Tuesday, September 24, 2024

Balancing risk and rigour in regulations

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Industry expert weighs in on welcome plans to overhaul rules for crop and animal treatments.
Reading Time: 3 minutes

While welcoming the government’s announcement that it will be overhauling and streamlining key regulations for crop and animal treatments, an industry expert is wary about the direction and how far the changes may go.

Dr Julia McNab, director of regulatory consulting company EpiVets, said in general the announcement to streamline the Agricultural Compounds and Veterinary Medicines (ACVM) and Hazardous Substances and New Organisms (HSNO) Acts is a good thing.

She is at the sharp end of helping corporate clients get approval for products including sprays, drugs and treatments, and has witnessed increasingly costly delays in getting their approvals over the line.

This includes getting approval on cutting edge methane mitigation treatments, a vital tool for farmers facing increasing processor demands to prove they are reducing their livestock emissions.

McNab said complex regulatory requirements have made New Zealand less attractive to some large corporations seeking approval for their products here.

“There are various areas the review can look at, with different issues in different sectors. 

“For crop treatments, it is much more influenced by the Environmental Protection Authority (HSNO Act agency) and their pace, compared to veterinary medicines which are more affected by the ACVM.

“This is a good opportunity to check back and ask if we have the balance right between ability to provide innovative products and the ability to manage risk.”

She said issues she has raised include allowing for more self-assessment on chemistry and manufacture of new products where risks are lower.

“This would certainly free up resources at ACVM.”

She noted that a lack of human resources at the EPA has been an issue, and something the agency itself has confirmed it has been trying to address.

“We only have a small talent pool in NZ, and they are a small team trying to do the same job as overseas regulators with three or four times more staff. 

“They do well with what they have. But there has also been a creep in the amount of information sought over time.” 

Come 2030, the European Union’s Green Deal will be in play. This is destined to have a material impact upon the types of crop and animal treatments NZ farmers can and can no longer use.

“The Green Deal puts more urgency around the need to overhaul the regulations. Given the time taken to get them sorted, we are already up against it. There are new families of treatments with better safety profiles likely to be coming through that require approval.”
She said methane inhibitors have proven particularly problematic to get approval for.

“At the moment veterinary products are either registered by ACVM or exempt.  We need a middle ground for lower risk products like feed additives, one that is streamlined.” 

She noted many methane inhibitors are feed additives that comprise innocuous compounds but have to go through the same processes as products with more potent, complex compounds in them.

“Maybe a bit of a lighter touch would be good here.”

At present farmers could theoretically buy a methane inhibiting product here but it would not have an assessed label claim, meaning it would not be valid for use on a farm supplying a processor that would require a label claim.

McNab has had a distinct sense some companies developing methane inhibitors are focusing on markets other than NZ due to the complexities here.

In Australia and the EU, an essential oil product called Agolin that mitigates methane is being sold widely.

“It is a low-risk product we should be able to sell here.”

She said any changes to the two Acts could still take time, and the speed of change would depend on whether they required a Parliamentary overhaul, or simply tweaks to operational processes.

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