03 June 2020
In our first-ever blog, we sat down with Eden’s most recent recruit, Director of Regulatory Affairs, Dr. Mike Carroll, to learn more about his role at Eden and hear his views on the current regulatory landscape.
Tell us a bit more about your career to date...
After graduating from the University of Bath in Biochemistry, I went on to do a PhD at the University of London, St Thomas’ Hospital Medical School. Originally, I wanted to do research in heart disease, but I ended up doing it in placental biochemistry so nothing to do with plants!
After seven years in the pharmaceutical industry, I joined Monsanto in Belgium. Monsanto were then looking to ramp up the defence of their plant protection products, so they hired me for my biochemical background. Being native English-speaking in Belgium and working for a US company was helpful, so it was really being in the right place at the right time. I was keen to experience living and working in the U.S. so I eventually moved there with Monsanto (at their global headquarters) and spent a few years living in St. Louis.
When I returned to the UK, I became the UK and Ireland regulatory manager for Monsanto which was learning at the sharp end as it was the time when the genetically modified food issues blew up and GM crops were labelled as “Frankenstein food” meaning that we were dealing with protests and media attention. It was a character-building experience, but then my career took me back to working at a European level-working in Belgium defending older molecules and getting new molecules approved for Monsanto.
After 15 years at Monsanto, I moved to Dow Agrosciences to focus more on crop protection products and chemistry, working mainly on herbicides. Following the Dow DuPont merger, I decided to leave to join Arysta and it was there that I led their Research and Development Group. At that time Arysta was owned by a hedge fund which gave me experience in stock market and investor issues.
Most recently, I was working for TSG Consulting, an AIM-quoted Science Group plc company that provides regulatory and scientific support to chemical companies around the world. I was delighted to accept the role of Director of Regulatory Affairs at Eden because I enjoy driving projects through to registration and commercialisation and the best place to do that is in a company.
Why were you interested in working at Eden?
It’s a very exciting time to be joining Eden at this point in their journey. They are in a strong position to embark on new product development and progress ambitions in key markets. I am confident Eden is heading in the right direction and I look forward to the challenges and successes ahead.
What does your role at Eden entail?
My role is about managing the approvals that we have and moving ahead with new registrations all over the world thereby increasing the ‘footprint’ that we have which allows us to subsequently grow sales. In terms of getting new products approved, the whole process is complicated, whether we are attempting to register biopesticides or conventional chemistry, but my role is to draw on my experience and navigate Eden through approval processes as quickly as possible.
One of the first things I did after starting was to help Eden join the International Biocontrol Manufacturers Association (IBMA), as part of my role is to improve communication with the regulators and those in the industry so we keep ahead and are always abreast of regulatory developments.
What do you hope to achieve over the next year at Eden?
I hope to help progress many of the pending authorisations we have in our pipeline. One of the big projects to note is the Mevalone and Cedroz authorisations in the United States. We are in the last stages of the federal authorisation which will allow states to give their own authorisations. We are currently actively working with EPA to answer their questions, and we are hoping to get a decision as soon as possible, ideally by the end of the year.
Which markets have Eden identified as major targets for product registration?
The US approvals for Mevalone and Cedroz will be significant for Eden. More specifically, within the US, California and Florida are the standout states in which our products are well-suited to be sold and used on major crops including grapes and high value fruit and vegetables. Apart from the US, we have various ongoing registration applications in Europe, Australia and New Zealand, which are well documented.
How do approval processes differ in each country and what drives successful authorisations?
In the EU, the Member States have most of the regulatory power and it is a bottom up system. Scandinavian counties can take a conservative approach to agrochemicals while Southern European Member States where agriculture is relatively more important cannot be so conservative.
In contrast to the EU, the US may have completely different views on toxicology. A molecule that Europe considers carcinogenic can be viewed in the US as safe, there is just a difference of opinion by scientists.
Science is chaotic, and it can take a long time for scientists to reach consensus, but society does not have that luxury and regulatory decisions have to be taken with imperfect knowledge. Therefore, ‘following the science’ which has come to prominence during COVID-19 is, in my opinion, a rather unfortunate phrase. We do not have time to wait for the scientists to resolve their internal conflicts, instead, society needs to take competent regulatory decisions. Regulation is ultimately a combination of political and economic factors. Some countries can take the view that ‘we need these pesticides because much of our economy is based on agriculture’ so you can have some systems where economic factors drive regulation. As a company, you can speak to regulators and present data, but one must keep in mind that the regulators all have their own political limits.
Consumers and politicians are keen for biopesticides to succeed at the regulatory level and in the marketplace because, in general, they have a more attractive safety profile than conventional synthetic chemical products.
How important is EU’s Farm to Fork strategy and how will it shape agriculture and the regulatory environment in Europe in the coming years?
The strategy highlights what is happening globally, so it is a helpful indicator from that perspective. The number of actives available to farmers is getting smaller and we have reached the point where politicians have said to the regulators, “there is little choice left for farmers” and this has facilitated the regulatory progress of biopesticides. There is no doubt the rise of biopesticides has been widely supported by farmers.
There is also a drift towards a less intensive agriculture in the EU and this will mean yields will go down as farmers won’t have many of the older chemical products which had health and environmental concerns. It is logical that biopesticides will become more important in European agriculture as environmentally acceptable alternatives to conventional chemical pest control.
How has COVID-19 affected the regulatory environment and what do you expect to be the longer-term impacts?
Logistically, the regulators will not be able to meet as often, so processes will no doubt be running behind schedule. Personally, I think coronavirus has highlighted a problem with the regulatory environment. Politicians are looking at the scientists for redemption; asking them what to do, but the scientists don’t have all the answers and that’s a good thing for our industry. We can use that to our advantage and say that whilst the regulators are doing their best to regulate, the politicians are constantly asking “are these products safe?”. The Coronavirus pandemic shows that science is only good at helping to make regulatory decisions if the science is mature and you have reached consensus. As I said earlier, regulation is essentially political so hopefully one result of the pandemic is that politicians and regulators start approaching novel technologies with pragmatic rather than absolute caution.
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