Streamlining the regulation of agvet chemicals

​​​​​​​​Public consultation on proposed changes to agricultural and veterinary chemical legislation is now open. Please read the consultation paper and exposure draft of the legislative changes for more information.


The Australian Government recognises the need to further reform the regulation of agricultural chemicals and veterinary medicines (agvet chemicals) to give farmers access to newer, better farm chemicals.

As part of the Agricultural Competiveness White paper, the government committed $17.1 million to improve farmers’ and other users’ access to agvet chemicals, while retaining protections for the health and safety of humans, animals and the environment.

The department extensively consulted on potential agvet chemical reforms during 2015 and 2016. Stakeholder feedback indicated widespread interest in reform and support for a more efficient and effective regulatory system.
Arising from this consultation the government is preparing two reform bills.

The first bill will make minor legislative changes to the Agricultural and Veterinary Chemicals Code Act 1994, the Agricultural and Veterinary Chemicals (Administration) Act 1992 and the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994. These changes are in the exposure draft of the Agricultural and Veterinary Chemicals Amendment (Operational Efficiency) Bill 2017. These minor legislative changes will deliver operational efficiencies to the regulator— the Australian Pesticides and Veterinary Medicines Authority (APVMA)—and reduce unnecessary regulatory burden and improve the operation of these Acts.

The second bill will follow later in 2017 with measures to further streamline agvet chemical regulation in Australia.

In April 2017 the Deputy Prime Minister announced the department will undertake a review of the agvet chemical legislative framework. The review will commence once the two reform bills have been introduced into the Australian Parliament.

Consultation on Agricultural and Veterinary Chemicals Legislation Amendment (Operational Efficiency) Bill 2017- consultation underway

Previous consultation

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First phase of consultation -​ completed

In 2014 and early 2015 we considered the issues and developed a range of ideas to improve the efficiency and effectiveness of our agvet chemical regulatory system and improve access to chemicals. These issues and ideas were presented in a public discussion paper in April 2015. We then engaged the chemicals industry, chemical users, state and territory governments and community members in a discussion about the merits of these reform ideas.

Thank you to all that talked with us; we’ve been encouraged in discussions thus far. Participating stakeholders showed a willingness to identify issues, explore ideas and to continue contributing to reform development.

We heard that there was general agreement to the reform objectives set out in the discussion paper. Overall, stakeholders were of the view that reform should be undertaken to improve the competitiveness of Australian producers through lowering the cost of regulation and improving access to chemicals for farmers and other users. Some individual proposals garnered more support than others and some specific feedback was received about all the measures to enable us to decide whether to recommend proceeding further.

Stakeholders said the department should continue to pursue ways:

  • to deliver improved access to chemicals, both to new chemicals entering the market and to new uses of existing chemicals
  • to increase efficiency in the regulation process and reduce red tape, principally by better aligning regulatory effort and burden with chemical risk
  • improving the effectiveness of regulatory system overall to manage the risks agvet chemicals pose to people, animals and environment.

Second phase of consultation - completed

We used stakeholder views to refine the detail of possible individual reforms and to identify potential operational or implementation issues. We have further developed the ideas, adding some suggestions raised by stakeholders and removing some other ideas that were not viable. These now form the basis of a second phase of stakeholder collaboration. Below is a collection of discussion papers, each addressing a specific area of reform. The papers detail the approach, issues and discussions and debates raised in the first phase of consultation on each area of reform.

Discussion papers

Summary of reform measures

Tables 1–3 provide a summary of the 15 measures including the reasons for implementing each reform (or otherwise) and the expected benefits. Each table corresponds to the timing of when we believe the reforms could be implemented: table 1 includes shorter-term measures: table 2 includes longer-term measures; and table 3 has one measure that we believe should not proceed in this package of reforms.

Table 1 Proposed shorter-term reforms
MeasureRationaleBenefits
1. Using overseas decisions as basis for registration
No longer assessing products that are registered by trusted regulators overseas where the risks of using the product are the same as in the overseas market.

No longer assessing new uses of products registered in Australia that are also registered by trusted regulators overseas where the risks of that use are the same as in the overseas market.
Implementing the measure gradually.

Some products used in Australia pose the same risks here as when used overseas. For example, household insecticides, companion animal products, products used in protected cropping or intensive livestock product.

There is no need for a bespoke Australian assessment of the use of these products if a trusted regulator overseas has already done this work.

The APVMA is finalising its policy on the use of international data, guidelines and standards.

The legislative changes proposed in this measure will provide certainty for applicants about how the APVMA will use international decisions.

Better regulatory efficiency; reduced red tape; quicker time to market for new products.

Improved access to new products and new uses of existing products at lower cost,

  • improved farm, fisheries and forestry industries productivity and sustainability.
2. Scope of regulation
Revising the scope of products regulated by the APVMA and revising methods for regulating product access to the market (eg self-registration of listed products or conditional registration).
The APVMA currently regulates products that pose similar risks to products managed by other competent Australian regulators (for example, most sanitisers and disinfectants). APVMA also has a predominantly one-size-fits-all approach to product regulation. APVMA should regulate products according to risk, where APVMA is the best placed regulator for the job.

APVMA is currently implementing reforms to ensure regulatory effort is accurately and transparently aligned with a product risk (including the CEBRA work).

Better regulatory efficiency; reduced red tape; reduced duplication of effort; quicker time to market for new product.

Improved access to new products at lower cost,

  • improved productivity and sustainability.
3. No longer performing efficacy assessments except on request
APVMA would no longer assess the efficacy of a product except at the request of the applicant (other than in relation to the safety of the product, eg for vaccines). Products labelled accordingly.
New chemicals are introduced by innovator multinationals. There is little chance these new chemicals will not work (because of the market response to the company). Other regulatory schemes have responsibility for ensuring products sold do what the manufacturer says they will do. Farmers have good systems and networks for communicating about suitable products.

Providing the applicant with a choice to no longer have their product assessed for efficacy reduces the cost of bringing new chemicals to Australia and prevents duplication of regulatory effort, resulting in improved access to newer and better chemicals.

Consumer law and general (tort and contract) law protect against ineffective products and misleading and deceptive trade practices.

Efficacy assessments by the APVMA will still be available for applicants at their request. Products would be labelled to indicate whether the efficacy of the product was assessed by the APVMA.

Better regulatory efficiency; reduced red tape; reduced duplication of effort; quicker time to market for new product.

Improved access to new products at lower cost,

  • improved productivity and sustainability.
4. Removing trade assessments except on request
APVMA would no longer assess the trade risk posed by a product except at the request of the applicant. Products labelled accordingly.
APVMA trade risk assessments are done for a point in time and not updated. The trade environment changes rapidly. APVMA trade risk assessments are likely to be out of date. Export focussed industries have systems independent of the APVMA to ensure exported produce meets the requirements of an importing country.

Providing the applicant with a choice to no longer have their product assessed for trade risk reduces the cost of bringing new chemicals to Australia and prevents duplication of effort, resulting in improved access to newer and better chemicals.

Products may continue to include trade information on their label or through other mechanisms in concert with export focussed industries (as they currently do, eg The Australian Wine Research Institute’s booklet, commonly known as the ‘Dog book’). Products would be labelled to indicate whether the trade risk posed by the product was assessed by the APVMA.

Better regulatory efficiency; reduced red tape; reduced duplication of effort; quicker time to market for new product; better management of trade risks.

Improved access to new products at lower cost, improved trade,

  • improved productivity and sustainability.
5. Crop grouping
Introduce representative crops for chemical use data.
Assessments of chemical risk in some representative crops can stand in for assessments for other crops in the same crop group. For example, an assessment of risk posed by a chemical in one apple variety can suffice as a proxy for the risks to all pome fruit. As a result, data about chemical safety need only be provided for the one representative crop in a group rather than for all crops individually. This reduces the cost of registration and improves access to newer and better chemicals.Better regulatory efficiency; reduced red tape; more uses of chemicals; quicker time to market for new uses.

Improved access to more uses of existing and new products at lower cost,

  • improved productivity and sustainability.
6. Contestable provision of assessment services
Accredit suppliers of assessment services and define assessment standards. Accept accredited assessor reports sourced by applicants.

Implementing the measure gradually.

An assessment of any building work done before a local council issues an occupancy certificate may be done by a private, accredited third party assessor. This approach can be taken to chemicals assessments, reducing the time taken for APVMA assessments and placing control over the time taken to register a chemical in the hands of the prospective registrant.

A legislated accreditation scheme is important to ensure scheme integrity and certainty for applicants.

Better regulatory efficiency; improved regulatory flexibility; quicker time to market for new product; greater responsibility for manufacturers.

Improved access to new products at lower cost,

  • improved productivity and sustainability.
7. Streamlining import and export regulation

(a) No longer requiring consents to import in the majority of cases
(b) No longer requiring export permits in the majority of cases
(c) Limit export certificates to registered products

(a) & (b): APVMA-issued import consents and export permits are not necessary in the majority of cases as the risks being managed are managed through other regulatory frameworks. This task is unnecessary.

(c): Issuing export certificates for unregistered products risks damaging the reputation and confidence the APVMA has developed, including internationally. Limiting provision of certificates to registered products is responsible only where APVMA has completed an assessment of the product and is able confirm information on quality and availability in Australia.

Better regulatory efficiency; reduced red tape; reduced duplication of effort, reduced reputational risk.

Lower cost,

  • improved productivity and sustainability.
8. Address delays in poisons scheduling Delays in scheduling agvet chemicals cause delays in registering new agvet chemicals.Better regulatory efficiency; reduced red tape; quicker time to market for new product.

Improved access to new products at lower cost,

  • improved productivity and sustainability.
9. Additional amendments to legislation
Addressing any outstanding issues with legislative drafting.
Fixes to problems identified by DA, APVMA and externally. Rationale differs per item (some listed below).

  • Publication of application information
  • Notifiable and prescribed variation of conditions of registration
  • More coherent provisions around particulars of label approval and information that must be contained on a label
  • False and misleading information powers re variation applications
  • Address suspended label variations
  • Introduce a Commonwealth coordinator
  • Provide for manufacturing tolerances of concentrations of ingredients in product
  • Consistently regulate viable plant material
Various.
Table 2 Proposed longer-term reforms
Measure Rationale Benefits
10. Establish a co-regulatory system
Co-regulation of agvet chemical use and allowing more freedom to use chemicals in QA-driven farm systems.

The approach recognises the shortcomings of current regulatory framework and leverages existing industry approaches to improve access to new uses of existing chemicals while improving management of chemical risk.

Increasing vertical integration, supply chain consolidation and greater export focus has increased reliance on quality management systems approaches to farm product quality and integrity. These systems (to differing degrees) manage risk of agvet chemical use, duplicating state efforts to regulate control of use.

Embracing accrediting benchmarked (including produce testing and third-party auditing) industry systems will allow duplication to be reduced and industry responsibility to be relied on to manage risk, eventually leading to greater industry management of residues risks and effective reliance on food law, no longer requiring APVMA residues assessment.

Directly addresses minor use election commitment

Better regulatory efficiency; reduced red tape; reduced duplication of effort; aligns with current industry trends.

Improved access to chemical products for new uses,

  • improved productivity and sustainability.
11. Improved product quality initiatives
Review and revise chemical product consistency and quality controls. Consider standards-based regulation of active constituent composition and approval of active constituents.
Once a chemical product is registered there are, apart from the licensing system for veterinary medicines, no effective controls over the quality and consistency of product supplied to the market.

A standards-based approach to in-market chemical product consistency and quality would reduce duplication in the pre-market access part of the regulatory system and improve control over the post-market access component through targeted product testing, audits of record keeping and market surveillance. This will improve chemical product safety and reduce the costs of access to the market.

Better regulatory efficiency; reduced red tape; better control of chemical product quality.

Improved safety of chemicals supplied to the market.

12. Rewarding trusted registrants
Embrace the good compliance and safety record of trusted registrants to reduce the regulatory burden on those trusted registrants.
Reform 11 is likely to mean increased surveillance of manufacturers and suppliers of chemical products. A risk-based approach to individual registrants will focus effort on issues of greatest concern and reduce regulatory burden on trusted market participants. This approach is similar in concept to that used by the Imported Food Inspection Scheme.

Trusted registrants would be identified through past good performance and would benefit through reduced regulatory burden imposed in both pre- and post-market access periods.

Better regulatory efficiency; reduced red tape for trusted registrants; better control of chemical product quality.

Improved safety, lower cost,

  • improved productivity and sustainability.
13. Veterinary Compounding
Address concerns with existing freedoms on compounding of veterinary medicines and impacts on agvet chemical innovation and quality.
Existing laws effectively allow unlicensed and unauthorised manufacture of registered veterinary medicines by pharmacists, without manufacturer licensing and at risk to the IP of registrants. This disincentivises development of new veterinary medicines and risks animal health. Reduced disincentives for innovation; better control of chemical product quality; better animal health outcomes.

Improved access to new products, improved safety of chemicals supplied to the market.

  • improved productivity and sustainability.
14. Environmental impact test for chemical review decisions
Consider including an environmental impact test when assessing the impact of removing a chemical from use via reconsideration.
APVMA decisions to remove a chemical from the market do not consider all the consequences for the environment of a decision to limit the use of an agvet chemical. It may be that those consequences are a greater harm than the harm the decision was to address. Removing use of a chemical may encourage practices that are more harmful to the environment than the use of the chemical.Reduced prospects of negative environmental consequences of a regulatory decision.

Continued access to safe products.

  • Improved sustainability.
Table 3 Not proposed to proceed in this reform package
Measure Rationale
15.Single active constituent approvals
No longer separately assessing active constituents.
See measure 11.

Expanding existing, and utilised, provisions for active constituents (see ss 14A and 15(2) of the Agvet Code).

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