Commonwealth Numbered Regulations - Explanatory Statements

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AGRICULTURAL AND VETERINARY CHEMICALS CODE AMENDMENT REGULATIONS 2004 (NO. 5) 2004 NO. 354

EXPLANATORY STATEMENT

Statutory Rules 2004 No. 354

Minute No. of 2004 - Parliamentary Secretary to the Minister for Agriculture, Fisheries and Forestry

Subject -        Agricultural and Veterinary Chemicals Code Act 1994

Agricultural and Veterinary Chemicals Code Amendment Regulations 2004 (No. 5)

Subsection 6(1) of the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code Act) provides that the Governor-General may make regulations prescribing matters required or permitted by the Code to be prescribed by regulations within the meaning of the Code or necessary or convenient to be prescribed by such regulations for carrying out or giving effect to the Code.

Subsection 5(1) of the Agvet Code Act provides that the Agricultural and Veterinary Chemicals Code set out in the Schedule to the Act may be referred to as the "Agvet Code" of the participating Territories. Section 3 of the Act defines "the Code" as the Agvet Code of the participating Territories. The Agvet Code is enacted under a Commonwealth Act that applies in the Australian Capital Territory (subsection 7(1) of the Agricultural and Veterinary Chemicals Act 1994). The Agvet Code operates nationally because the State and Northern Territory Governments have each passed complementary legislation to apply the Agvet Code in each of the States and the Northern Territory.

The US Free Trade Agreement Implementation Act 2004 (USFTA Act) consists of ten schedules that amend relevant Australian legislation to fulfil Australia's obligations under the Free Trade Agreement between Australia and the United States.

Schedule 2 to the USFTA Act amends the Agvet Code Act by inserting new provisions relating to the limits on the use of certain information given to the Australian Pesticides and Veterinary Medicines Authority (the APVMA) in certain circumstances relating to an application for or a variation to:

(a)       the approval of an active constituent for a proposed or existing chemical product;

(b)       the registration of a chemical product; or

(c)       the approval of a label for containers for a chemical product.

In particular, three of the amendments contained in Schedule 2 amend the Agvet Code to require the APVMA to publish certain information, which includes information to be prescribed by regulations. Details of the three provisions are set out below:

•       new section 11B of the Agvet Code provides that as soon as practicable after an application that is made under section 10 of the Agvet Code is acknowledged by the APVMA, the APVMA must cause a summary of the application to be published. New subsection 11B(2) of the Agvet Code requires the summary to include the details relating to the application that are prescribed by regulations (if any);

•       new section 28B of the Agvet Code provides that as soon as practicable after an application for variation of relevant particulars, or of conditions of registration that is made under section 28 of the Agvet Code is acknowledged by the APVMA, the APVMA must cause a summary of the application to be published. New subsection 28B(2) of the Agvet Code requires the summary to include the details in relation to the application that are prescribed by regulations (if any);

•       new section 34G of the Agvet Code sets out requirements in circumstances where the APVMA makes a decision to grant certain applications under the Agvet Code and, in making the decision, the APVMA relies on advice by a person, body or Government that the APMVA consulted under section 8 or section 8A of the Agricultural and Veterinary Chemicals (Administration) Act 1992. Under subsection 34G(2) of the Agvet Code, the APMVA will be required to publish a summary of the advice including the matters (if any) prescribed by regulations.

The purpose of the Regulations is to prescribe the information that must be included in a summary for the purposes of subsections 11B(2), 28B(2) and 34G(2) of the Agvet Code.

Details of the Regulations are in the Attachment.

Parts 1 and 2 of Schedule 2 to the USFTA Act will commence on the later of 1 January 2005 and the date on which the Australia-United States Free Trade Agreement, done at Washington DC on 18 May 2004 comes into force for Australia.

The Regulations commence on the commencement of Parts 1 and 2 of Schedule 2 to the USFTA Act.

Section 4 of the Acts Interpretation Act 1901 provides for the exercise of statutory powers between the passing and commencement of an Act. Therefore, even though the provisions of the USFTA Act which the Regulations give effect to have not yet commenced, the Regulations may be made as long as they are not expressed to commence prior to the commencement of the enabling legislation.

Authority:       Subsection 6(1) of the Agricultural and Veterinary Chemicals Code Act 1994

Attachment

DETAILS OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE AMENDMENT REGULATIONS 2004 (No. 5)

Regulation 1

Regulation 1 provides for the name of the Regulations to be the Agricultural and Veterinary Chemicals Code Amendment Regulations 2004 (No. 5).

Regulation 2

Regulation 2 provides for the Regulations to commence on the commencement of Parts 1 and 2 of Schedule 2 to the US Free Trade Agreement Implementation Act 2004.

Regulation 3

Regulation 3 provides that Schedule 1 amends the Agricultural and Veterinary Chemicals Code Regulations 1995 (the Principal Regulations).

SCHEDULE 1 - Amendments

Item [1] Subregulation 3(1), after definition of Act

This item defines the terms "active constituent number" and "application number". These new definitions are required to describe information that must be included in the summaries required to be published by the APVMA. The active constituent number is an administrative number the APVMA assigns to an active constituent at the time an application is received by the APVMA to enable the progress of the application to be tracked. The application number is an administrative number assigned by the APVMA to each application that it receives.

Item [2] Subregulation 3(1), after definition of British Pharmacopoeia (Veterinary)

This item defines a new term "chemical product number". This new definition is required to describe information that must be included in the summaries required to be published by the APVMA. The chemical product number is an administrative number the APVMA assigns to a chemical product at the time the application is received by the APVMA.

Item [3] Subregulation 3(1), after definition of purchaser declaration number

This item inserts two new definitions into regulation 3 of the Principal Regulations. They are "reference active constituent" and "reference chemical product". These new definitions are required to describe information that must be included in the summaries required to be published by the APVMA. The definitions are set out in regulations 3A and 3B respectively.

Item [4] - After regulation 3

This item inserts new regulations 3A and 3B, which define the terms "reference active constituent" and "reference chemical product" respectively.

Item [5] Before regulation 9

This item inserts new regulations 8A to 8E, which prescribe the information that the APVMA is required to include in a summary for the purposes of subsection 11B (2) of the Agvet Code. These requirements prescribe the information that must be included in a summary in relation to applications received by the APVMA under section 10 of the Agvet Code.

The Regulations:

(a)       provide greater transparency between the APVMA, approval holders/registrants and the general public;

(b)       ensure that within the data protection regime established by Schedule 2 to the USFTA Act, the owners of protected information are notified of the information to be relied upon by the APVMA and given an opportunity to object to the use of that information if the information is protected or ought not to be available to the particular applicant; and

(c)       encourage greater competition in the Australian market place.

The amendments contained in Item 5 differentiate between the requirements for applications that relate to companion animal products and those that do not relate to companion animal products to because companion animal products are exempt from some parts of the data protection regime established by Schedule 2 to the USFTA Act. The different requirements prescribed for companion animal products will reduce the competitive pressure placed on the information submitted for these products.

The amendments also prescribe different requirements in relation to an application for the registration of a chemical product that is to be marketed under a new brand name. This is to avoid the release of information that could compromise commercially sensitive arrangements without comprising the transparency in the National Registration Scheme for Agricultural and Veterinary Chemicals that the amendments intend to achieve.

Regulation 8A prescribes the information that must be included in a summary in relation to active constituents for companion animal products. The term "companion animal product" is defined in section 3 of the Agvet Code by virtue of the amendment in Item 5 of Schedule 2 to the USFTA Act.

Regulation 8B prescribes the information that must be included in a summary in relation to active constituents for chemical products other than companion animal products which are dealt with in regulation 8A.

Regulation 8C prescribes the information that must be included in a summary for applications for companion animal products.

Regulation 8D prescribes the information that must be included in a summary for applications for chemical products other than for companion animal products or for applications for registration of chemical products with a new brand name (repack).

Regulation 8E sets out the information that must be included in a summary for applications for a repack.

Item [6] - After regulation 19

This item insert new regulations 19AA to 19AD, which set out the information that must be included in a summary for the purposes of subsection 28B (2) of the Agvet Code. These information requirements apply in relation to an application made under section 27 of the Agvet Code to vary relevant particulars, or conditions, of approval or registration.

The purpose of requiring this information to be included in a summary is the same as that for the information requirements prescribed for subsection 11B (2) of the Agvet Code. Additionally, information relating to the companion animal products is not protected by the data protection scheme established by Schedule 2 to the USFTA Act. The information prescribed for these products is different to ensure that information that should otherwise be treated as protected information is treated as such.

Regulation 19AA is similar to regulation 8A. It prescribes the information that must be included in a summary published by the APVMA under section 28B in relation to a variation for an approval for an active constituent for companion animal products.

Regulation 19AB is similar to regulation 8B. It prescribes the information that must be included in a summary published by the APVMA under section 28B in relation to a variation for an approval for active constituents other than for companion animal products.

Regulation 19AC is similar to regulation 8C. It prescribes the information that must be included in a summary published by the APVMA under section 28B in relation to a variation for companion animal products.

Regulation 19AD is similar to regulation 8D. It prescribes the information that must be included in a summary published by the APVMA under section 28B in relation to a variation of a chemical product other than a companion animal product.

Item [7] After regulation 22

New subsection 34G of the Agvet Code requires the APVMA, in circumstances where:

•       it makes a decision under subsection 14(1) or 29(1) of the Agvet Code; and

•       in making that decision, the APVMA relied on advice given to it by a person, body or government that the APVMA consulted under section 8 or section 8A of the Agricultural and Veterinary Chemicals (Administration) Act 1992;

to publish a summary of the advice, which must include the matters (if any) prescribed by the Regulations.

Regulation 22A prescribes the information that must be included in a summary published by the APVMA under section 34G in relation to an application for an active constituent.

Regulation 22B prescribes the information that must be included in a summary published by the APVMA under section 34G in relation to an application for a chemical product.


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