Agricultural and Veterinary Chemicals Code (Application Requirements) Amendment Instrument 2020
Explanatory Statement
Issued by the Australian Pesticides and Veterinary Medicines Authority
Introduction
The Agricultural and Veterinary Chemicals Code, as scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (Code), establishes a regulatory scheme for agricultural and veterinary chemicals. Under the Code, persons may apply to the Australian Pesticides and Veterinary Medicines Authority (APVMA) for registration of a chemical product, approval of an active constituent and approval of a label.
The Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 (Application Requirements Instrument) specifies, pursuant to section 8B of the Code, formal requirements for applications in addition to those set out in subsection 8A(a) of the Code and in Division 1.2 of the Agricultural and Veterinary Chemicals Code Regulations 1995 (Regulations).
Once a chemical product is registered, or an active constituent or label is approved, the registration or approval holder may apply in certain circumstances to the APVMA to make a prescribed variation. A prescribed variation is a minor type of change which is made through a simplified application process, rather than the full technical assessment process under Division 3.
This Instrument amends the Application Requirements Instrument by inserting provisions specific to applications for prescribed variations.
Inclusion of the information specified in the Instrument, or its continued inclusion, is necessary for the APVMA to determine applications for prescribed variations. The Instrument therefore meets the requirement of subsection 8B(2).
Process before instrument was made
Regulatory impact analysis
A Regulatory Impact Statement has not been prepared. The Office of Best Practice Regulation (OBPR) was consulted about this Instrument (OBPR reference 42542).
On the basis of the information provided, OBPR considered that this Instrument is machinery in nature and likely to have no more than minor regulatory impacts on business, community organisations or individuals. Noting this, and the fact that this initiative is not being considered by Cabinet, OBPR considered that a Regulatory Impact Statement was not required.
Consultation before making
This Instrument does not make any substantive change to existing law or procedure.
The Instrument does not increase regulatory burden; it is arguable, in fact, that it reduces it by allowing overseas manufacturers to make changes to their sites as a prescribed variation rather than a full application. Consultation was not considered appropriate in those circumstances, and was not undertaken.
Statement of compatibility with human rights obligations
A statement of compatibility has been prepared and is at Attachment A.
Other issues
Matter incorporated by reference
This Instrument does not incorporate any matter by reference.
More information
A provision-by-provision explanation of the Instrument is provided in Attachment B.
Statement of Compatibility with Human Rights Attachment A
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Agricultural and Veterinary Chemicals Code (Application Requirements) Amendment Instrument 2020
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 for the APVMA to specify the information that must be included in applications for prescribed variations. Prescribed variations are minor variations of relevant particulars, which are made through a simplified application process, rather than the technical assessment process under Division 3 of Part 2 of the Code.
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.
Notes on Items Attachment B
Item 1 – Name of instrument
This item provides for the Instrument to be named as the Agricultural and Veterinary Chemicals Code (Application Requirements) Amendment Instrument 2020.
Item 2 – Commencement
This item provides for the Instrument to commence on the day after the day it is registered.
Item 3 – Authority
This item provides that the Instrument is made under subsection 8B(1) of the Agricultural and Veterinary Chemicals Code, as scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (Code).
Item 4 – Schedules
This item gives the amendments their legal effect, by providing that each instrument specified in the Schedule is amended as set out in the applicable items of the Schedule.
Schedule 1
Item 1
This item inserts a new Section 35B into the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014, after section 35A, comprising one item.
The new item 35B specifies the additional application requirements that apply for prescribed variations. These requirements specify that the applicant must hold certain evidence that the site of manufacture is comparable to the manufacturing principles and the Australian GMP code. It also requires the applicant to hold certain evidence about the product, including its storage stability and physical properties. This information is relevant to managing the risks of the replacement constituent to the safety to people, animals, plants or the environment or Australia’s trade or the product efficacy.
Overview
The Agricultural and Veterinary Chemicals Code (Application Requirements) Amendment Instrument 2020 was enacted to address the need for specific application requirements in relation to prescribed variations of agricultural and veterinary chemicals. The Instrument amends the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 by inserting provisions that specify the information required for applications of prescribed variations. This amendment was made under the authority of the Agricultural and Veterinary Chemicals Code Act 1994, with the primary aim of ensuring that the Australian Pesticides and Veterinary Medicines Authority (APVMA) has all necessary information to evaluate such applications. This streamlined process aids in the efficient management of minor changes to registered products, thereby reducing regulatory burden while maintaining safety and efficacy standards. The policy objective is to facilitate a more responsive regulatory environment that accommodates minor changes without the need for a full technical assessment, thus promoting innovation and efficiency within the industry.
Scope and Application
The Agricultural and Veterinary Chemicals Code (Application Requirements) Amendment Instrument 2020 amends the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014, applying specifically to applications for prescribed variations of registered chemical products, active constituents, or labels under the Agricultural and Veterinary Chemicals Code Act 1994. This Act pertains to the regulation of agricultural and veterinary chemicals in Australia. The amendments are designed to ensure that the Australian Pesticides and Veterinary Medicines Authority (APVMA) receives all necessary information to evaluate applications for prescribed variations, which are minor changes to the registered products. The Instrument applies to persons or entities that hold registrations or approvals for agricultural and veterinary chemicals, and who wish to make minor variations to their products. These changes can include alterations to the manufacturing site, product storage stability, and physical properties, which are crucial for managing risks to human health, animal welfare, plant life, the environment, and trade. The geographical scope of the Act is national, as it pertains to the regulation of chemicals across Australia. The Instrument does not specify any exclusions or exemptions; however, it does establish thresholds by defining what constitutes a prescribed variation, which is inherently a minor change. The Instrument extends the application of the Code by specifying additional information required for prescribed variation applications, thereby modifying the process without altering the fundamental legal framework established by the Agricultural and Veterinary Chemicals Code Act 1994.
Key Provisions
The main operative sections of this Instrument (F2020L01022) introduce specific requirements for applications of prescribed variations under the Agricultural and Veterinary Chemicals Code (Application Requirements) Amendment Instrument 2020. Section 35B of the amended Instrument, inserted after section 35A, outlines the information that must be included in applications for these variations. This includes evidence that the site of manufacture is comparable to the manufacturing principles and the Australian GMP code, as well as evidence about the product’s storage stability and physical properties (Schedule 1, Item 1). This information is essential for the Australian Pesticides and Veterinary Medicines Authority (APVMA) to manage risks associated with the replacement constituent and ensure safety for people, animals, plants, the environment, Australia’s trade, and product efficacy.
The obligations imposed by this Act on the parties or entities it governs include the requirement to provide detailed evidence regarding the manufacturing site and product characteristics. Specifically, applicants must demonstrate that the manufacturing site complies with Australian Good Manufacturing Practice (GMP) codes and that they have appropriate evidence about the product's storage stability and physical properties. These requirements ensure that any prescribed variation is assessed comprehensively to maintain the integrity of the regulatory scheme. The APVMA relies on this information to determine whether the prescribed variation will maintain the safety and efficacy of the chemical product without necessitating a full technical assessment.
Failure to comply with the requirements set out in this Instrument can result in civil and criminal consequences. While the explanatory statement does not specify the exact penalties, it is understood that non-compliance with the Code can lead to substantial penalties under the Agricultural and Veterinary Chemicals Code Act 1994. For instance, misleading or deceptive conduct, which could include submitting incomplete or inaccurate information, can attract civil penalties and, in severe cases, criminal penalties. The maximum penalties for such offences are not detailed in this specific Instrument but are governed by the broader legislative framework of the Act.
In summary, this Amendment Instrument amends the Application Requirements Instrument to include specific information that must be provided in applications for prescribed variations. This includes evidence of manufacturing site compliance and product characteristics. Non-compliance with these requirements can lead to significant penalties under the overarching Agricultural and Veterinary Chemicals Code Act 1994. The changes introduced aim to streamline the process for minor variations while ensuring the safety and efficacy of chemical products remain uncompromised.