David Wirth, a BC Law Professor and Dean’s Distinguished Scholar, sat down with BC Law Magazine to discuss his work on a groundbreaking paper entitled “Manufactured Chemicals and Children’s Health—The Need for New Law,” published in the New England Journal of Medicine in January. The report was the effort by an international team of experts and Boston College scholars—including global public health expert Philip Landrigan, vice provost and biology chair Thomas Chiles, planetary health and biology researcher Kurt Straif, and scientist and environmental law scholar Wirth—that argues that increased screening and surveillance efforts are needed to improve the health and safety of one of the world’s most vulnerable populations: children. Here, Professor Wirth discusses the legal dimensions of this issue and explains how he believes a safer, healthier population can be achieved. For more on the paper’s findings, please see this BC News story.
Professor Wirth focuses his research on international environmental law, an area in which he has practiced and taught for decades. His background as a chemist informs his expertise. Prior to his career in academia, he was the Senior Attorney and Co-Director of the International Program at the Washington, DC, office of the National Resources Defense Council where he focused on environmental reforms across the globe.
Interview conducted by Bella Burrell ’25
Q: Bella Burrell: How did you get involved in this project?
A: Professor David Wirth: I was originally trained as a quantum chemist. I have an undergraduate degree in chemistry and also a terminal master. For a variety of reasons, I decided I didn’t want to spend the rest of my life in a basement researching molecular beams. So, I took some time off and I went to work for a chemist in the industry.
Then I went to law school, anticipating that, given my background, I’d end up in intellectual property. But it turned out that my background was also useful for work on the environment. At least I could pronounce the names of the chemicals involved in the work.
I was also interested in Russian and Eastern affairs, particularly Soviet and then subsequently post-Soviet work, having been partially trained in the Soviet Union; and I speak Russian. (I later did a Fulbright at the Higher School of Economics from 2016 to 2017). But at the time, I managed to fortunately put this all together when I got my first job out of law school in the legal advisor’s office at the US State Department. I was also extremely fortunate to be assigned to the oceans environment and science portfolio. I’m actually celebrating the 40th anniversary of my very first intervention in a multilateral negotiation—what became the 1987 Montreal Protocol on Substances that Deplete the Ozone Layer, probably the most successful multilateral environmental agreement to date.
Q: Bella Burrell: Wow.
A: Professor Wirth: That’s me, and I continue to work on basically the same portfolio, which includes toxics. For the [New England Journal of Medicine report], Professor Philip Landrigan—the director of BC’s Global Public Health and Common Good Program in which I teach—was the ringleader. He did the original work that proved that lead is harmful for children. Also involved in this interdisciplinary group is Professor Wendy Wagner at the University of Texas. She and I are among the few legal academics with STEM backgrounds who work on the interface of law and science.
Q: Bella Burrell: Turning to the report you produced with this multidisciplinary cohort, can you talk about the inspiration for the research and what it seeks to illuminate?
A: Professor Wirth: The concern is between the data highlighted in the paper and the law. The principal law in this country is the Toxic Substances Control Act (TSCA), which was enacted in the seventies. It’s been amended as recently as 2016, but it is not adequate to finish the job. It basically assumes that chemicals come onto the market, and then pushes the burden on the government in the form of the Environmental Protection Agency to identify bad actors according to a cost benefit test, which the courts have interpreted in a very rigorous manner.
We’re also concerned that other countries are doing more. The European Union starts from a totally different perspective. They say, at least in theory, that they are reevaluating all chemicals from scratch and requesting new data. The problem is that that hasn’t been terribly successful either. It’s been very slow identifying substances of very high concern, which is the top level of regulation in the reach system.
One of the important points is that this is in the news today and every day. We’re looking at a globalized world where the market for chemicals is potentially global. It’s not necessarily helpful to have one country, one large market, the United States, with one approach, and then see the EU with a different approach. There isn’t any harmonization that’s going on. The bottom line is that neither of the two basic national approaches, the EU’s nor the United States’, appears to be doing the job. Moreover, they are not coordinating. And who pays the price for this lack of harmonization? Children whose immune systems are less well developed than adults’.
Q: Bella Burrell: Part of what struck me about the paper was the seemingly incessant need for post-market surveillance based on exactly what you’ve just told me—that children are paying the ultimate price for these national missteps. How do you see such a post-market surveillance system operating? Do you think there is a need for a total overhaul, or is there a pathway to succeed within the existing legal frameworks?
A: Professor Wirth: The answer is, we start all over. TSCA has had an emphasis on new chemicals, but it’s actually been shown that new chemicals aren’t necessarily cause for greater concern than existing chemicals. The Europeans at least have gone back to square one and attempted to re-evaluate all chemicals, but a lot of the efforts there have been undermined by confidentiality of data. Both the EU and American systems are that way. The European data are not as robust as they should be, so there is considerable room for improvement in terms of the quality of the data.
When talking about surveillance, it could exist independent of substantive regulation. However, it makes sense for the two of them (surveillance and regulation) to go hand in hand. This paper talks primarily about surveillance. We are advocating for a system of pre-market approval in this country. We have that for human drugs. Thus, unless the proposed new drug satisfies a test of safety, which is a reasonable certainty of no harm, it shouldn’t be allowed on the market. And to this end, it is clear that the regulatory tools are not doing enough.
For example, the EPA has recently included two “forever” chemicals known as PFAS associated with the production of many consumer products in its Superfund cleanup program. But that is well short of what is called for, as these chemicals are also turning up in sewage sludge recycled from water treatment plants that is widely used as fertilizer. And what about the other toxins that you and I are exposed to via sludge every day, that potentially get into our food when it is used as fertilizer?
Q: Bella Burrell: Speaking of the sheer volume of chemicals in our everyday lives, I was shocked by the growing body of evidence in the paper linking toxic exposure to chronic illness in children. And so, just to take our readers back to the glorious days of Civil Procedure, can you speak about particular challenges and hurdles in the way of affected people securing relief?
A: Professor Wirth: Basically, there are two channels. One is through toxic torts, which has a very high hurdle and very high demands for causation. And the other is through the regulatory process.
The regulatory process is generic and prospective, and the relief that’s available in that setting does not include compensation. That’s the primary difference between this and toxic torts. The relief in the regulatory scheme is basically to the public as a whole. Generally, this looks like declaratory and injunctive relief telling an agency to stop doing something and to do it better in the future.
Well, that doesn’t necessarily deal with past harms. It is, however, designed to deal with the future direction of regulation. Our paper’s proposal fits into both of those types of harm because it would flip the burden of proof onto the company attempting to put a particular drug into society. We would put the burden on the proponent of the drug to prove that it’s safe as opposed to assuming that it’s safe.
To use a criminal law analogy, chemicals are currently assumed innocent until proven guilty. Maybe there should be a presumption that their safety needs to be demonstrated. If we could deal with the safety issue first, that would be a major step forward.
Q: Bella Burrell: Right, and as the paper states, fewer than 20 percent of chemicals have been tested for toxicity, which is shocking to somebody who is not an expert in this field. Is there a role for lawyers to play in ensuring that more comprehensive testing is done on a wider variety of toxins?
A: Professor Wirth: Yes. In a sense, lawyers are public health professionals. While scientists can produce data, analyze it, and interpret it, they frequently stop short of being able to turn the data into public policy. That’s where we lawyers come in. Either through toxic torts litigation, which is a form of public policy, or through comprehensive regulations, lawyers have a direct role in creating lasting policy that benefits the public. That’s why the title of this paper is “The Need for New Law.”
Q: Bella Burrell: It’s so interesting to learn more about how lawyers can get involved in even these very science-heavy areas of research and development. As a professor, you have a significant role in developing the next generation of researchers, negotiators, and public policy advocates. Something notable during our time together has been your inherent passion for what you’re doing and how you enjoy teaching others about this area. Given that, what drives you as a professor and how do you take your own excitement for this content and translate it into a new generation of attorneys?
A: Professor Wirth: I am very fortunate because my passion is for international environmental policy and law. And I’m teaching this for the first time in quite a while here at Boston College Law School. Many of my students—past and present—are from all over the world and are out there doing exactly what we discussed in seminars. For example, I recently went to the Plastics Negotiations and it turns out that an alumna of my course is leading the team for the “Earth Negotiations Bulletin” that is published outside of the International Institute for Sustainable Development. She’s running an international team—my student—doing exactly what she was trained to do.
It’s tremendously rewarding as an educator when students go on and actually practice in these fields and apply the learning they, hopefully, get from my course and my work in the policy arena. I’ve been extraordinarily fortunate that I’ve been able to combine my interests throughout my entire career, and I hope to translate that into something that benefits the lives of my students as well.
For more information about Professor David Wirth, visit his faculty biography here.