Category: Risk Assessment Issues

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 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 16, 2020

Lynn L. Bergeson, “EPA Fee Controversy Continues,” Chemical Processing, December 16, 2020.

The Toxic Substances Control Act (TSCA) authorizes the U.S. Environmental Protection Agency (EPA) to collect fees from chemical manufacturers (including importers) to defray a portion of the costs associated with TSCA implementation efforts. The TSCA fees rule requires payment for eight categories of fee-triggering events under TSCA, including EPA-initiated risk evaluations under TSCA Section 6. The EPA must prepare a preliminary list of manufacturers subject to fee obligations for EPA-initiated...
December 10, 2020

EPA Issues Proposed Interim Registration Review Decision to Require New Risk Mitigation Measures for Chlorpyrifos

On December 7, 2020, the U.S. Environmental Protection Agency (EPA) issued for comment the Proposed Interim Decision (PID) for chlorpyrifos.  85 Fed. Reg. 78849.  EPA announced it is proposing new risk mitigation measures to address potential human and environmental risks identified in EPA’s September 2020 draft risk assessments.  The PID proposes the following measures: Label amendments limiting application to address potential drinking water risks of...
December 10, 2020

Manufacturer and Importer Liability under the TSCA Fees Rule for EPA-Initiated Risk Evaluations: An Opaque and Evolving Story

Under Toxic Substances Control Act (TSCA) Section 26(b), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), the U.S. Environmental Protection Agency (EPA) is authorized to collect fees from chemical manufacturers (defined to include importers under TSCA) to defray a portion of the EPA costs associated with TSCA implementation efforts. The TSCA Fees Rule, which became effective on October 18, 2018, requires payment of fees for eight categories of...
December 9, 2020

ANSES Evaluates R-Nano Register, Offers Recommendations to Improve Reliability and Optimize Its Use

On December 1, 2020, the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) announced the results of an assessment of R-Nano, France’s national reporting scheme for substances in nanoparticle form.  In 2013, France began requiring companies that manufacture, import, and/or distribute a “substance with nanoparticle status” in an amount of at least 100 grams per year to submit an annual report with substance identity, quantity, and use...
November 24, 2020

EFSA Publishes Environmental Risk Assessment of the Application of Nanoscience and Nanotechnology in the Food and Feed Chain

On November 19, 2020, the European Food Safety Authority (EFSA) published a report entitled “Environmental Risk Assessment (ERA) of the application of nanoscience and nanotechnology in the food and feed chain.”  The authors analyzed existing ERA guidance documents for their adequacy to cover issues that are specific for nanomaterials, but note that none of the guidance has a specific focus on the food and feed chain.  Each nanospecific issue was addressed by briefly reviewing the...
November 6, 2020

Jeffery Morris, Former OPPT Director, Examines TSCA As A Gap-Filling Statute

After reading the article below by Jeffery Morris, former Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT), we were inspired to post it. We appreciate having the opportunity to share his analysis with our audience. TSCA as a Gap-Filling Statute: Potentially Exposed and Susceptible Subpopulations By Jeffery Morris, PhD In its response to public comments on the scope documents for its next twenty chemical risk evaluations conducted...
November 3, 2020

Register Now for SNO and NanOEH’s Virtual Nanotechnology Conference

The Sustainable Nanotechnology Organization (SNO) and the Nanotechnology, Occupational and Environmental Health (NanOEH) Committee have partnered to present the 9th NANO Conference.  This conference combines the interests of SNO and NanOEH by offering a virtual program containing sessions that are of interest to both groups. SNO is a permanent non-profit corporation that provides the infrastructure to carry out its mission of research, education, and responsibility related to both...
November 2, 2020

Register Now for SNO and NanOEH’s Virtual Nanotechnology Conference on November 12 and 13, 2020

The Sustainable Nanotechnology Organization (SNO) and the Nanotechnology, Occupational and Environmental Health (NanOEH) Committee have partnered to present the 9th NANO Conference.  This conference combines the interests of SNO and NanOEH by offering a virtual program containing sessions that are of interest to both groups. SNO is a permanent non-profit corporation that provides the infrastructure to carry out its mission of research, education, and responsibility related to both...