How does a new termiticide get to market?

TERMITES

Whatever the industry, customers are always looking for the latest and greatest, the innovation that makes their lives easier or better. In the pest control world, coming up with new active ingredients, especially ones with a different mode of action, is actually a necessity to combat insecticide resistance. Discovering new active ingredients has never been easy, but with the increasing expectations around safety profile and environmental impact, it’s getting a whole lot harder.

A journey of discovery

When Syngenta termiticide, Altriset was introduced to the market in 2011, it had taken significant development work to get it to the point of market introduction. To introduce a new active ingredient like Altriset takes around 10 years of development from start to finish. The journey began back in 2001 when chlorantraniliprole (it only had a code number back then) was identified as a molecule of promise. If it was developed today it would be part of 100,000 molecules actively screened each year. Molecules identified as promising are then screened for spectrums and chemistry properties and progress to the next stage of development.

Investing in development

The next stage is where the significant financial dollar and time investments are made. The critical component of this investment cost goes into understanding what the product does and how it performs. Each product must go through several core areas: chemistry development (including process development and synthesis optimisation), biological development (including field and laboratory trials and validation), toxicology (including acute toxicity studies and non-target organism studies) and environment (including environment metabolism and residues). These aspects are important for performance and regulation compliance. Thirty per cent of the overall cost of developing a new active ingredient is now spent on product safety.

It’s through this stage that the key understanding of a product like Altriset’s active ingredient chlorantraniliprole is developed.

Trials in real world conditions

Laboratory trials are an important first stage of testing for all products, but substantial field efficacy trials are required to ensure products work how we say they are going to work with the expected performance under a range of conditions. Altriset trials carried out in the USA and other countries may be used in support of a registration but local work is a must for registration in Australia. This is why Syngenta set up extensive field trials in Australia, both south and north of the Tropic of Capricorn, to challenge Altriset in Australian temperate and tropical conditions. But also to ensure Altriset performed in a range of different soil types and on local termite species.

Syngenta researchers created an extensive trial setup that utilises a concrete slab construction to mimic a real life housing setup and provides a more realistic challenge for Altriset, certainly important when assessing non-repellent chemicals. Each concrete slab setup contains treatments of either a vertical, horizontal barrier or an untreated control. The slab on ground construction allows termites to travel through to wood placed at the slabs centre. Termites can access the wood by building over the edge of the slab or moving through a designed crack in the concrete – but they would have to pass through the non-repellent Altriset treated zone first. By comparing concrete slabs with untreated soil, the performance of Altriset can be assessed in real life replicated trials.

Trail setup for termiticides must last the test of time to support ongoing registration. For example the oldest Australian Altriset trials have reached 10 years with regular testing and maintenance performed on a yearly basis.

Soil residue studies

Soil residue studies are carried out to confirm the persistence of product residues and their long term performance. This is critical to soil applied termiticides like Altriset that is currently registered for 8 years south of the Tropic of Capricorn and 4 years north. All Syngenta field efficacy trial layouts include ‘residue plots’, from which soil samples are collected each year, when the performance of the field trials is assessed. Residue analysis is carried out to confirm the Altriset present in the soil.

‘Termite tube studies’ are then carried out to support the field trials by demonstrating the Altriset soil residues are sufficient to control termites and maintain an effective treated zone. Under standard laboratory conditions, termites are paced at one end of a tube; a food source is placed at the other end. The middle of the tube contains soil from the field trials, effectively creating a pressure situation where termites are compelled to travel through the barrier. This allows us to establish mortality and time-to-mortality: a process that successfully supports and demonstrates how aged soil residues maintain their effectiveness as a non-repellent barrier. The trial’s design is replicated and contains controls of untreated soil to maintain scientific rigor of the results.

Registration

All of this testing data, along with the toxicology, safety and environmental data packages is presented as part of the registration submission package to the APVMA. Registration of a new product, using a new active can take around 2 years. It was no different for Altriset.

It is estimated that the development of a new active through to first registration global is around US$300 million. A substantial investment for bringing new products and tools to the industry and is why when you purchase R&D products you are supporting the development of future tools and products to the industry.

The importance of a strong data package and efficacy package allows regulatory bodies to asses attributes related to the products. Though the information presented Australian regulators for able to allow Altriset to have the poison schedule heading of Unscheduled.

Real house trials

Alongside the field efficacy trials, Syngenta conducted trials with pest control companies in termite-affected houses around Australia to demonstrate the ability of Altriset to eliminate termites established in buildings. Treatments were applied by pest managers using different application equipment, under a range of different climatic conditions, soil types, construction types and against different termite species. The trials not only demonstrated the successful elimination of termite activity in the houses and structures, but yearly inspections also demonstrated ongoing protection. These trials not only gave the early users of Altriset confidence in its performance but also formed part of the registration submission for label extension purposes.

The research continues

Even after registration, research on Altriset continued and helped provide increased understanding on its exceptional level of insecticide transfer and its unique stop feeding effect. Of course ongoing field studies have confirmed the increased duration of protection provided by Altriset, with 8 years continuous protection in areas south of the Tropic of Capricorn and 4 years continuous protection in areas north of the Tropic of Capricorn.

Future-proofing our industry

Without innovation in our industry, regulatory pressure and resistance development will continue to reduce pest management options. New products are vital for the future. Syngenta is committed to this with $1.3 billion spent on R&D last year and more than 5000 employees dedicated to research and innovation, we are dedicated to providing the innovations and products required to future-proof the crop and pest control industries.