Reforms to regulation of agricultural chemicals and veterinary medicines

​​​​​​​​The Australian Government is implementing reforms to the regulation of agricultural chemicals and veterinary medicines (agvet chemicals) for the benefit of the community, manufacturers, importers, wholesalers, retailers and users of agvet chemicals. The government is committed to easing the burden imposed on the Australian economy and agricultural sector by reducing red and green tape on business by at least $1 billion per year.

Reforms to agvet chemical regulation aim to reduce red tape for farmers and other businesses and encourage the development of new chemistry. The reforms are expected to bring a a range of benefits for farmers and other users, the environment and the community, while retaining protections for the health and safety of humans, animals and the environment.

The Australian Pesticides and Veterinary Medicines Authority (APVMA) is the Australian Government regulator responsible for registration, quality assurance and compliance of agvet chemicals up to and including the point of retail sale.

The APVMA is responsible for implementation of changes to agvet chemicals legislation. Further information about the APVMA can be found through its website.

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Future reform

Industry, community, users and the Australian Government have identified a number of potential reform opportunities for improving regulation of agvet chemicals. The Department of Agriculture is prioritising and developing suitable future reforms in consultation with stakeholders. Please contact us if you would like to contribute to the development of future reforms.

Current reform proposal – Amending regulation of animal feeds as veterinary chemical product

The department has been working with animal feed industry, the livestock industry and other stakeholders to develop options to reform the regulation of certain stockfeed and pet food products currently regulated by the APVMA.

The department developed a draft regulatory impact statement (RIS) and draft amendments to the Agricultural and Veterinary Chemicals Code Regulations 1995 (the Principal Regulations) to achieve this reform.

On 7 October 2014, stakeholders were invited to provide submissions to the department outlining whether the RIS appropriately addresses current animal feed regulation issues, and to comment on the impacts of adopting the preferred reform option. A total of 14 submissions were received. The government is considering these submissions prior to making a final decision on the reform.

Current reform proposal – Variation to chemical formulation

On 1 January 2015, the changes to The Agricultural and Veterinary Chemicals Amendment Legislation Amendment (Removing Re-approval and Re-registration) Act 2014 (the Act) will be implemented. Companies will be able to effectively notify APVMA about changes in their products. Initially, these changes will focus on administrative variations such as contact details and product names.

During consultation it was found that minor chemical changes to a product could be another opportunity to improve regulatory efficiency and reduce costly red tape, which would address the need to respond quickly to changes in the supply chain or manufacturing variance, without the delay and costs of the current assessment process.

The department developed a proposal for potential reform ​​that would address these routine variations without increasing risks to safe and effective product use according to the label. We consider it would be possible to allow:

  • limited variations to the concentration of constituents of an agricultural chemical product without requiring any notification to the APVMA
  • limited variations to the identity of non-active constituents through simple assessment by the APVMA
  • applications for the above variations to be accepted unless the APVMA notifies otherwise within a 30 day period.

The proposal sets out the variations and other substitutions of constituents that may be allowed.

We would appreciate your thoughts to the questions below and the proposal more broadly, by 9am Monday 1 December 2014. These will inform how or if we should proceed with the reform.

The questions we have are:

  1. Would this proposal reduce the number of variation applications you currently make? If yes, how many applications would be saved? Can you estimate the amount of time and expenses saved making applications?
  2. Would this proposal reduce the effort required to prepare the variation applications that you currently make? If yes, can you estimate the potential saving in time and expense?
  3. Does the proposal align with the quality control processes, manufacturing tolerances and the routine needs of a manufacturer in managing production variations? If not, what changes are required so that it would?
  4. Would the proposal meet the routine needs of a manufacturer in addressing routine changes to constituents (for example, by changing supplier)? If not, what changes are required so that it would?
  5. If this proposal would not meet your needs, what changes are required?
  6. Do you consider that the safety or efficacy of a product (including the potential for pest resistance) would be adversely affected by the proposal? If so, how does this differ from the existing situation?
  7. Should the proposal be amended to introduce a hard limit minimum limit for active constituent concentration, being the concentration stated on the label? This would mean it would be unlawful to supply product with less than the stated concentration, regardless of whether this would be reasonable expected to impact the safety, efficacy or other risks of the product, but have concentrations above it consistent with the formulas described.
  8. If it is appropriate to introduce this barrier, do you support the increase in regulation this would represent (relative to the existing situation)? Would it be expected that this increase would result in any increase in regulatory costs for industry?

The proposal should not be taken as a pre-determined government position. It is an approach we are exploring to identify opportunities for regulatory burden reduction.

Please send responses to the agvet reform team. The team is also available to meet in person or via teleconference to discuss the proposal. All responses will be handled and protected in accordance with the department’s privacy policy.

Recent reforms

Reforms introduced in the Agricultural and Veterinary Chemicals Legislation Amendment Act 2013 commenced on 1 July 2014.

These reforms:

  • improve the efficiency and effectiveness of assessment processes for applications and for reconsiderations
  • enhance the consistency and transparency of assessments and reconsiderations
  • improve the ability of the regulator to enforce compliance with its regulatory
  • encourage industry to provide data to support ongoing registration of agvet chemicals and permit applications.

The Agricultural and Veterinary Chemicals Legislation (Removing Re-approval and Re-registration) Amendment Act 2014 gives effect to the government’s commitment to remove the requirement for agvet chemicals to be periodically re-approved and re-registered. It also:

  • provides for less frequent registration renewal
  • improves the APVMA’s ability to secure information about the safety of chemicals supplied in the market to improve health and safety and compliance
  • streamlines access to information about approvals and registration in the APVMA’s files
  • addresses some minor implementation issues identified in existing reform legislation.

Further information about the APVMA’s implementation of these reforms can be found on its website.

Further information

Email: Agvet Reform

Privacy Statement:

All personal information handled by the department is protected in accordance with the Privacy Act 1988. Any personal information contained in or related to your submission will be collected by the department and stored securely. Your name may be used to attribute authorship of your submission unless you indicate you wish to remain anonymous, in which case your name will not be published or otherwise disclosed. Your email address may be used to enable the department to contact you regarding your submission if it is incomplete or inaccessible. If you do not have an email address or would like to make an offline submission, please contact Marc Kelly, Director of Agvet Chemicals Regulation Reform on (02) 6272 5485.

Your personal information will not be used or disclosed for any other purpose unless authorised or required by law.
When sending in your submission, it is a requirement that you provide a first name, surname and email address. Although you have the option to remain anonymous you will still be required to submit these details in case the department needs to contact you. If you indicate that you wish to remain anonymous your name will not be published with your submission online.

If you do not have an email address, or feel you have a justifiable reason of not submitting your submission online, please contact Marc Kelly, Director of Agvet Chemicals Regulation Reform on (02) 6272 5485 and they will be able to provide you with alternate ways of sending in your submission.

Confidentiality:

All content contained in submissions may be published on the department’s website or otherwise made public, unless you specifically state you want all or part of your submission to be treated as confidential information.  Automatically generated confidentiality statements are not accepted by the department, and a claim for confidentiality must be justified, and any such material provided as a separate attachment, marked ‘Confidential’.   Material marked ‘Confidential’ will not be published on the department’s website.
Notwithstanding the above, no breach of confidence will occur if the department shares part or all of your submission with a third party referred to under the heading ‘Privacy’ above in seeking external advice or information in response to a submission.

Intellectual property:

Responsibility for compliance with Intellectual Property Rights (IPR) in submissions rests with the submission author(s), not with the department. In lodging your submission, you warrant that you have not knowingly infringed any third party IPR. By lodging a submission, you grant to the Commonwealth of Australia a permanent, irrevocable, royalty-free, world-wide, non-exclusive licence, (that is, a legal permission, including a right of sub-licence) to use, copy, reproduce, adapt, communicate and exploit all or any of the material contained in your submission.

For more information, please visit the department’s Privacy policy.

Our Privacy Policy also contains information about how you can seek access or correction to your personal information. It also contains details about how you can complain about a breach of the Privacy Act by us, and how we will deal with such a complaint.

Submissions received

Reforms to animal feed

On 7 October 2014 the Department of Agriculture invited stakeholders to provide submissions commenting on the draft regulatory impact statement. This document detailed the proposed changes to the regulation of animal feeds.

Stakeholders were asked to comment by 7 November 2014. A total of 14 submissions were received.

The submissions may not meet Australian Government accessibility requirements as they have not been prepared by the department.

All information in submissions (including names and contact details) has been published electronically unless the author specifically requested otherwise. Responsibility for copyright over submissions resides with the author/s, not the department.

Inaccessible third-party content

The submissions were not prepared by the department and may not meet Australian Government accessibility guidelines. If you require an accessible version of the publication, please contact its author.​

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