This note is not part of the regulations, but is intended to indicate their general effect.
These regulations, which come into force on 15 January 1998, prescribe the fees payable in respect of matters under the Pesticides Act 1979.
The regulations provide, among other things, for—
The regulations replace the Pesticides (Fees) Regulations 1993(as amended in 1995).
The regulations introduce differential fees for applications for registration of a pesticide. The current fee for these applications is a flat fee of $3,150. The new fee is broken down to reflect the number of stages through which an application may need to be processed. These consist of a pre-screening stage, followed by the full processing of the application. The various stages are as follows:
This consists of the administrative pre-screen, followed by the technical pre-screen. All applications received will be progressed through these 2 sub-modules. If there is a deficiency in the application, at the conclusion of this pre-screening section the application will be referred to the Board or its sub-delegated decision-making authority with a recommendation that the application be declined. The total amount payable at this point is $364.50.
All applications that are not declined at the end of the pre-screening module will attract a charge of $1,685.81 to cover all administration in respect of the processing of the application. This charge will make up part of the final application fee.
Every application will be evaluated under this module. The cost to the applicant per application is $136.69 for costs incurred in respect of an assessment of the chemical identity, properties, formulation details and manufacturing processes, including specifications and analytical methods for all formulation ingredients, and impurities in the final product. An assessment of the stability of the final manufactured product may be included.
Every application will be processed and evaluated in respect of toxicology. There are 3 different toxicology sub-modules. Every product which has a new active ingredient will be required to undergo an assessment of the full range of acute studies, short-term repeat dose studies, sub-chronic toxicity studies, long-term toxicity studies, reproduction studies, developmental studies, genotoxicity studies, metabolism and toxicokinetic studies, human toxicological data, special toxicity data (eg neurotoxicity), first aid and safety directions assessment and any other additional data which may be required to make a full assessment of the hazard or risk of the active ingredient and the product. The fee for the module is $3,280.50.
An alternative module will be applied where the active ingredient is known. The fee for this module is $911 25. Another alternative is the basic toxicological assessment module. The cost of the module will be $546.75.
Every product that is going to be used in respect of a food crop will be subject to an assessment in this module. The assessment will cover the data showing the nature and level of residues and significant metabolites resulting from the proposed use-pattern in the target crop, and the establishment of withholding periods. It reviews the analytical methods used to determine the residues. It also includes an assessment of the effect of any major variables needed to determine the need for, and if necessary, the establishment of residue limits. For the first food crop the product is claimed to treat pests, the cost under this module is $956.81. For every other food crop the product is claimed to treat pests, the cost will be an additional $455.63.
Environmental Fate and Toxicity Assessment
Every application will be required to be assessed in this area. There are 3 levels of assessment. Where the active ingredient is new, the assessment will be thorough and involves an assessment on environmental chemistry, fate, and toxicology. This will include full studies on degradation, mobility, accumulation and metabolism in the environment. The studies will include toxicity studied in birds, mammals, and other vertebrates, aquatic organisms, non-target invertebrates, and non-target plants. The cost of the assessment will be $1,959.19.
Where the active ingredient is a known active ingredient, the assessment will not be as thorough and will rely to some extent on established data. The cost of this will be $911.25.
A basic assessment will be made in other circumstances. The cost where a basic assessment is all that is required will be $546.75.
This module covers a review of the data provided in respect of efficacy against the pest and phytotoxicity in the host species. This will involve field trials and any other trials or studies to justify claims made in respect of the target pest. The cost under this module will be $1,184.63 for the first claim in respect of the target pest and $546.75 for each additional claim.