All Things Chemical

This week, I sat down with Jim Jones, Executive Vice President Strategic Alliances & Industry Relations at the HCPA, or Household & Commercial Products Association. Before moving into the private sector, as many of our listeners know, Jim served a long and very distinguished career with the U.S. Environmental Protection Agency in Washington, D.C. Jim began his career in the toxics office, specifically in pesticides, and eventually served as Assistant Administrator of the Office of Chemical Safety and Pollution Prevention in the Obama Administration.

We talk about Jim’s extraordinary background and how it prepared him for the task of helping to modernize the Toxic Substances Control Act in passing the Lautenberg Act amending TSCA in 2016. Jim takes us back to the summer of 2016 and paints a picture of what it felt like to watch with anticipation as the political proceedings surrounding the amendment unfolded.

In addition to talking about TSCA’s recent history and EPA’s implementation of it, Jim shares career advice, tips for other industry groups, and first-hand experiences about the difference between the private and public sectors of this industry.

Jim has a wealth of knowledge and experience, and I am excited to share my conversation with him with you. So, here is my discussion with Jim Jones about his experiences leading up to passage of the Lautenberg Act…

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

This week, I moderated a spirited discussion with two members of the B&C team:  Sheryl Dolan, a senior regulatory consultant who specializes in agricultural and biocidal chemical product registration and defense, and Dr. Richard Engler, our Director of Chemistry and a 17-year-veteran of EPA.  Both Sheryl and Rich are expert in marshaling new product chemical technologies through the gauntlet of federal, state, and international chemical product approval.

Throughout our discussion, Sheryl and Rich walk us through what it takes to bring a new technology to EPA (or any other regulatory authority) and to help the regulators understand the benefits and safety of the new technology, especially when dealing with older regulatory frameworks that are sometimes ill-suited to anticipate the challenges posed by cutting edge technologies.  We talk about the regulatory challenges that the developer of a new product is likely to face, and how our team recommends preparing for these often make or break challenges.  We also get into a bit of the history of TSCA and FIFRA, the impact that public opinion and transparency can have on the regulation process, and how regulatory systems are informed of and respond to technological change.

There is a lot to unpack in this discussion for anyone with an interest in the regulatory process, whether you are planning on bringing an innovative product to market or enhancing a new aspect of an existing product.  It was great having Sheryl and Rich in the studio to walk me through some of this, and I am excited to share it with you.  So, here is my discussion with Sheryl Dolan and Dr. Rich Engler about new technologies and their regulatory processes…

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

This week, I sat down with Lynn R. Goldman, M.D., M.S., M.P.H., Michael and Lori Milken Dean, Milken Institute School of Public Health; Professor of Environmental and Occupational Health.

Dr. Goldman is widely regarded as one of the most influential public health physicians of our time and served as Assistant Administrator for Toxic Substances in the U.S. Environmental Protection Agency from 1993 through 1998 under President Bill Clinton.  During her tenure, Dr. Goldman and her team are credited with implementing the 1996 amendments to our nation’s pesticide law, the Federal Insecticide, Fungicide, and Rodenticide Act or FIFRA, known as the Food Quality Protection Act.  This ground-breaking law modernized the legal framework for regulating pesticide residues on raw agricultural commodities and processed foods.

In our conversation about our industrial chemical law, Toxic Substances Control Act or TSCA, especially under her watch as Toxics Assistant Administrator in the ‘90s, we delve into Dean Goldman’s background as a pediatrician and how that came to influence her decisions in office.  We talk about new TSCA’s roots as the “Kids Safe Chemicals Act,” as well as about how Dr. Goldman and others built upon Senator Lautenberg’s interest in TSCA reform legislation, the parallels with implementing new TSCA, and Dr. Goldman’s experience implementing what was then considered the “new FIFRA.”  We also talk about some of the truly fascinating research that Dean Goldman has pursued at the Milken Institute School of Public Health at George Washington University, including the publication of the 2018 study evaluating the fatality account in Puerto Rico due to Hurricane Maria.

It was great speaking with Dean Goldman about her work, past and present, and to get some insight into the historical development of TSCA from someone who was involved in its shaping.  So, here is my discussion with Dr. Lynn Goldman, Michael and Lori Milken Dean at the Milken Institute School of Public Health at George Washington University….

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

This week, we have B&C’s and The Acta Group’s Senior Regulatory Consultant, Karin Baron, back in the studio to discuss K-REACH, its recent amendment, and potential harmonization of chemical regulations in the region.  K-REACH is the South Korean government’s industrial chemical substance registration program signed into law in 2013, and effective in 2015.

Karin is uniquely well-suited to provide practice tips and information on why our listeners should be aware of what is going on with this South Korea chemical regulatory program.  As a well-recognized expert in international hazard classification programs like the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) and domestic OSHA Hazard Communication, as well as a veteran of European Union  (EU) REACH chemical hazard and risk assessment issues, Karin draws upon her extensive experiential database to paint a picture of what stakeholders exporting chemicals to South Korea need to be aware of and navigate around to be commercially successful.  Like so many new global chemical programs, K-REACH is similar to EU REACH, but maddeningly different to cause serious commercial disruption for the unprepared.

In our conversation, Karin lays out the case for why everyone in the regulatory space might do well to pay close attention to K-REACH, not just those with business interests in South Korea.  Karin breaks down how K-REACH works, how it was developed, and how it differs from the EU REACH framework.  We discuss the fast-paced development and implementation of recent amendments to the legislation as well as the concept of “REACH-creep,” and what it might mean for the future of the ASIA-PACIFIC region.

Finally, for those with specific interests in South Korea, listen up, because Karin has some valuable information to share before moving forward and meeting important deadlines.

As always, it was great having Karin in the studio to discuss K-REACH.  Whether or not you currently have a business in South Korea, you are sure to get something useful out of this podcast.  So, here is my discussion with Karin Baron, Senior Regulatory Consultant here at B&C and Acta, about K-REACH.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

This week, I sat down with Scott Fulton, President of the Environmental Law Institute, on the occasion of ELI’s 50th anniversary.


Scott is ELI’s 5th President. As a former ELI Board member myself and a practicing lawyer in the environmental space, I have known Scott for years given his many high profile roles as a former EPA General Counsel, Assistant Chief of the Environmental Enforcement Section at the U.S. Department of Justice, among other prominent positions.

In our conversation, Scott explains the various lines of work in which the ELI is currently engaged, how the Institute has evolved over its 50-year history, and how it maintains its status as a well respected, internationally recognized, non-partisan organization. We talk about the impact of the current federal Administration on the legal infrastructure, ELI’s judicial training efforts around the world, the concept of “soft law,” as well as about the role that new technologies will play in in the future of environmental monitoring and law.

It was great speaking with Scott about his work at ELI, and to celebrate an organization that has been an important part of the environmental law landscape for the past fifty years. So, here’s my discussion with Scott Fulton, President of the Environmental Law Institute.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

This week, I sat down with Dr. Lisa E. Friedersdorf, the Director of the National Nanotechnology Coordination Office (or NNCO) to discuss all things nano.

For anyone in the nano space, Lisa is a rock star and well known to all. To those less familiar, Lisa joined NNCO several years ago, having served as the Associate Director of the Materials Research Center at Lehigh University and Director of the Industry Liaison Program. Lisa was also Director of the Virginia Nanotechnology Initiative. While with the University of Virginia, Lisa served as managing director of the nano STAR Institute and led the development of pan university initiatives as a program manager in the Office of the Vice President for Research.

As you can see, Lisa’s past positions have been squarely at the intersection of science, industry, and academia, and her experience has served her well for her current position. Lisa earned her Ph.D. and MSE in Materials Science and Engineering from the Johns Hopkins University and BS in Mechanical Engineering from the University of Central Florida.

In our conversation, Lisa breaks down the central goals and challenges of the National Nano Initiative, a governmental program designed to facilitate research and development in nanotechnology, educate people about nanotechnology, and ensure the responsible development of nano by understanding nano’s potential environmental, safety, and health implications. Lisa explains how her work at the NNCO helps direct and ensure that the many, many billions of dollars of funding available for nanotechnology applications and implications are allocated in ways that are efficient and invite the greatest return on investment and coordinated with other international nano initiatives. We also talk about some of the wonderfully surprising and unique applications for nanotechnology existing currently in our daily lives, as well as potential future applications of the technology for the field of agricultural and chemical production.

It was fantastic to speak with Lisa about her work and the field of nanotechnology, something about which we here at B&C are incredibly passionate and excited. So, here is my discussion with Dr. Lisa Friedersdorf, Director of the National Nanotechnology Coordination Office…

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

Last October, at the Annual Meeting of the International Bar Association in Rome, I was fortunate enough to be introduced to Katherine Meighan, the General Counsel of IFAD, the International Fund for Agricultural Development.  Katherine gave an eye-opening presentation at the IBA conference on IFAD’s efforts to address the issue of food security and world hunger, and I knew I had to have her on the podcast to share her message and to dig deeper into her work as General Counsel and IFAD’s incredible work in general.

Katherine’s unique background has served her well in preparing for the role of IFAD General Counsel.  Before joining IFAD, Katherine was Assistant General Counsel and Manager at the International Finance Corporation, where Katherine led the legal work globally for Financial Institutions, Treasury, and restructuring/litigation.  During her 17 years at IFC, Katherine was based in Buenos Aires, Istanbul, and Washington, D.C.  Previously, Katherine worked at a global law firm in Washington, D.C. and Paris focusing on international transactions and capital markets work for financial institutions.  Katherine has a law degree from the University of Virginia and an undergraduate degree from William & Mary, where she is a member of the Advisory Board of the International Center.

In our conversation, Katherine tells us more about IFAD, the entities with which it works, and how it operates.  Katherine explains why the organization focuses on supporting agricultural development of the “rural poor” and the “missing middle.”  I had Katherine walk me through the Sustainable Development Goals set-out by the United Nations and how IFAD has developed innovative funding mechanisms to leverage private funds and create partnerships to make progress on increasing food security worldwide.

We also touched upon the important social issues affecting global agriculture, including climate change and mass migration, as well as the tremendous gap between the number of women worldwide who are involved in food production and the number of women who actually own and manage land.

As you will hear, Katherine is passionate about her work, and I really enjoyed getting to learn more about her and IFAD’s inspiring and important mission to eradicate hunger for the world’s most underserved rural poor.  Bergeson & Campbell’s interest in food security is rooted in our deep engagement in the law and science of precision agriculture and fertilizers, and we are really excited to share with you IFAD’s important work on food security.  So, here is my discussion with Katherine Meighan, General Counsel of the International Fund for Agricultural Development.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

This week, I sat down with a highly-regarded member of the environmental NGO community, Eric Schaeffer, who currently serves as the Executive Director of the Environmental Integrity Project, which he co-founded in 2002.  Previously, Eric worked for more than a decade at EPA, including a five-year stint as the Director of EPA’s Office of Civil Enforcement, which, as you will hear in our conversation, was a very formative time for his thinking.

At a time when some news outlets and EPA detractors are reporting environmental enforcement numbers to be at historic lows, Eric and I had a great discussion about the possible reasons for this, as well as the other goals and methods that his organization employs to encourage compliance and help protect the environment.

Throughout our conversation, we also managed to touch on EPA’s evolving enforcement strategy, how ideally to address non-compliant companies, voluntary disclosures by businesses that discover indiscretions, remote pollution monitoring techniques, and even the much-discussed idea of cooperative federalism.

Eric has a well-deserved reputation for being tough but fair and honest.  His candid assessment of what is working well for EPA enforcement and industry compliance professionals and what needs improvement may surprise you.  What comes through in a very big way is Eric’s approach to analyzing and addressing issues, one that, not surprisingly, is based on the integrity of the enforcement process and a respect for the environment.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

I am so pleased to present a very special guest this week, the Assistant Administrator for EPA's Office of Chemical Safety and Pollution Prevention (OCSPP):  Alexandra Dunn.  Alex’s professional training could not be more perfect.  Alex is a lawyer and has practiced in both the private and non-profit sectors.  Alex has taught environmental law at several law schools and, while Dean of Environmental Law Programs at the Elisabeth Haub School of Law at Pace University, focused on environmental justice, a subject on which Alex has written and lectured extensively.

When Alex’s appointment was unanimously confirmed by the Senate at the beginning of this year, many of us were excited and confident that Alex would lead OCSPP with her characteristic integrity, resolve, and warmth.  Alex’s leadership over the past five months has well supported our confidence.  Alex has shown a commitment to making the work of the OCSPP more transparent, and her team has continued EPA’s streak of hitting every one of the deadlines imposed by the 2016 Toxic Substances Control Act (TSCA) amendments.

As Assistant Administrator Dunn has spent just over five months in office, we sat down and talked about what it’s been like to take over OCSPP at this crucial time when post-Lautenberg TSCA is just coming into its maturity.  We discussed the challenges OCSPP is currently facing, and how Alex and her team have kept morale up while managing to meet all of the many deadlines imposed on OCSPP thus far.  We touched on the role of litigation in EPA’s work, plans for TSCA at 3, the significance of certain Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration decisions, and how to channel the many voices of such a broad range of stakeholders as those the EPA must address.  And finally, we talked about what to expect and what is to come for the remainder of this year.

This was a fantastic opportunity to gain insight into what has been going on inside the OCSPP over the last few months, and what to expect from it in the next few months.  I really think you’re going to enjoy this one, so, here’s my conversation with Assistant Administrator Alexandra Dunn.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

We have a repeat guest this week: fan favorite, Dr. Richard Engler, Bergeson & Campbell’s Director of Chemistry and Toxic Substances Control Act (TSCA) guru-in-residence.  I sat down with Rich to find out more about so-called “New Chemicals” and the challenges faced by not only new chemical manufacturers, but also by the U.S. Environmental Protection Agency (EPA) in trying to fulfill its duties as a regulatory gatekeeper.

As a seasoned veteran of EPA himself, where he worked for 17 years in the Office of Pollution Prevention and Toxics’ (OPPT) Green Chemistry Program, Rich understands the pressures placed on both manufacturers and regulators, and uses this dual knowledge to inform his (and our) understanding of the timelines and processes involved in new chemical registration.

If you wish to learn a bit more about the inner-workings and pressures of EPA, are looking for tips on improving your innovative chemical’s registration process, or are just curious about what a “new chemical” even is anyway -- then this is an episode for you.  So, here’s my conversation with Dr. Richard Engler on Innovation and New Chemicals under TSCA.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.