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This week, I sat down with Dr. Jane Vergnes, Director of Toxicology and Vice President, Scientific Affairs, here at B&C and its consulting affiliate, The Acta Group (Acta®), and Dr. Richard Engler, Director of Chemistry, at B&C and Acta.  We discussed the provocative question “is everything carcinogenic?”  In asking this question, Jane and Rich discuss the marketing and labeling implications of a cancer classification for a chemical substance found as an...

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...

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”...

On February 8, 2021, the U.S. Environmental Protection Agency (EPA) received a petition seeking a rule reversing EPA’s 1991 Bevill regulatory determination excluding phosphogypsum and process wastewater from phosphoric acid production (process wastewater) from hazardous waste regulation under Subtitle C of the Resource Conservation and Recovery Act (RCRA). The petition also urges EPA to promulgate regulations under RCRA Subtitle C governing the safe treatment, storage, and disposal...

On March 10, 2021, the House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing on “The Path Forward: Restoring the Vital Mission of EPA.” According to the March 7, 2021, memorandum from Representative Frank Pallone, Jr. (D-NJ), Chair of the Committee, to the Subcommittee, the U.S. Environmental Protection Agency’s (EPA) current responsibilities include reviewing national air pollution standards and overseeing or carrying out cleanups at most of the...

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...

The United Kingdom (UK) Health and Safety Executive (HSE) published an HSE Biocides eBulletin on March 8, 2021, announcing upcoming deadlines for businesses under the Great Britain (GB) Biocidal Products Regulation (GB BPR). As of January 1, 2021, HSE no longer has access to the European Union’s (EU) information technology (IT) systems to access applications (including the data dossiers) previously submitted under those systems. Businesses must therefore resubmit applications for...

On March 5, 2021, the U.S. Environmental Protection Agency (EPA) announced that “[i‌]n support of the Biden-Harris Administration’s commitment to making evidence-based decisions to protect human health, U.S. Environmental Protection Agency (EPA) is taking an important step by proposing the cancellation of the registration of pentachlorophenol.” Pentachlorophenol, a well-recognized wood preservative in use for decades, is registered under the Federal Insecticide, Fungicide, and...

This week I sat down with Karin Baron, Senior Regulatory Consultant to B&C and our affiliated consultancy, The Acta Group, to discuss the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).  Listeners know GHS is the non-mandatory framework intended to aid in identifying, classifying, and communicating information on the hazards of chemicals or substances for occupational, consumer, and environmental exposures.  Despite the “harmonization” part in...

The European Chemicals Agency (ECHA) has begun a public consultation on a derogation to the exclusion criteria for creosote for product type 8 (PT 8; wood preservatives). Under the European Union (EU) Biocidal Products Regulation (BPR), active substances that meet the exclusion criteria can be approved or renewed only if they meet one or more of the following derogation criteria: exposure is negligible; the active substance is essential to prevent a serious danger to human or animal...

Bergeson & Campbell, P.C.’s (B&C®) podcast All Things Chemical reached the big 5 – 0 this month, with the release of episodes 49 and 50, the two-part series “How will the Biden Administration Interpret Amended TSCA?” and “How will the New Administration affect the EPA?,” fitting milestone episodes for this podcast dedicated to engaging and informing listeners with intelligent, insightful conversation around key issues affecting industrial, pesticidal, and specialty...

The United Kingdom (UK) Health and Safety Executive (HSE) published a REACH eBulletin on February 26, 2021, announcing upcoming deadlines for businesses for UK REACH. As reported in our February 9, 2021, memorandum, “Following Brexit, UK Establishes New Chemical Regulatory Regimes,” the UK brought the European Union (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation into law on January 1, 2021, as UK REACH. According to HSE, measures have...

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...

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...

On January 26, 2021, several public health advocacy organizations and scientists (Petitioners) filed a notice of intent (NOI) to sue the U.S. Environmental Protection Agency (EPA) to compel it “to perform its non-discretionary duty to address the use and disposal of ‘legacy’ asbestos” in its risk evaluation for asbestos under Section 6(b) of the Toxic Substances Control Act (TSCA). As reported in our January 4, 2021, memorandum, “EPA Publishes Final Risk Evaluation for...

This week, I sat down with Jim Aidala, Senior Government Affairs Consultant, and Dr. Richard Engler, Director of Chemistry, at B&C and its consulting affiliate, The Acta Group.  As both of these gentlemen previously worked at the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention, Jim as former Assistant Administrator of that office and Rich as a senior chemist and head of the Green Chemistry Division, each has a keen sense...

On February 16, 2021, the Occupational Safety and Health Administration (OSHA) published a notice of proposed rulemaking (NPRM) to amend the Hazard Communication Standard (HCS). The HCS is the federal-level regulation that sets forth the classification, labeling, Safety Data Sheet (SDS), and training requirements for hazardous chemicals intended to be used, handled, or stored in workplaces. The current HCS is based on the third revised edition (Rev 3) of the United Nations (UN)...

The American Law Institute Continuing Legal Education (ALI CLE) and the Environmental Law Institute’s (ELI) Environmental Law 2021 webcast educates lawyers on key current environmental law issues, including the latest developments in air, water, endangered species, climate change, chemicals, and renewable energy. A national faculty of seasoned private practitioners, governmental officials, law professors, and public interest advocates will cover what to expect from the change of...

The American Law Institute Continuing Legal Education (ALI CLE) and the Environmental Law Institute’s (ELI) Environmental Law 2021 webcast educates lawyers on key current environmental law issues, including the latest developments in air, water, endangered species, climate change, chemicals, and renewable energy. A national faculty of seasoned private practitioners, governmental officials, law professors, and public interest advocates will cover what to expect from the change of...

A change in Administration invites a sense of both excitement and anxiety.  Nowhere is this ambivalence more present that in the minds of regulated entities subject to the Toxic Substances Control Act (TSCA).  After four years of the Trump Administration’s implementation of the many TSCA amendments occasioned by Lautenberg, regulated entities and other stakeholders have come to understand the U.S. Environmental Protection Agency’s (EPA) interpretation of revised TSCA.  Not...