Putting yourself in a regulator's shoes - Watze de Wolf

In this episode, I speak with Dr. Watze de Wolf. 

Watze has had a long and accomplished career working as a scientist and manager in both industry and regulatory settings, including 15 years working at the European Chemicals Agency (ECHA). 

We have a wide-ranging discussion about his experiences and observations of how chemicals management has evolved over recent decades, and attempt to provide a diagnosis for the current situation and outlook for the years ahead. 

This includes:

• Watze’s background, career journey and people he worked with
• The tension between the uncertainty and complexity of science vs the need for clear and predictable regulation
• The importance of communication and meeting your audience where they are
• Contrasting sensitivities and drivers of behaviour in different industries
• The shift away from risk-based approaches, and the rise of persistence
• The importance of dialogue and the value of organisations like the Society of Environmental Toxicology and Chemistry (SETAC)
• Understanding EU regulations as complex systems 
• Experiences with REACH dossiers, from both industry and regulator perspectives
• What it’s like for early career scientists at ECHA
• Discussions and experiences from the ECHA Member State Committee
• Thoughts on the Biocidal Products Regulation (BPR)
• What a new harmonised classification of ethanol means for its ongoing use as a disinfectant
• The essential use concept and how it could re-define chemicals management in Europe
• Importance of EU Member State participation, and the impact of Brexit on regulatory discussions
• Regrettable restrictions and thoughts on the ongoing group-wide restriction of PFAS
• Thoughts on the overall direction of travel, broader technological and societal shifts, and the impact on science

Watze's website: rMSC.fi – rMSC

Member State Committee - ECHA

Trifluoroacetic Acid in the Environment: Consensus, Gaps, and Next Steps | Environmental Toxicology and Chemistry | Oxford Academic

Persistence Science Interest Group Pushes Forward with Global Collaboration and New Initiatives

Literature review on micro‐ and nanoplastic release from food contact materials during their use | EFSA

Reflecting on 40 years of regulatory developments in Europe – Peter Fisk — Embark Chemical Consulting

Visit my website for more content and insights www.embarkchemical.com

Transcript

Chris: Hello everyone and welcome to the Chemical Journeys Podcast. Today I'm speaking with Dr. Watze de Wolf of RegMSC, and formerly of the European Chemicals Agency. Watze. Thanks for joining me.

Watze de Wolf: Thanks Chris for having me. 

Chris: I'm very, very happy to have you on. You're actually the closest that I've been able to come so far, to having a, a regulator on the podcast. And I'm really, excited to, be able to speak with you and get your perspective. It's fair to say though, that you're not just any regulator, that you've had a really long and illustrious career starting out in industry where you've had senior roles at both Procter and Gamble and DuPont, and then you've worked for nearly 15 years at ECHA in various leadership roles, including the head of unit for REACH and also for Biocides, and also as the chair of the Member State Committee. and then in amongst all of that, you've also had voluntary roles, at SETAC, including as the world president and more recently, as a member of the board of directors of SETAC Europe, and also a member of the board of Trustees at the Health and Environmental Sciences Institute or HESI. So it's fair to say it's quite an accomplished, career and I'm really honored to welcome you to the podcast.

Watze de Wolf: Thank you, Chris. It sounds like you've, done your research. yeah, it's been a career. It's been quite some time and, since two years I'm formally retired, but that basically means, I'm still quite happy doing the things I like to do on environmental science. That's the advantage of being a retiree.

You can focus on the fun parts.

Chris: Yeah, it's nice to be able to pick and choose, I imagine. it was good to meet you also, in Vienna this year at the SETAC Europe conference. So perhaps, we can start this conversation by hearing it from, your perspective. So I've given a little potted, sort of CV for you there, but perhaps you could talk a little bit about your background, your career journey and your motivations, in your own words.

Watze de Wolf: Yeah. Well, thanks. And, and let me start with my educational background. I think that's, quite critical for what I have done in the rest of my career also. I'm by training a biologist. but then, in my masters I worked on QSARs, so I'm very strong in animal free ecotoxicology. And, in that period, we were using the, basically, KOW octanol water partition coefficient as a, a descriptor as a proxy for biological systems. And the fun part was for me that I was, basically in a group with only chemists, organic chemists, and I was the only biologist. So I learned from them a lot of chemistry and, I hope I taught them a little bit of, biology.

So on that interface between two, different, areas is where I've been working quite a lot. my supervisor was Joop Hermens. he, received one of the educational awards from SETAC, and he considered himself a clock maker. So he really wanted to understand how things worked so he could make things, not necessarily a vision of designer clock, but really, going in deep understanding all the different, cogs and stuff.

And I have a little bit, the same thing I want to understand. So for me, when you're working in QSARs, you can do it, with, statistical approaches such as neural networks, which are mechanistically speaking black boxes. And, I would say currently you would describe these things as AI systems to be fancy.

We were focusing more on trying to have mechanism driven, QSARs instead of statistical ones. understanding the mechanism is important and one of the things I learned also in that time was that, with QSARs, there's uncertainty in the application of QSARs. And when you are working in business, in the development of new chemistry, you can deal with that uncertainty, because you have, let's say 10 chemicals and you jotted down to a couple of lead ones.

So it's, it's okay to, miss maybe a chemical. When you go to regulatory action, you, also can, use QSARs, but there it becomes much more black and white. If you go into restriction of a chemical on the basis of a QSARs. So uncertainty on in the use, can be quite different from a business point of view or a regulatory point of view.

So uncertainty is, is a big thing I thing in, in QSARs and as I mentioned, yeah, working with organic chemists and analytical chemists, it continued in my PhD. I worked in the same group of Joop, of Joop, and, and then started to do basically, more bioconcentration work and understanding biotransformation as, as an impact on reducing the bioconcentration potential.

There I started to learn how to deal with chromo, basically gc, gas chromatography, HPLC. And, yeah, that was the, the PhD thesis was quite a nice, start for also then doing some postdoc work. I moved to the US for that. I went to a lab, which was basically the research lab, the toxicology lab for DuPont, in Delaware where I started again on an interface between different, fields.

I worked on acute inhalation toxicity in rats. so acute toxicity, through inhalation is basically the same as, fish toxicity and lungs or gills are sort of the same. So in, in the US you had in those days, a company, called, Toys ‘R’ Us. and, well, you also have a, certain strain of rats called fisher rats.

So we had, as a big thing in our lab, the fish comma R rats, which is the logo of the Toys ‘R’ Us. and when you go to acute inhalation, very easily, you can use again, Henry's law constant as a, as a partition coefficient between, air and water, and also KOW and that you can do a QSAR for, acute inhalation, with the exception for reactive chemicals.

Same applies in in Ecotox. and also the combination of, ecotoxicity with bioconcentration. Moving into the concept of internal lethal concentration, initially, pointed or poised by, by Lynn McCarty was a thing that we were combining. So we were looking in that postdoc also into what are the internal concentrations in the rat.

And I learned there about the, TTC concept, the threshold of toxicological concern, and in my further time, that led to development also of what I would call the ETNC concept, the environmental threshold of no concern. nowadays people call it the environmental threshold of concern, but this is communication.

It's for me, no concern. It's, if you're below that level, there is no concern. If you're above the level, there is a concern. And, and this is the strange thing in toxicology, a positive result is actually a negative thing. if you have toxicity, it's called a positive outcome.

Well, hmm. Is it positive if it is toxic,

Chris: And it's very difficult to prove. negative, let's say, or the prove the positive in that case.

Watze de Wolf: yeah, Exactly. But if you have a whole lot of data and analyze that, you can come to a sort of level, de minimis level below, which you do not see any toxicity. and then also depending maybe on the chemistry class. So this, this TTC concepts or the ETC concept is, is important if you lack data on the specific chemical.

From my, postdoc, I went to what I would call the Procter and Gamble University. so I started working within industry and Procter and Gamble has a lot of environmental scientists working, across the globe. on Ecotoxicology where, you had Scott Belanger working on experimental streams, environmental fate and behavior you had a biodegradation guru there called Tom Federle, and I would say a risk assessment. Brightstar, Tom Fytal. I worked with all of those people and they told me so many things. Yearly gathering of all these environmental scientists from the globe, and we were with 80 to a hundred individuals.

It was just a, a, a great time to further develop my knowledge and know how Proctor & Gamble allowed me to work, in ECETOC task forces, where we, among others worked on the TRA model. that later got incorporated into, REACH exposure assessments. I also became the environmental classification and labeling expert for industry because, classification and labeling was very important for a consumer products company.

You don't want to have a dead fish, dead tree on your consumer products. So that led me to be, the Cefic experts in, in the context of the OECD GHS development. And there I learned that expert committees doesn't mean environmental experts. So we were in the environmental, expert committee and we were talking about the bioconcentration factor cutoff, for the GHS labeling.

And I started discussing bioconcentration, kinetics uptake in elimination kinetics. And with the exception of a few people like Steve Robertson and Henrik Tyle, I saw the shutters go down on the majority are of the, of the members of the expert committee. So there I learned yeah, you, they were experts in, in policy setting and in politics, but not necessarily in environmental science.

Chris: Mm-hmm. Perhaps maybe I can just acknowledge that as well. it is important to recognize that we are working in a limited pool, of expertise here and quite a complex technical area. I think it's important to recognize that because a lot of people are interested in this area, but understanding can take quite some time to establish at a deep level.

Watze de Wolf: Exactly, and I think we need to understand that if we work so long in the field, I had a certain moment to chat with somebody from the European Parliament and I was explaining the difference between two chemicals. One was a salt and the other was, not a salt, was the acid. And I got the question, what is a salt?

So that realized to me that, okay, I need to go to chemistry 101 in order to make my message. So, you always learn to know your audience. When you, give a presentation find out what they know and provide that, tailored communication to what they know. So you as a scientist will have to adapt to the people you talk with.

It's not easy. We're not taught to do that, and, it's something that, throughout my career, communication has been important. And I think SETAC can also be a very nice platform to have more discussions between scientists and social scientist or communication experts on how we can, better communicate our science.

And I think it is critical these days with all the early communications on TikToks and, and other areas that, we, as a scientist. Get tools to, to be able to communicate there, so that the general public understands and appreciates our messages.

Chris: Yes. It's always been a challenge, hasn't it? It's always been a, and laborious process to actually work through this discourse and address understanding and whatnot. And if anything, it's gotten more difficult these days because of the general reduction in attention span that we all have.

Watze de Wolf: And I must say, as a scientist, I, I worked a lot with the communicators in ECHA. When we were, bringing messages out, I always was cringing, because I mentioned earlier uncertainty. and that is I think one of the things I cannot necessarily do black and white because there is not necessarily black and white, but my colleagues from the communication department didn't want that uncertainty because then the message gets diluted for them.

So there was always this finding that balance and, okay. For, for the podcast today, I've decided maybe to be less, dealing with uncertainty, maybe bit more black and white, Chris. So

Chris: that's fine, whichever way you wanna take it.

Watze de Wolf: yeah, because it's about what are, the messages you want to get across for me. I learned through my career. I've been a scientist, but I've also been, in a technical management role. I have was at a certain moment in time. Had a unit of a regulatory group at P&G that basically I started to learn.

Now that's not totally for me. Then I went back into the science and started to work with DuPont. there became basically over time, senior manager for health as well as environmental sciences. they wanted me to come to, the US to manage some groups there. I said, now I don't want to go to the US and nowadays I'm very happy I'm not there.

and then I went to Finland and started to work with the European Chemicals Agency. But yeah, before I, I go into that, maybe I can point to a, a message about the difference between consumer products industry and industrial chemicals industry. DuPont is more industrial chemicals, Proctor and Gamble consumer products.

And, as I mentioned, I was the Cefic classification and labeling expert when I was at P&G. The moment I started in, in DuPont, I, I left that field for the reason that for DuPont it was much less important. Yes, if a chemical gets labeled for environmental reasons, when you have a production plant of 50 million euros, you put in place measures to manage the releases, into the environment.

You do risk management in the sense of putting in place, processes that make sure you don't get releases. Consumer products industry, that is not necessarily possible. So the risk management strategy there is to move away from a chemical. When you have a classification and you find other products easily, well for chemicals industry or for industrial chemicals, you have 50 million invested in your plant that can produce maybe one chemical.

So you are not moving away that fast and you are probably more interested in also doing a lot of advocacy work on that chemical that is of critical importance for your final daily bread.

Chris: maybe I can reflect a bit on that point. 'cause you, you were. You were, you were clearly classification, environmental classification was a, was a key driver when you were at Procter and Gamble. and less so when you were at DuPont. And I suppose that when I look at the recent developments, with the, with the CLP regulation, for instance, where, the new hazard classes like PBTs and PMTs and vPvMs and vPvBs have been, introduced, to me signals a shift in the, the potency or the severity of environmental hazard classification under that regulation.

The previous classifications weren't, they, they weren't, let's say nice. but assumption around PBT, for instance, is that there is no real safe threshold to emit those to the environment. But I'm sure you'll come on to, a bit more about that 

Watze de Wolf: Yeah, we definitely can talk more about that. also given that, in the discussions about the PMT, criteria or the concept even of PMT, those discussions took very much place in the member State Committee of ECHA And, I was chairing that member state committee when we had those discussions.

I can give some insights in that. although I wasn't involved in the PBT, in the original development of those criteria, in the context of GHS, yes, but that was a translation of the EU system into a more global system.

Chris: Mm-hmm.

Watze de Wolf: But with the, the B there, the bioconcentration, you at least had, let's say, somewhat more a biological element in the criteria.

When you talk about PMT, there is no biology there. It's, purely the environmental fate and behavior aspect. And, the protection target for PMT or vPvM, chemicals is a little bit. Let's say unclear. In, in, in the regulations, in the discussions, it became very clear that basically our protection target is humans.

Chris: Yeah.

Watze de Wolf: The concern is driven by these materials moving through the environment, not being able to be removed in drinking water preparation and therefore, leading to contamination of drinking water and therefore leading to human health issues, possibly. But the environmental factor there is- so the biological element is not there. For, if a PMT is released into the environment, then, what is the concentrations that you can get in an ecosystem?

What's the buildup through, biomagnification. It's not there anymore. So with the PMT concept we, I think, have lost the biology. and with the P concept that we are now moving into, only looking at P, I think we're even losing overall the, the link to human health. Persistence in itself for me is not a hazard. It's not a risk. And, we have been moving with the classification and labeling from a little bit of risk, with PBT/vPvB, to a situation where we are just looking at a property only, which I think for me as a risk assessor is really difficult to accept. I do acknowledge that for policy makers there is this need for maybe easier tools than the complex risk assessment.

But, I see it as a simplification of the world and, yeah, I'm, I'm living in a complex world and I prefer to continue living in a complex world.

Chris: Yeah, I think that's, I mean, I'm sorry. I think I've completely derailed our discussion now. But, perhaps we can linger on this before you carry on with your discussion on your career experience. I've been working on persistence and, the topic has kind of fascinated me.

I feel like I've been kind of watching it all unfold, over the last sort of 10 years, a complete paradigm shift in our approach to handling chemicals and accepting chemicals in our society. And I do think that part of this relates to, and I think the PMT concept captures it well, is that we no longer consider risk with chemicals.

We just don't want them getting out into the environment or we don't want them getting towards people, perhaps via drinking water such that… It has always been the case that people can be exposed to chemicals via the environment, but it was always something that was understood and accepted by risk assessors as a necessary trade off of our human development. Whereas now it's kind of caught up with everybody who at least had expertise in this area that this wasn't well understood societally and it's very difficult for people to accept. And it's a source of kind of runaway policy developments, which is kind of catching us all, uh, you know, threatening to wash us all away, let's say.

Watze de Wolf: Yeah, it's an evolution when I look over the 30 years, in the beginning, and this is, again, a black and white statement. But, you could say, well, shoot the environment or shoot the analytical chemist. Why would you want to shoot the analytical chemist? Well, they can detect anything. A few molecules can be detected.

And when you detect and then publish that, I found this substance here and there, you got a lot of non-acceptance in society. It wasn't put into context, it wasn't put into context of risk assessment. How, so what? That you find it. And, uh, that so what question is very, very critical. Uh, and I think we have moved not only away from, yeah, “I can find it and therefore it's a problem”, into, with the persistence discussion, it's more like “you could find it and therefore it's a problem”. And yeah, as I said, I'm more of a risk assessor. I prefer to put that then into the context of, okay, what are the different concentrations that you find?

What are the tox information that we have, what are the over time increases in the concentrations you find? When do we get to this level that, possibly poses a risk? And, yeah, we're not good in communicating that also because, okay, Anglo-Saxon language has this difference between risk and hazard. But many languages do not distinct between risk and hazard. And if you just raise a hazard, then people are immediately like, okay, no, no, not for me. No, no chemicals for me. And yeah, we will have to live with chemicals. Some of the most toxic ones are natural, so.

Chris: Indeed. Yes. Yeah. Yeah. I almost see it as a kind of, I can take it almost further, I think in that, well, first of all, for persistence, we've had this concept of persistence, but as you sort of mentioned earlier, this was always part of the PBT assessment. And as a result of that, we had criteria where we would say that, beyond this, above this level of slowness to degrade in the environment, you would be considered persistent.

Because if combined with bioaccumulation, then there was this multiplication of the, exposure and, you know, the concern of magnification up the food chain, such that, that was the basis for establishing those criteria. But we now have – and I think this was always, this was actually a blind spot in all of this – was these issues of effectively non-degradable chemicals like PFAS, which, the argument has been made that, well, if we emit these, they are going to build up in the environment because they don't degrade.

And, that's not acceptable. That's not, you know, sustainable. That we're polluting the environment with non-degradable chemicals. And I feel that that was another blind spot for risk assessors, because we tend to, in risk assessment, always assume a steady state concentration or that, there'll be a maximum concentration at a point source and the rest of it will get, you know, diluted away and eventually degraded. Well, if the chemicals don't degrade, I think that challenges the paradigm. And, ultimately, the way I see persistence now is that it has become the ultimate inversion of our risk assessment paradigm in that, early on, 10 years ago even, you couldn't really get people to talk about persistence.

It just wasn't that interesting to them. It was one component of a very complex risk assessment process. Well, now it's become the top of the triangle, and I see that, almost universally across industry, this sort of bewilderment, that this has happened, you know, kind of just almost overnight.

Watze de Wolf: Yeah. Um, it's not necessarily overnight, but it is hitting now rather directly. I mean, we've had discussions, about very persistent substances, like dioxin, like PCBs. But they also, some of them had very bioaccumulative properties. We've now moved indeed to persistence as a thing by itself.

We forget about the biology, but we also forget about the whole concept of non-extractable residues. There are substances that do bind to materials in the environment and bind such that they cannot be extracted anymore. So how does that mitigate potential persistence is something another blind spot, Chris, that I'm not seeing much work on that going on.

Chris: Yes. Well, I mean, yeah, again, it was another thing that the regulation found impossible to deal with, that uncertainty, to the point where they had to assume that it was all the original chemical and that one day it might come out and, and get you.

Watze de Wolf: Yeah. Well, and this, on the persistence side and specifically the PFAS discussion, it was interesting. I recently read an article which defines the PFAS as substances that cannot be degraded. But later in the article, there was then the concern raised that these PFAS materials would, have an ultimate degradation products, trifluoro acetic acid.

And, yeah, that was a little bit inconsistent. It cannot be degraded, but you have an ultimate degradation product, so. The PFAS discussion is a bit mixed in the sense that, is it now, fully persistent forever chemical, or are we talking about, TFA as an ultimate degradation product? And if we're talking about TFA as an ultimate degradation product, again, it becomes complex in the sense that for every PFAS you would need to get a little bit more information on how fast does it degrade to this TFA.

But, for TFA, you would need to generate information on how fast does it increase in the environment and, what are the toxicity profiles. And when you look at TFA from an environmental point of view, it has a relatively low toxicity. Maybe on the human health side the toxicity concerns are bigger, but then we are getting into a discussion again about drinking water, problems potentially in the future with TFA.

So we're just by saying it's persistent and on that basis, do regulation. I'm not very happy. Regulating it on the basis of it could give rise to TFA. Well, tell me, give me a risk assessment for TFA, give me a timelines for, at what moment in time do you expect TFA to rise to levels that become, from a risk assessment point of view, unacceptable. Not from a societal point of view, but from a risk assessment point of view. I must say I haven't seen those yet.

Chris: Yes. Well, I've seen one paper, I think that looked at the kind of very, very long-term projections, recognizing that in the end, a lot of these chemicals that do flow in water, have typically an end destination, which is the ocean, and the deep ocean, eventually. And calculating what concentrations might ultimately be reached in the deep ocean, by the end of the century, uh, let's say.

But again, a lot of it is about the timescale that we're working to and the setting, and there's always a nuanced picture there. And the danger is when we rush to simplify, that situation, I've certainly noticed that when I've been working on persistence, over these last years, that a lot of our assumptions are to simplify the environment.

You know, using models, we simplify the environment to boxes or four boxes, you know, a water box, a sediment box, a soil box, and an air box. When you actually go out and try and, uh, you know, the danger is that, that, uh, you incorporate that into your conception of the real environment and then you start to overlook a lot of things.

Chris: I'm conscious that I've completely derailed our discussion, so feel free at any time to go back to it. 

Watze de Wolf: No, no. I like this. Yeah, we are simplifying seriously. Also on the tox side, we have our algae, daphnia, and fish, and that's the world. But, whatever lives in that deep ocean, what are the sensitivities of those species for chemistry? Is it comparable to our three model species?

It's a totally different environment, also biologically, we don't know much about. On the one hand, if we do the risk assessment on the basis of our model species and our model compartments, how well does that reflect the actual environment? There's always the issue that is difficult to address, and it's easier to say then, since we don't know, we need now to take regulatory action, because the uncertainty is too high.

And yeah, maybe I'm, I'm too much optimistic there. I think, the uncertainty is not necessarily too high there. But, going back to my background a little bit and pitching that on the persistence still, you started the persistence interest group within SETAC and thanks for that.

I think it's very important that you did that, and SETAC is actually a great place for doing these type of things, for having these discussions that you and I are having. SETAC has been part of my, scientific, career, all over. It's been, very important and I would advise any aspiring, scientist in the environmental field to go to SETAC meetings.

Disclaimer, I have your conflict of interest because I'm in the board of directors of SETAC. But really it is the place where you meet people, where you can build your networks, where you can launch some ideas that can either be picked up or shot down. No problem if they are shot down. This is part of the scientific process. 

I got already, at my P&G time, the opportunity to start being engaged in the, also the SETAC governance. And that continued when I was working in, DuPont. So basically I started with SETAC in the previous century, and in the early years of this century, SETAC didn't have an executive director anymore, and the SETAC board or executive committee came to me since I was working around the corner of the offices to become interim executive director for a year. And my then boss at DuPont was also a scientist, and he saw the advantages of it, in the sense of also reputation for DuPont, of course. But also for me building further my network with environmental scientists across Europe and across the globe. So, he allowed me to do that for one day a week. It led to me, after a year, picking up becoming the treasurer. I then got into the SETAC World Council. That in those days was SETAC World was in the initiating stages. And in 2006, I became world president. There I took the initiative to get SETAC recognized as an environmental NGO at UN level. And, um, yeah, very, very satisfying times. In 2010, I then moved to ECHA, and there was, less, opportunity for me to go to SETAC meetings, mainly because I became, again, a manager and not necessarily an environmental scientist.

And I also believe that it was important for the young scientists in ECHA to go into SETAC. So I stepped away, for some years. And since my retirement, I feel like, okay, I still have something to contribute to the governance of SETAC, so I, again, let myself be elected. I put up myself up for election and, been on the, SETAC board of directors since May this year.

but in my ECHA times, more on the backgrounds, pushing SETAC within the organization, I think it's critical for the scientists in ECHA to be exposed, if I can say so, to academics, to industry, outside of a context of REACH or the biocidal products directive, or any of the other, chemicals legislations that they, work on or are going to work on.

I can only advise that to young scientists. you will find there are still people that do risk assessment. So it's a good way of expanding your know-how and knowledge.

Chris: Yeah, they do still exist, that’s for sure. I can totally attest to SETAC being a real, life-changing organization, providing so much opportunity for insight, learning, and development within that precious week. Each year at SETAC Europe — I’ve been to every conference since 2013, apart from one, which coincided with the arrival of my son. So yeah, I can totally attest to how great SETAC has been.

Watze de Wolf: Yes. I’ve also been quite active in the context of ECETOC, which is an industry scientific organization, and CEFIC LRI, which works with externals on scientific projects. But it’s different from being in that bubble of industrial scientists — going into a SETAC meeting where you get other views. And the same for ECHA scientists: you’re in a bubble of regulatory science, and then being exposed to a broader world is critical.

For me personally, SETAC has been my scientific home. I took my career into industry and the regulatory field early on. I probably should have gone into academia because I’m much more interested in that than in managing. I can do managing, but after a while it starts to itch and I need to leave for something new. At ECHA I actually did that. I initially started as head of unit in evaluation, looking at dossiers that industry had brought in and reviewing them with the team. My main motivation for doing that was: in DuPont I had been preparing dossiers and preparing strategies, and then they wanted me to go to the US. I didn’t want to go there. So when this opening at ECHA came up, I thought: if I go there, I can learn how others look at this legislation and go again outside of my own bubble — broadening my views and experience.

It was a very nice experience. I learned there that I had been very blessed by working for companies that had a strong scientific interest and risk assessment interest, and also did the right thing from a regulatory point of view. I must say that looking at some of the dossiers submitted to ECHA, and having had discussions with some of the companies that submitted those dossiers, I can understand why regulators are skeptical about industry.

There are white ravens, but there are also industries that do not deliver on what they are preaching. And that gives rise to skepticism.

Chris: Yes.

Watze de Wolf: I think that’s rightly so. If you do not see somebody delivering on what they said they were going to do, then why would you give them a chance? So that skepticism with the regulators also trickles through to the policy makers within the ministries, and policy makers at the EU level. And yeah, you become a little bit more concerned maybe about what some industries are doing. As I said, not all — those involved within ECETOC or CEFIC LRI are much more proactive than many others.

I’ve had the privilege of working with that side of companies.

Chris: You come at this from quite a unique perspective in that you have experience from both sides. As you’ve alluded to, you had the best opportunities to work with organizations that were really doing important work on developing methodologies and doing the science within industry. But that was not a universal situation in every company by any stretch. I also wonder whether over time that quality, or the amount of work going on within companies, has kept pace with the development of regulations within Europe, and also the taking on of additional responsibilities at ECHA and the additional obligations on industry to feed this system that we’ve built.

Watze de Wolf: Yeah. It is very much a paper system, in the sense that industry submits dossiers to ECHA, ECHA scientists look at them, and they need to decide if they’re compliant or not, and then come to a decision together with the member states about whether or not further information needs to be generated. And there is limited human interaction, which I find a pity.

It’s difficult to write something up that is unequivocally understood by everybody. So when you write things up, there’s always some ambiguity, and in an environment of skepticism, you would assume the worst — you would basically assume that the one who submitted the dossier didn’t do their job.

I have personally done some dossier evaluations. I came across one dossier where it was unclear what they were actually meaning. I happened to know the name on that dossier — the individual I knew through my SETAC activities. So I decided to give the person a call and say, “Hey, listen, I have no idea what you mean.” Then we talked, and — “Oh, is that what you did? Why don’t you write that up? Because that I can accept.” So I gave them some time to update, and then looked at the dossier again. Yes, now we understood. Now we could say: yes, this is fine. There was no need to go into a very tedious decision-making process.

Why was I able to do it? Because I have my network. I’m relatively confident in my science. I’m willing to talk to people. And that’s why I could do this. But I would say the poor young scientists who have to go through this, who don’t necessarily have these contacts — they may feel rather threatened by picking up the phone, and they may feel it’s easier to go through this tedious process of writing a decision, communicating only through paper.

So it’s important that the scientists at ECHA have the opportunity to build some confidence — also because in this tedious process, they will have to defend the outcome of their process to scientists of the member states in the member states committee. And you know, one scientist, two scientists, three opinions. So if you are a young scientist going to the member states committee, you get a load of opinions and you need to defend yours. That’s daunting. It’s very daunting. So it’s not an easy job for those scientists. Building the confidence is very important, and SETAC can help there.

Chris: Yes.

Watze de Wolf: Yeah, sometimes that basically means there is no communication, and therefore there are also decisions that are rather strict.

Chris: And perhaps — yeah, we can linger on this for a bit, because I think it’s very important to capture that perspective of the typical ECHA scientist trying to deal with this, but also how that translates into the system that we’re all working in with the regulation.

I mean, we spoke earlier about the tendency to simplify things. But on the other hand, there is also huge complexity to the regulatory system, with hundreds of pages of guidance. And as you said, it’s almost automated in a way — we’ve built these rules and this risk assessment structure such that we’ve kind of outsourced our expert discretion to a large degree, in order to have a one-size-fits-all regulation.

I can attest that this also translates to the other side as well, when industry is trying to make sense of the regulation and build a case around a substance. They have to try and digest that regulatory complexity and interpret it, and maybe it doesn’t fit perfectly to their particular situation, and they don’t have an opportunity to discuss the specifics of that with anybody. That creates a lot of anxiety, I think — they’re investing huge time and effort with not a lot of confidence that things will work in the end.

And it might still end up in a dead end. Read-across is one example where there is this ambiguity that has to be grappled with and this uncertainty. There’s been friction between regulators and industry about when read-across should be used and the added costs of having to do additional testing when it gets rejected.

Watze de Wolf: Well, I can only advise industries that want to make sense of REACH to also follow the discussions in the member states committee, because that is where the member states together with ECHA try to make sense of the regulation. That’s where we sort of develop further rules on how to interpret the law.

The member states committee, as I mentioned earlier, was where the whole discussion about the PMT concept took place. The whole discussion about simulation testing and setting the temperature requirements of 12 degrees or 20 degrees — those discussions took place in the member states committee as well.

So for technical developments, the member states committee has played a very important role, both in substance evaluation decisions and in the substances of very high concern area and their developments.

Chris: Mm-hmm.

Watze de Wolf: Well, we were talking about confidence and developing the confidence with scientists, especially young scientists.

I cannot refrain from telling you a nice anecdote about overconfidence. We had a discussion about a certain dossier evaluation decision, and there’s always the possibility for an industry expert to join in the discussion. It’s very valuable for the member states committee to have that communication, to have that discussion with them.

But here we had a very interesting toxicologist who was a little bit overconfident. I cannot refrain from saying that this individual came from the US and lectured the member states committee as follows: “You do not know how to interpret REACH. It has to be read like this.” Now, that was, for the member states committee that had to interpret REACH, rather offensive.

So after that intervention, that overconfidence, there was limited interest in coming to a decision that was more favorable for the company. They were rather strict in their interpretation after that.

This skepticism towards industry — how can it be overcome? The only way is to engage with the scientists at ECHA, definitely through written communication in the beginning. But any opportunity you have to meet them in person is an opportunity you have to take, either at SETAC or at ECHA events. It’s also good for the scientists at SETAC or at ECHA to see perspectives from an industrial point of view, because, let’s be honest, if you have not worked in industry, it may be a little bit of a strange beast, and you may also live a little bit — like academics sometimes — in an ivory tower, if you confine yourself to the Helsinki environment.

Chris: Mm-hmm.

Watze de Wolf: But that is very much focused on the evaluation side. You have other elements in the authorization and restriction groups that work on that. They’re much more involved, I think, with discussions with industry and know more about industrial processes.

And then of course you have the people working in the biocidal products area — a small group. I had the opportunity to work there as head of unit for biocidal products for the last two years that I was at ECHA. I must say, as a risk assessor, that is much more hands-on: there are a lot of risk assessment possibilities, many different uses, many different exposure scenarios.

It was very nice. And there is a slightly different perspective there than on the REACH side, in that there is more communication between industry and the member states, but also, I think, more willingness to listen to industry’s arguments.

The difficulty for industry there — and not only for industry, but also for the regulatory authorities — is that the BPR is super complex and has an issue with moving goalposts. Dossiers take a lot of time, and during the dossier review, new guidance gets published. And then there’s a tendency to redo the whole assessment on the basis of the new guidance, which makes it long and unpredictable for industry. It creates a lot of workload for them and for the regulators too. Basically, the whole system is clogged up — there are different bottlenecks, both on the active substances and on the products.

Chris: Is that a testament to too much science perhaps — that it’s tried to accommodate all that nuance?

Watze de Wolf: I wouldn’t say that because I’m biased — I like science.

Chris: Yeah, it’s never—

Watze de Wolf: But the processes are just too complex. One of the things I would suggest: if you have an update of guidance, don’t restart the assessment at that moment. Continue with the dossier on the basis of the original guidance. And if you see a potential concern after a quick screening assessment on the basis of the new guidance, you could always say: okay, we can approve this substance for now, but we start an expedited review process. Then you can focus on the new elements, and the old elements are basically covered.

And if the new elements do not raise toxicity concerns beyond the thresholds that you used in the original assessment, then you’re done.

But we have introduced endocrine disruption as an endpoint in the BPR, and basically everything now needs to be assessed with that endpoint. In the context of a lack of data, industry gets a possibility to generate the data in the REACH context. There was this idea of tiered data generation, which from an animal welfare point of view may be the right thing to do — with decision points at each interim step: do we go to the next step, or does it mean more animal use? But that has led, I think, to a lot of delays in approvals. It has also led, at this moment in time, to no slots in contract labs for doing testing — even more delays. And in the meantime, you keep a substance on the market that, for other endpoints, you might already say, “Hey, we need to ban this stuff, we need to get it off the market.” That is where I have a concern: the endocrine disruption endpoint leads to lots of delays, but we could have substances that we should remove on the basis of other endpoints, but we are not doing so because we’re waiting for the endocrine disruption assessment.

There is a review of the BPR at the moment going on, which is a good thing. And maybe in the future there will be a possibility to do things slightly differently there.

Chris: Mm-hmm.

Watze de Wolf: The BPR is interesting because the classification and labeling authorities have always shied away from going through a harmonized classification for ethanol.

Chris: Yeah.

Watze de Wolf: And that’s purely a political decision, because from a toxicologist’s point of view, we know ethanol is a reproductive toxicant category 1B for sure, maybe 1A. Nobody wanted to burn their fingers on that because ethanol is rather widely used across our society. And once you’ve been classified as Repr. 1B, you cannot use it in consumer products.

Now, in the context of biocides, ethanol is also a biocidal product active. So now there is this assessment going on for ethanol, and in that assessment there will have to be a determination — although it is not a harmonized classification — but the authorities will have to come to a conclusion: is this now a reproductive toxicant or not? And if it is, then many uses will have to be banned — disinfection uses in hospitals, for instance.

So I’m going a little bit back to my original aversion to classification and labeling. We will get calls from many people saying, “Yeah, but my use is so essential that we cannot ban it. We still need to allow this in product A, B, or C.” And instead of using risk assessment as a tool for policy makers to make a judgment — is it safe or not — we will now have to move to concepts that are not well defined, and maybe not even defined at all: essential use. And that just becomes a political decision instead of a scientific one.

I prefer risk assessment. This is going to be — let me say this with a Chinese proverb — we live in interesting times. I think we’re going to get interesting times once ethanol has been classified by the BPR regulatory authorities, and I don’t think they can get away from not classifying it as Repr. 1B.

Chris: Oh—

Watze de Wolf: So.

Chris: —interesting to have that forecast, a realistic forecast of the direction we’re heading in. And yeah, the essential use concept is interesting because, as you say, there is some degree of science to it, especially social science, but a lot of it would be value-driven and therefore political.

I see that as well. Linking back to persistence, I see a lot of value elements going into that rather than the objective science. At least when we had everybody on board with risk assessment, we could work a little bit more in the natural science domain, measure things objectively, and make decisions that way.

Watze de Wolf: Yes.

Chris: Do you have any more reflections about your time at ECHA? I guess one thing that occurs to me is that both from your time in the member states committee and then also with your work on biocidal products, there was a heavy involvement of member state competent authorities in the work that you did.

Watze de Wolf: Yes, absolutely. And I think that’s essential, because it’s not possible for ECHA to have such broad expertise that it can cover everything. The link with the member states is, to me, critical. There are many good scientists there, and they gave some counterbalance to some of the groupthink — if you live in your ECHA bubble.

I think we’ve lost a lot of very good scientists from the UK since Brexit. In my view, the UK brought a very sound voice of reason to all of the discussions. The UK scientists in the member states committee — in sometimes somewhat more politically charged debates — were always focusing back on the science. And to the point where, if the member states decided not to fully follow the science, they were still working and helping to develop the decision such that it was as scientifically rigorous as possible.

With them moving out of the EU, we don’t have that type of perspective anymore. I cannot say much about the past four years because I have not been in the member states committee, so I don’t know how it has further developed. But some old dinosaurs have left — like Henrik Tyle, who was one of those who could bring a lot of science to the table, and who also had the courage to say at a member states committee meeting: “Yeah, I came here with the mandate to vote against, but I’ve listened to the arguments and I hear that we haven’t looked at everything from all the scientific angles — and having heard the discussion, I will now vote in favor.” He then had the courage to go back home and defend that move, having not followed his mandate.

I don’t know if there are still those types of characters in the member states committee. I’ve lost touch there in the past four years. But I hope there are people who are willing to say, “Hey, but this is not correct — are we like lemmings going in one direction? What is the scientific evidence?”

Chris: Yes. And I think you highlight how important it is to have good people across the board working in these different areas — people who have the competence and also the agency to speak up. I don’t think we’re any better over here in the UK for having done our Brexit. It certainly seems like our regulatory environment is probably on life support — we still don’t seem to know what we want to do, and as a result we just kind of muddle along. But yeah, I’ve heard many times from people that it was very regrettable that the UK left a lot of these discussions.

Watze de Wolf: And Chris, you just mentioned a key word: “regrettable.” We’ve been talking about regrettable substitution as a concept. But I think we’re also moving into “regrettable restriction.” Ethanol could be one example, but I think the whole PFAS discussion could lead to regrettable restrictions. We’re talking about a group of substances — tens of thousands — and we’re bringing them all together in one pot because of persistence. And then we’re using, maybe, some toxicity information from a few of the substances in that pot to develop health thresholds.

For me, that is moving in the wrong direction. When we talk about QSARs and read-across and applying them to fill information gaps, we’re very concerned about extrapolation — you should not extrapolate beyond the database that you have. Well, I see a lot of extrapolation going on in the context of the PFAS toxicity assessment. And it’s really the contrast I see there with the early days when I was involved in environmental sciences with the dioxins and the PCBs. There, we developed toxicity equivalency factors. We recognized that there was one dioxin that was highly toxic and others were less toxic, so we took that into account in an overall toxicity assessment. It’s not happening anymore. It’s just one number for all of them.

So I think we will restrict the use of some perfluorinated substances and we will regret it — substances that may not be inherently toxic, that may have some possibility for further degradation, and that may not necessarily have TFA as a final degradation product. And we’re doing that because we’re not using risk assessment.

And yeah, I have moved from being an optimist to maybe more of a realistic pessimist. This is where I see the evolution going — moving away from risk assessment. In my early days, I had hoped that we would move from binary risk assessment — the PEC/PNEC ratio of more than one or less than one giving you the answer — to a more probabilistic risk assessment, where we would be able to deal with the uncertainties in the parameters and the species, and give more of a probabilistic feedback to risk managers: “We’re close to one. We have a certain probability of exceeding one.” We’re not moving into probabilistic risk assessment, I think. So I’m pessimistic there. I had hoped for it, but in this society we’re not willing to deal with uncertainty. It’s black and white, we’re polarized. And as scientists, we’re not good at communicating uncertainty.

Chris: Yes. I get the sense that this is in part driven by an overall lack of trust — trust in authority, trust in expertise, and in the ability of technocratic solutions to address societal problems. And we’re just one example of where that is now impacting how we make decisions as a society. But do you have any thoughts on how we can improve that situation — what we can potentially change to reverse this?

Watze de Wolf: Well, I think we have a lot of pseudo-facts going around. I think it starts with educating young people about trying to understand the reliability of the information they gather. Education is key. For me, I’m already far beyond — well, I’m still educatable — but it doesn’t have a big impact anymore. It really is for the younger generation: how to deal with uncertainty, how to assess whether information is accurate, how to deal with AI, with ChatGPT. You can get all kinds of nice answers, but when you put your human eye over it, you will have to make a lot of adjustments.

I do believe AI could have some impact in the sense of doing meta-analyses of the information that has been published. Chris, it’s easy to publish because publishing is a business. You have journals that just want to make money, so they publish anything, and then you accumulate a lot of garbage that gets distributed to the public. They get scared by it.

A very nice example, I think, was a recent meta-analysis by EFSA — and I don’t know if they used AI to help perform it — but they looked at the body of evidence on micro- and nanoplastics in food. They had 1,700 publications. In the end they analyzed somewhat fewer, but they looked at all of that information to assess the evidence on micro- and nanoplastics in food. They came to the conclusion that yes, it’s probably there, but they also found that a lot of the published information had all kinds of flaws. And on that basis they came to the conclusion that it’s not necessary at this moment to raise a red flag about micro- and nanoplastics themselves, but to raise a red flag about the quality of the underlying science.

And the nice thing is you can give that type of message, but it also gives scientists a very clear opportunity to ask critical questions for future research. If you know where the flaws are, you know where to focus further scientific development. One of the flaws was analytical — with nano- and microplastics, identification is definitely a key issue, and contamination is definitely a key issue that needs to be addressed.

But going back to how to improve things: this is where AI might help, with the overload of information, to start sifting through what is key information and what is garbage. I would love to do some similar type of work as EFSA did — if I had the skills to work with AI across all of the micro- and nanoplastics literature, and find out which of it is really good science that we can base conclusions and risk management on, and which information needs to be discarded. And then think about what communication we can give to the general public, who are mainly looking at TikTok. I’m not good at that, but I think we need to engage some social scientists to bring some of those messages to those type of platforms.

So that’s where we can improve, and where we should improve. But I don’t have a solution, Chris. The issue of “publish or perish” is a big one for academics. Publication is the key currency for a scientist. And if you can create a buzz around your topic, then you will be able to publish a lot — maybe good, maybe not so good. And the more you publish, the more possibilities you also have for generating projects and money.

In the old days — sorry, getting older — many countries were giving academics grants for research that was just fundamental, that didn’t have an immediate impact or a clear application pathway. Well, that wasn’t irrelevant. That type of money has sort of gone now. In your project proposals, you already need to start talking about applications. So it becomes much more focused. And if there is a buzz around an issue, your research might get more funding.

Chris: Mm.

Watze de Wolf: Science has become a business.

Chris: Yeah.

Watze de Wolf: And that’s where I’m pessimistic. How do we break through that? How can we make science less of a business? That’s a challenge — and maybe a discussion also within SETAC.

Chris: Yes, I think that’s very true. I think you’d have to be practicing quite a lot of willful blindness to deny how corrupting those forces can be on the scientific enterprise. And yeah, I see it in every corner of modern life — we’re all on treadmills, all blinkered toward our short-term goals, and constantly being tempted to not do the responsible thing or to take shortcuts. We also less and less afford the time to have dialogue amongst our peers.

I think things are getting slightly better perhaps — people are more willing to talk to one another, and we don’t have to always be right. I think people are hopefully getting more comfortable with not necessarily being the authority that everybody looks to, and with providing space for more constructive discourse. But I think we do have a long way to go. And we also have many different opinions — the people who are in favor of this universal approach on PFAS think they are just as correct. And that problem comes from a position of values and worldviews again, and less so from science.

One of my hopes is that we can start to tease these things more out into the open, because they colour a lot of the conversations we have. And I’d also say that because risk assessment does seem to be a bit of a dying art, and there are a lot of people lamenting that situation — I hope more people can come out into the open to champion it, and to talk about why it is so valuable, why it’s what we’ve relied on for the last 30, 40, 50 years to guide our developments, and what the costs could really be of doing something differently.

Watze de Wolf: Yeah. And Chris, a value-free scientist doesn’t exist. I think indeed some of the discussions are driven by values. And we need to be willing to be open about what values we are bringing to the table. But yeah, the dying art of risk assessment — yes. If I had to give advice to young scientists about exposure risk assessment science, I’m not sure it’s where to go.

I’ve always worked on the interface between different disciplines. I would advise looking into polymer chemistry. With the REACH revision coming up and with polymers being under scrutiny — both in the sense of being registered under REACH with all the science developments that are required, but also asking: are the traditional degradation tests well suited for polymers? What type of parameters do we use for assessing polymer behaviour in the environment? How do polymers actually get into animals, given that they’re so large and there are membranes that could act as a barrier for uptake?

Understanding polymer chemistry is essential for all of that. So even if you’re a biologist, know your polymer chemistry. This is one of the fields that I still want to learn more about. For me, I’m not going into PFAS — that’s something DuPont has been very much engaged in in that debate. I was also involved in the first PERFORCE project, which was the perfluorinated substances research project funded by the EU, from a DuPont perspective — we were a partner in that project. So I have a bit of history there, but I don’t want to persist in that area. I want to go more into polymer chemistry and into the future discussions about microplastics.

What type of polymers can form microplastics? How do they behave? Hard plastics in the environment are not the same as the ones that are produced. How does biology but also environmental factors influence the particles in the environment? What is the actual risk that we have?

I can remember, 10 to 15 years ago, a SETAC meeting where there was a science slam and people were making fun of microplastics research in the context of “there is no toxicity.” Well, that has evolved into, I think, a lot of scare in society — but is it founded? And I think by understanding polymer chemistry, you’re able to much better address some of the questions in that field.

So if you’re a young scientist, go on that interface. Start to learn polymer chemistry combined with biology, which is still my first love, and then environmental engineering with models and fate and behaviour. Become a polyglot.

Chris: Yes. Yeah, I think that’s really good advice. We are going to have to take a multidisciplinary view in many areas in the future. And I’m glad you raised the topic of polymers as well, because I think there is an almighty reckoning coming with polymers — we have a huge diversity of polymers that we use in modern life for all kinds of different applications, and they provide a huge amount of benefits. But it seems clear to me that they’re unlikely to fare well with the sort of default approach being applied in regulation and with the current direction of travel. So I would definitely second what you say: we need to get good minds focusing on tackling this problem.

Watze de Wolf: Yeah. And maybe also bring in the social scientists or the communication specialists who are able to translate our nerdy talk into something that everybody understands.

Chris: Yeah, absolutely. Well, it’s been absolutely fantastic talking with you. We’ve spoken for an hour and a half and it’s absolutely flown by. I really appreciated speaking with you as somebody who truly has a huge wealth of experience and insights to share. In preparation for this conversation, I also re-listened to the one that I had with Peter Fisk, right at the beginning of my podcast adventure.

Watze de Wolf: Great episode.

Chris: And he had some really great insights as well. I think you and he are aligned in many areas in terms of your perspective. So I would encourage anyone listening: if you haven’t listened to that episode, please give it a listen as well.

But just to wrap up — I normally ask my guests a couple of questions. I think you’ve already answered the second one, which is about advice for somebody new in their career. But is there one big goal that you’re working towards in the months ahead?

Watze de Wolf: Sorry Chris, but I’ve listened to your podcast too much, which is why I already answered the second question. But what am I working towards in the months ahead?

It’s very personal, but it’s fine. It’s something my wife and I are working towards. We’re living in a big apartment; her daughter has a small apartment and no income. So we’re working towards starting to live together — she’s 30-plus and has a boyfriend and a dog, who was very silent. Happy to hear that. And it’s a very nice experience to live with some youngsters. They have a totally different perspective on the world. It’s going to be interesting to see how it works out.

And that may also be advice to youngsters: it’s about trying to understand the other person, listening to the other person — what are your needs, what are my needs? Keep the communication open, don’t assume you’re right, and be willing to change your views.

So that’s what I’m working towards currently, next to my Swedish lessons to become a Finnish citizen, my intercultural communication course that I’m following, and my international humanitarian law studies with the Red Cross. What I’m working towards is still keeping enough time to do all the things I love to do.

Chris: That’s fantastic. And I’m really glad you shared that personal experience and phase that you and your family are going through. It’s nice that you did that, because so often we’re always driving at professional goals — utilitarian endeavors. This is more just about learning to cohabit with people as a new experience, and perhaps learning a bit about what it means to be human. So yeah, really appreciate you sharing that. And also, that’s really great advice. Once again, thanks very much for this. This has been fantastic. And thanks to everybody who’s been listening — your time is really precious, and I’m really grateful that you’ve spent it with us. If you’ve enjoyed this podcast, please tell your friends and colleagues about it. I look forward to speaking to you next time. Thank you, Watze.

Watze de Wolf: Thank you, Chris. And see you soon at the SETAC meeting, for instance.

Chris: Yeah, I hope so.

Watze de Wolf: Bye.