Tuesday, May 21, 2024

Clearer path sought for methane inhibitor approval

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Concern over government process a brake on bringing methane blockers to market.
Intuit Regulatory director Julia McNab says it is a case of ‘you go, no you go’ when it comes to companies being first movers for seeking methane inhibitor approval.
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With at least three methane inhibitor products waiting in the wings for commercialisation, questions remain over the process to get government approval for farmers to access and use the technology to reduce greenhouse gas emissions.

Late last year the Animal Compounds and Veterinary Medicines (ACVM) division of the Ministry for Primary Industries published long-awaited guidelines containing the information needed to support an application for methane inhibitor use in livestock.

These included an outline of the study design, quantifying efficacy claims, and the type of measurement techniques used when trialling product compounds. 

But, while welcoming the arrival of guidelines, a regulatory consultant fears they are still too generalised, and fail to embolden commercial companies to be the first to set foot on the regulatory pathway.

For farmers the clock is ticking on mitigation, with He Waka Eke Noa requiring a 10% reduction by 2030, and few tools on the table so far to do so.

Julia McNab, director of regulatory consultants Intuit Regulatory, noted the guidelines are relatively explicit about the type of technology that should be used to measure compounds’ efficacy, including respiratory chambers and the GreenFeed feed portioning and gas monitoring equipment.

“But it is considerably less specific about how many trials you need, including what different stock classes and the feed types that efficacy needs to be trialled upon,” McNab said. 

“There is some guidance there, but not enough. Companies don’t want to go through their trial programme only to find that ACVM will only grant them a limited label claim.”

The draft guidance document states trial animals should be clinically healthy and representative of the age, sex, and class for which the inhibitor is to be administered. 

Stock are to be “typical to the average NZ farm for that species and class”. 

Efficacy claims have to state the compound achieves “at least x% reduction in methane yield for x% of days”.

McNab said the concern within the industry is the lack of feed type specificity, which needs tightening up.

“It means things could get quite complicated and you could end up having to conduct dozens of trials. We are still looking for clarity and guidance.”

She agreed that as more and more overseas countries start to grant approval to methane inhibitors, there is a real risk New Zealand will be left behind.

“There is a sense that no one company wants to be the first to seek approval through the ACVM guidelines. Many are starting to think perhaps it is easier to get over the line in the likes of Europe, or Australia.”

NZ Food Safety deputy director-general Vincent Arbuckle told Farmers Weekly farmers need to be confident that inhibitors are safe and fit for purpose for NZ farming conditions.

He said the inhibitor guidance documents include public consultation and targeted consultation with key stakeholders, including inhibitor manufacturers, with generally positive feedback on the documents.

“It is not possible to provide prescriptive details on how many trials or what measures are needed, as there are too many variables, and different kinds of inhibitors will likely need a different trial/research approach. 

“These variables include the target animal type, it’s physiological state (whether it’s pregnant or growing or lactating), types of animal feed and how the inhibitor is to be applied. 

“Instead, the documents provide advice on key components and statistical information to ensure the appropriate number of animals are used in a trial,” he said in a written statement.

So far, 20 of the 21 applications for approvals have been granted for research purposes.

Dutch nutrition giant DSM confirmed last year its methane mitigator Bovaer is available for commercial use in Australia after following market approval processes. 

A DSM spokesperson said the company is working hard to complete some of the NZ-specific and unique requirements, and anticipates handing in its registration in the course of this year.

Fonterra confirmed it is continuing to investigate its Kowbucha inhibitor. Long-term trials are underway to determine reproducibility of earlier results and the company remains optimistic about the solution and continues to work with regulators to support the process.

McNab likened the process for methane inhibitor approval to that of getting a new drench active over the line – costing millions and taking several years. 

She also has concerns over the lack of testing infrastructure in NZ, including the number of respiratory monitoring chambers.

Mark Aspin, manager for Pastoral Greenhouse Gas Research Consortium, agreed there are few gas testing facilities.

“But yes, we are going to see more of them. There are plans afoot to double the number of chambers from four to eight with AgResearch in Palmerston North, and possibly another set in the South Island. Infrastructure for respiratory study does hold us back.”

Aspin is hopeful the guidelines will cope with having data that is used in product development at scale also feeding into regulatory efficacy data, helping save research dollars in the process.

He said his understanding of discussions to date is that if a company has the data, and it meets the criteria, there is a real likelihood it can go ahead with production.

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