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 and ineffective. The new TSCA, promising to fix a broken statute, received bipartisan support and was the first major environmental law in a quarter century.

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 this, it comes as a bit of a surprise when investors, poised to make multimillion-dollar investments in start-up businesses, neglect to focus on the regulatory integrity of the start-up. This lack of focus invites costly mistakes. This article explains why, and how to avoid making these mistakes.

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” regarding the PIP (3:1) rule, is demonstrable proof of TSCA’s enormous reach. The reasons behind this regulatory action are revealing and demonstrate why the PIP (3:1) experience is a cautionary tale.

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 regulation in general.

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 up. Modern life as we know it would not exist without the continued invention, production and use of new chemicals.

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 of the action.

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.”

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. 

On January 11, 2021, the U.S. Environmental Protection Agency (EPA) proposed to amend the 2018 Toxic Substances Control Act (TSCA) fees rule. This column discusses the proposal and its improvements to the rule.

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 mergers and acquisitions (M&A) trends and explains why skilled help is essential to avoid liability. A PDF of this article can be downloaded here.