April 21, 2021

Lynn L. Bergeson, “EPA Eyes Stricter Phosphogypsum Rule,” Chemical Processing, April 21, 2021.

In early April, a Florida pond that sits atop phosphogypsum tailings sprung a leak. State authorities scrambled to keep the pond from collapsing and flooding the surrounding area with millions of gallons of contaminated water. This situation likely wasn’t top of mind on February 8, 2021, when a group of environmental protection advocates prepared and submitted to the U.S. Environmental Protection Agency (EPA) a petition under Section 21 of the Toxic Substances Control Act (TSCA)....
April 19, 2021

Lynn L. Bergeson, “EC Scientific Committee’s Preliminary Opinions for Certain Gold and Platinum Nanomaterials Open for Comment,” Nanotechnology Now, April 19, 2021.

On April 16, 2021, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) posted two preliminary opinions for comment: Opinion on Gold (nano), Colloidal Gold (nano), Gold Thioethylamino Hyaluronic Acid (nano) and Acetyl heptapeptide-9 Colloidal gold (nano) and Opinion on Platinum (nano), Colloidal Platinum (nano) and Acetyl tetrapeptide-17 Colloidal Platinum (nano)....
April 16, 2021

Lynn L. Bergeson, “The New Toxic Substances Control Act is Now Five Years Old: A Report Card – It Is a Mixed Bag, but We Are Getting There,” The Debate, from ELI The Environmental Forum , May/June 2021.

June 22 of this year will mark the fifth anniversary since President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Popularly still known by the name of the 40-year-old statute it replaced, the new version of the Toxic Substances Control Act had a vision to follow in reforming a system for evaluating and regulating chemicals in commerce that everyone, from industry to green NGOs to government officials, agreed was weak...
March 17, 2021

Lynn L. Bergeson, “The importance of regulatory diligence in funding,” Financier Worldwide, April 2021.

Lawyers counselling companies in the biotechnology, biopesticide and related crop protection and industrial biotechnology areas appreciate the critically important role federal agencies play in ensuring the success of start-up businesses. Federal agencies, including the US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA), among others, wield enormous power over businesses that require premarket product approval. While we product approval practitioners know...
March 14, 2021

Lynn L. Bergeson, “Better Understand TSCA’s Long Reach,” Chemical Processing, March 14, 2021.

If anyone on planet Earth thinks the Toxic Substances Control Act (TSCA), as amended, is not commercially consequential, think again. The implementation of the 2016 amendments by the U.S. Environmental Protection Agency (EPA) is triggering tremendous commercial disruption. The EPA’s March 8, 2021, announcement seeking comment on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, and, importantly, granting a rare “No Action Assurance”...
March 10, 2021

Lynn L. Bergeson, “What Might EHS Expect from the Biden EPA?,” EHS Daily Advisor, March 10, 2021.

As a new administration arrives in Washington, D.C., few things are certain except that 2021 is sure to be an eventful year. While underlying partisan jockeying and prospects for bipartisan cooperation will greatly affect what may happen in the more limited context of chemical regulation, the Biden administration has already laid out priorities on the environment that will surely influence the U.S. Environmental Protection Agency’s (EPA) positions on climate change, the role of science, and...
February 22, 2021

Richard E. Engler, Ph.D. and Jeffery T. Morris, Ph.D., “Why the US EPA can, and should, evaluate the risk-reducing role a new chemical may play if allowed on the market,” Chemical Watch, February 22, 2021.

In the 21st century, we take as given a continuous stream of new and better products. From electronics to building materials to transportation solutions, the flow of new and better products and applications seems unending. New chemical substances play a fundamental role in creating those products and making existing products better. If the pipeline of new chemicals were closed off, the flow of new products and applications would slow to a trickle and eventually dry...
February 21, 2021

Lynn L. Bergeson, “EPA Orders Testing For Nine Chemicals,” Chemical Processing, February 21, 2021.

The U.S. Environmental Protection Agency (EPA) announced on January 15, 2021, that it has issued test orders under Section 4 of the Toxic Substances Control Act (TSCA) to obtain additional data on nine of the next 20 chemicals undergoing risk evaluation. Many in the industrial chemical community expect the EPA to use its TSCA testing authority much more in the coming years. The January orders seem to confirm that expectation. This article discusses the significance...
February 4, 2021

Lynn L. Bergeson, “Environmental Justice: Operationalizing TSCA to Fulfill Its Destiny,” American College of Environmental Lawyers (ACOEL) Blog, February 4, 2021.

The Biden Administration has embraced environmental justice with unprecedented gusto.  In its July 2020 Plan to Secure Environmental Justice and Equitable Economic Opportunity (Plan), the Biden Administration sets out in broad terms how it intends to use an “All-of-Government” approach to “rooting out systemic racism in our laws, policies, institutions, and hearts.”...
February 2, 2021

Lynn L. Bergeson, “OECD Will Hold Webinar on Assessing the Dispersion Stability and Dissolution of Nanomaterials in the Environment,” Nanotechnology Now, February 2, 2021.

On February 25, 2021, the Organization for Economic Cooperation and Development (OECD) will hold a webinar on “Assessing the dispersion stability and dissolution (rate) of nanomaterials in the environment” to discuss the scope, content, and use of Test Guideline No. 318: Dispersion Stability of Nanomaterials in Simulated Environmental Media and its accompanying guidance document. ...
December 23, 2020

Lynn L. Bergeson and Lara A. Hall, “M&A activity in the analytical services sector: points to consider,” Financier Worldwide, January 2021.

There has been remarkable consolidation in the analytical services sector in the US and elsewhere globally over the past few years. Make no mistake; the need for analytical and related testing services is growing significantly. Because of the legal and regulatory frameworks that demand such services, however, there is considerable need for attendant technical expertise to staff these laboratories, and the need for specialised expertise is also growing exponentially. This article summarises...
December 16, 2020

Lynn L. Bergeson, “EPA Fee Controversy Continues,” Chemical Processing, December 16, 2020.

The Toxic Substances Control Act (TSCA) authorizes the U.S. Environmental Protection Agency (EPA) to collect fees from chemical manufacturers (including importers) to defray a portion of the costs associated with TSCA implementation efforts. The TSCA fees rule requires payment for eight categories of fee-triggering events under TSCA, including EPA-initiated risk evaluations under TSCA Section 6. The EPA must prepare a preliminary list of manufacturers subject to fee obligations for EPA-initiated...
November 20, 2020

Lynn L. Bergeson, “EPA Announces Carbon Tetrachloride Risks,” Chemical Processing, November 20, 2020.

The U.S. Environmental Protection Agency (EPA) published the final risk evaluation for carbon tetrachloride on November 4, 2020. The EPA found unreasonable risks to workers and occupational non-users (ONU) for 13 of the 15 conditions of CCl4 use, but no unreasonable risks to the environment. According to the EPA, there are no consumer uses of this chemical. Most agree the findings are not unexpected. This article explains the assessment and the results....
November 2, 2020

Lynn L. Bergeson and Eve C. Gartner, “The essentials of TSCA practice,” ABA Section of Environment, Energy, and Resources Trends, November/December 2020.

The Toxic Substances Control Act (TSCA) is not the arcane federal law it once was. Amended in 2016 in response to a demand so loud and persistent from nongovernmental organizations, consumers, and, eventually, the industrial chemical community that Congress could no longer ignore it, TSCA is now a force with which to be reckoned. While the U.S Environmental Protection Agency’s (EPA’s) implementation of the 2016 Lautenberg Act that amended TSCA invites criticism among stakeholders, there...
October 26, 2020

Lynn L. Bergeson, “Pandemic Spurs Enforcement Revisions,” Chemical Processing, October 26, 2020.

The White House Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA) issued memorandum M-20-31 on August 31, 2020, on the implementation of Section 6 of Executive Order (EO) 13924, “Executive Order on Regulatory Relief to Support Economic Recovery.” This article explains the guidance, why it may prove useful to know about its content, and how to leverage the guidance successfully in future enforcement actions and adjudications....
September 16, 2020

Lynn L. Bergeson, “EPA Tells Businesses To Pay Up,” Chemical Processing, September 16, 2020.

On August 26, 2020, the U.S. Environmental Protection Agency (EPA) released the much-anticipated interim final list of businesses subject to risk evaluation fees for the 20 chemicals designated as “high priority” under the Toxic Substances Control Act (TSCA). Making the interim final list available now gives businesses and other stakeholders an opportunity to review the list for accuracy. It also provides time for businesses to reach out to form consortia to share in fee payments....
September 9, 2020

Lynn L. Bergeson, “Feeling the Pinch: who pays TSCA risk evaluation fees?,” Financier Worldwide, September 2020.

Ordinarily, government fees command little interest in corporate finance and board-level business circles. Newly imposed fees to defray the US Environmental Protection Agency’s (EPA’s) risk evaluation of high-priority chemical substances under Section 6 of the Toxic Substances Control Act (TSCA) are extraordinary, however, and are commanding significant interest. This article explains why....
August 31, 2020

Lynn L. Bergeson, “Off to the Races—CDR Reporting Begins!,” Washington Watch, Fall 2020.

As the expression goes, it is that time of year again.  Section 8 of the Toxic Substances Control Act (TSCA) requires manufacturers, including importers, to provide the U.S. Environmental Protection Agency (EPA) with information on the production and use of chemicals in commerce at four-year intervals.  The last reporting cycle for the requirement, known as the Chemical Data Reporting (CDR) requirement, was in 2016, so TSCA stakeholders have been gearing up since then for the...
August 31, 2020

S. Bhandari, P. Delmonte, M. Honigfort, W. Yan, F. Dionisi, M. Fleith, D. Iassonova, L. Bergeson, “Regulatory Changes Affecting the Production and Use of Fats and Oils: Focus on Partially Hydrogenated Oils,” Journal of the American Oil Chemists’ Society, Volume 97, Issue 8, August 2020.

Partially hydrogenated oils (PHO), the products of incomplete catalytic hydrogenation of food oils, have been widely employed by the food industry for more than a century. Their exceptional stability and technologic characteristics made them the preferred choice for the production of several food products including margarines, bakery goods, and frying oils. Some of these highly prized characteristics were provided by the high content in trans fatty acids (TFA), defined as fatty acids...