New Zealand’s Ministry for Regulation has launched a comprehensive review of the approval pathways for agricultural and horticultural products, which are set out in the Agricultural Compounds and Veterinary Medicines Act 1997 and the Hazardous Substances and New Organisms Act 1996. The review is expected to lead to regulatory reform aimed at striking a better balance between enabling access to essential products while ensuring associated risks to human and animal health, exports and the environment are well-managed.

The Ministry is inviting stakeholders - including farmers, growers and industry representatives - to provide their insights and evidence through written submissions, online meetings, and targeted engagements to inform the review process. The deadline for written submissions is 8 September 2024. This alert provides further information to enable interested stakeholders to participate in this important process. 

Background

Agriculture and horticulture are crucial to New Zealand’s economy, contributing significantly to export revenue and employment. Timely access to new agricultural and horticultural products is essential for maintaining competitiveness, meeting consumer expectations, and ensuring agricultural security. Farmers and growers use a variety of products such as feeds, fertilisers, veterinary medicines, pesticides, and environmental inhibitors to support their productivity and protect against pests. Access to newer and improved products is vital for maintaining competitiveness and addressing resistance. 

However, new agricultural and horticultural products can present risks, including residues in food that could impact human and animal health, exports, and the environment. To manage these risks, products are approved under the Agricultural Compounds and Veterinary Medicines Act 1997 (ACVM), and hazardous substances or new organisms also require approval under the Hazardous Substances and New Organisms Act 1996 (HSNO). These regimes regulate agrochemicals, fertilisers, veterinary pharmaceuticals, seeds, animal feeds, biological products and environmental inhibitors, among other products. 

Regulatory review 

The review will be led by the Ministry for Regulation (Ministry) in collaboration with other government agencies. Its primary objectives are twofold:

• enabling access to products: Ensuring that farmers and growers can access the products they need to remain competitive and meet market demands; and 
• managing risks: Safeguarding human health, trade, animal welfare, agricultural security, and the environment by ensuring that the risks associated with these products are well-understood and properly managed.

The review will evaluate the effectiveness of the current regulatory approach by:

• assessing the ACVM and HSNO systems from the perspective of those seeking product approval;
• identifying the problems addressed by the regulations and determining if these systems achieve their intended purposes;
• grounding the review in economic analysis, considering market failures, and evaluating the costs and benefits of the regulations;
• benchmarking New Zealand’s approval pathways against international standards and best practices; and
• examining the overlap and interface between the ACVM and HSNO systems managed by government agencies.

The review will consider:

• all products regulated under the ACVM system, including those also regulated under the HSNO system;
• the approval process, from information collection for applications to product approval for domestic use;
• reassessment processes and thresholds for triggering reassessments;
• regulatory design, practice, and the interface between the ACVM and HSNO systems;
• the quality and quantity of information required from applicants, decision-making models, and regulator performance; and
• stakeholder perspectives, including those of farmers, growers, processors, exporters, international supply chains, public health, the environment, and Māori cultural considerations.

The review will not address:

• gene technology regulation under HSNO;
• products solely regulated under HSNO;
• regulations outside the ACVM and HSNO systems, though linkages may be considered;
• individual applications, complaints, or actions of specific regulatory staff; and
• compliance, enforcement, standard setting, and regulator funding levels.

Stakeholder engagement is critical to the review’s success. Industry representative groups, businesses, farmers, growers, and other stakeholders are invited to provide their insights and evidence. This review process will involve online town-hall meetings, written submissions, and targeted engagement with a Sector Reference Group composed of technical experts from key organisations.

Next steps

At this stage, the Ministry is inviting written submissions from interested stakeholders, including those seeking to bring new products to market, New Zealand farmers and growers, processors and exporters, and parties in their international supply chains. Officials are particular keen to understand:

• Are the regulations working?
• What are the biggest issues with the current approval path?
• What are some causes or contributors to these issues?
• How would you solve them?
• What evidence can you provide?
• What market failures justify government intervention?
• What are the costs and benefits of regulation, and how are they distributed?

The review will then progress in the following stages:

• Deadline for submissions: 8 September 2024
• Substantive analysis: September to November 2024
• Draft report: December 2024
• Cabinet paper: February 2025 

Further information, including the review’s Terms of Reference, is available here.

Our view

We think there is significant scope to improve New Zealand’s approval pathways for agricultural and horticultural products, including by:

• streamlining the approval processes to reduce delays and costs for new agricultural and horticultural products, ensuring timely access for farmers and growers;
• enhancing risk assessment protocols by incorporating advanced scientific methods and international best practices, ensuring comprehensive evaluation of potential impacts on human and animal health, exports, and the environment; 
• fostering greater collaboration between regulatory agencies to eliminate overlap and enhance efficiency;
• increasingly transparency and stakeholder engagement throughout the regulatory process, ensuring that industry insights and public concerns are adequately addressed; and 
• regularly reassessing and updating regulations to adapt to emerging risks and technological advancements, maintaining a dynamic balance between accessibility and safety.

We look forward to assisting interested stakeholders to draft their compelling submissions. 

How we can help? 

MinterEllisonRuddWatts is home to some of New Zealand’s leading public and regulatory lawyers. We routinely assist clients with the full spectrum of regulatory matters, offering comprehensive solutions tailored to each client’s unique challenges. We specialise in: drafting law reform submissions; conducting regulatory due diligence; developing proactive compliance strategies; conducting internal investigations; and providing strategic counsel and representation during regulatory investigations and litigation.