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 has 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.

Future reform

Industry, community, users and the 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. Our contact details are below.

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

The Department of Agriculture (the department) has been working with some animal feed industry, 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 has developed a draft regulatory impact statement (RIS) and draft amendments to the Agricultural and Veterinary Chemicals Code Regulations 1995 (the Principal Regulations) to further inform the government’s eventual decision about this reform. Links to the RIS and draft amendments are below. The draft amendments should be read in conjunction with the existing Principal Regulations and are not a compilation of the Principal Regulations if amended.

The department seeks written stakeholder comments on both the RIS and draft amendments. The closing date for submissions is 7 November 2014.​

The department is seeking stakeholder views on the following questions:

  1. Does the RIS accurately reflect the issues surrounding the regulation of stockfeed and pet food that are currently regulated veterinary chemical products?
  2. Which RIS option do you prefer?
  3. Will any specific RIS option better encourage new products to enter the Australian market? If yes, how soon would new produ​​​cts be introduced? What effect will the introduction of new products have on the market for stockfeed and pet food products?
  4. Are the assumptions about regulatory costs (presented in RIS Annex A) accurate?
  5. Will the preferred option in the RIS improve the balance between regulatory cost and the risks of using stockfeed and pet food products?
  6. What changes, if any, to the preferred option in the RIS are required?
  7. What costs, if any, are increased under the preferred option in the RIS? Are these costs reduced more under another option?
  8. What risks, if any, are increased under the preferred option in the RIS? Are these risks reduced more under another option?
  9. Considering the criteria for excluded nutritional and digestive products in the draft regulations (see clauses @5 to @8 on pages 7 to 13):
    1. On ingredients—the preferred option in the RIS does not require that direct fed microbial ingredients of stockfeed and pet food products be treated differently to other kinds of ingredients. Should this be changed so that direct fed microbial ingredients instead require registration? If yes, why? (see clause @5)
    2. On labelling—should a crude nutrient analysis (describing every ingredient of the product) or a key nutrient analysis (where only ingredients that relate to claims made about the product) be required? Should the analysis be as is required for human foods? (see clause @7(1)(d))
    3. On manufacturing—are there other quality assurance requirements that could be included that are the equivalent of those already described? (see clause @8)

Please note these questions are also detailed in section 1 of the RIS.

The draft amendments also include (at schedule 2) proposed changes to the Agricultural and Veterinary Chemicals (Administration) Regulations 1992  to align with Australia’s international obligations under the Rotterdam Convention for export of azinphos-methyl. Comments may also be made in relation to this reform. The Office of Best Practice Regulation has previously provided an exemption from the need for a RIS on these matters as they are considered mechanical in nature.

All responses (except where confidentiality issues are identified by the author/submitter and accepted by the department) will be made available through the department’s website. Personal details other than the author’s name and organisation (if any) will not be published. If any information contained in a submission should be treated as confidential, the author should clearly identify the sensitive information and provide reasons for treating it in-confidence.

Submission should be made to Agvet Reform.

The department will acknowledge the receipt of all submissions, but will not formally reply to each submission.

Current reform proposal – Variation to chemical formulation

The Agricultural and Veterinary Chemicals Amendment Legislation Amendment (Removing Re-approval and Re-registration) Act 2014 (the Act), introduced a means for companies to effectively notify APVMA about changes in their products. Initially, the simple changes permitted focus on administrative variations such as to contact details and product names. These provisions ‘go live’ on 1 January 2015.

During the consultation period on the Act, members of ACCORD, CropLife Australian Limited and Animal Medicines Australia, amongst others, advocated that minor chemical changes to a product could be another opportunity to improve regulatory efficiency and reduce costly red tape. The prime example being 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 of Agriculture has developed a potential reform proposal ​​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, and
  • limited variations to the identity of non-active constituents through simple assessment by the APVMA.

The attachment sets out this proposal and describes formulation variations that would be allowed without notifying the APVMA and other substitutions of constituents that would be allowed by a very simple application to the APVMA, with a default ‘yes’ answer after 30 days.

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 attached 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.

This information will soon also be available through the department’s website​. Feedback should be sent to agvetreform@agriculture.gov.au. We are also available to meet in person or via teleconference to discuss the proposal. You should contact us via our contact details below.

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; and
  • 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