EXPLANATORY STATEMENT
Agricultural and Veterinary Chemicals Code (Prescribed Relevant Particulars) Instrument 2014
This Instrument is made by the Chief Executive Officer of the APVMA for the purposes of sections 8B and 29B of the Agricultural and Veterinary Chemicals Code, scheduled to the Agricultural and Veterinary Chemicals Code Act 1994.
Section 32(1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 provides that the Chief Executive Officer of the APVMA may exercise any of the powers and functions of the APVMA.
The Commonwealth and all States and Territories have agreed to a National Registration Scheme for Agricultural and Veterinary Chemicals. The National Scheme sets out the regulatory framework for the management of pesticides and veterinary medicines in Australia by a single agency. The APVMA is the current name for the National Registration Authority for Agricultural and Veterinary Chemicals (NRA) established in 1993 as an independent statutory authority responsible for the Commonwealth’s regulatory functions under the Scheme.
The National Registration Scheme also provides for a national, uniform and cooperative legislative regime throughout Australia administered by the APVMA. The centrepiece of the legislation is the Agvet Code, which has been applied to all Australian states and territories. Under the Agvet Code, the APVMA is responsible for the registration, quality assurance and compliance of pesticides and veterinary medicines up to and including the point of retail sale in Australia.
One of the changes brought about by the Agricultural and Veterinary Chemicals Legislation Amendment Act 2013 is to enable holders of approvals and registrations under the Code to apply to the variation of certain kinds of relevant particulars known as ‘prescribed relevant particulars’: see the new Division 2A of Part 2 of the Code. The Division 2A process is a streamlined variation process in relation to minor, low regulatory concern variations through which an application need not undergo a ‘preliminary assessment’.
A relevant particular is a prescribed relevant particular if it is set out in an instrument made by the APVMA for the purposes of s 26B of the Code. The first role of this Instrument is to set out the prescribed relevant particulars. This is done in section 5. Section 5(1) lists 6 kinds of relevant particulars that, due to their largely mechanical nature, the APVMA considers appropriate to be subject to the streamlined process for variation in Division 2A. Three of the 6 kinds of relevant particulars are defined in part by reference to the kind of variation sought.
Applications under the new Division 2A process must meet ‘the application requirements’: see section 26B(2). To meet the application requirements an application must, among other things, contain or be accompanied by the information specified for the application under section 8B of the Code. The second role of this Instrument is to specify the information that must be contained in, or accompany, applications for the variation of prescribed relevant particulars. This is done in section 6, which lists only the kind of information necessary for the APVMA to determine a Division 2A application.
No Regulatory Impact Statement has been prepared for the Instrument. The Office of Best Practice Regulation 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).
Documents incorporated by reference
The Instrument does not incorporate any documents by reference.
Public Consultation
This Instrument was released for public consultation from 19 June 2014 to 25 June 2014. Industry and community stakeholder groups were informed of the release. Comments were provided with respect to the content of the Instrument. These comments were taken into account in preparing 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 (Prescribed Relevant Particulars) 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
This Instrument sets out the prescribed relevant particulars of approvals and registration that can be varied under Division 2A of Part 2 of the Agricultural and Veterinary Chemicals Code. The Instrument also specifies the information that must be contained in, or accompany, applications for such variations.
Human rights implications
The Instrument does not engage any applicable rights or freedoms.
Conclusion
The Instrument is compatible with human rights.
Overview
The Agricultural and Veterinary Chemicals Code (Prescribed Relevant Particulars) Instrument 2014 was enacted to provide a streamlined process for varying certain kinds of prescribed relevant particulars of approvals and registrations under the Agricultural and Veterinary Chemicals Code. This Instrument was made by the Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority (APVMA) for the purposes of sections 8B and 29B of the Agricultural and Veterinary Chemicals Code, scheduled to the Agricultural and Veterinary Chemicals Code Act 1994. The APVMA, established as an independent statutory authority under the National Registration Scheme for Agricultural and Veterinary Chemicals, administers a national, uniform legislative regime for the management of pesticides and veterinary medicines in Australia. The Instrument aims to facilitate minor, low regulatory concern variations by enabling holders of approvals and registrations to apply for variations of prescribed relevant particulars without undergoing a preliminary assessment, thereby streamlining the process. This Instrument also specifies the information that must be contained in, or accompany, applications for such variations to meet the application requirements under section 26B(2) of the Code.
Scope and Application
The Agricultural and Veterinary Chemicals Code (Prescribed Relevant Particulars) Instrument 2014 is an instrument made by the Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority (APVMA) under sections 8B and 29B of the Agricultural and Veterinary Chemicals Code, which is scheduled to the Agricultural and Veterinary Chemicals Code Act 1994. This Instrument outlines the prescribed relevant particulars that can be varied under Division 2A of Part 2 of the Agricultural and Veterinary Chemicals Code, which is a streamlined process for minor, low regulatory concern variations in the approval and registration of agricultural and veterinary chemicals. It also specifies the information that must be contained in, or accompany, applications for such variations. The APVMA is responsible for the registration, quality assurance, and compliance of pesticides and veterinary medicines in Australia, and this Instrument facilitates a more efficient process for certain types of variations to existing approvals and registrations. The Instrument applies to all entities involved in the approval and registration of agricultural and veterinary chemicals in Australia, including manufacturers, importers, and retailers. The Instrument does not incorporate any documents by reference and was subject to public consultation prior to its release. It is compatible with human rights as it does not engage any applicable rights or freedoms.
Key Provisions
The main operative sections of the Agricultural and Veterinary Chemicals Code (Prescribed Relevant Particulars) Instrument 2014 (F2014L00865) are sections 5 and 6 (paragraphs 1, 2). Section 5 specifies the kinds of relevant particulars that are considered appropriate for a streamlined variation process, known as Division 2A, due to their largely mechanical nature. This section lists six kinds of relevant particulars, three of which are defined partly by the kind of variation sought. Section 6, on the other hand, specifies the information that must be contained in, or accompany, applications for the variation of these prescribed relevant particulars. This includes information necessary for the APVMA to determine a Division 2A application. These sections are critical for facilitating the streamlined variation process for minor, low regulatory concern variations, ensuring that applications meet the application requirements set out in section 26B(2) of the Code.
The Act imposes specific obligations on entities and individuals involved in the application process for variations under Division 2A. Applicants must ensure that their applications include or are accompanied by the information specified in section 8B of the Agricultural and Veterinary Chemicals Code (Agvet Code). This requirement is designed to facilitate a smooth review process for the APVMA, enabling them to efficiently assess the applications without the need for a preliminary assessment, given the low regulatory concern of the variations. The streamlined process aims to expedite the variation process for minor changes, while still ensuring that all necessary information is provided to maintain regulatory oversight.
There are no specific offences, penalties, or civil/criminal consequences mentioned in the Instrument for breach of its provisions. However, any failure to comply with the requirements of the Agvet Code or the Instrument could potentially lead to the APVMA rejecting the application for variation, or taking other regulatory actions if the non-compliance is deemed significant. The primary focus of the Instrument is to streamline the process for minor variations, rather than to impose penalties for non-compliance. The emphasis is on ensuring that the applications are complete and contain all necessary information, to facilitate efficient processing and decision-making by the APVMA.