Commonwealth Numbered Regulations - Explanatory Statements

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AGRICULTURAL AND VETERINARY CHEMICALS CODE AMENDMENT REGULATIONS 2004 (NO. 3) 2004 NO. 251

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 Tree Trade Agreement Implementation Act 2004 (USFTA Act) consists of nine 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 a new Division 4A - Limits on use of information into the Agvet Code. This Division sets out limits on the uses that the Australian Pesticides and Veterinary Medicines Authority (the APVMA) can make of certain information given to it in connection with applications made to it.

New subsection 34F (1) of the Agvet Code contains a table that sets out the period during which the APVMA is prohibited from using certain information provided to it. Subsection 34F (2) enables the period specified in item 1 or 2 of the table in subsection (1) to be extended by a period of 1 year for each 5 distinct uses that meet the requirements of subsections 34F (3), (4) and (5).

Subsection 34F (5) provides that one of the three requirements for the period to be extended is that all 5 of the uses are prescribed by the regulations.

The purpose of the Regulations is to prescribe the uses for the purposes of subsection 34 F (5) of the Agvet Code.

Details of the Regulations are in the Attachment.

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

Part 1 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.

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 commenced 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. 3)

Regulation 1

Regulation 1 provides for the name of the Regulations to be the Agricultural and Veterinary Chemicals Code Amendment Regulations 2004 (No. 3).

Regulation 2

Regulation 2 provides for the Regulations to commence on the commencement of Part 1 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] After regulation 22

The table in subsection 34F (1) of the Agvet Code sets out the period during which the Australian Pesticides and Veterinary Medicines Authority (the APVMA) is prohibited from using certain information provided to it. Subsection 34F (2) of the Agvet Code enables the period specified in item 1 or 2 of the table in subsection (1) to be extended by a period of 1 year for each 5 distinct uses that meet the requirements of subsections (3), (4) and (5). The period of protection specified in item 1 or 2 of the table in subsection (1) cannot be extended so that it exceeds 11 years (see subsection 34F (6) of the Agvet Code).

One of the three requirements for the period to be extended is that all 5 of the uses are prescribed by the regulations (subsection 34F (5)).

The policy intention behind the opportunity to extend the base period of protection as set out in the table in subsection 34F (1) is that the mechanism be used to encourage registrants to include more uses, other than major (and more economic) uses, onto a label for a chemical product.

To that end, uses included in new Schedule 3A (see item 2 below) for the purposes of subsection 34F (5) are uses ("non-major" uses) set out in a list that is based upon an existing mechanism by which the APVMA determines whether a use is a use for the purpose of an approval of a permit (a Minor Use permit) under section 112 of the Agvet Code. Accordingly, registrants will shift their innovation effort to smaller and less economic crop and animal situations to gain the advantage offered by section 34F with the result that Australian users will have a greater range of products to choose from and higher levels of certainty in domestic and export markets.

Regulation 22A provides, for the purposes of subsection 34F (5) of the Agvet Code, that a use is prescribed if:

(1)       the use is:

(a)       a non-major crop use. A non-major crop use is a use for a food crop that is listed is column 4 of Part 1 of Schedule 3A or a use for a non-food crop or situation use listed in column 4 of Part 3 of that Schedule; or

(b)       a non-major animal use. A non-major animal use is a use for an animal that is listed in column 4 of Part 2 of Schedule 3A; and

(2)       an application has been made to the APVMA, data has been submitted to the APVMA for the purposes of the application and the data is directly and specifically relevant to the use; and

(3)       the data was required, and relied on by the APVMA to grant the application; and

(4)       the use is specified on a label (either directly or as an element of the corresponding group of uses).

Subsection 22A(2) describes when a non-major crop use is taken to be specified on a label for the purposes of paragraph 22A(1)(d). Subsection 22A(2) provides that if a crop group, listed in column 2 of Schedule 3A, is specified on a label, the non-major food crop or non-food crop or situation (as the case may be) is taken to be specified on the label, if the item in Part 1 or Part 3 of Schedule 3A mentions the relevant non-major food crop or non-food crop or situation.

Item [2] After Schedule 3

A new Schedule 3A to the Principal Regulations is inserted listing the uses that are prescribed for the purposes of subsection 34F (5) of the Agvet Code. As is noted in Schedule 3A the text of Schedule 3A is derived from the Codex Alimentarius. The table is divided into 3 parts. Part 1 lists food crops and food crop groups. Part 2 lists animal foods and animal food groups. Part 3 lists non-food crops and situation groups.

The tables in each Part of Schedule 3A are divided into 4 columns. For Parts 1 and 2 of Schedule 3A, column 1 lists the Codex number for the food crop or food crop group or, the animal food or animal food group, as the case may be. Column 2 lists the crop/situation group. Column 3 lists the major uses corresponding to the non-major uses. Column 4 lists the non-major uses. The uses listed in column 4 are the uses that are prescribed by regulation 22A.

Columns 1 and 3 are not referred to in the Regulations. However, the columns have been included because, as indicated in the note to Schedule 3A they are of assistance to users of the Codex and the agvet regulatory framework.