All Things Chemical

This week, I invited my friend and business colleague, the former U.S. Ambassador to Belgium, Howard Gutman, into the studio to talk about what every CEO needs to know about the world right now.

I know I say this a lot, but it’s really true this time around: We covered a lot of ground in this conversation. Howard provides his perspective on what to pay attention to with regard to Brexit, energy policy, climate change, trade, the globalized economy, and the 2020 presidential election. Ambassador Gutman also provides advice on how to manage business perception, create opportunities from regulatory changes, and even shares some helpful thoughts on how to fill board seats to be more innovative.

Howard’s resume is, well, extraordinary. He is a Harvard educated lawyer, who clerked for the U.S. Court of Appeals for the Fifth Circuit. He worked for Cravath Swaine, left its employment to clerk for Supreme Court Justice Potter Stewart, then worked for the celebrated Washington D.C. powerhouse litigation firm, Williams & Connolly, which is where Howard and I became friends, as he counselled Bergeson & Campbell. Howard went on to become Special Assistant to FBI Director Bill Webster, and then rejoined Williams & Connolly.

Throughout his legal career, politics was always part of Howard’s DNA. Howard has worked with Al Gore, Bill Clinton, and Barack Obama, who named Howard U.S. Ambassador to Belgium in 2009, a post he served until 2013. Howard is also an actor -- he is a card carrying member of the Screen Actors Guild and has appeared in the HBO series K Street, Tim Robbins’ Film Noise, and the 2009 film Fame. Howard’s consulting firm, The Gutman Group, focuses on a broad array of cross-border investment, market access, venture capital, and international relations issues.

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 my colleague Jim Aidala, a Senior Government Affairs Consultant here at the firm, to discuss 2019 and the state of industrial and agricultural chemical regulation: what is to come, what to expect, and how we can prepare for it.

We begin, of course, by looking at 2018, chiefly, the appointment and confirmation of Alexandra Dunn, the new EPA Assistant Administrator in the Office of Chemical Safety and Pollution Prevention, the office tasked with administering TSCA and FIFRA.

Jim fills us in on EPA’s current and projected workload and what can be expected regarding Pesticide Registration Improvement Act (PRIA) deadlines. We also touch on the updated TSCA chemical Inventory, issues arising under the Endangered Species Act, and what it means to be identified as a high- or low-priority chemical under EPA’s newly implemented chemical prioritization process.

As a former Assistant Administrator of the Toxics office, Jim’s observations are always spot on and honed by his significant experience as a former Capitol Hill staffer and as a senior government affairs consultant in private practice tackling some of the most challenging science policy issues of our time.

There is a lot packed into this episode, so if you or your organization needs to know what is coming with regard to TSCA or general chemical regulation in 2019, listen up!

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 offer something a little different. My colleague Christopher Bryant, a senior regulatory consultant here at the firm, invited Daniella Taveau and Daniel Pearson into our studio to sit down and talk about trade issues.

As you will hear, their conversation ranged far and wide, hitting upon all aspects of the trade discussion which might be relevant to anyone working in the chemical manufacturing space.

Listeners will hear about developing a historical context in which to understand the U.S.’ shifting trade policies; analysis and speculation about current and possible future trade policies as well as their philosophical underpinnings (or lack thereof); and specific discussion about practical current issues such as re-negotiating NAFTA, the effects of the trade war with China, the automobile industry, and what stakeholders should be doing in this moment of protectionist policies.

Chris’ extensive dealings in trade matters pertinent to the chemical community makes him the perfect person to moderate this spirited discussion. There are few areas of chemical regulatory and trade practice that Chis has not explored, and his mastery of this space shines through and guides this session.

Daniella Taveau is a Regulatory and Global Trade Strategist and founder of Bold Text Strategies. Daniella an internationally-recognized expert in developing global business and regulatory strategies encompassing areas such as international trade, finance, agriculture, food safety, and industrial chemicals. She has extensive experience working with senior political officials and multinational corporations in six continents.

Daniel Pearson is principal at Pearson International Trade Services, LLC, a trade policy consultancy. His focus includes speaking and writing on behalf of trade liberalization, business consulting, and consulting on trade remedy proceedings.

If your or your business’ interests have anything to do with trade, then this episode is for you. Without further delay, here’s Chris’ conversation with Daniella and Daniel about all things trade related.

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 my colleague Sheryl Dolan, a senior regulatory consultant here at Bergeson & Campbell, to discuss all things pesticides: past, present, and future.

In our discussion, Sheryl provides the historical and legal/regulatory background necessary to understand the current state of pesticide regulation, which the U.S. Environmental Protection Agency (EPA) manages under the Federal Insecticide, Fungicide, and Rodenticide Act, or FIFRA, as we like to call it.

Among other interesting topics, Sheryl sheds light on the legal and regulatory differences between conventional and non-conventional pesticides, highlights exciting technological developments in biopesticides, and explains the nuances of the regulatory hurdles facing businesses seeking registration of new products.

Leaning on our experience bringing many of these newer products to market, we discuss some of the pitfalls and stumbling blocks that many companies face when first approaching FIFRA and EPA’s Office of Pesticide Programs. Sheryl offers a peak behind the curtain as to how our firm advises clients to prepare for this challenging but also rewarding process.

I was excited to speak with Sheryl about this topic because Sheryl has deep experience in registering new innovations and knowing how to work with EPA scientists and regulators in defining new technologies in a way that even an aging regulatory infrastructure can accommodate. Sheryl is also excellent at shepherding businesses new to this commercial space through this complex regulatory gauntlet. Sheryl is an extremely accomplished expert and a joy to work with here at B&C.

Whether you are an innovator of a new chemical product looking for tips, or a grizzled regulatory veteran looking to bone up on the historical evolution of pesticide regulation law, you are sure to get something out of this conversation. So, without further delay, here is my conversation with Sheryl Dolan about pesticides and navigating new technologies under FIFRA.

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.

Recently, the European Commission kicked-off a process to evaluate and likely revise the current EU Food Contact Materials (FCM) legislation. Now, this is a big deal for any stakeholders in this space—domestic or European -- considering that the current legislation has been in in-place for many years and the proliferation of national standards has greatly complicated an already complex area. That is why I was excited when Renato Addis, of the Brussels-based regulatory consulting firm EPPA and this week’s guest, told me that he had been invited to participate in this kick-off meeting.

Renato talked to me about what he learned during this important meeting and all the reasons why 2019 will be a critical year for anyone following this space. We had an interesting and wide-ranging discussion that covered a whole lot of ground: we discussed the term “fit for purpose”, the EU’s regulation of single-use plastics, the timeline of important opportunities for stakeholders to engage in the process of shaping this new legislation, and even the potential impact of Brexit.

Renato and his firm, EPPA, are long-time friends and collaborators with B&C and our consulting affiliate, The Acta Group, which conveniently has an office in Brussels co-located with EPPA. Renato is a partner with EPPA. His prior’s. experience of working with the EC’s External Affairs Directorate, representing the Commission before the European Parliament, the Economic and Social Committee, and the Committee on the Regions make him ideally suited to discuss the law, politics, and logistics of the FCM initiative.

There is sure to be a lot of interest in this legislative review, and Renato does a fantastic job of helping us here in the U.S. begin to wrap our minds around it.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 took part in a roundtable discussion about biobased products with my colleagues Kathleen Roberts and Dr. Rich Engler. Over the last several years, there has been a significant trend towards the use of renewable, biobased chemicals. Although these chemicals often have similar, if not identical, functionalities as the non-renewable, fossil-based chemical that they are intended to replace, there are a number of regulatory challenges in bringing these to market. In this conversation, we discuss what these commercial challenges are, why the EPA has, in most cases, “pre market approval authority” over the commercialization of these chemicals, and get down into the science of what exactly constitutes a “biobased” chemical anyway.

I am excited to have Rich and Kathleen on this episode. Rich managed EPA’s Green Chemistry program when he was at EPA and has considerable experience with EPA’s review of biobased chemical substances from a TSCA perspective. Kathleen is Vice President of B&C Consortia Management and manages the Biobased and Renewable Products Advocacy Group (BRAG), which has as one of its primary goals aligning regulatory frameworks for biobased and more traditional fossil-based chemical substances.

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 Karin Baron, a senior regulatory consultant here at Bergeson & Campbell and all around expert on chemical product labeling to discuss recent developments pertinent to the United States Hazard Communication Standard (HCS). These regulatory developments have been proposed to bring the HCS more in line with GHS, the Global Hazard Communication Standard. Karin unpacks this complex but really important area of the law and focuses on the aspirational and important goals of harmonization, in a way that focuses on the realities of a world that actually ensures dis-harmonization.

Karin has more than 15 years’ experience developing, implementing, and managing complex chemical regulatory compliance matters for some of the world’s largest industrial and specialty chemical companies. One of Karin’s many talents is the ability to communicate clearly and make sense out of the complex morass of global product hazard warning and labeling requirements.

Our conversation touches upon the intricacies of this issue, including product labeling processes, managing Safety Data Sheets, the implications of harmonization on competition and anti-trust, as well as the interactions with TSCA and 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.

Recently, we published a 3 part article with Bloomberg News entitled: New Chemicals Under New TSCA—Stalled Commercialization. This week, I sat down with Charles Auer, a Senior Regulatory and Policy advisor here at the firm, and Dr. Richard Engler, our Director of Chemistry, two of my co-authors on this article to talk about it.

Our thesis is simple: EPA’s interpretation of our brand new industrial chemical law, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, signed into law in June 2016, needs to change. We believe that Congress never intended fundamentally to overhaul the new chemical review process and to require that EPA regulate north of 80% of all new chemicals. Ironically, that is exactly what the new law is being interpreted to do, in contrast to old law that regulated, appropriately, about 10-15% of new chemicals. Our article explains the new law, contrasts it with the old law, and critically reviews the numbers—the new chemical statistics from EPA’s database, to prove our point. We then offer some suggestions to fix the problem.

Charlie Auer and Rich Engler are the perfect guests. Charlie ran the Office of Pollution Prevention and Toxics for years before he joined our staff and knows more about EPA’s workings in this area than anyone. Rich review about 10,000 new chemical notifications during his 17 years at EPA before joining our staff and has been working closely with clients and EPA to address these issues.

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. Richard Engler, our Director of Chemistry, to discuss Confidential Business Information (CBI). CBI is both a term of art under the Toxic Substances Control Act (TSCA) and can be understood broadly to be anything from trade secrets to you know, the secret sauce of a chemical formulation that makes a product profitable. In our conversation, we focused on how this concept of CBI functions under TSCA and how businesses need to handle CBI during the EPA’s chemical review process.

Rich is the perfect person to discuss the concept of CBI. Rich is 17-year veteran of the U.S. Environmental Protection Agency (EPA). He has participated in thousands of Toxic Substances Control Act (TSCA) substance reviews at EPA, and knows the ins-and-outs of how CBI should be handled.

Our conversation touches upon some of the most important legal and business considerations when dealing with CBI and the EPA: how the EPA exactly defines CBI, where problems can arise, and how to avoid these through careful preparation and planning.

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 Michael Wenk, one of our senior regulatory consultants, to discuss his new book Chemical Regulation in the Middle East. Michael’s book focuses on eight countries in the Middle East that have a combination of well developed and emerging chemical regulatory schemes. His book provides a comprehensive examination of the main chemical management laws in force for each particular country, and summarizes general trends and issues facing the region as a whole.

Michael has managed global regulatory affairs and product stewardship divisions at Fortune 500 chemical and chemical product companies for over 20 years. Michael’s book reflects his expertise in this area of chemical practice, which compliments Michael’s internationally-recognized expertise in chemical regulation in Central and South America.

If you are interested in Michael's book, you can find links to both an executive summary as well as purchasing instructions from our website.

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.