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On September 29, 2022, the U.S. Environmental Protection Agency (EPA) issued final significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for certain chemical substances that were the subject of premanufacture notices (PMN), including multi-walled carbon nanotubes (MWCNT) (generic). 87 Fed. Reg. 58999. The SNUR requires persons who intend to manufacture (defined by statute to include import) or process the chemical substance identified generically as MWCNTs (PMN...

Download transcript. This week, I welcomed back to the studio Karin F. Baron, Senior Regulatory Consultant at B&C and our consulting affiliate, The Acta Group. Karin and I discuss the U.S. Food and Drug Administration’s (FDA) initiative called the New Era of Smarter Food Safety. The goal of this initiative is to diminish the number of foodborne illness, which, surprisingly, has not diminished since the Food Safety Modernization Act was enacted 11 years ago. We discuss FDA’s...

On September 20, 2022, the European Commission (EC) began a public consultation on a draft act that would introduce new hazard classes as part of its revision to Regulation (EC) No 1272/2008 on the Classification, Labeling, and Packaging of Substances and Mixtures (CLP). Hazard classes and criteria would be added for endocrine disruptors and substances that are persistent, bioaccumulative, and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile, and toxic...

October 26, 202212:00 p.m. - 1:00 p.m. (EDT)Register Now  The U.S. Food and Drug Administration (FDA) reports that 48 million people in the United States (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases. In 2011, President Obama signed into law the Food Safety Modernization Act (FSMA) in part to address this significant public health issue. FSMA is a comprehensive law intended to shift the focus of foodborne illness management from responding to...

On September 12, 2022, the European Commission (EC) opened a call for evidence on a proposal for a basic regulation for the European Chemicals Agency (ECHA). According to the EC, this initiative aims to strengthen ECHA governance and adapt it to its future role, as well as streamline the working methods of ECHA bodies and make their financing more sustainable. Responses are due October 10, 2022. The EC plans to adopt a regulation in the second quarter of 2023. Title X of the...

The U.S. Environmental Protection Agency (EPA) will hold a webinar on October 13, 2022, on its web-based Interspecies Correlation Estimation (Web-ICE) tool. According to EPA, protecting the diversity of species from the adverse effects of chemicals is a significant environmental challenge. EPA acknowledges that information on the effects of chemicals on species is either very limited or lacking entirely, making management and mitigation of environmental contaminants difficult. EPA developed...

By Lynn L. Bergeson and Carla N. Hutton   The Congressional Research Service (CRS) published a CRS report, updated on September 19, 2022, entitled The Bioeconomy: A Primer. The report provides an overview of the bioeconomy, details the efforts of the United States and other selected nations pertaining to the bioeconomy, and offers policy considerations for strengthening the role of the United States in the global bioeconomy. The report does not examine the policies and programs of...

Cleanup costs under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) are about to get a lot more expensive. The U.S. Environmental Protection Agency (EPA) announced on September 6, 2022, that it will propose to designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), two of the most widely used per- and polyfluoroalkyl substances (PFAS), as hazardous substances under CERCLA. The rulemaking would also require entities immediately to report...

Gov4Nano, NANORIGO, and RiskGONE, three projects funded by the European Union (EU), are working together “to develop and establish a robust public policy framework for the use of nanomaterials based on scientific evidence supporting a clear understanding of risks, their assessment and management within wider societal considerations.” The projects are conducting a survey to understand better how the needs of different stakeholders can be addressed through the outputs of the...