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.

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