April 17, 2018
Smithers Viscient: Can you brief me on the current regulatory context for biopesticides?
Jose Carvalho: It is complex; we would be talking for hours. If we focus on Europe, as that’s actually the topic of my talk, there is no different regulatory process for registering biopesticides like in the US. In Europe, the origin of what we call the “plant protection product” does not matter. The EU assesses the use and risks of the substance, regardless of its origin. It is a fact, however, that some biologicals are listed as low-risk substances.
There are additional challenges to work through including fees, the amount of time the product takes to go to market, complexity to address some data requirements (e.g. botanicals extracts). Some of the regulatory “benefits” for biopesticides that are present in the US, are non-existent in the European legislation. At least not connected to the origin of the substance/product – for example, if the substance is naturally occurring or not, plant based or a synthetic chemical. The European Regulatory framework is more focused on the risk of the substance being used for plant protection. There are however different types of data requirements for different biopesticides, mainly for microbials vs. chemicals.
During the Workshop, we will have the chance to look at key differences between the EU and US, and other countries, regarding the processes for registering biopesticides.
Smithers Viscient: How about on a global scale beyond the US and EU?
Jose Carvalho: There are countries that set different regulatory processes for biopesticides, like the USA and Canada, making them more interesting markets for registration of these products. The processes for registering a biopesticide in these countries are better defined and there is an existing body of experts who oversee the registration of these products at these Agencies. In the EU, it is much more expensive to register than in the US, it is more uncertain, and you go through the same regulatory process as the chemicals. Therefore, it can take 4-6 years to get into the market with a biocontrol product in the EU, which is a similar timeframe to register a conventional pesticide. This is discouraging companies to invest in EU registrations when other markets are so much more appealing. The good news is that there are initiatives going on to address these issues and improve the regulatory process. There is a consensus that the current framework in Europe is discouraging innovation and investment. My talk at the conference will briefly discuss the potential changes and the willingness from policy makers to refine the situation while providing better guidance documents to promote the registration of biocontrol products.
Smithers Viscient: What are the biggest challenges we are currently facing regarding the registration of biocontrol products?
Jose Carvalho: A common and broader understanding of biocontrol, the definitions problem, and regulatory agreement between countries.
When you look at the challenges for global registration, there is a barrier just at the start: terminology and definition – what is a biopesticide? Then you go to the non-harmonized data requirements, the testing and studies requirements, approaches to risk-assessment, etc. Which tests should be conducted and submitted to the different regulatory agencies? How do you plan your data generation for multi-country registrations? I think we need more alignment in terms of data generation so companies don’t need repetition of studies with the associated costs. This could be the first step.
Smithers Viscient: What are the regulatory concerns and how are they being addressed?
Jose Carvalho: Two big issues at the moment, not necessarily related only to biologicals but impacting registration of products in general: the ongoing discussion about endocrine disruptors and how to test substances for endocrine disruptor activity, including agreement on methodology; and the setting of tolerances for imports/exports of food and animal feed which is impacting global trade. How are they being addressed? You will have to attend the summit, I am sure there will be very interesting discussions in Alexandria.
Smithers Viscient: What challenges do you foresee 5 years down the line?
Jose Carvalho: Looking at what is going on with precision agriculture and soil research for example, the landscape of crop protection will surely be changing in the next five years. The impact of the present situation will still be a driving force in the future: the final consumer actually being the regulator. People want better food, safer food, reduced environmental footprints, and the rest we know. What is usually forgotten by the final consumer s how food gets to the supermarket shelves. In the past decade, we have seen a fast-growing distance between consumers and food production. This is one of the problems we see today in agriculture. More and more people are living in cities and are distanced from agriculture and food production. There is a detachment from the land and a lack of understanding at the consumer level. People do not seem to understand what is required to produce foods and why do you need to treat plant diseases and insect pests in order not to waste the crop (and not to waste the soil and the water used to produce the crop).
Use of GMOs and biodiversity will continue to be hot topics. Other serious challenges in terms of agriculture which will have an impact in regulatory are water scarcity, soil erosion, extreme climatic conditions, etc.
Smithers Viscient: Why is this event important to the agrochemical market?
Jose Carvalho: This event is a fantastic platform to get an update about what is going on in the different scientific disciplines, regulatory and research and development. It is an extremely useful platform to network with people working in these areas. I really enjoyed last year’s event in Raleigh and I am very much looking forward to Alexandria!
Smithers Viscient: What does Knoell hope to achieve and what can we see happening over the next few years with regards to the future of Agchem in international markets?
Jose Carvalho: We are a global regulatory consultancy supporting companies getting access to markets in the different global regions, improving agriculture production, food safety and security. For the next few years we plan to keep broadening our portfolio of regulatory services and expand the already long list of countries we are operating to keep supporting our clients with their expansion goals. We will keep investing in our people and their knowledge to ensure we are ready to deliver ours clients’ new technologies to farmers and to address the new challenges in regulatory. The world keeps changing and we like to be ready.
On a business note, we aim at keep our growing path of the past 20 years and keep attracting the best people to our workforce of 580 people today.
What can we see happening in the AgChem Market? Continued change. For us the core principles should remain the same: be ready for changes, deliver on time and ensure the registered label is as close as possible to what the client aimed for and to what the farmer needs.
Smithers Viscient: What innovations would you like to see in the future?
Jose Carvalho: An innovative look at agriculture, this is an innovation I would like to see! Looking at agriculture from a more holistic perspective, a broader view of the challenges to safe food production, i.e. not focusing on each technology individually, but framing them in the context of sustainable agricultural systems.
We need to have a more integrated approach when looking at plant health and food production – from the seeds to exporting the crop into another market. In terms of regulatory, the system is still working in the same way it was working in the 1980’s by assessing product by product – this is extremely difficult for new technologies, as very often they don’t fit into these existing rules. We need to look at the bigger picture from seed to fork, addressing plant nutrition, plant health and plant protection, crop harvesting and storage, soil erosion, water management, etc. The FDA in the USA has recent examples of approvals of non-conventional therapies, in the human genetics area, and maybe we could learn from the human pharmaceuticals to improve our regulatory framework in agriculture and food.