fipronil Tier 1 Environmental Risk Assessment (PDF, 569kb) | (RTF, 1MB) July 2012
Fipronil Refined Risk Assessment (PDF, 693kb) | (RTF, 5.6MB) July 2012
Fipronil—Preliminary Review Findings Report (PDF, 1.27MB) | (DOC, 954kb) June 2011
Safety of Fipronil in Dogs and Cats: a review of literature (PDF, 249kb) | (DOC, 344kb) June 2011
A review of Animal Safety Studies for Fipronil in the dog and cat (PDF, 247kb) | (DOC, 109kb) June 2011
Occupational Health and Safety Assessment of Fipronil (PDF, 1.35MB) | (DOC, 963kb) June 2011
Review of the Mammalian Toxicology and Metabolism/Toxicokinetics of Fipronil (PDF, 2.60MB) | (DOC, 2.13Mb) June 2011
Gazette Notice: reconsideration of approvals and registrations related to fipronil Oct 2003
Fipronil Review Scope Document—Part 1 (PDF, 77kb) Sep 2003

Contact

For more information contact:

Chemical Review

Phone: +61 2 6210 4749

Fax: +61 2 6210 4776

Email: chemicalreview@apvma.gov.au

Product Search

Search the PUBCRIS database for registered products that contain fipronil.
Note: In the Active Constituent 1 field enter fipronil.

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