Environmental Law Series: Inside The Toxic Substances Control Act (TSCA)

Episode Notes

Transcript

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Female Speaker: There’s a lot of controversy right now about how can we make Chemical Innovation more, efficient more predictable, as protective as we believe EPA wishes it to be and as protective as all manufacturers worse than a new chemical to be but without unduly burdening these innovative new chemicals in a way that torts innovation.

Intro: Welcome to the award-winning podcast Lawyer 2 Lawyer with J. Craig Williams, bringing you the latest legal news and observations with the leading experts in the legal profession. You’re listening to Legal Talk Network.

J. Craig Williams: Welcome to Lawyer 2 Lawyer on the Legal Talk Network, I’m Craig Williams, coming to you from Southern California. I write a blog named “May It Please the Court,” and we have two books out titled “How to Get Sued” and “The Sled.”

Well, like last year, we’re going to have another series of 12-part series this year. We’re going to concentrate on environmental law, where we will cover the cradle to grave treatment of chemicals and our laws on environmental biology.

In this first episode, we’re going to spotlight the toxic Substances Control Act as well as the Federal Insecticide Fungicide and Rodenticide Act that address the manufacturing processing and distribution use and disposal of commercial and industrial chemicals. To speak more on this topic, our guest today is managing partner of Bergeson & Campbell, P.C., Lynn Bergeson. She’s earned an international reputation for her deep and expensive understanding of TSCA, the Toxic Substances Control Act and FIFRA, the Federal Insecticide, Fungicide and Rodenticide Act as well as the European Union REACH program known as the Registration Evaluation Authorization and restriction of Chemicals.  Welcome to our show, Lynn.

Lynn L. Bergeson: Thank you, Craig. I really enjoyed being here.

J. Craig Williams: Well, then I’ve read through your resume, it’s absolutely amazing. You’ve certainly developed an enviable reputation in chemical and pesticide regulatory work. And as we mentioned in the introduction, particular experience in nanotechnology, can you give us a little bit of background about yourself and how you got involved in this practice area?

Lynn L. Bergeson: Thank you for those kind words. I had been practicing in the chemical space for many years. As some of your listeners may know, both TSCA, the industrial chemical law and its counterpart in the pesticide biocidal space FIFRA, are statutes that are managed in kind of regulated out of Washington. They’re not delegated to the states like the clean air act, clean water act and so forth. So, I moved to Washington about 40 years ago, love the policy, legislative, regulatory space and decided to drop my anchor and working on chemical laws, largely because that’s the epicenter of the universe, Washington D.C. and, of course, our consulting affiliate has offices in Brussels where we take care of the European side of the chemical equation.

But once I became engaged in TSCA and FIFRA, there was no looking back. We started Bergeson & Campbell back in the early 90s and decided to address problem solving using all of the resources and capabilities that chemical law policy and regulation require. So, our staff consists mostly, Craig, of non-lawyer professionals. Consisting of exposure, assessors, toxicologists, PhD. chemists and regulatory scientists and lawyers to help frame the issues as they arise under TSCA, FIFRA, REACH and so forth.

It’s a fascinating practice. We have grown with almost 55 people now focusing only in the chemical space in Washington. There’s lots and lots and lots going on and we love what we do. So, I hope that’s helpful in terms of how we practice, who does it and why we have such a diverse team of lawyers and non-lawyer professional scientists.

J. Craig Williams: It is. It’s certainly a complementary group of people giving this subject area. Can you describe for our listeners, a little bit of just generally speaking about TSCA and its purpose in the scheme of regulatory framework that deals with chemicals from as we talked about in the beginning from cradle to grave.

Lynn L. Bergeson: Sure. Well, TSCA was originally enacted in 1976. Now 40 some years ago, right? And it was intended to address the absence of regulation at that time to the import manufacture and distribution of neat.

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Meaning pure chemical substances. We had emerging environmental statutes with the NIPA, with the Clean Air Act. 1976, as you probably know too was the same year that RCRA, the Resource Conservation and Recovery Act was enacted into law. CERCLA was still a twinkle in congress’s eye.

But there was no federal management scheme relating to the manufacturer of industrial chemicals nor did EPA then have authority to regulate or to compel the production of scientific data on chemicals to ensure that chemicals coming into the United States from outside the United States, met certain safety standards. EPA had no ability to track the distribution of neat chemical substances once they arrived or were produced in the United States. So, TSCA was intended to fill that void. Though it kind of bumped along from 1976 to 2016. Largely as an industrial chemical manufacturers law, TSCA in the grand scheme of things was thought to be very niche. A little bit quirky and not well understood, both by lawyers, practicing in the space, in the environmental space and by M&A and transactions lawyers as well.

I recall many deals in which we’ve been involved doing due diligence, where TSCA and its counterpart, FIFRA, are often kind of overlooked as areas of potential liability because they’re just, they were never mainstream like clean air, clean water, RCRA, CERCLA, everybody those statutes. So, in 2016 congress completely revised, revamp, strengthen and modernize TSCA. And since 2016, there has been a tsunami of regulatory developments that has really extended the jurisdictional reach and relevance of TSCA as an exceedingly important federal law that lawyers in multiple spaces need to be aware of and monitor on behalf of their clients.

J. Craig Williams: Sure. And when it did start out, it was largely responsible for what our manufacturing clients know, is the manifest system, right?

Lynn L. Bergeson: Well, the manifest system is largely attributed to the Resource Conservation Recovery Act. In the United States we have something called pre-manufactured notices for new chemicals and for existing chemicals if they are imported into the United States or distributed in the United States or manufactured and then distributed in the United States. You really don’t have a lot of paperwork associated with moving it from A to B. The manifest system or versions thereof are used as commercial paper to track the distribution of chemicals in commerce. EPA has lots of authority under TSCA to compel the submission of information regarding what you’re producing, where you’re producing, who’s being exposed to it and how do you track it when you’re moving it from A to B to C, until it’s ultimately consumed or used in the processing and manufacture of a product, which of course, that’s what all chemicals are for, right? Their feedstock ingredients to produce the products and goods, and services, and electronics that make our lives as convenient as we now enjoy.

So, a version of the manifest is definitely part of it, but it’s a little bit different than the manifest, which is largely associated with the tracking of industrial waste under RCRA.

J. Craig Williams: Right. RCRA is the tail end of the –

Lynn L. Bergeson: Exactly. Exactly right, Craig.

J. Craig Williams: So, in the birth of chemicals, how does TSCA affect the development? Like Dow Chemical for example says, we’re going to create a new chemical and poof here it is. How does that chemical process through TSCA?

Lynn L. Bergeson: That is an excellent question and a very controversial one these days. Once upon a time when TSCA was first enacted into law and EPA the federal agency that implements the law was tasked with implementing regulations, EPA took the position under the law that existing chemical substances, those chemicals that existed back in 76 and more specifically 78, when EPA created what is called the chemical inventory, which is just a great big giant list of some 88,000 chemicals that have been listed as used commercially in the United States, okay.

So, back then, in 76 all the way up to 2016, if you used manufactured imported or distributed, the chemical that was on that inventory list. There were largely few regulatory measures that applied to those chemicals

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which has been the source of considerable controversy and debate and one of the reasons why TSCA was so significantly amended in 2016. But if you want to innovate and there’s so much chemical innovation going on right now, very exciting stuff. Largely to make the world more sustainable, greener, better, cheaper, faster, whatever. If you want to innovate a new chemical before 2016, you submitted a pre-manufactured notification, largely waited 90 days, which is the statutory time frame within which EPA must render a decision.

And then most chemicals were reviewed in either added to that inventory list and considered existing and hence could go about its merry way and live happily ever after. Or if EPA discovered some toxicological or environmental fate goober, it would regulate that through the issuance of a consent order that ultimately matured into a significant new use rule. And we won’t go into all that stuff. But we have lots of stuff on our webpage. Talk about snores, snubs and PMNs, and the whole wonderful alphabet of TSCA.

J. Craig Williams: It can be a nightmare, can it?

Lynn L. Bergeson: Well, it can be somewhat dense and we toss canards enjoy talking about this stuff, but at a 3,000-foot above level in 2016 congress amended TSCA to now make it more challenging to innovate new chemicals. Because now instead of submitting a PMN, a pre-manufacture notice, the agency must make an affirmative determination as to the risk that a new chemical might pose. So, it either poses no — there’s no reason to believe that poses an unreasonable risk. The agency lacks sufficient information to make that determination and other seeks more information or imposes restrictions on the chemical or determines that it really is not ready for prime time and you know, the PMN is withdrawn.

So, that change has made commercializing it, innovating new chemicals, Craig, in measurably more difficult time-consuming and uncertain as to its commercial viability. And that’s where the – there’s a lot of controversy right now about how can we make chemical innovation more efficient, more predictable as protective as we believe EPA wishes it to be and as protective as all manufacturers wish their new chemicals to be but without unduly burdening these innovative new chemicals in a way that torts innovation.

J. Craig Williams: Lynn, we’re going to take a quick break to hear a word from our sponsors. We’ll be right back.

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And welcome back to Lawyer 2 Lawyer on the Legal Talk Network. I’m joined by managing partner of Bergesen & Campbell, P.C, Lynn Bergeson and we are spotlighting the Toxic Substances Control Act. And we’ve been talking right before the break about the particular use of chemicals and the controversies that have arisen as a consequence of the recent changes. Well, not that recent now. But Lynn, what happened with the so-called Lautenberg. I think it’s pronounced. Amendments in 2016.

Lynn L. Bergeson: Well, in 2016, on June 22, then president Obama signed the Frank R. Lautenberg chemical safety for the 21st century act. We all call it Lautenberg or new TSCA. And because the law has many different triggers in it, EPA was and is required to engage in dozens of rulemakings that ultimately give expression to congress’s intent. But also form the framework for the new chemical program that Lautenberg inspired. So, since 2016, which, Craig, to those of us in the space, seems like yesterday. And I know we’re recording this in 2023

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but there has just been dozens and dozens of rulemakings that have really significantly impacted manufacturing practices in the United States.

So even this year, coming down the first quarter of 2023, we’re looking at the asbestos risk management rule should be coming out. We have the pee fast reporting rule coming out, we have EPA’s revisitation of TSCA fees that were submitting comment on next week. So, although the law was signed into action in 2016, its impact is really being felt every month in material ways. In ways that manufacturers of products and offshore chemical producers need to be aware. And for those of your listeners in the M&A space, transactions, real estate attorneys, entities representing the electronic sector, automotive sector, paint and coatings. Any industrial sector having any material component that rests or includes industrial chemicals has a dog in this fight. It’s very, very interactive, very fast changing and lots, and lots and lots going on.

And then you put the patina of sustainability and climate change on top of all that. You’re looking at an increasingly sophisticated supply chain that is much more inquisitive now about the chemicals that are being sourced to them whether or not any contains a (00:16:39) or any of the Pantheon of super nasties that the agency has in its sights as it were.

J. Craig Williams:

Well, one of the things that particularly interests me is that your firm has come out with a 2023 forecast of the regulatory environment in this particular area. And as an environmental litigator, I handle the contamination litigation side of it. I’ve seen over the years a big swing between administrations and I noticed in your forecast that you had a similar observation.

Lynn L. Bergeson: We often — and thank you for mentioning that, Craig. You’re very kind to do so. We put a lot of effort into our 100-plus page forecast where we try to handicap what’s going to happen in the United States. And in most mature markets around the world in the chemical, industrial biocidal markets. And we do make a point of emphasizing that given the leadership in the white house right now and the divided congress were likely to have a different regulatory experience in 2023 and 24 than what we had in 2021 and 2020. Largely because we appreciate that congressional oversight has a very significant impact on directionally what EPA does with regard to setting policy and implementing relatively new laws like TSCA.

So, we spend a lot of time in our forecast just speculating on enhanced oversight hearings that are probable in 2023 with regard to TSCA implementation. EPS management of the new chemicals program, which is the program that administers review of new chemical innovations and technologies. And in similar issues, how EPA is conducting risk evaluations, as I noted earlier, the first risk management role will come out, which is precedents in the EPA will be letting the world know how it intends to manage the unreasonable risk associated with asbestos. And then probably after that, leveling chloride. These are all chemicals that everyone knows and recognizes but EPA has not yet implemented in final, a risk management role.

So, we in the TSCA community are all excited about what’s going to look like, what judicial challenges we expect, how might it pretend risk management framework for fourth coming risk evaluations for the other 10 priority chemicals and the 20 that are in the queue. So, there would be much to learn from that role, even though asbestos is as you know, is somewhat unique chemical with a challenging legacy that will probably be subject to unique restrictions because of that legacy.

J. Craig Williams: All right. Well, then again, we’re going to take a quick break to hear a word from our sponsors. We’ll be right back.

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And welcome back to Lawyer 2 Lawyer on the Legal Talk Network. I’m joined by Attorney Lynn Bergeson. We’ve been discussing general TSCA. Lynn, I know that there are, just a jump back to the generalities for a moment. There are certain things that are not regulated by TSCA. What are those?

Lynn L. Bergeson: TSCA regulates industrial chemicals. But of course we all know that chemicals are deployed to many different markets. The food and drug administration for example, manages food, food additives, materials that are in direct or indirect contact with food ,cosmetics. So, anything that falls into the jurisdictional bucket of the Federal Food Drug and Cosmetic Act is explicitly not regulated by TSCA. Similarly, our friends in the pesticide world, if a chemical is designed to achieve a pesticidal potency or to deploy its pesticidal properties on a pest or bacteria, or microbe, those are all subject to the jurisdictional provisions of the Federal Insecticide, Fungicide and Rodenticide Act. There are a couple of other specific exemptions from TSCA, firearms, ammunition, stuff like that but those –

J. Craig Williams: Drugs, cosmetics?

Lynn L. Bergeson: Yeah. Drugs, cosmetics and food are all subject to FFDCA, pesticide, antimicrobials all subject of FIFRA and industrial chemicals are in that third bucket subject to TSCA. And of course, many chemicals, I have multiple functionalities, right? You can have a chemical that goes into the industrial market and the chemical that goes into the food use market. So, I’m sure you listeners are mindful of how depending upon the use of a particular chemical will dictate what jurisdictional bucket it resides and what regulatory provisions apply to that use.

J. Craig Williams: All right. And some of the chemicals that TSCA does cover are, what commonly as you mentioned, asbestos, PCBs that are found in transformers in the like radon and lead-based paint, commonalities. But one of the things that interest in me is that, there seems to be a change in this scope of TSCA from the standpoint of biology and nanotechnology. How is that expansion in those areas?

Lynn L. Bergeson: But the EPA has taken the position explicitly with regard to nanotechnology, which was a very big deal back in the early 2000s. It came to EPA’s attention that chemicals were being manufactured at a smaller and smaller and smaller scale to functionalize properties that could not be achieved at the bolt range. So, with regard to the type of technology EPA is taking the position that TSCA for example, in industrial chemicals applies and the same provisions of TSCA apply. But if you are engineering an existing chemical at a nano range that is considered a new chemical substance for purposes of TSCA.

So, EPA I think has done a very good job of integrating these expanding technologies and evolving technologies. Because technologies evolve all the time. The technologies of yesteryear when TSCA was first implemented 1976 are vastly different than they are now. So, I think EPA has done a very good job of making the fundamental framework of the industrial chemical laws, sufficiently elastic through its implementation of policies and its own evolution of regulatory frameworks and rulemakings to apply in ways that we don’t need a new TSCA nanotechnology act, because that would never work, right?

We could never get an increasingly dysfunctional congress to periodically update all of our laws to accommodate newer and more precise technologies. So, these older laws like TSCA and FIFRA and FFDCA continued to apply

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even though the technologies that they now regulate are vastly different than they were when they were first — when the laws were first enacted. So, EPA’s done a great job, FFDA’s done a great job and of course it’s the same EPA but different offices that manage TSCA and FIFRA.

J. Craig Williams: You bring up a very interesting point given the recent series of decisions that have come out of the United States Supreme Court. They have turned on the theory of originalism when you look at the interpretations of the constitution. There have been the conservative justices of all. So, you know we’re going to interpret these statutes, this particular situation according to the statutes as they were originally written or as the constitution was originally written. Yet you’re praising the EPA and other agencies for becoming elastic with the changes that have occurred as a result of technology. They don’t have a direct application to one another. But what are your thoughts about how the interplay of an executive branch agency like this, taking the steps to grow with the times and our own constitution being interpreted as it was written long ago.

Lynn L. Bergeson: I credit the United States Environmental Protection Agency and the career staff there that have been devoted to applying all of the statutes to which they are tasked with implementing. To do so in a way that accommodates the fast-changing technological evolutions that are part and parcel of their beat as it were. So, we talked a little bit about, well, if you have a new administration, the policies are going to change and they do, how this EPA applies TSCA and defines risk evaluation is vastly different than the preceding administration. But throughout these changes of administration, there’s been a core allegiance to the letter of the law and an appreciation that what congress intended to do and creating EPA and expanding TSCA through the Frank R. Lautenberg chemical safety for the 21st century act and amending FIFRA back in 1996 when it implemented the FQPA. That at the end of the day, these laws are intended to protect human health and the environment.

So, I really credit the career EPA staff and the political appointees that are derivative of a diversity of administrations to embrace what these laws are intended to do and to be creative and nimble in deploying them in a way that achieves that core goal. That’s the thread that is consistent throughout all of the administrations. And we lawyers, in the space quibble over well, is this more hazard base or risk base and is EPA interpreting these provisions in a way that our clients think is appropriate and reasonable people will disagree. And we disagree frequently and respectfully with the EPA. But credit the agency for being, for curating these laws in a way that really does the best for human health and the environment. But it is a challenge and we don’t always agree but that’s the fun stuff, Craig.

J. Craig Williams: It sure is. Well, we’re just about reached the end of our program. So, I’d like to take this opportunity to invite you to share your final thoughts and your contact information. And I also want to take a moment to commend our listeners to your podcast, all things chemical, for a more in-depth view of the things we’ve just talked about a barely scratch the surface of what’s available on your podcast and I think it looks like a fantastic resource with, listen to a couple of episodes and I’ve been very impressed.

Lynn L. Bergeson: Thank you, Craig. You’re very kind. Then we enjoyed doing all things chemical for the last three years. We’re approaching our hundreds. I know that pales in comparison to your commitment to the podcast space, Craig. But we enjoy it. I urge anyone listening, if they wish to learn more about TSCA, FIFRA, synthetic biology, nanotechnology and all of the other ologies that are chemical laws applied to. Go look at our webpage www.lawbc.com. The forecast that Craig was kind enough to mention is posted and downloadable. We have four or five blogs on TSCA, FIFRA, bio stuff, nano stuff, REACH or European counterpart.

And for the listeners in the crowd that are interested in TSCA and don’t know a lot about it but our members of the United States legal Community.

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Take a look at some of the articles we have posted. Because TSCA is not what it used to be. And our clients are increasingly aware of the commercial pressures that are being brought to bear by EPA’s focus on chemicals and their inclusion in products that we all know and love. So just happy to answer any questions if you add them to our web portal and would be happy to get back to anybody should you seek more information.

J. Craig Williams: Great. I’d like to thank our guest Lynn Bergeson for joining us today. It’s been a pleasure having you on the show.

Lynn L. Bergeson: Thank you, Craig.

J. Craig Williams: Well, for our typical listeners, this episode has been highly technical and covers a specific act that deals with the beginning of environmental regulation of chemicals from the cradle list. Lynn, mentioned all the way through the time that we disposed of them also known as the grace of chemicals. This is a very interesting area of the law. One that is coming up more frequently and many law schools have turned to creating particular programs to deal with this are of law. I know that different law school and the university of California at Irvine have particular programs developed to train lawyers in this highly technical area of the law. A good solid background in biology or engineering or chemicals would serve you well if you’re starting out in this area. Just to follow up a little bit on our series from last year, the start of life of a lawyer from start to finish.

But this highly technical are of the law has a lot of facets to. One of them that Lynn deals with is how it’s regulated. And another one that I deal with is litigation of contamination that results from the disposal of chemicals. So, I’m really looking forward to this year’s exploration really of this are of the law and delving into this environmental areas. I think you’ll find it fascinating, technical but fascinating. Well, if you like what you heard today, please rate us on Apple Podcast or your favorite podcasting app. You can also visit us at legaltalknetwork.com, where you can sign up for our newsletter. I’m Craig Williams. Thanks for listening. Please join us next time for another great legal topic. Remember, when you want legal, think Lawyer 2 Lawyer.

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