Blogs

On November 22, 2019, the European Commission (EC) Directorate-General for Internal Market, Industry, Entrepreneurship, and Small- and Medium-Sized Enterprises (SME) requested two scientific opinions from the Scientific Committee on Consumer Safety (SCCS): Request for a scientific opinion on platinum (nano)-colloidal platinum (nano) (Chemical Abstracts Service (CAS) No. 7440-06-4, EC No. 231-116-1) and acetyl tetrapeptide-17 colloidal platinum (nano) (CAS and EC Nos. not available); and Request...

By Lynn L. Bergeson On November 15, 2019, Sarah Yim, M.D., acting director of the Food and Drug Administration (FDA) Office of Therapeutic Biologics and Biosimilars in FDA’s Center for Drug Evaluation and Research, released a statement on FDA’s continued progress facilitating competition in the biologic marketplace with approval of its 25th biosimilar project. In her statement, Dr. Yim highlights FDA’s approval of one of nine new biosimilar products approved in 2019. Bringing...

By Lynn L. Bergeson On November 20, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced a public meeting to engage with stakeholders interested on the implementation of the Toxic Substances Control Act (TSCA) New Chemicals Program. The meeting will be held on December 10, 2019, from 10:00 a.m. to 3:00 p.m. (EST), and will include: An overview of EPA’s updated “Working Approach” document that builds on...

By Lynn L. Bergeson On November 14, 2019, Senator Tom Udall (D-NM) and Representative Peter Welch (D-VT) introduced legislation seeking to reform the Renewable Fuel Standard (RFS) under the Clean Air Act (CAA). The Growing Renewable Energy through Existing and New Environmentally Responsible (GREENER) Fuels Act is intended to mitigate the “harmful environmental impacts of the corn ethanol mandate,” according to a press release issued by the lawmakers. The bill would phase out the...

On November 14, 2019, the U.S. Court of Appeals for the Ninth Circuit issued its decision in a case challenging the U.S. Environmental Protection Agency’s (EPA) prioritization and risk evaluation rules.  Safer Chemicals, Healthy Families v. EPA, No. 17-72260.  Petitioners argued that provisions in the risk evaluation rule relating to EPA’s evaluation of the risks from a substance’s “conditions of use” violate several of the Toxic Substances Control Act’s (TSCA) requirements. ...

The National Nanotechnology Initiative (NNI) announced on November 19, 2019, the launch of the Nanotechnology Entrepreneurship Network (NEN), “a new community of interest to support entrepreneurs interested in commercializing nanotechnologies.”  According to NNI, NEN will bring new and seasoned entrepreneurs together with the people and resources available to support them.  NNI states that NEN will provide a forum for sharing best practices for advancing nanotechnology...

On October 15, 2019, EPA posted a total of 11 documents to the registration review docket for paraquat dichloride (EPA-HQ-OPP-2011-0855).  Of primary interest in the registration review process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) are the draft human health and ecological risk assessments.  Additional supporting documents posted to the docket include dietary, residential, and occupational exposure assessments; a review of analytical...

The European Commission (EC) announced on November 15, 2019, that it published an updated catalog of nanomaterials used in cosmetic products on the European Union (EU) market.  As reported in our June 19, 2017, blog item, the EC first published a catalog in June 2017.  The catalog compiles information that responsible persons shared with the EC through the cosmetic products notification portal (CPNP) as of December 31, 2018.  The catalog lists 27 nanomaterials used...

On August 13, 2019, the U.S. Environmental Protection Agency (EPA) released the list of 20 chemical substances that it proposes to designate as low-priority substances for which risk evaluation under the Toxic Substances Control Act (TSCA) is not warranted at this time.  EPA’s August 15, 2019, proposed rule provides a summary of the approach used by EPA to support the proposed designations, the proposed designations for each of the chemical substances, and instructions on how to access the...

On November 12, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Nanomaterials in Europe’s workplaces:  what are the risks and how can they be managed?” and written by Elke Schneider, European Agency for Health and Safety at Work (EU-OSHA).  Schneider states that at the EU level, the requirements for managing nanomaterials and their potential risks are the same as those for managing other hazardous substances.  Under the EU’s...