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Risk management methodology

The ACVM Group, in association with the Agricultural Compounds and Veterinary Medicines Advisory Council, has been working on a comprehensive description of the risk management methodology used by MAF to make decisions on the regulatory control of agricultural compounds and veterinary medicines.

The task has been complicated by the rapidly changing discipline of risk management and the evolving use of risk management terminology. MAF is confident that its decision rationale is sound, but it is aware that over the past two years the shifting meaning of risk management terms has generated a significant level of confusion and uncertainty.

Australian/New Zealand standard

In future the ACVM Group will present its rationale in terms of the recently revised Australian/New Zealand standard on risk management (AS/NZS 4360:1995) and will publish its methodology as soon as it has been converted into the terminology of the Australian/New Zealand standard. However, as parties anticipate the commencement of the ACVM Act and prepare applications for registration or attempt to understand the rationale behind the recommendations to exempt certain agricultural compounds from registration, some aspects of MAF's methodology need explanation now.

ACVM Group functions

With the creation of the Food Assurance Authority (see page 3), the ACVM Group will have two main and distinct functions:

• specifying the maximum residue limits for substances in the domestic food residue standards set under the Food Act 1981; and

• regulating agricultural compounds and veterinary medicines under the ACVM Act (Animal Remedies, Stock Foods, Pesticides and Fertilisers Acts until the ACVM Act commences).

Risk management

In terms of the AS/NZ standard for risk management only the first function can be considered ’risk management'. It establishes the context in which residues should be considered. It identifies, analyses and prioritises the risks. It sets acceptable levels of risks, specifies the parameters to be used to measure the risks and sets the thresholds above which the risks are unacceptable. When carrying out this function MAF will maintain a process by which the public can participate in the setting of thresholds and will make all the agreed thresholds readily available.

Hazards

Since the assessment of the risks and the establishment of the tolerable limits would have already been done, the second function focuses on identifying and managing hazards rather than risks. According to AS/NZS 4360, a hazard is "a source of potential harm or a situation with a potential to cause loss" (ie in this case, a source or situation that could cause a threshold to be exceeded). To be consistent with the standard the ACVM Group will use the term ’hazard' to describe the sources or situations that must be addressed in applications for registration of trade name products or that are addressed when MAF decides whether or not an agricultural compound group should be exempted from registration.

It is hoped that all parties will understand that the term 'hazard' does not refer to the hazardous characteristics relevant to the Hazardous Substances and New

Organisms Act 1996. The Environmental Risk Management Authority will be concerned about different hazards and different thresholds related to risks to public health and the environment.

The section of the ACVM Group that regulates agricultural compounds and veterinary medicines does not set thresholds for any of the risk areas specified in the ACVM Act. That section uses the thresholds that will be set in other parts of the Food Assurance Authority and the Biosecurity Authority and endeavours to reduce the hazards via regulatory control of agricultural compounds and veterinary medicines.

Relevance to applicants

So what does this change in perspective and terminology mean to people regulated under the ACVM Act?

• Applicants will not be asked to provide information concerning the potential impact of exceeding particular thresholds because the assessment of risks would have been completed and the thresholds established already.

• Applicants will not be asked to assess the risks (ie the probability that a threshold will be exceeded times the magnitude of impact of exceeding the threshold as stated in earlier ACVM public discussion documents). The registration standards being developed by the ACVM Group do not specify any information requirements that would allow the impacts of exceeding thresholds to be assessed.

• Applicants will be asked to identify and quantify the hazards associated with their products that may cause any of the thresholds (for any of the risk areas specified in the ACVM Act) to be exceeded.