December 29, 2020

OECD Publishes Report on Moving toward a Safe(r) Innovation Approach for More Sustainable Nanomaterials and Nano-Enabled Products

The Organization for Economic Cooperation and Development (OECD) published a report entitled Moving Towards a Safe(r) Innovation Approach (SIA) for More Sustainable Nanomaterials and Nano-enabled Products.  According to the Executive Summary, the report “presents common working descriptions to ensure a common understanding of concepts such as: Safe(r) Innovation Approach and its elements, Safe(r)-by-Design and Regulatory Preparedness.”  The report compiles existing risk...
December 29, 2020

EPA Releases Final Chemical Risk Evaluation for NMP

On December 23, 2020, the U.S. Environmental Protection Agency (EPA) released the final risk evaluation for N-methylpyrrolidone (NMP). Of the 37 conditions of use that EPA reviewed, EPA found that 26 present unreasonable risks to workers and consumers. These uses include an unreasonable risk to workers when domestically manufacturing or importing NMP, processing NMP for a variety of uses, and when used in a variety of industrial and commercial conditions of use. These uses also include an...
December 24, 2020

EPA Compliance Advisory Addresses Applicability of TSCA to Chemicals Made from Petroleum and Renewable Sources Used as Fuels, Fuel Additives, and Distillates

The U.S. Environmental Protection Agency (EPA) has posted a Compliance Advisory entitled “Applicability of the Toxic Substances Control Act to Chemicals made from Petroleum and Renewable Sources Used as Fuels and Fuel Additives and Distillates.”  The Compliance Advisory states that EPA is reaffirming that chemical substances used as fuels, fuel additives, and distillates made from either petroleum or renewable sources are subject to the Toxic Substances Control Act (TSCA).  Anyone who...
December 23, 2020

OECD Publishes Report on Ability of Biopersistent/Biodurable Manufactured Nanomaterials to Induce LMP as a Prediction of Their Long-Term Toxic Effects

The Organization for Economic Cooperation and Development (OECD) has posted a report entitled Ability of biopersistent/biodurable manufactured nanomaterials (MNs) to induce lysosomal membrane permeabilization (LMP) as a prediction of their long-term toxic effects.  The report describes “the expanding knowledge on the implications and biological significance of lysosomal and autophagy dysfunction and the subsequent assembly and activation of inflammasome NLRP3 induced by biodurable...
December 23, 2020

Comments by Lynn L. Bergeson and Richard E. Engler, Ph.D., Featured in Bloomberg Environment Article “Fuel-Chemicals Advisory Seen as ‘Unwanted’ EPA Parting Gift”

On December 23, 2020, comments by Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®) and Richard E. Engler, Ph.D., Director of Chemistry, B&C, were featured by Bloomberg Environment regarding a recent U.S. Environmental Protection Agency (EPA) compliance advisory describing how the Toxic Substances Control Act (TSCA) applies to certain petroleum-based chemicals, along with renewable substitutes made from crops, fats, and waste oil. [T]he EPA’s...
December 23, 2020

EPA Publishes Interim Guidance on Destroying and Disposing of Certain PFAS and PFAS-Containing Materials

On December 22, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of new interim guidance on destroying and disposing of certain perfluoroalkyl and polyfluoroalkyl substances (PFAS) and PFAS-containing materials for public comment.  85 Fed. Reg. 83554.  The interim guidance outlines the current state of the science on techniques and treatments that may be used to destroy or dispose of PFAS and PFAS-containing materials from non-consumer products,...
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 23, 2020

EPA Releases Final TSCA Section 6(h) Rules for Five PBT Chemicals

The U.S. Environmental Protection Agency (EPA) released on December 22, 2020, final rules under Section 6(h) of the Toxic Substances Control Act (TSCA) for five persistent, bioaccumulative and toxic (PBT) chemicals -- decabromodiphenyl ether (decaBDE); phenol, isopropylated phosphate (3:1) (PIP (3:1)); 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP); hexachlorobutadiene (HCBD); and pentachlorothiophenol (PCTP). TSCA required EPA to take expedited action on specific...
December 22, 2020

OECD Publishes Reports on Outcome of Project on Advancing Adverse Outcome Pathway Development for Nanomaterial Risk Assessment and Categorization

In 2016, the Organization for Economic Cooperation and Development’s (OECD) Working Party on Manufactured Nanomaterials (WPMN) included the Advancing Adverse Outcome Pathway (AOP) Development for Nanomaterial Risk Assessment and Categorization (NanoAOP) project in its program of work.  The objective of the project is to contribute to the future development and application of AOPs for manufactured nanomaterial regulatory decision making by following the principles established by the OECD...
December 22, 2020

EPA Releases Proposed Amendments to TSCA Fees Rule

On December 21, 2020, the U.S. Environmental Protection Agency (EPA) released a proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule.  According to EPA, the proposed rule “reflects real-world situations, narrows the broad scope of current requirements, significantly reduces the burden on American businesses, and increases the flexibility for surrounding TSCA fees requirements.”  Under TSCA, EPA collects fees from chemical...