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:
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.
Conditions imposed
The conditions that will be imposed will be designed to reduce hazards.
They will not be designed to mitigate the impact of exceeding thresholds. In effect,
regulatory control under the ACVM Act will contribute to risk management only to the
extent that the control reduces specific hazards.
Example
For example, one of the outcomes of the first function listed above
will be specific statements about the maximum residue limits for substances that will be
tolerated. Once a maximum residue limit has been set the applicant must address the
hazards in relation to that limit. The only information that will be required from the
applicant in regard to residues will be that which shows whether or not the residue limit
will be less than the specified maximum limit when the product is used as recommended.
Each of the thresholds will be dealt with in the same way as in the
residue example above. The threshold will be set outside the scope of the ACVM Act and the
applicant must provide the information that shows whether or not a particular threshold
will be exceeded when the product is used as recommended.
This will be explained in the public statement on MAF's rationale for
regulating agricultural compounds and veterinary medicines. However, potential applicants
should take note that the risks will be assessed by MAF and the thresholds specified. The
applicant will be responsible for providing the technical information and assessment of
the hazards posed by their products.
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