Agricultural and Veterinary Chemicals Regulations

Agricultural and Veterinary Chemicals Regulations

Statutory Rules 1989 No. 165 as amended

made under the

Agricultural and Veterinary Chemicals Act 1988

This compilation was prepared on 12 January 2001
taking into account amendments up to SR 1994 No. 216

[Note: The enabling legislation of this Statutory Rules was repealed by Act No. 36 of 1994]

Prepared by the Office of Legislative Drafting,
Attorney-General’s Department, Canberra

Contents

Page

 1 Citation [see Note 1] 

 2 Interpretation 

 3 Declaration of substances not to be agricultural chemical products             

 4 Declaration of substances not to be veterinary chemical products             

 5 Fees — application for clearance or variation 

 6 Fee — application for certificate in respect of exportation 

 7 Fees — where payable 

 8 Circumstances in which NRA may waive fees otherwise applicable             

 9 Orders 

Notes 

1 Citation [see Note 1]

  These Regulations may be cited as the Agricultural and Veterinary Chemicals Regulations.

2 Interpretation

  In these Regulations, unless the contrary intention appears:

formulation change, in relation to a chemical product to which a clearance has been granted, means any difference from the specifications contained in the application for the clearance, being a difference in respect of the composition of the product involving a change in an excipient of the product, but not in any of the product's active constituents otherwise than by way of an alteration in the concentration of such a constituent in the product as a consequence of a change in an excipient.

registered chemical product means a chemical product that has been registered by a scheme participant for use in a State or Territory.

the Act means the Agricultural and Veterinary Chemicals Act 1988.

3 Declaration of substances not to be agricultural chemical products

 (2) A substance or a mixture of substances of a kind:

 (a) that is not available commercially to the public;

 (b) that is used only for experimental purposes; and

 (c) the formula of which has not been finally evaluated by its user;

  is declared not to be an agricultural chemical product for the purposes of the Act.

4 Declaration of substances not to be veterinary chemical products

 (2) A substance or a mixture of substances of a kind referred to in subregulation 3 (2) is declared not to be a veterinary chemical product for the purposes of the Act.

5 Fees — application for clearance or variation

 (1) The fee payable in respect of an application for clearance of a chemical product is:

 (a) in respect of an application to which subregulation (3) or (4) does not apply — $10,000;

 (b) in respect of an application to which subregulation (3) applies — $500; and

 (c) in respect of an application to which subregulation (4) applies — $300.

 (2) The fee payable in respect of an application for the variation of conditions to which the clearance of a chemical product is subject is:

 (a) in respect of an application to which subregulation (3) or (4) does not apply:

 (i) where the variation relates only to a formulation change $500; and

 (ii) in any other case — $6,000;

 (b) in respect of an application to which subregulation (3) applies — $500; and

 (c) in respect of an application to which subregulation (4) applies — $300.

 (3) This subregulation applies to an application for a clearance, or for the variation of conditions to which a clearance is subject, in respect of a chemical product, where the application is an application:

 (a) to vary the concentration of an active constituent in a registered chemical product;

 (b) to vary the packaging or the brand name, logo, design, warning, safety directions or other material (not being directions for use of the product nor relating to the formulation of the product) contained on the label of a registered chemical product;

 (c) to vary an excipient or another constituent, other than an active constituent, used in a registered chemical product;

 (d) to vary the form in which a registered chemical product is to be used from a wettable powder, a suspension concentrate or a water dispersible or dry flowable granule to another of those forms;

 (e) in respect of a mixture, or the equivalent of a mixture, of 2 or more registered chemical products — where:

 (i) the species in respect of which the mixture of products is proposed to be used:

 (A) are species that are specified in common in respect of all of he registered chemical products of which it is, or is the equivalent of, a mixture; and

 (B) are species in respect of which the National Health and Medical Research Council has recommended a maximum residue limit in respect of each active constituent of the mixture;

 (ii) the claims in respect of the mixture are claims that are specified in common in respect of all of the registered chemical products of which it is, or is the equivalent of, a mixture;

 (iii) rates of use recommended in respect of the mixture are the same as the rates of use that are specified in common in respect of all of the registered chemical products of which it is, or is the equivalent of, a mixture; and

 (iv) other directions for use of the mixture are the same as the other directions that are specified in common in respect of all of the registered chemical products of which it is, or is the equivalent of, a mixture;

 (f) to extend the use of a registered chemical product:

 (i) to affect a pest not specified in the original application;

 (ii) in a State or Territory not specified in the original application; or

 (iii) to affect a plant that is in the same crop group as a crop specified in the original application, being a crop group in respect of which the National Health and Medical Research Council has recommended a maximum residue limit;

 (g) to extend the use of an agricultural chemical product:

 (i) by altering the rate, timing or frequency of use of the product where the application of such an alteration would not give rise to residues in food for animal or human consumption being residues that are greater than those that would arise if the directions for use specified in the original application in respect of the product are followed; or

 (ii) so as to conform with the claims made in respect of a comparable registered agricultural chemical product;

 (h) that, in respect of the information it contains (being information of a kind referred to in subsection 12 (3) of the Act) is substantially the same as the application for clearance in respect of a registered chemical product, or, where fewer claims are made in the application in respect of the first-mentioned chemical product than were made in the application in relation to the registered chemical product, substantially the same as the application in respect of that registered chemical product in all other respects;

 (i) in respect of an ectoparasiticide for companion animals; or

 (j) in respect of an agricultural chemical product for use in domestic gardens in residential areas.

 (4) This subregulation applies to an application for a clearance, or for the variation of conditions to which a clearance is subject, in respect of a chemical product where the application specifies that the chemical product is to be used only in the control of a pest or condition:

 (a) that occurs infrequently;

 (b) that is not of economic significance; or

 (c) that occurs only in a situation that the NRA determines, after consideration of the application and the circumstances adverted to in the application, is a situation involving another minor use of the product.

 (5) A fee payable under paragraph (1) (a) or subparagraph (2) (a) (ii) is payable by the applicant in the following amounts:

 (a) on lodging the application to which the fee relates:

 (i) in the case of an application for clearance of a chemical product — $7,500; or

 (ii) in the case of an application for the variation of conditions to which the clearance of a chemical product is subject — $4,500; and

 (b) not more than 14 days after the day on which the applicant is notified that the application has been granted or refused by the NRA or where, before that day, notice is given to the applicant in writing by an authorised person, not later than 30 days after the day on which that notice is given to the applicant — the balance of the fee prescribed under paragraph (1) (a) or subparagraph (2) (a) (ii) in respect of such an application.

 (6) A fee payable under paragraph (1) (b) or (c), subparagraph (2) (a) (i) or paragraph (2) (b) or (c) is payable by the applicant on lodging the application to which the fee relates.

 (8) In this regulation, authorised person means a person authorised in writing by the NRA for the purposes of this regulation.

6 Fee — application for certificate in respect of exportation

  The fee payable in respect of an application for the provision of a certificate to the government of, or to authorities of, a foreign country for exportation purposes is $100.

7 Fees — where payable

  Fees payable under these Regulations are payable to the Collector of Public Monies in the Department of Primary Industries and Energy, Canberra.

8 Circumstances in which NRA may waive fees otherwise applicable

 (1) Where:

 (a) an application is withdrawn by the applicant before work is commenced in respect of the application; or

 (b) taking into account the nature of the chemical product and the nature of the application and, where an application is refused, the amount of work done in respect of the application before its refusal — the work done in respect of the application is substantially less than the work that would otherwise be expected to have been done in respect of such an application;

  that circumstance is a prescribed circumstance for the purposes of subsection 40 (5) of the Act.

 (2) Where a fee is payable under these Regulations in 2 amounts, then, for the purposes of subsection 40 (5) of the Act, each of the amounts so payable shall be regarded as a separate fee.

9 Orders

 (1) Subject to section 49 of the Act, the Minister may make orders, not inconsistent with the Act or regulations under the Act, with respect to any matter for or in relation to which provision may be made by regulations under the Act.

 (2) In particular, but without limiting the generality of subregulation (1), the orders may declare a substance or a mixture of substances of a kind specified in the declaration not to be an agricultural chemical product or a veterinary chemical product, as the case requires, in addition to the substances and mixtures of substances so declared by these Regulations.

Notes to the Agricultural and Veterinary Chemicals Regulations

Note 1

The Agricultural and Veterinary Chemicals Regulations (in force under the Agricultural and Veterinary Chemicals Act 1988) as shown in this compilation comprise Statutory Rules 1989 No. 165 amended as indicated in the Tables below.

Table of Statutory Rules

Table of Amendments