TSCA

Lynn L. Bergeson, "Citizens Challenge EPA," Chemical Processing, March 21, 2018.

A petition filed under Section 21 of the Toxic Substances Control Act (TSCA) was one of the first actions reviewed by a federal district court since TSCA was substantially rewritten in June 2016.The rulings described below pose interesting and potentially formidable challenges for TSCA stakeholders.

Lynn L. Bergeson, "New TSCA inspires new litigation," Chemical Watch Global Business Briefing, March 2018.

When the Toxic Substances Control Act (TSCA) was legislatively ‘modernised’ in June 2016, no one in the legal community doubted litigation was in our collective future. We have not been disappointed.

The US Environmental Protection Agency (EPA) and its legal counsel for these purposes, the US Department of Justice (DoJ), are facing multiple lawsuits in several federal appeals courts and the very real possibility of more litigation deriving from TSCA Section 21 citizen petitions in the light of a recent decision. While none of this is especially unexpected, it is nonetheless disquieting. This article is a quick summary of where the cases stand and a discussion of what is at stake.

Lynn L. Bergeson, "EPA Proposes TSCA User Fees," Chemical Processing, February 21, 2018.

The cost of compliance with the Toxic Substances Control Act (TSCA) will soon rise. On February 8, 2018, the U.S. Environmental Protection Agency (EPA) signed off on proposed TSCA user fees. As amended by the Frank Lautenberg Chemical Safety for the 21st Century Act, TSCA authorizes the EPA to levy fees on certain chemical manufacturers, including importers and processors, to “provide a sustainable source of funding to defray resources that are available for implementation of new responsibilities under the amended law.” This column summarizes the proposal and its significance.

Lynn L. Bergeson, "Expect the EPA to Be Busy in 2018," Chemical Processing, January 23, 2018.

The new year promises to be a busy one in the chemical area. The U.S. Environmental Protection Agency (EPA) hit all of its new Toxic Substances Control Act (TSCA) marks in timely promulgating rules or taking other steps required by the new TSCA. 

Lynn L. Bergeson, "EPA: Mercury Merits Attention," Chemical Processing, January 2, 2018.

The U.S. Environmental Protection Agency (EPA) continues to implement reporting requirements pertinent to the supply, use and trade of mercury in the United States. This column provides more information and a closer look into the EPA’s October 2017 proposed rule.

Lynn L. Bergeson, "Resetting the TSCA Inventory: Why This Is Important," Environmental Quality Management, Volume 27, Issue 1, Fall 2017.

On August 11, 2017, the U.S. Environmental Protection Agency (EPA) published the third Toxic Substances Control Act (TSCA) framework final rule in the Federal Register, the TSCA Inventory Notification (Active-Inactive) Requirements (EPA, 2017). This final rule is now in effect. This Washington Watch column explains why the rule is important, and what stakeholders should be doing to protect their interests.

Lynn L. Bergeson, "Information Required," Manufacturing Today, November 1, 2017.

After a decade of trying, the U.S. Environmental Protection Agency (EPA) now has in effect a final Toxic Substances Control Act (TSCA) Section 8(a) information gathering rule focusing on nanoscale materials. This article explains the final rule, what stakeholders are required to do, and by when.

Lynn L. Bergeson, Richard E. Engler, Ph.D., and Lauren M. Graham, Ph.D., "TSCA Affects on Algae, Other Novel Biosources, and Bioprocesses," Industrial Biotechnology, Volume 13, Issue 5, October 2017.

The Toxic Substances Control Act (TSCA) is the federal gap-filling chemical control law regulating chemical substances used in applications other than food, drugs, cosmetics, and pesticides, and other uses that are regulated by other federal authorities. Chemical product innovators need to understand how TSCA, significantly amended in 2016, applies to biomass starting material, including industrial microorganisms (such as algae), intermediates, and commercial products, and build TSCA compliance into business timelines and budgets. Doing so will better assure uninterrupted business operations and consistent TSCA compliance.

Lynn L. Bergeson, "EPA Promulgates Final SNUR for Bimodal Mixture Consisting of MWCNTs and Other Classes of CNTs," Nanotechnology Now, October 4, 2017.

On October 3, 2017, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes (MWCNT) and other classes of carbon nanotubes (CNT), which was the subject of premanufacture notice (PMN) P-11-482.

Lynn L. Bergeson, "EPA Issues Final TSCA Inventory Notification Rule," Manufacturing Today, September 26, 2017.

On June 22, 2017, the U.S. Environmental Protection Agency (EPA) issued the final inventory notification rule under the amended Toxic Substances Control Act (TSCA). The rule establishes an electronic notification of chemical substances listed on the TSCA Inventory that were manufactured/imported for nonexempt commercial purposes during the 10-year time period ending on June 21, 2016, with provision to also allow processor notification. These notifications will be used to distinguish "active" from "inactive" substances. A summary of this rule follows.

Lynn L. Bergeson, "Chemical Compliance: Get Familiar with TSCA’s Inventory Rule," Chemical Processing, August 22, 2017.

On August 11, 2017, the U.S. Environmental Protection Agency (EPA) published the third Toxic Substances Control Act (TSCA) framework final rule in the Federal Register, the TSCA Inventory Notification (Active-Inactive) Requirements. This final rule is now in effect. Here is why the rule is important, and what stakeholders should be doing to protect their interests.

Lynn L. Bergeson, James V. Aidala, Jr., Charles M. Auer, Richard Engler, and Oscar Hernandez, "Practitioner Insights: Enhancing TSCA Reform Implementation," BNA Daily Environment Report, August 2, 2017.

The Frank R. Lautenberg Chemical Safety for the 21st Century Act significantly amended the Toxic Substances Control Act. The act, which has been in force for just over a year, made substantive changes to multiple sections of TSCA that are proving to be even more consequential than anticipated (new TSCA is identified as Pub. L. No. 114-182 and old TSCA was identified as Pub. L. No. 94-469).

This paper, authored principally by former EPA officials and a practicing TSCA lawyer, all with long experience under old TSCA, provides suggestions for new approaches or ‘‘fixes’’ that could assist the agency and interested groups in moving toward smoother implementation of the new law, achieving policy goals, and ensuring greater transparency. These suggestions are presented in no particular order and in the spirit of urging other stakeholders to also think of creative ways to ensure that new TSCA fulfills Congress’s mandate to develop an effective domestic chemical management program.

Lynn L. Bergeson, "EPA’s Regulatory Agenda Includes TSCA Section 8(a) Nanomaterials Rule with TBD Effective Date," Nanotechnology Now, July 24, 2017.

On July 20, 2017, the Trump Administration published its Unified Agenda of Regulatory and Deregulatory Actions. The Agenda includes a U.S. Environmental Protection Agency (EPA) item (RIN 2070-AJ54) concerning the Toxic Substances Control Act (TSCA) Section 8(a) reporting rule for nanoscale materials.

Lynn L. Bergeson, "The Final Rule," Manufacturing Today, July 21, 2017.

The U.S. Environmental Protection Agency (EPA) issued on Jan. 12, 2017, a final rule under Section 8(a) of the Toxic Substances Control Act (TSCA) establishing reporting and recordkeeping requirements for certain discrete forms of chemical substances that are manufactured or processed at the nanoscale. This column summarizes the rule.

Lynn L. Bergeson, "EPA Issues TSCA Framework Rules," Chemical Processing, July 18, 2017.

The U.S. Environmental Protection Agency (EPA) issued in June final framework rules under the Toxic Substances Control Act (TSCA). Each is summarized in the article.

Lynn L. Bergeson, "The Trump Administration and Likely Impacts on Environmental Law and Policy," Environmental Quality Management, Volume 26, Issue 4, Summer 2017.

2016 was full of surprises, two of which are driving much of the environmental agenda for the U.S. Environmental Protection Agency (EPA) in 2017.  First, Congress significantly amended the Toxic Substances Control Act (TSCA) in June of 2016.  The changes are intended to reform the program to address the widely recognized deficiencies in the law, especially regarding existing chemicals, chemical testing, Confidential Business Information (CBI) claims, and preemption of state actions.  EPA has been busy implementing the new law, as the all-important “framework rules” must be issued in final in June 2017.  The second surprise event was even more unexpected -- the election of Donald Trump as President.  His election is already having a significant impact on environmental law and policy.  This column briefly offers some thoughts and predictions on the impact of the new Administration on environmental issues of interest to our readers.

Lynn L. Bergeson, Daniel B. González, Anabela Aldaz, and Christopher J. McNevin, "Mini-Roundtable: Environmental Disputes," Corporate Disputes, July-September, 2017.

A major change, brought about by the November elections, is the uptick in citizen suit litigation, and lawsuits brought by third parties against the government. Given the current administration’s position on climate change, environmental regulation generally, and the perception that regulations impede economic growth and job development, there has been a significant slowdown in regulatory and administrative activity and the initiation of enforcement actions. NGOs and third-party activists will continue to fill this void by private lawsuits as citizen litigants.

Lynn L. Bergeson, "Regulation: Prepare for the TSCA Inventory Reset," Chemical Processing, June 20, 2017.

With the recent 2016 Chemical Data Reporting (CDR) dataset and the initial interim list of “active” substances released with the February 2017 copy of the Toxic Substances Control Act (TSCA) Inventory, the magnitude of effort needed for the TSCA Section 8(b)(4) Inventory Reset is becoming clear. Stakeholders should waste no time in preparing to meet their obligations; the final rule was issued in June.

Lynn L. Bergeson, "TSCA Implementation: What’s In Trump’s Playbook?," The ABA SEER Joint Newsletter: Energy, Climate Change, and Environmental Law under Trump, Volume 18, Issue 1, June 2017.

Most people knew candidate Trump was no fan of climate change regulation or the Clean Water Rule (CWR). Mr. Trump’s views on chemical management were never clearly articulated, however. Some may have interpreted this notable silence as support for Toxic Substances Control Act (TSCA) reform, given the broad bipartisan support it enjoyed before its enactment last June. Others may have assumed candidate Trump, in the heat of the campaign, was unaware of the significant commercial, legal, and trade implications occasioned by enactment of the Frank R. Lautenberg Chemical Safety of the 21st Century Act (Lautenberg), the most sweeping legislative overhaul to our domestic chemical management law in four decades. Similar to candidate Trump, President Trump has kept his TSCA cards close to his vest. To the extent money talks, the President’s fiscal year 2018 budget doubles down on slashing the U.S. Environmental Protection Agency’s (EPA) budget by over 30 percent. The chemicals program, however, would largely be spared cuts and in fact would get a boost under the Trump budget submitted to Congress in late May, suggesting solid support for ensuring the new law is implemented timely.

Lynn L. Bergeson, "TSCA Reform: Key Provisions and Implications," Environmental Quality Management, Winter 2016.

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The text of the law is available at: http://www.congress.gov/bill/114th-congress/house-bill/2576/text. The law substantially amends the Toxic Substances Control Act (TSCA), and in so doing, fundamentally alters the domestic management of industrial chemicals, the lifeblood of many manufacturing processes. This article summarizes key changes and explains their likely impacts on the manufacturing sector. For the purposes of this article, reference is made to the amended TSCA as “new TSCA.”

Lynn L. Bergeson, "TSCA Targets Mercury: EPA regulation aims to minimize mercury use," Chemical Processing, April 14, 2017.

On March 29, 2017, the U.S. Environmental Protection Agency (EPA) released its initial inventory report of mercury supply, use and trade in the United States pursuant to the requirements of the amended Toxic Substances Control Act (TSCA). This article outlines this development in the context of mercury regulation under the TSCA.

Lynn L. Bergeson, Douglas Bryden, and Kindra L. Kirkeby, "Chemical Management: What All Environmental, Energy, and Resources Lawyers Need to Know about TSCA Reform and Why," American Bar Association Section of Environment, Energy, and Resources, March 30, 2017.

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg). The new law amended significantly the Toxic Substances Control Act (TSCA) and in so doing, is redefining supply chain relationships, rewriting the rules of engagement for due diligence in mergers and acquisitions, reopening debate on new avenues in product liability and tort law, and raising important questions regarding right-to-know vs. confidential business information (CBI). TSCA, as amended, is no longer an arcane chemical statute that only chemists, consultants, and counsel for chemical manufacturers need to understand. We discuss below the significant changes in commercial transactions, supply chain relationships, and related legal areas of which Section members need to be aware, anticipate, and address. We also briefly consider TSCA and its alignment and differences with the European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, and speculate on the impact Brexit might have on chemical management.

Lynn L. Bergeson, "TSCA Implementation Remains On Target: The EPA is issuing framework rules on a timely basis," Chemical Processing, March 22, 2017.

Implementation of the newly amended Toxic Substances Control Act (TSCA), signed into law last June, is in full swing. The U.S. Environmental Protection Agency (EPA) has been working hard to meet statutorily imposed deadlines for promulgating three “framework” rules by June 2017. To date, the EPA is on target. This column discusses the three framework rules.

Lynn L. Bergeson, "Report Your Nanoscale Materials," Chemical Processing, February 17, 2017.

The U.S. Environmental Protection Agency (EPA) finally concluded January 12, 2017, a ten-year effort to issue a Toxic Substances Control Act (TSCA) Section 8(a) rule establishing reporting and recordkeeping requirements for certain discrete forms of chemical substances manufactured or processed at nanoscale. This column summarizes the rule. Reports are due to the EPA no later than May 12, 2018. The final rule is effective May 12, 2017.

Lynn L. Bergeson, Charles M. Auer, and Carla Hutton, "Practitioner Insights: A Review and Analysis of TSCA Reform Provisions Pertinent to Manufacturers and Processors of Nanoscale Materials," BNA Daily Environment Report, January 26, 2017.

On June 22, 2016, President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Pub. L. No. 114-182, and in so doing significantly revised the Toxic Substances Control Act (TSCA) for the first time since its enactment in 1976. This article reviews and analyzes TSCA as amended and focuses narrowly on how new TSCA specifically impacts nanoscale materials. Although the new TSCA dramatically changes how the Environmental Protection Agency (EPA) evaluates and manages industrial chemicals, including nanoscale chemicals, the absence of words or phrases such as nano or nanoscale materials means that there are no specific or additional requirements that apply explicitly to such materials. This was a significant shift from many of the earlier TSCA reform bills, which explicitly addressed nanoscale materials by proposing new definitions such as “substance characteristics” and “special substance characteristics” that included concepts such as size or size distribution; shape; surface structure; and reactivity. The new TSCA is noticeably silent on this subject and does not distinguish nanoscale materials or treat such materials differently from other chemical substances regulated under TSCA.

Lynn L. Bergeson, "The EPA Seems Set for a Busy 2017 Under Trump Administration," Chemical Processing, January 24, 2017.

Last year was full of surprises, two of which will drive much of the agenda in 2017 for the Office of Chemical Safety and Pollution Prevention (OCSPP) of the U.S. Environmental Protection Agency (EPA). First, Congress significantly amended the Toxic Substances Control Act (TSCA). Although many thought the chances of successful TSCA legislation were slim, the second surprise event was even more unexpected — the election of Donald Trump as President.

Lynn L. Bergeson, "Enlisting Modern Technologies to Ensure a Safe Food Supply," Natural Resources & Environment, Volume 31, Issue 3, Winter 2017.

Nanotechnology, biotechnology, and synthetic biology are the ploughs and tractors of the twenty-first century. These precision farming tools are ensuring a sustainable food supply otherwise threatened by climate change and population growth, among other global challenges. Genetically modified E. coli is being used to produce synthetically derived pheromones, substances beneficially used in agricultural applications to attract, capture, and eliminate harmful pests. Nanopesticides and nanofertilizers are being effectively used in drought-stricken regions, eliminating or minimizing the need for conventional agricultural chemicals. These and similar technologies are essential to enable today’s agricultural professionals to compete with an increasingly unforgiving Mother Nature and an ever-increasing demand for food.

 

These emerging technologies do not come without potential risks, however. How to regulate them is a  subject upon which stakeholders disagree.

 

Against this backdrop, this article considers emerging agricultural technologies, and discusses domestic agricultural oversight systems and their ability to keep pace with innovation. As discussed below, the domestic governance system is capable of addressing comprehensively the potential risks posed by these evolving technologies. The system, however, could be improved by better integration of measures  to educate policy makers and regulators on these technologies, and greater involvement by the private  sector in facilitating a predictable flow of information on these technologies to all stakeholders.

Lynn L. Bergeson, "EPA Targets Formaldehyde Vapors," Chemical Processing, January 2, 2017.

On December 12, 2016, the U.S. Environmental Protection Agency (EPA) issued a long-awaited final rule to reduce exposure to formaldehyde vapors from certain wood products produced domestically or imported into the United States. Formaldehyde is found in the adhesives used in a range of composite wood products. This column summarizes the new rule.

Lynn L. Bergeson, "Next Generation Compliance and Its Implications for Industry," Environmental Quality Management, Volume 26, Issue 1, Fall 2016.

“Next Generation Compliance” is the U.S. Environmental Protection Agency’s (EPA) signature initiative intended to increase compliance with environmental regulations by using advances in pollution monitoring and information technology and by more effectively using and designing regulations and permits to reduce pollution and enhance compliance.  This column describes EPA’s initiative, discusses several examples of its applications in rulemakings and civil enforcement settlements, discusses another new compliance-related tool, eDisclosure, and outlines the implications for industry of these novel approaches to incentivizing compliance.

Lynn L. Bergeson, "EPA Speeds Review of Chemicals," Chemical Processing, October 24, 2016.

The U.S. Environmental Protection Agency (EPA) is continuing its brisk pace to be on target with implementing the new requirements of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (see “Grasp the Gravity of the New TSCA,” and “EPA Releases Q&As on New TSCA”). Congress has in its sights persistent, bioaccumulative, and toxic (PBT) chemicals — with the goal to reduce exposures to them. The EPA’s recent action to fast track review of five such chemicals does just that. Here’s what the EPA announced, and its impact on industry.

Charles M. Auer, Lynn L. Bergeson, "Role of ‘Conditions of Use’ Under Sections 5 and 6 of Amended Toxics Law," BNA Daily Environment Report, October 14, 2016.

President Barack Obama signed into law amendments to the Toxic Substances Control Act on June 22. The amendments bring sweeping changes to the nation’s primary chemicals law. In this Bloomberg BNA Insights, Charles M. Auer and Lynn L. Bergeson look specifically at the role of ‘‘conditions of use’’ in Sections 5 and 6 under the amended law and other chemical exposure considerations.

Charles M. Auer, Lynn L. Bergeson, "Is The Section 5 Review Period Fixed Or Flexible In New TSCA?," ABA Section of Environment, Energy, and Resources PCRRTK Newsletter, September, 2016.

 Among its other requirements and authorities, Section 5 of new TSCA generally requires that a company timely submit to EPA a notice of its intent to manufacture or process a new chemical or significant new use (NC/SNU). EPA is then required to conduct a review of the Section 5(a)(1) notice and make a determination on the NC/SNU and take required additional actions. Questions have been raised as to whether the review period is fixed and requires that EPA determinations and actions be completed within that period, or if the statute can be read to permit a more flexible review period along the lines of how it was interpreted and applied in old TSCA with the use of voluntary suspensions. This article analyzes that question.

Lynn L. Bergeson, "EPA Releases Q&As on New TSCA," Chemical Processing, September 20, 2016.

On September 2, 2016, the U.S. Environmental Protection Agency (EPA) released additional guidance on its implementation of the new Toxic Substances Control Act (TSCA) in the form of additional questions and answers (Q&As). This column explains the significance of this guidance.

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act, ushering in a significantly enhanced, and effective immediately, chemical management law. (See “Grasp the Gravity of the New TSCA.")

The EPA has wasted no time in beginning the challenging process of implementing the law. This first step consists of preparing rulemakings and issuing guidance documents in the form of useful Q&As on a variety of topics.

Charles M. Auer, "Old TSCA, New TSCA, and Chemical Testing," BNA Daily Environment Report, August 16, 2016.

It is the author’s view that the central failing of old TSCA was its inability to produce the testing needed by EPA to assess and understand the hazards, exposures, and risks of existing chemicals. New TSCA makes important changes to the authority available to EPA to compel industry to generate the information needed by EPA to meet the purposes articulated under the new law. This paper briefly reviews the issues and problems that EPA encountered in using old TSCA for this purpose, discusses the improvements in new TSCA, and discusses why the author believes they offer the potential of future success in the testing area.

Lynn L. Bergeson, Charles M. Auer, "An Analysis of TSCA Reform Provisions Pertinent to Industrial Biotechnology Stakeholders," Industrial Biotechnology, Volume 12, Issue 4, August 2016.

The Frank R. Lautenberg Chemical Safety for the 21st Century Act, P.L. 114-182, significantly amends the Toxic Substances Control Act (TSCA). The Act was signed into law by President Obama on June 22, 2016. The date of signature is both the date of enactment and of entry into force of amended TSCA. New TSCA fundamentally changes the U.S. Environmental Protection Agency's (EPA) approach to evaluating and managing industrial chemicals, including genetically engineered microorganisms. The body of changes, the careful balancing of countless competing needs and interests, and artful drafting yield a statute that has been greatly strengthened and addresses virtually all of the deficiencies that have impeded TSCA's effectiveness over the years.  The changes are consequential, and stakeholders in the industrial biotechnology community could be greatly impacted by them, depending upon how EPA interprets and discharges its new authorities. This article highlights key changes of which stakeholders should be aware, sets forth the law's schedule by which EPA is to implement the changes, and identifies opportunities for stakeholders to engage in rulemaking or other activities to help influence the implementation process to ensure that it is firmly rooted in a clear understanding of the science, and of the risks and benefits offered by products of industrial biotechnology.

Kathleen M. Roberts, Richard E. Engler, Ph.D., Charles M. Auer, Lynn L. Bergeson, "An Analysis of Section 8 of the New Toxic Substances Control Act," BNA Daily Environment Report, August 9, 2016.

The Frank R. Lautenberg Chemical Safety for the 21st Century Act significantly amends the Toxic Substances Control Act (TSCA), particularly with regard to Section 8 record keeping and reporting obligations. This article highlights a number of important changes and deadlines of which companies subject to TSCA should be aware.

Lynn L. Bergeson, "Grasp the Gravity of the New TSCA," Chemical Processing, July 13, 2016.

The Frank R. Lautenberg Chemical Safety for the 21st Century Act makes seismic changes in domestic industrial chemical management. If you think the extensive revisions to the Toxic Substances Control Act (TSCA) enacted on June 22, 2016, don’t impact your business, think again. TSCA reform affects virtually every domestic business sector involving chemicals and manufactured goods containing chemicals, and will continue to do so for years to come.

Lynn L. Bergeson, "In-House Counsel Beware: TSCA Reform Impacts Everyone," Law360, June 15, 2016 .

In-house counsel unfamiliar with the tsunami-like changes in domestic chemical management headed our way soon may wish to read this article. If you think for a second that the extensive revisions to the Toxic Substances Control Act (TSCA) expected to be enacted imminently do not impact your legal practice or your client’s business operations, think again. TSCA reform impacts virtually every business sector in the United States, and will continue to do so for years to come. Here are the reasons why you should care.

Lynn L. Bergeson, "TSCA Reform: Is It Still in Our Future?," Industrial Biotechnology, April 5, 2016.

Toxic Substances Control Act (TSCA) reform has been a “work in progress” for years. House and Senate passage in 2015 of substantive TSCA reform measures considerably improved the odds that Congress would enact TSCA-reform legislation in 2016. Recent events suggest otherwise, however, and as of this writing in mid-March the fate of TSCA reform remains decidedly uncertain. Momentum has dissipated as a dithering House has been slow to engage with Senate counterparts to reconcile the different approaches contemplated under each bill. The surprisingly harsh Republican response to Associate Supreme Court Justice Scalia’s untimely demise has hardened the partisan divide that threatens to tank Congressional action on any important initiative, let alone legislation as significant and potentially divisive as TSCA reform. It is hoped that cooler heads will prevail and leverage the hard work and momentum that has brought us to this momentous place in history. This Commentary provides an update on the current state of TSCA reform efforts.

Charles M. Auer, Frank D. Kover, James V. Aidala, Mark Greenwood, "Toxic Substances: A Half Century of Progress," Protecting the Environment: A Half Century of Progress, EPA Alumni Association, March 1, 2016.

PUBLIC CONCERNS LEAD TO CHEMICAL LAW

In the 1960s and early to mid-1970s, new reports of chemicals causing cancer appeared in the press or on TV almost every month. Polychlorinated biphenyls (PCBs), used in electrical transformers for over 40 years, were being found in fish and environmental samples from around the country. Other chemicals, including those not thought to be harmful, caused serious health or environmental effects. Chlorofluorocarbons (CFCs) were depleting the earth’s protective ozone layer. Asbestos, a mineral fiber widely used in insulation, caused lung cancer, especially in workers. Polybrominated biphenyls used as flame retardants were mistakenly mixed into animal feed and poisoned people and cattle in Michigan. Eating fish contaminated with mercury caused a severe neurological syndrome in adults as well as birth defects in Minamata, Japan. And the list went on.

Although society reaps enormous benefits from chemicals, there was little or no knowledge of the effects on health or the environment of the thousands of chemicals used and released into the  environment. There was not even a list of the chemicals made and used in America. The drumbeat of concerns contributed to a growing realization that environmental chemicals might cause major problems. People were suddenly aware that a man-made chemical environment of unknown dimensions literally surrounded them. Other studies pointed to the large gap in existing laws for dealing with these problems. During the 1970s, the groundswell of public concern resulted in legislative action.

Ruth C. Downes-Norriss, Leslie S. MacDougall, "What is Happening with Chemical Regulation Outside of the European Union?," Elements, the Chemicals NorthWest Magazine, Autumn 2015.
James V. Aidala, Jr., Charles M. Auer, Lynn R. Goldman, M.D., and James B. Gulliford, "Practical Advice for TSCA Reform: An Insider Perspective," The American Bar Association Section of Environment, Energy, and Resources Special Committee on TSCA Reform, August 2010.
Charles M. Auer, James V. Aidala, Lynn L. Bergeson, "TSCA Reform Legislation and Its Workability: Thoughts on Steps to Help Ensure Successful Implementation at the Outset and Over Time," Bloomberg BNA Daily Environment Report, July 23, 2015.

Competing proposals are working their way through the House and Senate to amend the Toxic Substances Control Act, the nation’s primary law for managing chemicals in commerce. In this article, former senior Environmental Protection Agency officials Charles Auer and James Aidala and attorney Lynn Bergeson discuss making the bill clearer and how congressional direction can be provided on what EPA is to do with certain new provisions to implement them in the first years of any amended TSCA.

Richard E. Engler, Ph.D., "The Impact of Toxic Substances Control Act Nomenclature on the Commercialization of Biobased Chemicals," AOCS Inform, July/August, 2015.

Imagine receiving a certified letter from the US Environmental Protection Agency (EPA) announcing that it plans to conduct an audit of your company’s facility in two weeks. The audit will focus on your company’s compliance obligations as a chemical manufacturer under the Toxic Substances Control Act (TSCA). Would you be prepared or are you unsure of what TSCA is and whether it applies to you? This article explains how TSCA applies to biobased chemicals and how nomenclature and chemical identity can impact commercialization.

Richard E. Engler, Ph.D., "Thought Leadership: The Toxic Substances Control Act and the Bioeconomy: Part 3, Call to Action," Biofuels Digest, May 18, 2015.

In the second installment of this series, I wrote about how the Toxic Substances Control Act (TSCA) regulates products across a manufacturing process, from feedstock to product. In this last installment, I present options for updating TSCA and the related implementing regulations to put novel, biobased chemistry on an even footing with incumbent products and processes that were grandfathered in as part of the original TSCA Inventory. The key is to find a way to level the field without compromising the U. S. Environmental Protection Agency’s (EPA) mission and authority to protect human health and the environment.

Lynn L. Bergeson, "TSCA Reform May Be Closer Than You Think," Chemical Processing, May 18, 2015.

On April 28, 2015, the Senate Committee on Environment and Public Works held a hearing to consider the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697). Since then, S. 697 has gained additional backing from both Republicans and Democrats. These events are important because they demonstrate significant bipartisan support for reform of the Toxic Substances Control Act (TSCA), and suggest TSCA reform actually may be in our future.

Richard E. Engler, Ph.D., "Thought Leadership: The Toxic Substances Control Act and the Bioeconomy: Part 2, Reportable Substances across the Manufacturing Process," Biofuels Digest, May 1, 2015.

In the first installment of this series, I wrote about how the Toxic Substances Control Act (TSCA) regulates products. In this article, we will look across a manufacturing process. TSCA applies to chemical substances that are used for purposes other than food, food additives, animal feed, cosmetics, drugs, tobacco and tobacco products, pesticides, munitions, and nuclear source materials. Biobased chemicals, that is, chemicals made from lignocellulose or other biomass, are finding markets in food and cosmetic markets, but much of the recent innovation focuses on biobased fuels and commodity chemicals. For these final products, TSCA applies. Chemical products must be listed on the TSCA Inventory of Chemical Substances (the Inventory) or be eligible for an exemption. If the product is not listed on the Inventory, the manufacturer must file a premanufacture notification 90 days before manufacturing (or importing) that substance or qualify for an appropriate exemption.

Richard E. Engler, Ph.D., "The Toxic Substances Control Act and the Bioeconomy: Part 1, The Impact of Nomenclature on the Commercialization of Biobased Chemicals," Biofuels Digest, April 26, 2015.

Bioeconomy companies recognize that their products are subject to a variety of federal chemical regulations, especially if they sell food, food additives, cosmetics, or other products regulated by the U.S. Food and Drug Administration (FDA). Unfortunately, companies may not recognize all the ways that the U.S. Environmental Protection Agency (EPA) regulates bioproducts, perhaps because of the understandable focus on the Clean Air Act (CAA) and the various programs under that authority: Renewable Fuel Standard, fuel additive registration, or other CAA submissions. TSCA also applies to bioproducts used in industrial, commercial, and most consumer products, including fuels. TSCA reporting requirements are in addition to, and separate from, CAA reporting.

Lynn L. Bergeson, "EPA Eyes Nanoscale Materials," Chemical Processing, April 13, 2015.

On April 6, 2015, the U.S. Environmental Protection Agency (EPA) proposed a Toxic Substances Control Act (TSCA) Section 8(a) rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured (including imported) or processed at the nanoscale. 

Lynn L. Bergeson, "EPA Proposes Significant New Use Rule for Certain Nonylphenol and Nonylphenol Ethoxylates," Environmental Quality Management, Spring 2015.
On October 1, 2014, the US Environmental Protection Agency (EPA) proposed a Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA) for certain related chemical substances commonly known as nonylphenols (NP) and nonylphenol ethoxylates (NPE) (Federal Register [Fed. Reg.], 2014). For 13 NPs and NPEs, the EPA would designate any use as a “significant new use,” and for two additional NPs, the EPA would designate that any use other than use as an intermediate or use as an epoxy cure catalyst would constitute a "significant new use" (Fed. Reg., 2014, p. 59186). For a variety of reasons, which are discussed next, the proposed rule is interesting and significant. The EPA has already agreed to extend the comment period to mid-January in response to several industry-trade groups’ requests for more time.
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