Understanding TSCA And Its Impact On Chemical Regulations With Lynn L. Bergeson
I am speaking with Lynn L. Bergeson, managing partner of Bergeson & Campbell. She has earned an international reputation for her deep understanding of TSCA, FIFRA, REACH, and all the other fun acronyms that our regulatory programs represent. Particularly, it pertains to topics around nanotechnology, industrial biotechnology, and other emerging technologies. You definitely want Lynn and her team on your side if you’re going to have to face Congress, US EPA, FDA or any of these other governing bodies. I first got introduced to Lynn through her podcast, All Things Chemical®, which just recently published its 60th episode.
Lynn, welcome to the show.
Thank you. I’m delighted that you’ve asked me onto your show. I want to applaud your efforts, and congratulations on launching The Chemical Show.
We are both on this journey together.
I find it fascinating the space that you’re working in. As a woman working in this space for as long as you have at the intersection of chemicals, how did you get started? What’s your origin story?
It was probably more serendipity than thoughtful and careful planning. For reasons that I will never understand, I have always been fascinated by chemicals. I didn’t have a scientific background in college. When I became a lawyer and was first introduced to the wonderful world of industrial chemicals, I had an affinity for TSCA.
I worked in that space for a while and similarly worked in the agrochemical biocidal space under FIFRA. As I became a more experienced practitioner and also had an affinity for business, I found that I enjoy business. I work in three different organizations that are all a part of the Bergeson & Campbell platform including our consulting affiliate and our consortium management company. I thought what better way than to work in a space that I both substantively love as a lawyer, and can develop a domestic and international chemical practice. I also became more aware of the fact that I liked Washington, DC.
Not a lot of people can say that all the time.
I grew up in Michigan, and as much as I love the Midwest, I find Washington a very exciting area. It’s not everyone’s cup of tea, I grant you that, but it’s a fascinating and beautiful city. If you are a young lawyer or a transitioning lawyer, TSCA and FIFRA are not delegated to the States. All of the action, the rule-making, and the policy development are here in our nation’s capital. It represented a trifecta. I love the area, I love building my own business, and I worked in an area that is not delegated to the States, which means from a business perspective, people come to Washington lawyers to assist them on areas relating to industry on agrochemicals. Hence, the birth of this practice.
I don’t often hear people say they have an affinity for TSCA, so that’s remarkable itself. TSCA has undergone some significant revision. How has that changed or influenced chemical manufacturing and distribution?
Dramatically, in a word. I’m not sure our clients and big chemical in the United States fully appreciated the seismic influence that the Lautenberg Act in 2016 had and is having on domestic chemical production and distribution. The Lautenberg fundamentally altered the architecture of industrial chemical regulation, putting far more emphasis on targeted chemicals. Those chemicals are identified as high-priority substances under TSCA. With regard to existing chemicals, those chemicals are now subject to seriatim risk evaluation, which means from a business perspective, there will be a long and happy life for TSCA practitioners.
From a new chemical perspective, the changes to EPA reviewing and approving new chemicals have changed dramatically as well. There have been many changes that are now being implemented and continue to be reinterpreted by EPA. This is our third presidential administration since the 2016 amendments, so there have been many policy changes and reinterpretations. The pace of change and implementation of TSCA has made for a very active space since June 2016.
It also has increased, in my view, the review of these changes by consumers and NGOs. The engagement in chemical exposures, the emphasis on environmental justice, and the chemicals of concern including PFAS and endocrine disruptor chemicals and other chemicals are high. In short, it has put industrial chemicals and their potential exposure to targeted subpopulations in the media and NGO crosshairs, and makes careful planning in this space absolutely essential.
I think your point about the increasing media, personal and geo focus is challenging. It goes across a variety of topics but especially topics related to chemicals. The danger is there’s so much misinformation that is easily spread in our media and social media channels now that makes it difficult to find the right navigable path through it.
You raised an excellent point, and your experience in this space is demonstrated by even raising the question. There is considerable misinformation. It is all the more important for chemical manufacturers, processors, distributors, and brand owners to ensure that the chemicals that they use are fairly represented, disclosed, and their potential risks and benefits are fairly communicated to third-party and downstream others.
How do they do that or how do you help people navigate this? It’s not easy.
Number one, our business philosophy is to always follow the science. While we are a law firm and consulting firm, we have many more scientists, industrial chemists, toxicologists, and exposure assessors on our staff. We feel very strongly that you need to be transparent, clear, and scientifically grounded in communicating the benefits and potential risks of your products. Whether you are a neat chemical manufacturer, a formulator or a brand owner, it’s important to be clear with your upstream suppliers and them with you, and your downstream customers, to be absolutely rock-solid when you’re asked a question about, “What’s in this product? Will it harm me?” You want to be clear that you know what’s in your product, and you are able to confidently, comfortably, and transparently say, “It will not harm you.” Any lesser standard of transparency and diligence is likely to pose formidable problems for you down the road.
In 2021 in particular, and maybe it’s because it’s bubbled up in my newsfeed through algorithms, I see a lot about PFAS. What’s changing? What does that mean for chemical companies?
There is a lot of focus on PFAS, and there has been for years. This is a synthetic class of chemicals that have been around for a long time. Because of their widespread and well-known persistence, and potential adverse human health and environmental effects, there is certainly a domestic and increasingly global focus on diminishing the amount of PFAS as a chemical class in the environment and in products. It has been the source of considerable regulatory activity here in the United States. The classes of chemicals are well-known. There are thousands of them. The agency in 2020 put forward a definition of a PFAS substance, which has helped everyone understand what it includes and what it doesn’t include.
Chemical manufacturers, processors, distributors, and brand owners must ensure that the chemicals they use are fairly represented, and the potential risks and benefits are properly disclosed.
It definitely helps to know what the category is and set boundaries because then you can work with those boundary conditions.
At least you can have clarity with regards to it if you are required to. EPA has proposed a rule earlier in 2021 to disclose the types of PFAS substances that you manufacture and distribute or might be included in an article that is being imported into the United States. You need to know what you are required to do, so the definition is helpful in defining the universe of chemicals that EPA has expressed interest in. Ultimately, there are many other rulemakings in other environmental media.
Most particularly though, under the Toxic Substances Control Act with respect to disclosing the presence of PFAS, there are a number of rulemakings with regard to whether a PFAS that is not yet listed on the TSCA inventory should be permitted into the United States through a manufacturing import opportunity or even subject to what we call a low volume exemption. There’s considerable scrutiny in trying to really understand how a PFAS substance might both impart properties that are valuable and reasonable, and not allow chemicals that are perceived to add to environmental harms through their persistent bio-accumulative and toxic nature. Anybody in this space or relying upon the functionalities of these substances needs to be mindful of what these chemicals are and what the potential regulatory opportunities are because that could diminish their commercial utility.
Eventually, I think things could get regulated away, though they are used still.
There are some. I like to think that the agency continues to implement TSCA in a way that imposes a risk-based analysis. It’s not that chemicals must pose no risk, but they must pose no unreasonable risks. You know as a stakeholder in this space that chemicals are capable of posing risks. The question is not whether they do but whether they are reasonable given the valuable properties and essential nature that they provide. That’s the delicate balance that we will be dealing with for years to come. It’s how to allow certain PFAS substances that offer value and are essential in electronics and in other industry sectors versus diminishing, if not eliminating, PFAS substances that pose unreasonable risks, and hence need to be regulated.
The whole aspect of risk management around this is critical. We are seeing a lot of innovation across the chemical industry. There’s an accelerated focus on sustainability and digitization, which on its surface is less about chemicals but when you get into the computers, there are all kinds. Also, a lot of green chemistry. We’ve got a lot of focus on innovation, and yet you referenced earlier that with the revisions to TSCA and stuff. It’s becoming maybe a bit more challenging with the chemicals.
What do you see are some of the challenges with chemical innovation in bringing in new chemicals or new ways of manufacturing chemicals?
We spend an awful lot of time helping chemical innovators enable their substances to enter the stream of commerce. Since the 2016 Amendments to TSCA, it now forces EPA to make 1 of 3 determinations. The regulatory burden has shifted considerably to the innovator to prove that the chemical they wish to innovate and commercialize in the United States poses no unreasonable risks. The process is considerably more challenging now than it was in the 40 years TSCA has existed when it was first implemented in 1976.
As I noted earlier because three different administrations have taken a shot at implementing Congress’ writings in 2016, the standards and interpretation of how to demonstrate no unreasonable risks have been a little bit of a moving target. In addition to the shifting standards, the fees associated with commercializing a chemical are considerably higher than they used to be.
It used to be $2,500 to submit a new chemical PMN application. Now, it’s about $16,000. Often, the absence of specific data with respect to your new chemical innovation can be the subject of considerable frustration because the agency uses various computer models to predict the toxicity of a chemical, which tends to be very conservative. At the end of the day, the process has become more expensive, uncertain and challenging. It has the effect of perhaps chilling the submission of new chemical applications, and those that are submitted are subject to very significant scrutiny.
If you’re a new chemical innovator, you’re often relying upon investor resources to kickstart your company. The absence of certainty with regard to whether you will have an approved PMN substance after the 90-day review period tends to put a crimp in commercializing products where it’s not a sure bet. For a variety of reasons, the number of applications has decreased since Lautenberg. The percent of chemicals that are now subject to restriction through the imposition of significant new use restrictions or consent orders has increased dramatically.
Is it easier to get a product approved in the US if it’s already been approved elsewhere? Is there a benefit that you get? Does that drive innovation in different regions or do you see it as being neutral?
It’s probably pretty neutral depending upon what other jurisdiction to which you are referring. If it’s the European Union, you might have greater access to data that could support a new chemical application here in the United States, which is an upside. The fact that another jurisdiction has approved a chemical doesn’t necessarily help or hinder an application here in the United States. The agency’s legal burden is clear. The agency’s response to the absence of data on a substance is clear, and that the agency will use various computer models to assess a chemical’s risk potency. It probably values neutral more than anything in my view. The reverse is probably not true. If you have a new chemical approved here, I continue to think that it’s the gold standard. You might have an easier time marketing it in other jurisdictions.
That’s good to know. It’s good for US innovation.
One of the things, when you talk about the agency, is we’ve gone through a change in presidency and administration. I hear through the news that things are being replaced. They replaced a new head of the EPA and other aspects. Is the EPA perfectly staffed? How much does it matter? How much of the rest of the organization changes when there’s a change at the top? Is that a big influence on where we are at the moment? We’re less than a year into a new administration. Is that part of the timing aspects that we see or not?
Sometimes we are challenged when the client calls and says, “I submitted a PMN application six months ago.” There are a couple of things. Number one, changes of administration or changes at the top are inevitable. Generally, the staff and the career workers at EPA don’t rotate out as seeing what your political appointees do. Number two, under the prior administration, there was diminished resourcing for EPA across the board. Also, given the maturity of EPA, we had what we call a brain drain. A lot of senior people that had been around the agency for a long time elected to leave the agency and retire.
It’s a confluence of factors that have rendered EPA, particularly in the chemicals program area under the leadership of Dr. Michal Freedhoff significantly understaffed. In fact, Assistant Administrator Freedhoff testified before a House Subcommittee on October 27th, 2021 and said that with regard to the new chemicals program, EPA is down about 50% of the requisite staffing needs to ensure a functioning office of chemical safety and pollution prevention.
The good news is that the Appropriations Bill would fund the EPA significantly more to help make up for some of those staffing deficits. It also enabled the agency to get more different skillsets engaged in both new chemical and agrichemical reviews. It’s a combination of factors. The proverbial perfect storm of an aging EPA infrastructure and the administration that was not in all cases kind to staffing the agency with the funds and the resources it needed. We hope that with the new Appropriations Bill, that will change.
What about global regulations? What are the effects of global regulations on US-based businesses? Is there anything new? When REACH was introduced, it had far greater reaching effects than anybody had anticipated. Is there anything on the horizon at the moment that is as far-reaching as REACH?
You want to be clear about what’s in your product so you can confidently, comfortably, and transparently attest to its standards and safety.
You are so right. You are wise beyond your years. REACH had a remarkably significant impact on domestic industrial chemical regulation by jump-starting the initiatives that had begun years before to revitalize and modernize TSCA in a way that would help address some of the concerns that have been articulated with respect to TSCA long before 2016. A couple of things that are pushing the envelope and finding their way across the pond include the European Green Deal, and in particular, the sustainable chemicals component of the European Green Deal.
Under the terms of that Green Deal, the European Union is expected to be climate neutral and achieve a circular economy by 2050. Some of the lessons learned in the context of those initiatives are having a greater impact on the domestic interpretation of sustainability and circularity. It might not necessarily be felt in all cases in regulatory initiatives but with respect to the investor, consumer, and NGO demand, it will hasten a move to a much more consciously circular economy. It’s one that is more demonstrably sustainable. Given our prior discussion of the challenges the new chemical innovators are facing, it could pose some dramatic points of tension between TSCA implementation and a need for more sustainable and circular chemicals.
Many of the chemical manufacturers that we represent offer faster, greener, less toxic chemical technological platforms. They are certainly more sustainable and circular than the chemicals that they would like to replace. If they’re having a hard time getting commercialized, it’s putting efforts back to make our chemicals more sustainable and circular if we can’t get them into commerce.
I’ve heard this from people in the industry who are trying to bring on some new bio-based products, for instance, that it has been far longer than they anticipated and yet there’s a need for it. There’s a demand from their customers and it fits into this broader picture of circularity and sustainability.
You launched a podcast, All Things Chemical®, a few years ago. What prompted that and what have you learned from that podcast?
What prompted it was our collective belief that there is a wonderful story to tell with regard to chemical substances both in the industrial agrichemical and bio-cycle space. All of the other platforms in which we operate, we have four blogs, we maintain a vigorous email memorandum, a system where we push out information, but it’s very one dimensional. It’s just reading. Many of the very diverse stakeholders in the community in which we’re fortunate enough to work including chemical leaders, government affairs specialists, members of Congress, EPA officials, NGOs, and others have fabulous stories to tell.
I don’t mean stories in the sense of fictional stories, but their commitment to this space and navigating a very challenging commercial space given all the influences that are brought to bear in commercializing, maintaining, and developing a product that at its roots is premised on chemicals. We thought, “Wouldn’t it be fun to bring some of these stories to life?” We created the podcast series in a way to fulfill that expectation and round out our portfolio of offerings for people to understand what it is we do and why we do it.
Kudos to you for launching it and for having a successful podcast years later.
Thank you, Victoria. You’re very kind.
What is on the horizon for you and/or chemical regulations as we get ready to enter 2022?
There’s a lot in store. We’re coming into the midterm season. 2022 legislatively will be challenging, so I certainly don’t see much on the horizon there. This EPA under Dr. Freedhoff’s leadership is very committed to continuing to implement TSCA, which means the first ten chemical risk evaluations and EPA’s ongoing tinkering with the risk evaluation framework will start bearing fruit in 2022. We’ll see more emphasis on what exactly environmental justice means with regard to risk evaluation, and how are certain targeted demographics impacted by the agency’s evolving policies.
We’ll see much more with PFAP, the EPA Fast Action Plan, and how that will play out in the various media, the RCRA cleanup, CERCLA cleanup, Clean Water Act regulations, Safe Drinking Water Act regulation, and PFAS that are trying to make their way through the low volume exemption and new chemical application. We will see an additional emphasis on not just PFAS but all of the chemicals that have been identified to date in the existing risk evaluation process, with the 10 that are through and the 20 that are going through, and what products are implicated by conditions of use by those chemicals.
More generally, we will see enhanced regulation of articles finished in consumer goods that contain substances of concern to the agency. That has been a big deal in 2021 as a consequence of EPA’s regulation of five PBT chemicals. That will continue to stress the supply chain both in terms of the availability of products that contain chemicals of concern like PIP 3:1 and deca-BDE, but also stress the system in terms of supplier certifications.
We began this conversation with transparency and the need to be aware of what chemicals are in your products, so you can report that to your downstream customers, and you can ask your upstream customers, “What’s in this product?” That will continue for many years to come, which will stress supply chain availability and supply chain communications. We’ll continue to see all of that in 2022 and probably lots more.
I’m sad to hear that you think regulations are going to start impacting some of these supply chain availabilities because I know everyone across the industry has been struggling with it. It also makes sense in terms of where we are, and where the industry and regulations are going.
You raise a good point. The supply chain disruptions that we are seeing are occasioned by the pandemic and a variety of other issues. It’s a very complicated economic equation, but the regulation of articles has added to that supply chain stress in ways that I think EPA may not have fully appreciated when the rule came out in January of 2020.
Lynn, it has been delightful to talk with you. I’m so glad that you joined us and I appreciate you taking the time to be on The Chemical Show.
Thank you again for inviting me to your house. I wish you all my very best with regard to your own show.
Thank you, and thanks to everyone. Please remember to share, follow and give some feedback. We love to hear from you.
About Lynn L. Bergeson
Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C., has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether advocating before Congress, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), or other governance and standard-setting bodies.