December 31, 2017

Zameer Qureshi, “Brexit: An examination of key developments and their potential influence on European chemical laws,” Environmental Law & Management, Volume 29, Issue 4, 2017.

On 23 June 2016, more than 30 million people voted in a referendum to decide whether the United Kingdom (UK) should ‘Leave’ or ‘Remain’ in the European Union (EU). The referendum turnout was 71.8 per cent and the Leave campaign won by 52 per cent to 48 per cent, making ‘Brexit’ an important and imminent probability, with potentially substantial implications for a range of stakeholders, including the chemicals industry. Between then and now, there have...
December 1, 2017

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....
November 14, 2017

Lynn L. Bergeson, “Warning Labels: Q&A Clears Up Proposition 65,” Chemical Processing, November 14, 2017.

California’s Proposition 65 (Prop 65) has been a keen area of client interest for years. One question repeatedly asked is “what is a clear and reasonable warning?” The California Office of Environmental Health Hazard Assessment (OEHHA) released a Questions and Answers for Businesses (Q&A) document specifically covering “clear and reasonable warnings” requirements. The Q&A aims to help companies comply with new Prop 65 notice requirements that become effective next August. This...
October 31, 2017

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...
October 30, 2017

Lynn L. Bergeson, “California Targets Cleaning Product Ingredients,” Chemical Processing, October 30, 2017.

On October 15, 2017, California governor Jerry Brown (D) signed the Cleaning Product Right to Know Act of 2017. The law requires manufacturers of cleaning products to disclose certain chemical ingredients on the product label and on the manufacturer’s website. The online disclosure requirements apply to a designated product sold in California on or after January 1, 2020, while the product label disclosure requirements cover products sold in California on or after January 1, 2021....
October 12, 2017

Lynn L. Bergeson and Bethami Auerbach, “Innovation, Consumer Products, and Legal Risk: Points to Consider,” Paper presented at the 2017 Retail Law Conference, October 12, 2017.

Products that embody tried, true, and especially cutting-edge technologies are generally embraced by retailers as sure-fire pathways to marketing success. What’s not to like about best sellers and newer, faster, cleaner, or otherwise improved products? Sometimes overlooked is what is hidden behind the technology curtain — what is the secret sauce that makes the product faster, cleaner, or better? In marketing products with new modes of action and spiffy new attributes, retailers are part...
October 4, 2017

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....
September 26, 2017

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...
August 22, 2017

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....
August 10, 2017

Lynn L. Bergeson, “NIEHS Using Survey to Update 2012-2017 Strategic Plan,” Nanotechnology Now, August 10th, 2017.

NIEHS is developing a plan to guide its next five years and seeks broad input. NIEHS has created an online survey, “Trends & Insights: Next Steps for NIEHS,” through which stakeholders can provide feedback on the existing Strategic Plan, as well as offer any other relevant comments....
August 2, 2017

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...
August 1, 2017

Lynn L. Bergeson and Timothy D. Backstrom, “Appellate Court Vacates Conditional Nanosilver Registration,” ABA Section of Environment, Energy, and Resources PCRRTK Newsletter, Volume 18, Issue 5, August 2017.

On May 30, 2017, the U.S. Court of Appeals for the Ninth Circuit responded to two petitions for review of the U.S. Environmental Protection Agency’s (EPA) conditional registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) of a nanosilver pesticide product and vacated that conditional registration. NRDC v. EPA, No. 15-72308. The Natural Resources Defense Council (NRDC), the Center for Food Safety (CFS), and the International Center for Technology Assessment (ICTA)...
August 1, 2017

Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala, “EPA’s Evaluation and Determination of Epidemiological Data for Chlorpyrifos,” ABA Section of Environment, Energy, and Resources PCRRTK Newsletter, Volume 18, Issue 5, August 2017.

Among the many legal, regulatory, and policy issues being watched closely by pesticide registrants as the U.S. Environmental Protection Agency’s (EPA) long and contentious review of chlorpyrifos registrations continues is the controversy concerning when EPA may appropriately apply a tenfold uncertainty factor pursuant to the Food Quality Protection Act (FQPA 10X). This issue centers around EPA’s novel and unprecedented use of epidemiological data and the statutory requirements that govern...
July 28, 2017

Lynn L. Bergeson, “The Montreal Protocol is Amended and Strengthened,” Environmental Quality Management, Spring 2017.

Climate change watchers know that October, 15, 2016, was a historic day for international climate action. On that day, nearly 200 countries reached an agreement to phase down use of hydrofluorocarbons (HFCs) at the 28th Meeting of the Parties to the Montreal Protocol in Kigali, Rwanda. The meeting to discuss the Amendment took place from July 15-23, 2016. This seemingly impossible alignment of international interests reflects years of effort. This column summarizes this historic event...
July 24, 2017

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....
July 24, 2017

Lynn L. Bergeson, “The State of Play,” Manufacturing Today, July 24, 2017.

Waters of the United States has been a “fluid” concept for years. It defines the jurisdictional limits of the authority of the United States under the Clean Water Act (CWA). President Trump’s Feb. 28, 2017, Executive Order (EO) directing the U.S. Environmental Protection Agency (EPA) and the U.S. Army Corps of Engineers (Corps) to rescind and replace the Clean Water Rule (CWR) is the latest development to resolve the question of which surface waters and...
July 21, 2017

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....
June 30, 2017

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...
June 22, 2017

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...
June 20, 2017

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....
June 12, 2017

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,...
May 19, 2017

Lynn L. Bergeson, “EPA Eyes ‘Burdensome’ Rules,” Chemical Processing, May 19, 2017.

On February 24, 2017, President Trump issued Executive Order (EO) 13777, Enforcing the Regulatory Reform Agenda. The EO offers opportunities for stakeholders to improve regulations. This article summarizes efforts to implement this EO, and identifies opportunities stakeholders may wish to pursue to eliminate or amend regulatory initiatives they feel have outlived their utility or were ill-conceived from the get-go....
April 14, 2017

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....
April 14, 2017

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...
March 30, 2017

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...
March 22, 2017

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....
February 17, 2017

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....
February 15, 2017

Lynn L. Bergeson, “NIOSH Seeks Comment on Proposed Survey of Engineered Nanomaterial OSH Practices,” Nanotechnology Now, February 15, 2017.

The National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice on February 10, 2017, inviting comment on a proposed information collection plan, “Survey of Engineered Nanomaterial Occupational Safety and Health (OSH) Practices.” The goal of the project is to assess the relevance and impact of NIOSH’s contribution to guidelines and risk mitigation practices for safe handling of engineered nanomaterials in the workplace. The intended use of...
February 3, 2017

Lynn L. Bergeson, Timothy D. Backstrom, and Bethami Auerbach, “Something Inside That Shoebox Really Stinks,” Focus, February 2017.

Each year, millions of consumers, including large numbers of children, are exposed to unknown quantities of anti-mold pesticides when they open a shoebox. Although the active ingredient in these mostly unregistered anti-mold pesticides is undisclosed and the products are marketed as all natural, many stickers contain allyl isothiocyanate (AITC). These stickers have not been registered for this use, nor has this use, or the resulting exposure to consumers, been reviewed for safety by the U.S....
February 1, 2017

Lynn L. Bergeson, “OECD Publishes Report on Alternative Testing Strategies in Risk Assessment of Manufactured Nanomaterials,” Nanotechnology Now, February 1, 2017.

The Organization for Economic Cooperation and Development (OECD) published a report entitled Alternative Testing Strategies in Risk Assessment of Manufactured Nanomaterials: Current State of Knowledge and Research Needs to Advance Their Use....
January 26, 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...
January 24, 2017

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....
January 11, 2017

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...
January 2, 2017

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....
December 21, 2016

Lynn L. Bergeson, “OSHA Sustainability Paper Notes Opportunity to Integrate Sustainability and Nanotechnology Research,” Nanotechnology Now, December 21, 2016.

The Occupational Safety and Health Administration (OSHA) released on December 20, 2016, a white paper entitled Sustainability in the Workplace: A New Approach for Advancing Worker Safety and Health. See https://www.osha.gov/sustainability/docs/OSHA_sustainability_paper.pdf The paper highlights the importance of including worker safety and health in the growing movement toward sustainability and corporate responsibility. According to the paper, research on sustainability does not...
December 1, 2016

Lynn L. Bergeson, “Australian Draft National Standard for the Environmental Risk Management of Industrial Chemicals Addresses Nanomaterials,” Nanotechnology Now, December 1, 2016.

On November 24, 2016, the Australian Department of the Environment and Energy began a public consultation on the Draft National Standard for the Environmental Risk Management of Industrial Chemicals and a supporting Draft Explanatory Document. See http://www.environment.gov.au/protection/chemicals-management/national-standard/draft-national-standard-environmental-risk-management-industrial-chemicals  According to the Department, the primary purpose of the papers is to outline the...
November 28, 2016

Lynn L. Bergeson, “Chemical Compliance: Montreal Protocol Addresses HFCs,” Chemical Processing, November 28, 2016.

October 15, 2016, was a historic day for international climate action: nearly 200 countries reached an agreement to phase out use of hydrofluorocarbons (HFC) at the 28th meeting of the parties to the Montreal Protocol in Kigali, Rwanda. This column summarizes this historic event and its implications. The Montreal Protocol is the international treaty designed to protect the earth’s ozone layer by requiring the phasing out of production and use of chlorofluorocarbons (CFC), substances believed...
November 25, 2016

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,...
October 27, 2016

Zameer Qureshi, “The REACH Implementing Regulation on joint submission of data and data sharing: is it fair, transparent and non-discriminatory?,” Elements, the Magazine of Chemicals Northwest, Autumn, 2016.

Commission Implementing Regulation (EU) 2016/9 (Implementing Regulation) entered into force with retroactive effect on 26 January 2016, providing several new and important considerations and obligations for companies sharing data under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. The Implementing Regulation aspires to: (1) provide useful clarity on data sharing and data compensation under REACH by providing detail on the “fair, transparent and...
October 24, 2016

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...
October 14, 2016

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....
September 30, 2016

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...
September 20, 2016

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...
August 17, 2016

Lynn L. Bergeson, “Pollution Monitoring: New Tools Help Speed Compliance,” Chemical Processing, August 17, 2016.

The U.S. Environmental Protection Agency (EPA) has made much of its “Next Generation Compliance” initiative, created “to increase compliance with environmental regulations by using advances in pollutant monitoring and information technology combined with a focus on designing more effective regulations and permits to reduce pollution.” This involves more effective regulations and permits that include built-in compliance mechanisms, such as continuous monitoring for stationary sources;...