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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...