Regulatory review vital to primary sector growth

Words: Animal and Plant Health New Zealand

In coming weeks, the primary sector expects the outcomes from the vitally important agricultural and horticultural products regulatory review.

Liz Shackleton.

This review by the Ministry for Regulation has the potential to facilitate farmers and growers getting access to innovative new products to improve sustainability and productivity.

The Ministry is reviewing the agricultural and horticultural product approval pathway through both the Agricultural Compounds and Veterinary Medicines (ACVM) and Hazardous Substances and New Organisms (HSNO) regulatory systems, as implemented by the regulators Environmental Protection Agency and NZ Food Safety (Ministry for Primary Industries).

The Ministry’s timetable suggests Cabinet is due to consider the findings of the review in February.

Animal and Plant Health NZ members seek tangible action from the review to address the current backlog of new products awaiting approval.

They want to see the backlog prioritised in a way that is fair and consistent for all stakeholders.

NZ’s farmers and growers are facing big challenges such as climate change, emerging biosecurity threats, and increasing productivity and export value.

They need rapid access to new tools to tackle these challenges – such as treatments for emerging diseases, softer improved crop protection treatments, biologicals, vaccines and innovative solutions like methane inhibitors.

Currently there is a significant backlog of applications for approval of new products.

As at September 2024, the EPA reported 116 release applications in the queue.

A 2023 Sapere report estimated two to four years to clear the queue, assuming no new applications and an additional 12-18 months assessment.

Members recognise the need for appropriate regulation to manage risks but want to see a balanced risk mindset and a more efficient, consistent and effective approvals process.

Members’ feedback is that the system currently is not striking the right balance.

They are concerned the primary sector is at risk of diminishing investment and innovation for plant and animal health products because of unpredictable delays, time to market, and a lack of clarity around the decision-making process.

Members support adequate resource for regulators but say that more industry funding has not moved the dial to date.

For example, members report their ACVM funding doubled in the past five years to support more resource, but they are still experiencing delays in their approvals.

Members want to see greater transparency of how sector funding is being used, resource focus and the outcomes that are being delivered for that.

Clear objectives, a business-like approach and strong governance are important for NZ to grow.

Members want to work with the regulators and have identified potential solutions to current issues.

The first proposed solution is a Group Standard for Trial Products, for example for lower risk trials run to international standards, and away from environmentally sensitive areas.

A group standard sets out conditions that enable a group of hazardous substances to be managed safely.

Most domestic and workplace chemicals and veterinary medicines are approved under group standards. Compliance requirements still apply.

This approach saves time and frees up resources to reduce the backlog of other applications.

Members also propose a strategic leadership forum bringing together regulators, government, industry and independent expertise.

This offers a forum for meaningful strategic engagement, inclusive of all stakeholders, to inform risk management, priorities and resource allocation.

For agricultural compounds and vet medicines, members propose streamlining minor changes that align with international practices for well-established products and processes, by introducing self-assessment.

Members also propose harmonising with international standards, for example rule of two for companion animals (that is, where two regulators in selected countries have approved a product, then it can be accepted here) and label harmonisation where appropriate.