Sodium fluoroacetate (1080) chemical review

Sodium fluoroacetate is in Schedule 7 of the Standard for the Uniform Scheduling of Medicines and Poisons and is a restricted chemical product. It is only available to specialised or authorised suppliers/users who are trained to handle it safely.

Frequently Asked Questions

This document is organised in two parts. Part 1 contains information specific to 1080 and the review of 1080. Part 2 contains general information about the APVMA and about the review process.

PART 1

What is 1080?

1080 is a poison used for the purpose of vertebrate pest control. The chemical name for 1080 is sodium monofluoroacetate.

What is it used for?

1080 is used for the control of pest animals (for example rabbits, foxes, wild dogs and feral pigs) in forest and agricultural production, as well as for biodiversity conservation. It is also used for the control of browsing and grazing native animals in forestry management in Tasmania.

How is it used?

1080 is applied to food materials such as carrot pieces, oats, meat or offal. The poisoned baits are distributed in the habitats of the pest animals to be controlled.

Products containing 1080 are available in three types of formulation- aqueous solutions, short-life baits and shelf-stable baits. The aqueous formulations are not used directly to poison the animals, but are loaded into baits. Shelf-stable baits last up to 1 year after manufacturing. Semi-dried meat baits and dry oat baits are typical examples of shelf-stable baits. Short-life baits generally need to be used within a day after preparation. Fresh meat baits and carrot baits are two examples of the short-life baits.

What is its role in biodiversity conservation?

Rabbits, feral pigs, foxes and wild dogs in Australia cause environmental damage by removing native vegetation, competing for resources, degrading habitat, spreading disease and preying on native animals. Use of 1080 can reduce pest animal competition with and predation on native animals and can lead to the recovery of the threatened species.

What are the controls that apply to 1080?

The supply and use of 1080 is tightly controlled by a combination of Commonwealth and State regulations. The APVMA regulates 1080 up to and at the point of retail sale. Once sold or supplied, to the end user, it comes under the regulation of individual States.

Special regulations restricting the availability, storage and use of 1080 apply. Under State poisons legislation 1080 is a Schedule 7 poison. This means that 1080 is only available to specialised or authorised users who have the skills necessary to handle it safely.

Under the Agricultural and Veterinary Chemicals Code Regulations 1995 products containing 1080 are also declared to be ‘Restricted Chemical Products’. As such, the products can only be supplied to or used by ‘authorised person(s)’. Individual States set the authorisation criteria taking the APVMA’s and State regulatory requirements into account.

Why is the APVMA reviewing 1080?

The APVMA is reviewing 1080 because of concerns over poisoning of non-target animals. The review is examining a number of issues including persistence of 1080 in the environment, effects on non-target animals, poisoning incidents, effectiveness on biodiversity conservation and animal welfare.

What is the APVMA reviewing?

The scope of the 1080 review was determined by the specific concerns about the chemical and the criteria that are set out in the legislation. Before starting the review the APVMA invited public submissions to help it determine the scope of the review.

The scope of the review was defined as environmental aspects, animal welfare considerations, and assessment of product labels and associated extension material. The environmental aspects identified in the document include the persistence of 1080 in baits and poisoned animals, effects on non-target animal populations (particularly mammals, with a focus on native carnivores such as quolls and phascogales), consideration of incident reports, and the effectiveness of 1080 as a vertebrate pest control agent and its role in biodiversity conservation.

What kind of information did the APVMA assess?

The information assessed in the review included a large number of published and unpublished scientific studies as well as field observations and reports. Scientific studies from different regions within Australia as well as New Zealand and US studies were available for review. In conducting the review of 1080 the APVMA obtained specialist advice from the Department of the Environment and Heritage (DEH).

The use of 1080 in Australia and New Zealand has recently been reviewed by the Vertebrate Pests Committee (VPC ). The VPC made its unpublished report available to the APVMA’s review. The report contains information on current policies, practices and procedures for the use of 1080 and the role and importance of 1080 in vertebrate pest management, and recommendations on procedures for targeted and effective use of 1080.

What has the review found and what are the APVMA recommendations?

The initial findings contained in the report released for public comment on 23 May 2005 are, at this stage of the review process referred to as ‘preliminary review findings’ and are based on all the information available to the APVMA at this time.

Following the public consultation period these preliminary findings will be revisited to include the assessments of the public submissions received in response to the report.

Persistence of 1080 in baits and poisoned animals

In use, 1080 does not accumulate in the environment. It is applied locally at relatively small rates and is readily degraded in soils, surface waters and by micro-organisms.

The usual fate of 1080 in baits is to be consumed by the target pests in the days or weeks following baiting. Rain or dewfall may leach 1080 from some bait materials such as oats. When leaching does not occur, the baits can remain toxic for several weeks. However, they typically dry out and become unpalatable.

Most of the 1080 ingested by animals is rapidly metabolised and/or excreted, with only low levels retained in the carcass.

The review recommends that to the extent possible, untaken baits must be recovered at the end of a baiting campaign and be destroyed by burning or burial. The review also recommends that to the extent possible, animal carcasses must be recovered during and for 14 days after a baiting campaign and be destroyed by burning or burial. Further, incidents where it is suspected that non-target animals may have been poisoned by 1080 be notified to State authorities.

Effects on non-target animal populations

Poisoning of non-target animals may occur with 1080 baiting. However, the impacts are either localised, or limited to individual animals and do not result in significant adverse effects on the non-target animals at a population level.

Careful attention to the selection of bait material, amount of 1080 in each bait, timing and placement of baits combined with preliminary free feeding to reduce bait shyness, increases the acceptance of poisoned baits by target animals.

The review recommends that labels on the products used for control of herbivore pests control must contain specific warning that 1080 is toxic to birds and other wildlife. The labels must also instruct that the baits must not be laid in such places and at such times that they are likely to be consumed by non-target wildlife. To minimise poisoning of non-target carnivores such as quolls, 1080 products used for the control of fox and wild dogs must specify that the product is toxic to carnivorous native mammals, and instruct that no more than 2 baits/km be laid where native carnivorous mammals are active. Products used for pig control should specify that the baits should be buried where possible to restrict non-target animal feeding and that baiting should always be preceded by free feeding to maximise target specificity.

The review also proposes that the supporting material available to the users of 1080 (eg. code of practice for the use of 1080, manuals or standard operating procedures as developed by State agencies) should continue to be provided in the form of State-based documents, but their content and availability be made a specific condition of product registrations.

Incident reports

An assessment of the incident reports provided to the review showed that dogs are the most common nontarget casualties. This is not unexpected due to the fact that dogs are highly sensitive to 1080. They also tend to pick up a broad range of bait materials.

Timely notification of adjoining neighbours is essential to allow them to muzzle or restrain their dogs. Signage in the area where 1080 baits have been laid is necessary to inform people using or entering the land of the potential risk.

The review recommends that product labels must include instructions for neighbour notification, signage in the area where baits are laid and the minimum distance 1080 baits can be laid from dwellings, watercourses, fences and roadways. Signage must include date baits laid, contact numbers, toxin name, target animal and a warning that non-target animals can be affected. As this risk to domestic dogs will continue, signs should be maintained for a period after baiting occurs. The product labels must also carry an advice to muzzle dogs during 1080 baiting programs to avoid accidental poisonings.

Product labels

The current 1080 product labels do not contain adequate information and instructions for use. Many labels do not contain basic information such as specific target pests, 1080 dose rates, bait materials and size, bait preparation, storage and transportation of baits, neighbour notification about imminent baiting, minimum distance requirements for bait placement and the requirement of signage in baiting locations. Specific directions for use are often contained in a variety of documents issued by individual state agencies. These include regulations, codes of practices, manuals or standard operating procedures. These supporting materials cater for the specific needs of individual States’ eco-systems but are not currently part of the approved product label.

The review proposes that comprehensive instructions be included on all product labels. The labels must specify target pest animals and must contain instructions for neighbour notification about imminent baiting, minimum distance requirements for bait placement, requirement of signage in baiting locations, 1080 dose rates in the baits, bait materials and size, bait preparation method, storage and transportation of baits, protection of domestic and farm dogs, bait and carcass recovery. The labels must also contain information about the potential risks to non-target animals and instructions to ensure minimal poisoning of non-target animals. For detailed information on label instructions please see section 8.1 of the Preliminary Review Findings report.

The review also proposes that the supporting material available to the users of 1080 (eg. code of practice for the use of 1080, manuals or standard operating procedures as developed by State agencies) should continue to be provided in the form of State-based documents, but their content and availability be made a specific condition of product registrations.

Has the APVMA considered animal welfare issues?

There is public concern about the humaneness of using 1080. The Preliminary Review Findings report provides an overview of available information of 1080 and animal welfare. However the report has not formulated any conclusions on this matter. This is because animal humaneness is not a specific criterion in the Agvet Codes and because there are no well established scientific criteria for assessing or making decisions about animal humaneness. However the report notes that humaneness aspects in relation to the use of pesticides, is a broader government policy matter. The report summarises current government activities in this area.

Why is the APVMA proposing to continue the registration of 1080 while the government has announced phasing out 1080 in Tasmanian forestry?

The APVMA’s functions are governed by the Agvet Code. As a regulatory authority, the APVMA must make regulatory decisions based on scientific risk assessments. The1080 initial review findings and proposed regulatory measures are based on the scientific evaluation conducted by the DEH of all scientific information available to this time. The decision about phasing out 1080 in Tasmania is separate and a policy matter for the State. The proposed regulatory measures do not in any way preclude such initiatives from being implemented.

Are there any alternative vertebrate pest control techniques available?

Several other vertebrate pest control techniques- such as fencing, shooting and trapping, tree guards in plantations, are available as non-chemical alternatives to 1080. Some of these alternative options are often included in vertebrate pest control programs.

It is important that all the vertebrate pest control programs thoroughly consider all the available control options.

Is any further research work being carried out to find new vertebrate pest control agents?

The Commonwealth Department of the Environment and Heritage, the Victorian Department of Primary Industries and the Department of Conservation and Land Management in Western Australia have been examining the potential of a control agent called PAPP (p-aminopropiophenone) as an alternative to 1080 for the control of feral cats.

The Pest Animal Control CRC, funded by Australian Wool Innovation, is currently assessing the potential of PAPP for control of wild dogs and foxes in Australia. The Pest Animal Control CRC has recently identified three promising control agents for feral pig control which are to be tested on penned feral pigs.

PART 2

What is the Australian Pesticides and Veterinary Medicines Authority (APVMA)?

The APVMA is the Australian Government statutory authority responsible for the regulation of pesticides and veterinary medicines up to the point of retail sale.

All pesticides and veterinary medicines must be registered by the APVMA prior to being supplied, sold or used throughout Australia.

Pesticides include products that are used around the home garden and those used for commercial or agricultural purposes.

What is product registration?

Registration means that the pesticide or veterinary medicine has been rigorously assessed to ensure that it works, is safe for people, animals and the environment, has been manufactured to appropriate standards and does not pose an unacceptable risk to Australia’s trade with other countries.

All registered products have an approved label that includes instructions for correct use and relevant safety information. Only registered products have a distinguishing number on the label APVMA Approval no. xxxxx/ or NRA Approval No. xxxxx/.

What is a chemical review?

The APVMA has a program for reconsidering (reviewing) the registration of older chemicals that are currently on the market. Reviews are undertaken when there is new information that raises potential concerns about a chemicals ongoing use, suggesting that its registration should be reassessed.

Reviews can be triggered by new research or other evidence that has raised concerns about one or more of the following:

• the safety of people using the chemical or the product;
• an effect that is harmful to public health;
• an unintended effect that is harmful to animals, plants or to the environment;
• a prejudice to trade or commerce between Australia and places outside Australia;
• whether the product is effective when used as instructed by the label; and
• labels instructions for the safe and effective use of the product.

When the APVMA decides to reconsider the registration of a chemical it will call for any relevant new information from registrants and the public, it may also require registrants to conduct new studies. The APVMA then assesses all the information and publishes a review report that details its findings. The assessment also forms the basis for decision about the future availability of the chemical or how it is used.

There are three possible outcomes from a review:

• The APVMA is satisfied that products are safe and effective and chemical use can continue based on existing instructions;
• The APVMA has identified that some aspect of the chemical or its use may not be safe and therefore makes changes to the conditions of registration and/or the label instructions; or
• The APVMA is not satisfied that continued use of the chemicals will be safe and effective and suspends or cancels the chemical.

Impact of 1080 Review Outcomes

On State and Territory Authorities:
1080 is an important chemical for State and Territory agencies in the management of pest species and for the conservation of biodiversity. Under the review outcomes these agencies will continue to exercise their statutory use control powers in relation to 1080.

On registrants (manufacturers) of the 1080 product:
The review outcomes require registrants to provide new labels and instructions with the chemical to provide more explicit information about its use and management.

On primary producers:
1080 is an important tool for farmers in managing pest animals. Farmers will continue to be able to access the chemical to manage predation of stock and other biodiversity issues albeit under tighter controls.

From public submissions to the APVMA in response to the release of the review scope document, it was evident that there was strong public concern about the humaneness of sodium fluoroacetate, and that the community considered that this issue should be considered by the review. The preliminary review findings report provided an overview of available information on sodium fluoroacetate and animal welfare, but it did not reach any conclusions on this matter, as animal welfare is not a specific criterion under the Agvet Code that can be taken into account in decisions about the future use of sodium fluoroacetate.

Preliminary review findings report

In May 2005, the APVMA released the Sodium fluoroacetate (1080) preliminary review findings report. The APVMA’s key finding was that the labels for products containing sodium fluoroacetate did not contain adequate instructions to ensure the safe use of those products.

In the report, the APVMA proposed varying product labels to:

• delete all use of the general terminology ‘vermin’ and ‘vertebrate pest(s)’, and replace those terms with details of specific target species
• include stronger safety directions to reduce the risk to non-target species
• include the warning that sodium fluoroacetate is a restricted chemical product
• include instructions on bait materials, preparation and dosage
• include instructions on bait storage, transport, placement and timing, and the recovery of baits and carcasses
• include instructions on notifying neighbours of baiting and the requirement to place warning signage in the area where baits have been laid.

Final review report: review findings and regulatory outcomes

In January 2008, the APVMA released the Sodium fluoroacetate (1080) final review report and regulatory decision.

The review found that poisoning of non-target animals does occur with 1080 baiting. However, it concluded that when appropriate attention is paid to bait density, placement, timing, substrate and other matters, impacts can be localised or limited to individual animals and thus do not appear to result in significant adverse effects on non-target animals at the population level.

Careful attention to the selection of bait material, the amount of 1080 in each bait, timing and placement of baits combined with preliminary free feeding can increase the acceptance of poisoned baits by target animals.

The review added several new instructions to the container labels to better protect the environment and non-target animals. The review also reduced the bait rate to 10/km transects for aerial baiting of wild dogs.

Contact the APVMA for printed copies of this report.