EXPLANATORY STATEMENT
Agricultural and Veterinary Chemicals Code Regulations (Pre-application Assistance Fee) Instrument 2014
The Agricultural and Veterinary Chemicals Code Act 1994 (Act) provides, within a Code set out in the Schedule to the Act (Agvet Code), a low regulatory scheme for agricultural and veterinary chemicals.
A person may apply to the Australian Pesticides and Veterinary Medicines Authority (the APVMA) for assistance in preparing or making an application to the APVMA under the Agvet Code or the Agricultural and Veterinary Chemicals Code Regulations 1995 (Regulations) (regulation 8AT). The Regulations may prescribe a method of working out the fees to be paid for making an application to the APVMA (see section 164(1) of the Agvet Code). Regulation 69B of the Regulations provides for the fees payable for pre-application assistance provided by the APVMA under regulation 8AT.
This Instrument, the Agricultural and Veterinary Chemicals Code Regulations (Pre‑application Assistance Fee) Instrument 2014 (the Instrument), is made under section 164(1A) of the Agvet Code and sets out what constitutes a unit of pre-application assistance for: (a) holding a meeting with the applicant; and (b) providing a written response to the applicant.
Part 1 of the Instrument sets out the preliminary details of the instrument including the overview and definitions. The fee for 1 unit (or part of 1 unit) of pre-application assistance is $192.50 (GST inclusive) (section 3). There are 4 APVMA expert areas that may be involved with providing pre-application assistance (section 4(2)).
Part 2 of the Instrument sets out what constitutes a unit of pre-application assistance the APVMA gives by holding a meeting with the applicant.
A unit is comprised of the time:
- an APVMA expert area spends attending a meeting (section 6);
- an APVMA expert area spends preparing for that meeting (section 7); or
- an APVMA officer spends recording the outcomes of the meeting (section 8).
One-sixth of a unit is constituted by each 10 minute period spent by:
- an APVMA expert area at a meeting;
- an APVMA expert area preparing for a meeting; or
- an APVMA officer recording the outcomes of a meeting.
One unit is constituted by an hour spent by an APVMA expert area at or preparing for a meeting or spent by an APVMA officer recording the outcomes of a meeting.
The number of units an APVMA expert area spends preparing for a meeting is capped at 1 unit, even if more time is spent. Similarly, the number of units that APVMA officers spend recording the outcomes of the meeting is capped at 1 unit.
Part 3 of the Instrument sets out what constitutes a unit of pre-application assistance the APVMA gives by responding to the application for assistance in writing. One-sixth of a unit is each 10 minute period spent by an APVMA officer processing the application or giving the written response.
The Instrument commences immediately on the commencement of the Agricultural and Veterinary Chemicals Legislation Amendment (2013 Measures No.2) Regulation 2013 (see clause 2).
No Regulatory Impact Statement has been prepared for the Instrument. The Office of Best Practice Regulations was consulted about this Instrument and has advised that no further analysis (in the form of a Regulatory Impact Statement) is required (OBPR ID: 17109).
Public consultation
This Instrument was released as part of the draft Regulatory Guidelines published on the APVMA website on 20 January 2014. Public consultation was sought from 30 April 2014 to 21 May 2014. Industry and community stakeholder groups were informed of the release. Comments provided with respect to the content of the Instrument were taken into account in finalising the Instrument.
STATEMENT OF COMPATIBILITY WITH HUMAN RIGHTS
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Agricultural and Veterinary Chemicals Code Regulations (Pre-application Assistance Fee) Instrument 2014
This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Legislative Instrument
The purpose of this Instrument is to set out what constitutes a unit of pre-application assistance for: (a) holding a meeting with the applicant; and (b) providing a written response to the applicant.
Human rights implications.
The Instrument does not engage any of the applicable rights or freedoms.
Conclusion
The Instrument is compatible with human rights as it does not raise any human rights issues.
Overview
The Agricultural and Veterinary Chemicals Code Regulations (Pre-application Assistance Fee) Instrument 2014 was enacted to address the need for a structured fee schedule for pre-application assistance provided by the Australian Pesticides and Veterinary Medicines Authority (APVMA) under the Agricultural and Veterinary Chemicals Code Act 1994. The Act establishes a regulatory framework for agricultural and veterinary chemicals, allowing applicants to seek pre-application assistance from the APVMA. The Instrument was made under section 164(1A) of the Agvet Code and was introduced to define what constitutes a unit of pre-application assistance, whether it be a meeting with the applicant or a written response, and to set the associated fee. This legislative instrument aims to ensure transparency and consistency in the fees charged for the pre-application assistance services provided by the APVMA. The Instrument was developed following consultation with relevant stakeholders and was released for public comment to incorporate feedback before finalisation.
Scope and Application
The Agricultural and Veterinary Chemicals Code Regulations (Pre-application Assistance Fee) Instrument 2014 applies to entities and individuals involved in the pre-application assistance process for agricultural and veterinary chemicals, specifically those who seek assistance from the Australian Pesticides and Veterinary Medicines Authority (APVMA) under the Agricultural and Veterinary Chemicals Code Act 1994 and the Agricultural and Veterinary Chemicals Code Regulations 1995. This Instrument is integral to the regulatory framework governing the fees associated with pre-application assistance provided by the APVMA, thereby affecting the conduct and transactions related to the application process for chemicals. The geographical scope of the Instrument is national, as it pertains to the Commonwealth level, influencing the regulatory environment across Australia. Notably, this Instrument does not specify exclusions, exemptions, or thresholds beyond those already established within the overarching Agvet Code and Regulations. The fee structure outlined in this Instrument extends the application of the Agricultural and Veterinary Chemicals Code Regulations by providing a detailed breakdown of what constitutes a unit of pre-application assistance, which is essential for fee calculation.
Key Provisions
The Agricultural and Veterinary Chemicals Code Regulations (Pre-application Assistance Fee) Instrument 2014 (the Instrument) outlines the parameters for determining the cost of pre-application assistance provided by the Australian Pesticides and Veterinary Medicines Authority (APVMA). Specifically, section 3 of the Instrument sets the fee for one unit (or a fraction thereof) of pre-application assistance at $192.50, inclusive of GST. This fee applies to both meetings with applicants and written responses provided under the Agricultural and Veterinary Chemicals Code Regulations 1995.
The Instrument delineates the obligations of the APVMA in delivering pre-application assistance. According to section 6, a unit of assistance is constituted by the time an APVMA expert area spends attending a meeting with the applicant. Similarly, section 7 stipulates that a unit is also constituted by the time an APVMA expert area spends preparing for such a meeting, while section 8 specifies that a unit includes the time an APVMA officer spends recording the outcomes of the meeting. The Instrument caps the number of units an APVMA expert area can spend preparing for a meeting at one unit, regardless of the actual time spent. Likewise, the number of units APVMA officers can spend recording the outcomes of a meeting is also capped at one unit. For written responses, section 10 states that one-sixth of a unit is constituted by each 10-minute period an APVMA officer spends processing the application or providing a written response.
The Instrument imposes specific obligations on parties seeking pre-application assistance, requiring them to engage with the APVMA in accordance with the defined units of assistance. Failure to comply with these provisions could potentially lead to disputes over the calculation of fees or the adequacy of the assistance provided. Although the Instrument does not explicitly detail penalties for non-compliance, breaches of the Agricultural and Veterinary Chemicals Code Act 1994 or the Agricultural and Veterinary Chemicals Code Regulations 1995 could result in civil or criminal consequences, depending on the nature and severity of the breach. The Act and Regulations provide for various penalties, including fines and imprisonment, for serious or repeated breaches.