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What needs to happen before the APVMA can take a chemical product off the Australian market?

4 May 2010

Under our legislation the APVMA has the power to take a chemical product off the Australian market. There are two preconditions that must be met before this can happen. First, the APVMA must be satisfied that there is likely to be a causal link between the use of a registered product and an unintended harmful effect when that chemical product is being used correctly. Credible scientific studies are typically required to define the link and identify the resultant risk.

Second, once this new risk is identified, the APVMA is required to work with the product manufacturers and users to determine whether there is a practical way to manage it. It is only if the APVMA is convinced that the risk cannot be successfully managed that it can take the step of removing the product from the market. A product that is removed cannot generally be supplied on the Australian market unless authorised.

Some people equate removal with the word ‘ban’. This word has no meaning in a risk-based system. For example, should the manufacturer come up with new information proving that the risk can be effectively managed, it is likely that the product could be approved for renewed use in Australia.

More information

The decision to register a pesticide or veterinary medicine is made after an assessment of a wide range of scientific information that considers the toxicity, metabolism and kinetics, residues, environmental fate, efficacy and safety and other characteristics of a proposed new chemical product. The information must address the APVMA’s legislative requirements and data must be of a standard consistent with international best practice.

In making a decision to approve a product, the APVMA must be satisfied that it can be used safely, subject to the conditions of use outlined on product labels. Decisions are made using the best information available at the time.

Sometimes, after a product has been registered, credible new scientific information emerges suggesting the existence of previously unrecognized risks to human health, the environment or trade. In these cases the APVMA typically initiates a formal reconsideration of the product. This generally involves the manufacturers being required to produce further information, often new scientific studies, that the APVMA assesses against contemporary regulatory standards. Any credible risks may be confirmed, or may be dismissed at this stage of the process.

At this point, if a credible risk remains, the APVMA must then work with the manufacturer to determine whether there are ways to manage this new risk. Many strategies are used. They include limiting the way the product can be used, requiring the use of personal protective equipment, requiring special training of users, imposing new withholding periods, placing further warnings on product labels, restricting availability, imposing new export slaughter intervals and so on.

In many cases, a range of these mitigation measures is sufficient to reduce the risk to a level where the APVMA can be satisfied that a product is likely to be safe to use.

In some cases, however, the APVMA remains concerned that an identified risk will remain even if all reasonable risk management measures are implemented. In this event, the APVMA must suspend or cancel the product, thus preventing it from being supplied and used in Australia.

Some people call this a ‘ban’ and it is true that most chemicals that are suspended or cancelled rarely return to the market. However, the system provides that if a manufacturer is able to provide new evidence that can convince the APVMA that the risk can be effectively managed, the chemical could be approved for renewed use in Australia.

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