Overarching principles and processes for the effective and efficient regulation of agricultural and veterinary chemical products

1. What is this guideline about?

  1. This guideline is made pursuant to section 6A of the Agvet Code.
  2. The purpose of this guideline is to outline our principles and processes for effective and efficient regulation of chemical products and their constituents. It does this by setting out our approach to:
    1. using and following the guidelines
    2. performing our functions and exercising our powers under the Agvet Code and the Agvet Code Regulations
    3. exercising discretion in relation to the decisions we make under the Agvet Code and the Agvet Code Regulations
  3. This guideline commences on 1 July 2014.

2. When do we use and follow the guidelines?

  1. We will have regard to the guidelines in performing our functions and exercising our powers under the Agvet Code and the Agvet Code Regulations.
  2. However, we are not bound by the guidelines. We will consider each case on its merits and may depart from the guidelines in special circumstances.
  3. Where we depart from the guidelines, we will make a record setting out our reasons for departing from the guidelines.
  4. Any reference in the guidelines to us or the ‘APVMA’ exercising a particular power or making a particular decision should also be taken as referring to a delegate of the APVMA exercising the power or making the decision. 

3. What is our regulatory approach?

3.1. General principles

  1. We perform our functions and exercise our powers in accordance with the provisions of the Agvet Code and the Agvet Code Regulations, and all other applicable laws (including the principles of administrative law).
  2. We administer the Agvet Code and the Agvet Code Regulations in accordance with the Australian National Audit Committee's Better Practice Guide on Administering Regulation (March 2007).
  3. We recognise that, in performing our functions and exercising our powers, we must:
    1. act within power and comply with specific statutory requirements
    2. exercise our power in good faith, and in a fair, ethical, professional and responsible manner
    3. in making decisions, act fairly and equitably in accordance with administrative law principles, and apply our discretion in a rational and demonstrably justifiable way
    4. manage any real or perceived conflicts of interest
    5. apply the law with probity, balance, judgement, common sense and without bias
    6. enforce the law equitably, fairly and swiftly.
  4. We understand that failure to act in accordance with the above requirements may result in:
    1. incorrect or invalid decision-making and inefficient administration of the Agvet Code and the Agvet Code Regulations
    2. potential damage to stakeholders
    3. the compromise of our regulatory efforts and the undermining of incentives for compliance with the Agvet Code and the Agvet Code Regulations, and
    4. the erosion of public confidence in us.

3.2. A risk-based approach based on science

  1. Our regulatory approach is:
    1. risk-based (consistent with the risk standard AS/NZS ISO 31000:2009)
    2. consultative, and
    3. consistent with international best practices and leading scientific approaches, research, technologies, practices, and evidence.
  2. We apply our risk-based regulatory approach such that:
    1. the likelihood and severity of potential threats to the health and safety of human beings, animals and the environment are minimised
    2. the likelihood and potential benefits of opportunities for Australia, the public and regulated industry are increased, and
    3. opportunities associated with new active constituents or chemical products will be considered, even if there are potential risks.
  3. In this context, we will select scientific approaches and information that realistically identify and assess the potential risks and opportunities associated with agricultural and veterinary chemical products and their constituents.
  4. The risk tolerance level in respect of a particular decision made under the Agvet Code or the Agvet Code Regulations will usually be set out in the guidelines or a document referred to in the guidelines. Where this is not the case, we will assign a risk tolerance level having regard to:
    1. the requirements of the Agvet Code and the Agvet Code Regulations
    2. the principles and processes of risk management provided in the risk standard AS/NZS ISO 31000:2009
    3. the evidence available to us in relation to the risk.
  5. In determining an application (or doing other things) under the Agvet Code or the Agvet Code Regulations, we will balance the risks we identify with granting the application against the purpose of the application, the opportunities that may arise from granting the application, the extent to which the risk can be mitigated by imposing conditions on the grant, and the practicability and cost of adopting particular risk mitigation measures.

4. How do we exercise discretion under the Agvet Code and the Agvet Code Regulations?

  1. In making decisions under the Agvet Code and the Agvet Code Regulations, we are often required to exercise discretion.
  2. The requirement to exercise discretion in decision making can add a level of complexity and uncertainty to the process as the factors that the decision maker must, may or must not take into account in making the decision (and the weight to be attributed to each factor) are not always clear or obvious. 
  3. We recognise that, where we are required to exercise discretion in our decision making, we must do so:
    1. consistently with the objects and provisions of the Agvet Code and the Agvet Code Regulations
    2. in line with administrative law principles
    3. based on the nature and merits of the individual application or case
    4. taking into account, where appropriate, special circumstances (that is, unusual or extraordinary circumstances that, if not taken into account, may result in an unjust, unreasonable or inappropriate outcome)
    5. in a way that promotes streamlining of the regulatory process, and improves its flexibility.

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