Anticoagulant Rodenticide Regulatory Review – Proposed Regulatory Decision

The APVMA has completed a review into anticoagulant rodenticide use in Australia. This is a summary of the proposed regulatory decision and next steps in the process.

 

 

In 2021, the Australian Pesticides and Veterinary Medicines Authority (APVMA) announced a review into anticoagulant rodenticides. The review has now been completed and the proposed regulatory decision has been published. Public consultation is now underway. When the final regulatory decision is made it is likely to have a significant impact on rodent management.

 

Why is there a regulatory review into anticoagulant rodenticides?

Anticoagulant rodenticides have been under review for many years in a number of countries, with the reviews in the US (in particular, California), EU and the UK having particular relevance to the APVMA review. The focus of these reviews and subsequent changes to regulations was primarily on non-target poisoning and the risk of secondary poisoning to carnivores, in particular birds of prey, but also covered aspects of user safety.

The current APVMA review into anticoagulant rodenticides included, “…assessment of chemistry, toxicology, worker and public exposure, residues (including trade) and environment aspects of anticoagulant rodenticide active constituent approvals, products registrations and label approvals.”

 

What was the assessment of the risks regarding the use of anticoagulant rodenticides?

There is obviously a risk to mammals through direct ingestion of rodenticides by non-target animals. The review assessed whether the products and their current use patterns sufficiently mitigated these risks.

When it comes to the environmental impact of anticoagulant rodenticides, their impact on birds has been a particular focus. In terms of poisoning through direction ingestion, the APVMA assessment states that, “…based on dietary exposure studies, the second-generation actives brodifacoum, bromadiolone, difenacoum, difethialone and flocoumafen and the first-generation active, coumatetralyl, were all determined to have a high toxicity to birds.”

In terms of secondary poisoning, which is of concern regarding their impact on birds of prey, “…only second-generation anticoagulant rodenticides appear to pose a significant risk… with the secondary poisoning hazard potential being the highest for the active constituents brodifacoum and difenacoum.”

 

 

The review assessed the impact of anticoagulants on a wide range of animal groups. For example, it is noted that, “…the limited reptile toxicity studies support the position that reptiles have a high tolerance to anticoagulant rodenticides poisoning.”

The review also notes that terrestrial invertebrates, particularly slugs and snails, will feed on rodent baits. The conclusion is then made, “…meaning that secondary poisoning of non-target invertebrate-eating wildlife is possible.” However, no data is presented to support this conclusion.

As a result of the APVMA assessment, the regulator makes the following conclusions regarding the safety and use patterns of anticoagulant rodenticides:

In relation to the anticoagulant rodenticide chemical products listed in Attachment A of this notice: Under section 34A(1)(a) of the Agvet Code, I am not satisfied that the chemical products meet the safety criteria, as I am not satisfied that the use of chemical products in accordance with current instructions:   

• would not be likely to have an unintended effect that is harmful to animals, including non-target terrestrial vertebrates and aquatic species44 Section 5A(1)(c) Agvet Code.
• would not be likely to pose an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues, including potential safety concerns for professional workers who handle the chemical products during application and/or people who are involved in clean-up activities.
• would not be likely not have an effect that is harmful to human beings, including potential safety concerns related to vulnerable human beings who may invertedly access baits, human beings who may hunt for wild game in treated areas and/or the potential for contamination of food commodities that may be consumed by human beings.

In relation to the labels for anticoagulant rodenticide chemical products listed in Attachment A of this notice: Under section 34A(1)(a) of the Agvet Code, I am not satisfied that these labels meet the labelling criteria as they contain inadequate instructions to ensure, as far as reasonably practicable, that the associated chemical product meets the safety criteria.

However, the regulator is satisfied that the particulars of the registrations and labelling can be varied in such a way as to meet the safety and labelling criteria.

As a result of the assessment, significant changes have been proposed to anticoagulant product availability and use patterns.

 

What is the proposed regulatory decision?

Note: It is important to note that the summary below is of the PROPOSED regulatory decision. These changes are yet to be confirmed and are subject to alteration based on submissions received from interested parties during the ongoing public consultation period.

Key proposed use pattern changes

• Anticoagulant rodenticides can only be used indoors for the control of mice.
• When using anticoagulant rodenticides outdoors for rats, they must be placed in tamper-resistant bait stations, secured in place, and can only be used outdoors within 2 metres of the building (does not apply to coumatetralyl).
• Burrow baiting as use pattern for rat control will no longer be allowed.
• Update label instruction to Search for and dispose of dead rodents at each visit to prevent secondary poisoning. In case slugs/snails are present, move bait station to another location within the rodent infested site, away from slugs/snails.
• Inspect bait sites at intervals no more than 7 days apart.
• DO NOT use the product beyond 35 days without an evaluation of the state of the infestation and of the efficacy of the treatment.
• Remove all uneaten bait at the end of treatment.
• All dead or moribund animals and rodent faeces MUST be removed from areas accessible to livestock and poultry.
• Dispose of slugs/snails, dead rodents and uneaten bait by wrapping in paper, placing in plastic bag and putting in garbage.
• A range of restrictions are proposed to limit contact with livestock, poultry and wildlife likely to be collected for human consumption.

Consumer product changes

Consumer use patterns are considered higher risk due to the lack of user training. In addition to the proposed use pattern changes above, consumer pack sizes are to be limited, and all bait must be placed in tamper-resistant bait stations.

Occupational user safety – application and PPE changes

• Wear disposable gloves and DO NOT touch bait during application, with the instruction to use a scoop or measure, no matter the formulation (i.e. not just pellets but also blocks and soft baits).
• In terms of clothing requirements, the new proposal includes the requirement to “Wash clothes after performing re-handling activities”. (Re-handling activities include post-treatment bait clean-up operations and droppings clean-up activities).

Proposed product changes

• All anticoagulant products must contain bittering agent and dye or registrations will be cancelled.
• Liquid and powder product registrations will be cancelled.

 

What is the potential impact of the proposed regulatory decisions?

Clearly, if all the above proposed changes are implemented, they will have a significant impact on rodent management practices. Whilst restriction on consumer access to rodenticides is welcome, some of the proposed changes will impact the costs and practicalities of delivering effective rodent control programs.

There are three main areas of concern in both the assessment and the impact of the proposals if implemented:

• The data used by the APVMA to make some of these decisions is incomplete or based largely on overseas data. For example, pindone is a widely used anticoagulant for rabbit control and is not referenced in the review. Much of the data referenced from Europe is based on the Norway rat, whereas the roof rat is the most common pest rat in Australia and New Zealand. There is no data to support the slug/snail route for secondary poisoning.
• The review does not appear to demonstrate a full understanding of current best practice rodent management processes and the practicalities of rodent treatments. Nor does it demonstrate an appreciation of how the changes will impact the feasibility of carrying out efficacious and cost-effective rodent management.
• There is no consideration of the potential negative impacts of reduced rodent treatment efficacy that is likely should these proposals be implemented in full. Increased rodent numbers will have a negative impact on native wildlife, impact agricultural and livestock production and increase the risks of rodent-borne diseases.

 

What happens next?

We are currently in a three-month public consultation period, which ends on March 16, 2026. This allows for submissions from industry and any interested parties, to provide feedback on the proposed regulatory changes.

AEPMA and rodenticide manufacturers have already made submissions, to ensure decisions are based on the best available science, relevant data, an accurate understanding of how best practice rodent management is applied and the impacts of restricting rodent control options, whilst still appreciating the need to minimise environmental impact and ensure user and human safety. It is hoped that the APVMA will take the feedback on board and modify the proposal accordingly. However, it should also be noted that there will be submissions from interested parties claiming that the changes to not go far enough.

Either way, it is important to realise that there will certainly be changes to rodenticide registrations, labels and use patterns. Whatever these changes may be, although some of these changes may present challenges and variations to current rodent management processes, the proposed changes do put more emphasis on professional rodent management services, which may ultimately be good for the environment and industry.

A date for the final regulatory decision has yet to be confirmed.

Pest managers are welcome to make their own submissions. Any feedback should be made in the context of the general objective to reduce non-target and secondary poisoning risks, and increase user safety, whilst proposing changes that still deliver efficacious, practical and cost-effective rodent control options.