Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1698943620929.pdf (New Zealand)
Pesticides (Fees) Regulations 1997 (SR 1997/368) PURSUANT to section 76 of the Pesticides Act 1979, His Excellency the Governor­General, acting by and with the advice and consent of the Executive Council, makes the following regulations.

Contents 1 2 3 Title and commencement Fees Revocations Schedule Fees payable under Pesticides Act 1979 Page 1 1 2 2 1 (1) (2) 2 (1) (2) Title and commencement These regulations may be cited as the Pesticides (Fees) Regu­ lations 1997.
These regulations come into force on 15 January 1998.

Fees The fees set out in the Schedule are payable in respect of the matters to which they relate.

The fees prescribed by these regulations are inclusive of goods and services tax.

Note These regulations are administered in the Ministry of Agriculture.
1 r 3 3 Pesticides (Fees) Regulations 1997 Reprinted as at 3 September 2007 Revocations The Pesticides (Fees) Regulations 19931 and the Pesticides (Fees) Regulations 1993, Amendment No 12 are consequen­ tially revoked.

Schedule Fees payable under Pesticides Act 1979 Reg 2 $ 55.00 66.00 1.
On application under section 21 for authority to import pesticides for use by their proprietors, for each importation of each pesticide— (a) Where the application is made by a single proprietor ...................................... (b) Where the application is made by 2 or more proprietors (payable in such propor­ tions as the proprietors decide) ............... 2.
On application under section 22 for registration of a pesticide (other than an application in respect of a pesticide for which an experimental use permit referred to in clause 5(b) is in force)— Pre­screening cost ................................... 364.50 Plus administration cost .......................... 1,685.81 Plus manufacturing assessment............... 136.69 Plus toxicology evaluation— 1 SR 1993/172 2 SR 1995/102 2 Reprinted as at 3 September 2007 Pesticides (Fees) Regulations 1997 Schedule (a) For an application for a pesticide with an active ingredient that is new to pesti­ cides or to pesticides of that type ............ (b) For an application for a pesticide with no active ingredient that is new to pes­ ticides or to pesticides of that type, but which requires more than the basic evalu­ ation referred to in paragraph (c) ............ (c) For an application which involves only minimal public or environmental exposure, which requires no assessment of data, and which requires only a basic toxicology evaluation .............................. Plus, in the case of pesticides that are to be used in respect of a food crop and that require a residues/metabolism evaluation,— (a) For the ﬁrst named food crop to which the pesticide is to be applicable............... (b) For each additional named food crop to which the pesticide is to be applicable Plus environmental fate and toxicity assessment— (a) For an application for a pesticide with an active ingredient that is new to pesti­ cides or to pesticides of that type ............ (b) For an application for a pesticide with no active ingredient that is new to pes­ ticides or to pesticides of that type, but which requires more than the basic as­ sessment referred to in paragraph (c) ...... $ 3,280.50 911.25 546.75 956.81 455.63 1,959.19 911.25 3 Schedule Pesticides (Fees) Regulations 1997 Reprinted as at 3 September 2007 (c) For an application which involves only minimal public or environmental exposure, which requires no assessment of data, and which requires only a basic environmental fate and toxicity assess­ ment......................................................... Plus efﬁcacy/phytotoxicity review— $ 546.75 (a) For the ﬁrst named pest and crop to which the pesticide is to be applicable.... 1,184.63 (b) For each additional named pest or crop, to which the pesticide is to be ap­ plicable .................................................... 3.
On application under section 22 for registration of a pesticide in respect of which an experimental use permit referred to in clause 5(b) is in force— 546.75 Pre­screening cost ................................... 364.50 The fee, or part of the fee, that would have been payable if the application had been made under clause 2 Plus, in respect of each of the following modules that would be required if the ap­ plication had been made under clause 2, and that have not been successfully com­ pleted and passed during the processing of the application for the experimental use permit: manufacturing assessment, tox­ icology evaluation, residues/metabolism evaluation, environmental fate and toxi­ city assessment, and efﬁcacy/phytotoxic­ ity review................................................. 4.
On application to vary any registration or experimental use permit, or to revoke or vary any term, condition, or requirement imposed by the Board,— 4 Reprinted as at 3 September 2007 Pesticides (Fees) Regulations 1997 Schedule (a) For minor changes (including change of proprietor’s name and address, change of trade name, transfer of registration or experimental use permit, and administra­ tive change to a label) ............................. (b) For substantive changes (including change in sourcing of active ingredients, change of manufacturer or method of manufacture, and change in the shelf­life) On application under section 25 for an experimental use permit— $ 364.50 The fee, or part of the fee, that would have been payable if the application had been made under clause 2 (a) Where the product is not for sale....... 364.50 (b) In the case of any other application...
The fee, or part of the fee, that would have been payable if the application had been made under clause 2 6.

Annual registration fee payable in re­ spect of any pesticide, payable on 1 July in each year ............................................. 7.
On application for transfer of rights of proprietor under section 32(2) or for reinstatement of any registration that has been cancelled or revoked at the request of the proprietor or revoked for failure to pay the annual fee,— 562.50 5 Explanatory note Pesticides (Fees) Regulations 1997 Reprinted as at 3 September 2007 (a) In the case of an application made within 24 months of the cancellation or revocation of the registration .................. $ A fee equivalent to the annual fees that would have been payable under clause 6 between the date of cancellation or revocation and the date of application, if the registration had not been cancelled or revoked (b) In the case of any other application...
The fee, or part of the fee, that would have been payable if the application had been made under clause 2 MARIE SHROFF, Clerk of the Executive Council.

Explanatory note 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, pre­ scribe the fees payable in respect of matters under the Pesticides Act 1979.
The regulations provide, among other things, for— (a) Fees payable in respect of an application for registration of a pesticide: Fees payable in respect of amendments to the register: Fees payable in respect of an application for an experimental use permit: Fees payable in respect of reinstatement of registration: The annual fee for a registered pesticide, payable on 1 July in each year.
The Board has power to revoke the registration of (b) (c) (d) (e) 6 Reprinted as at 3 September 2007 Pesticides (Fees) Regulations 1997 Explanatory note a pesticide if the annual fee remains unpaid for more than 6 months (s 27A(2)).

The regulations replace the Pesticides (Fees) Regulations 1993(as amended in 1995).

The regulations introduce differential fees for applications for regis­ tration 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 pre­screening stage, followed by the full processing of the application.

The various stages are as follows: Pre­screening Module This consists of the administrative pre­screen, followed by the technical pre­screen.

All applications received will be progressed through these 2 sub­modules.
If there is a deﬁciency in the applica­ tion, at the conclusion of this pre­screening section the application will be referred to the Board or its sub­delegated decision­making authority with a recommendation that the application be declined.

The total amount payable at this point is $364.50.

Administrative Cost All applications that are not declined at the end of the pre­screening 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.

Manufacturing Assessment 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 de­ tails and manufacturing processes, including speciﬁcations and ana­ lytical methods for all formulation ingredients, and impurities in the ﬁnal product.
An assessment of the stability of the ﬁnal manufac­ tured product may be included.

Toxicology Module Every application will be processed and evaluated in respect of tox­ icology.

There are 3 different toxicology sub­modules.
Every prod­ uct which has a new active ingredient will be required to undergo an assessment of the full range of acute studies, short­term repeat dose studies, sub­chronic toxicity studies, long­term toxicity stud­ ies, reproduction studies, developmental studies, genotoxicity stud­ 7 Explanatory note Pesticides (Fees) Regulations 1997 Reprinted as at 3 September 2007 ies, 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.

Residues/Metabolism Module 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 signiﬁ­ cant metabolites resulting from the proposed use­pattern in the target crop, and the establishment of withholding periods.

It reviews the an­ alytical 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 environ­ mental chemistry, fate, and toxicology.
This will include full studies on degradation, mobility, accumulation and metabolism in the envir­ onment.

The studies will include toxicity studied in birds, mammals, and other vertebrates, aquatic organisms, non­target invertebrates, and non­target plants.

The cost of the assessment will be $1,959.19.

Where the active ingredient is a known active ingredient, the assess­ ment will not be as thorough and will rely to some extent on estab­ lished 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.

Efﬁcacy/Phytotoxicity Module This module covers a review of the data provided in respect of efﬁ­ cacy against the pest and phytotoxicity in the host species.

This will 8 Reprinted as at 3 September 2007 Pesticides (Fees) Regulations 1997 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.

Issued under the authority of the Acts and Regulations Publication Act 1989.

Date of notiﬁcation in Gazette: 18 December 1997.

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