The Agricultural and Veterinary Chemicals Legislation Amendment (Operational Efficiency) Bill 2017 was introduced into the Australian Parliament on 25 October 2017. Information about the Bill is available from the Australian Parliament web site. The proposed legislative changes set out in the Bill would streamline industry reporting, support the operational efficiency of the Australian Pesticides and Veterinary Medicines Authority (APVMA), clarify ambiguities in the legislation and remove unnecessary and redundant provisions. The APVMA is the independent Australian Government regulator of agricultural and veterinary chemicals.
The proposed legislative changes would amend the:
- Agricultural and Veterinary Chemicals (Administration) Act 1992
- Agricultural and Veterinary Chemicals Code Act 1994
- Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994.
Specifically the changes propose to:
- establish a governance board for the APVMA (introduced through a government amendment)
- reduce the regulatory burden on industry by simplifying reporting requirements for annual returns
- reduce the administrative burden on the APVMA and industry by increasing the flexibility of the APVMA to manage errors in an application at the preliminary assessment stage
- reduce the regulatory burden on industry by enabling the APVMA to grant part of a variation application under section 27 of the Schedule to the Code Act (the Agvet Code)
- enable a person to apply to vary the relevant particulars or conditions of a label approval that is suspended, to the extent that the variation relates to the grounds for suspension
- establish civil pecuniary penalties for contraventions of provisions relating to providing false or misleading information in the Agvet Code and the Administration Act
- amend the notification requirements in section 8E of the Agvet Code so that the APVMA and FSANZ will have the flexibility to agree on appropriate timeframes for notifications
- amend the definition of expiry date in the Agvet Code to mean the date after which a chemical product ‘must not’ be used and
- make minor and technical amendments to the Administration Act and the Agvet Code, including the repeal of redundant provisions.
Public consultation on an exposure draft of the Bill occurred between 20 June 2017 and 19 July 2017. Following consultation, two proposed measures were omitted from the final Bill prior to its presentation to parliament. The below measures were omitted:
- The APVMA’s handling of confidential commercial information measure was omitted after the APVMA developed a practice statement in relation to applying confidential information protections.
- The requirement for the APVMA to consider the potential for human exposure to antimicrobial resistant microorganism as a specific consideration in the safety criteria was omitted following concerns the measure, as drafted, would be inefficient for the APVMA to implement and may have too broad an effect (potentially capturing agricultural products, rather than novel antibiotics for veterinary application). The Australian Strategic and Technical Advisory Group on Antimicrobial Resistance (ASTAG), has developed and implemented Australia’s antimicrobial resistance strategy with the aim of reducing the impact of antimicrobial resistance on human and animal health. ASTAG is co-chaired by the Government’s Chief Medical and Chief Veterinary Officers and includes the APVMA as a member.
A total of 14 submissions were received on an exposure draft of the Agricultural and Veterinary Chemicals Legislation Amendment (Operational Efficiency) Bill 2017, including three provided in-confidence. Links to the public submissions can be found below.
Published submissions may not meet Australian Government accessibility guidelines as they have not been prepared by the department.
Although the period for submissions has closed, the original consultation document and exposure draft is still available to view through the links below. The consultation paper included details of the proposed legislative changes.
If you have difficulty accessing these files, visit web accessibility for assistance.
The exposure draft set out the legislative changes as proposed when consultation commenced.
This publication was not prepared by the department and may not meet Australian Government accessibility guidelines. If you require an accessible version of the publication, please contact the department.