Normal

Agricultural and Veterinary Chemicals Code Regulations (Pre‑application Assistance Fee) Instrument 2014

Agricultural and Veterinary Chemicals Code Regulations 1995

I, Kareena Arthy, Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority, make this Instrument under subsection 164(1A) of the Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Agricultural and Veterinary Chemicals Code Act 1994.

Kareena Arthy

Chief Executive Officer

Dated this 25th day of June 2014

Placeholder 1 of 11

Placeholder 2 of 11

Placeholder 3 of 11

Placeholder 4 of 11

Placeholder 5 of 11

Placeholder 6 of 11

Placeholder 7 of 11

Placeholder 8 of 11

Placeholder 9 of 11

Placeholder 10 of 11

Placeholder 11 of 11

Part 1 Preliminary

Placeholder

1 Name of Instrument

This Instrument is the Agricultural and Veterinary Chemicals Code Regulations (Pre-application Assistance Fee) Instrument 2014.

2 Commencement

This Instrument commences on the commencement of the Agricultural and Veterinary Chemicals Legislation Amendment (2013 Measures No. 2) Regulation 2013.

3 Overview

(1) This Instrument sets out what constitutes a unit of pre‑application assistance for each of the following different kinds of assistance:

(a) holding a meeting with the applicant (Part 2);

(b) providing a written response to the applicant (Part 3).

(2) The fee for 1 unit, or a part of 1 unit, is $192.50 (GST inclusive).

Note: See subregulation 69B(3) of the Agricultural and Veterinary Chemicals Code Regulations 1995. Parts of units are rounded up to the nearest whole.

4 Definitions

(1) In this Instrument:

APVMA expert area: see subsection (2).

APVMA officer means a person who is:

(a) the Chief Executive Officer of the APVMA or a person acting as the Chief Executive Officer; or

(b) a member of the staff of the APVMA; or

(c) a person whose services are made available to the APVMA in accordance with section 46 of the Agricultural and Veterinary Chemicals (Administration) Act 1992; or

(d) a person engaged by the APVMA as a consultant, or a person employed or engaged by such a consultant, pursuant to section 47 of the Agricultural and Veterinary Chemicals (Administration) Act 1992.

meeting includes face to face meetings at the APVMA’s premises, telephone conferencing and video conferencing.

(2) The following are the APVMA expert areas, to which individual APVMA officers may be assigned:

(a) Area 1, comprising officers dealing with:

(i) general requirements, guidelines and processes for approvals and registrations (including variations); and

(ii) general requirements and processes for permits; and

(iii) requirements and processes for licences; and

(iv) efficacy, including crop or animal safety; and

(v) general labelling requirements; and

(vi) other legislative requirements not mentioned elsewhere in paragraphs (a) to (d) (including the limit on use of information);

(b) Area 2, comprising officers dealing with:

(i) chemistry and manufacture; and

(ii) residues and trade;

(i) human toxicology and work health and safety; and

(ii) environmental toxicity and fate;

(d) Area 4, comprising officers dealing with:

(i) reconsiderations; and

(ii) special data requirements, meaning data requirements that are not dealt with by officers in Areas 1, 2 or 3; and

(iii) compliance.

Placeholder

Part 2 Units of assistance – meetings

5 Attendance at meetings

(1) Where the APVMA provides pre‑application assistance by holding a meeting with the applicant, the APVMA must take the following steps:

(a) Work out, for each APVMA expert area involved in providing the assistance, the number of units for time spent attending the meeting (section 6). The result is the expert area attendance total.

(b) Add the expert area attendance totals together. The result is the attendance total.

(c) Work out, for each APVMA expert area involved in providing the assistance, the number of units for preparing for the meeting (subsection 7(1)). The result is the expert area preparation total, except that if the number of units for an expert area is greater than 1, the expert area preparation total for that area is 1 unit.

(d) Add the expert area preparation totals together. The result is the preparation total.

(e) Work out the number of units for recording the outcomes of the meeting (subsection 7(2)). The result is the recording outcomes total, except that if the number of units is greater than 1, the recording outcomes total is 1 unit.

(f) Add together the attendance total, the preparation total and the recording outcomes total.

(2) The work done by the APVMA in relation to the meeting constitutes the number of units produced by taking the steps in subsection (1).

6 Time spent at the meeting

For each APVMA expert area, each period of 10 minutes for which one or more APVMA officers of the area is present at the meeting constitutes one‑sixth of a unit.

Example 1: A meeting runs for 60 minutes. Two ‘reconsideration’ officers attend the whole of the meeting. That attendance constitutes 1 unit, even though there are 2 officers present.

Example 2: A meeting runs for 90 minutes. Three officers are in attendance. A ‘residues and trade’ officer attends for the whole meeting; that attendance is 1.5 units, attributed to Area 2. Two ‘reconsideration’ officers attend but only for the first 60 minutes; that attendance is 1 unit (even though there are 2 officers), attributed to Area 4.

Example 3: A meeting runs for 60 minutes. One ‘reconsideration’ officer attends for the full 60 minutes; that attendance is 1 unit, attributed to Area 4. Two ‘residues and trade’ officers attend. One attends for the first 10 minutes; the other for the first 30 minutes. That attendance is 0.5 units for Area 2, because there was no more than 30 minutes of the meeting for which an Area 2 officer was present.

Example 4: A meeting runs for 60 minutes. One ‘reconsideration officer attends for the full 60 minutes; that attendance is 1 unit, attributed to Area 4. Two ‘residues and trade’ officers attend. One attends for the first 30 minutes and then leaves; the other attends only for the second 30 minutes. That attendance is 1 unit for Area 2, because there was an Area 2 officer present during all 60 minutes of the meeting.

7 Preparation for, and recording the outcomes of, the meeting

(1) For each APVMA expert area, each period of 10 minutes spent by each APVMA officer of the area preparing for the meeting (including conducting administrative tasks to process the application or prepare for the meeting) constitutes one‑sixth of a unit.

(2) Each period of 10 minutes spent by each APVMA officer recording the outcomes of the meeting (including reviewing any minutes prepared by the applicant) constitutes one‑sixth of a unit.

Example 1: See Example 1 under section 6. Each of the 2 ‘reconsideration’ officers spends 50 minutes preparing for the meeting. The preparation time is five‑sixths of a unit for each officer, totalling 1.67 units. This time will only be charged as 1 unit, pursuant to paragraph 5(c).

Example 2: An applicant seeks pre‑application assistance in relation to a proposed application for the registration of a chemical product and the approval of an active constituent for the product. The following officers are involved in preparing for a meeting with the applicant to provide the assistance:

(a) one product evaluator from Area 1 spends 20 minutes (0.33 units) and another also spends 20 minutes (0.33 units);

(b) a ‘residues and trade’ officer (Area 2) spends 30 minutes (0.5 units);

(d) an environment officer, from Area 3, spends 40 minutes (0.67 units);

(e) a health officer, also from Area 3, spends 40 minutes (0.67 units).

The expert area preparation totals for Area 1 and Area 2 are 0.67 and 0.83 units respectively. The total for Area 3 would be 1.33 units, but paragraph 5(c) provides that this total is capped at 1 unit. The preparation total, for the purposes of paragraph 5(d), is therefore 2.5 units (0.67 + 0.83 + 1).