Gazette APVMA 6, 7 June 2005 page 48

NOTICE

Preliminary Review Findings of the Review of Registrations and Approvals
Related to Sodium Fluoroacetate (1080)

Sodium fluoroacetate, commonly known as 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.

The APVMA, in accordance with Part 2, Division 4, of the Agvet Code, has reviewed the following aspects of product registrations and label approvals for 1080:

• Environmental aspects, including:

- Persistence of 1080 in both baits and poisoned animals
- Effects on non-target animal populations – Toxicity to birds and particularly mammals was the priority because of their sensitivity. There was limited consideration of less susceptible organisms (reptiles, amphibians, aquatic life and terrestrial invertebrates). Native carnivores, notably quolls but also phascogales, received particular attention because of their likely sensitivity to 1080, their vulnerable or endangered status, and the likelihood that they may be exposed to 1080 by direct consumption of meat baits laid for predators or by scavenging of carcases. The likely magnitude and importance of any non-target impacts was determined.
- Poisoning incidents – consideration of incident reports.

• Effectiveness of 1080 as a vertebrate pest control agent and its role in environmental protection.
• Animal welfare considerations.
• Assessment of product labels and associated extension material.

Following the review of 1080, the APVMA has found that:

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.
1080 baits are usually 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.
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.
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 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.

In view of these findings, the APVMA is proposing the following.

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.
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.
Label instructions will specify to the extent possible, untaken baits must be recovered at the end of a baiting campaign and be destroyed by burning or burial. 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. Incidents where it is suspected that non-target animals may have been poisoned by 1080 be notified to State authorities.
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.
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.

The APVMA’s detailed findings and recommendations can be found in the APVMA Preliminary Review Findings document, available on the APVMA website - http://www.apvma.gov.au.

The APVMA invites persons and organisations to submit their comments and suggestions on this Preliminary Review Findings document directly to the APVMA.

Your comments will assist the APVMA in preparing the Final Review Report and Regulatory Decision. Submissions specifically addressing the areas of concern noted in the Preliminary Review Findings document must be in writing and reach the APVMA by 31 August 2005, by email to

chemrev@apvma.gov.au or by mail to:

Evaluator 1080 Review
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604
For further information please contact ph. (02) 6272 3213 or fax (02) 6272 3218