Background to the reforms and the section 6A guidelines

1. About us

  1. In Australia, agricultural and veterinary (agvet) chemical products and their constituents are regulated through a cooperative National Registration Scheme for Agricultural and Veterinary Chemicals (the NRS). The NRS was agreed on by the Australian Agriculture Council (now the Standing Council on Primary Industries) and is a partnership between the Commonwealth and the States and Territories of Australia.
  2. The Agricultural and Veterinary Chemicals Code (the Agvet Code), which is the schedule to the Agricultural and Veterinary Chemicals Code Act 1994 (Cth), is a Commonwealth law that operates for the Australian Capital Territory; the Agvet Code has been picked up and applied as a law by each of the States and the Northern Territory so that it effectively operates as a national code. The Agricultural and Veterinary Chemical Code Regulations 1995 (Cth) (the Agvet Code Regulations), made under the Agricultural and Veterinary Chemicals Code Act 1994 (Cth), have similarly been given a national operation.
  3. The Commonwealth's responsibilities are discharged, primarily, by us, the Australian Pesticides and Veterinary Medicines Authority (the APVMA). We are established by the Agricultural and Veterinary Chemicals (Administration) Act 1992 (the Admin Act). We are part of the Australian Government Agriculture Portfolio. We are responsible for regulating agvet chemical products and their constituents up until the point of retail sale. Control of use of agvet chemical products and their constituents after retail sale is the responsibility of the individual States and Territories.
  4. We are responsible for administering a number of pieces of legislation including, importantly, the Agvet Code and the Agvet Code Regulations as they apply in each of the States and Territories.
  5. We are responsible for, among other things, the evaluation, registration or approval, and control of supply (up until the point of retail sale) of agvet chemical products and their constituents. We are also responsible for issuing permits for use.
  6. We perform our functions and exercise our powers with various objects in mind. Our first priority is ensuring the protection of the health and safety of human beings, animals and the environment. We are also concerned with the effectiveness of agvet chemical products and their effect on trade and commerce between Australia and other countries. 

    Note: Sections 1 and 1AA of the Agvet Code set out the objects of the Code and the manner in which it is to be implemented.

  7. Our regulatory approach reflects established best-practice standards for the assessment and management of risk, based on science. We perform our functions and exercise our powers fairly and equitably, consultatively (with input from other government agencies where appropriate), and in accordance with the law.
  8. For further information on us and our regulatory functions and powers, please see the additional information available on our website www.apvma.gov.au.

2. The reforms to the Agvet Code and the Agvet Code Regulations 

  1. The Agricultural and Veterinary Chemicals Legislation Amendment Act (2013) (the Amendment Act) makes amendments to the Agvet Code, among other Acts. These amendments commence on 1 July 2014.
  2. The Amendment Act implements reforms to the approval, registration and reconsideration of agvet chemical products and their constituents to improve the efficiency and effectiveness of the current regulatory arrangements and provide greater certainty to the community that those chemicals approved for use in Australia are safe. The Amendment Act makes it clear that the health and safety of human beings, animals and the environment is the first priority of the regulatory system.
  3. The reforms aim to encourage the development of newer and safer chemicals by providing more flexible and streamlined regulatory processes with higher levels of transparency and predictability for business seeking approval for agvet chemical products and their constituents to enter the market. The reforms should result in a more straightforward assessment process that is easier to understand and more cost effective to administer. In many cases, particularly for products of low regulatory concern, the reformed system as established by these amendments should be faster, deliver more predictable outcomes and result in improved health and environmental protection for the broader community.
  4. Benefits to human health and the environment flow particularly from improved access to newer and safer chemistry, increased scrutiny of currently available chemicals for their human and environmental health and safety impacts, and from improved mechanisms to ensure compliance with regulatory decisions. Business benefits through increased certainty over regulatory requirements and timeliness, reduced application requirements where permitted by appropriate risk management, improved limits on use of information provisions and increased community confidence in regulatory outcomes.
  5. The amendments:
    1. enhance the consistency, efficiency and transparency of approvals, registrations and reconsiderations of agvet chemical products and their constituents through the development, publication and implementation of a risk framework, which we must have regard to, aligning regulatory effort with chemical risk
    2. improve the timeliness, efficiency and effectiveness of assessment processes for approvals, registrations, variations and reconsiderations of agvet chemical products and their constituents
    3. improve our ability to enforce compliance with our regulatory decisions by providing us with a graduated range of compliance and enforcement powers and introducing a power to apply statutory conditions to registrations and approvals
    4. improve consistency in data protection provisions and remove disincentives for industry to provide data in support of ongoing registration of agvet chemical products and their constituents
    5. address perceptions of a conflict of interest by providing for an agency other than us to collect the chemical products levy referred to in the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994, should it be cost effective to do so
    6. remove redundant provisions and amend out of date provisions.
  6. To improve the efficiency and effectiveness of the regulation of agvet chemical products and their constituents through increased transparency and predictability of decision-making, the amendments provide, among other things, for us to make, publish and have regard to guidelines (that is, the section 6A guidelines referred to below). These guidelines are to form part of an overarching regulatory guidelines developed, maintained and published by us.
  7. To complement the reforms made by the Amendment Act, amendments have been made to the Agvet Code Regulations, by the Agricultural and Veterinary Chemicals Legislation Amendment (2013 Measures No. 2) Regulation 2013, which also commence on 1 July 2014. 

3. Background to the section 6A guidelines 

3.1. An overview of section 6A

  1. Section 6A of the Agvet Code provides that we may make written guidelines for performing our functions and exercising our powers under the Agvet Code and the Agvet Code Regulations (the guidelines).
  2. If we make the guidelines, we must have regard to them in performing our functions and exercising our powers under the Agvet Code and the Agvet Code Regulations.
  3. Section 6A provides that the guidelines must include:
    1. principles and processes for effective and efficient regulation of chemical products and their constituents; and
    2. principles and processes relating to:
      1. preliminary assessment
      2. the approval of active constituents for proposed or existing chemical products
      3. the registration of chemical products
      4. the approval of labels for containers for chemical products
      5. the variation of relevant particulars and conditions
      6. the issue of permits and licences, and
      7. the reconsideration of approvals and registrations.
  4. The guidelines must not be inconsistent with an 'agvet law' (which is defined in the Agvet Code to mean the Agvet Code, as well as certain other Acts). If there is a conflict between the guidelines and an agvet law, the agvet law will prevail.
  5. The guidelines do not constitute legal advice and do not replace legal obligations under the agvet law.
  6. The guidelines are not a legislative instrument. They state the general position as to how we will perform our functions and exercise our powers under the Agvet Code and the Agvet Code Regulations. In particular, they apply to the decisions we make under the Agvet Code and the Agvet Code Regulations.
  7. When the guidelines refer to us or the ‘APVMA’ in the context of the exercise of a particular power, or the making of a particular decision, they should also be taken as referring to a delegate of the APVMA (see section 11 of the Admin Act).
  8. While we must 'have regard to' the guidelines in performing our functions and exercising our powers under the Agvet Code and the Agvet Code Regulations, we are not bound to follow the guidelines and will depart from them in appropriate cases. This allows for us to be appropriately flexible in circumstances particularly where the guidelines have not taken into account a specific circumstance or particular matter.
  9. The purpose of the guidelines is to improve the efficiency and effectiveness of the regulation of agvet chemicals and their constituents through increased transparency, consistency, accountability and predictability of decision-making.

3.2. The content of the guidelines we have made

  1. We have made guidelines for the purposes of s 6A of the Agvet Code (that is, the guidelines).
  2. The guidelines cover those matters expressly provided for in section 6A(3) of the Agvet Code; namely, principles and processes for or relating to:
    1. effective and efficient regulation of chemical products and their constituents
    2. the approval of active constituents for proposed or existing chemical products
    3. the registration of chemical products
    4. the approval of labels for containers for chemical products
    5. the variation of relevant particulars and conditions
    6. the issue of permits and licences, and
    7. the reconsideration of approvals and registrations.
  3. The guidelines also cover the following matters:
    1. preliminary assessment
    2. section 159 of the Agvet Code
    3. recategorising applications made under the Agvet Code
    4. altering applications made under the Agvet Code, and
    5. limits on the use of certain information obtained by us under the Agvet Code.
  4. Where appropriate, the guidelines may refer to other documents that are taken into account by us in performing our functions or exercising our powers under the Agvet Code and the Agvet Code Regulations.
  5. The guidelines commence on 1 July 2014 or on the commencement date referred to in the particular guideline (whichever is later).
  6. We may amend the guidelines from time-to-time.

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