Blogs

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On March 4, 2020, FDA announced that it has issued in final a guidance for industry titled “The ‘Deemed to be a License’ Provision of the BPCI Act: Questions and Answers,” which addresses FDA’s “transition” provision of the BPCI Act. Established in 2009, the Biologics Price Competition and Innovation Act (BPCI Act) deemed applications for an approved biological product under Section 505 of the Federal...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On March 4, 2020, the U.S. Food and Drug Administration (FDA), in collaboration with EPA and the U.S. Department of Agriculture (USDA), launched a new initiative called “Feed Your Mind” to help consumers better understand genetically engineered (GE) foods. Consisting of science-based information, the initiative’s features include a wide range of resources designed to teach consumers, health care professionals, and students...

By Lynn L. Bergeson On March 2, 2020, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced open meetings of the Biomass Research and Development (R&D) Technical Advisory Committee. Occurring on March 24, 2020, from 8:00 a.m. to 5:00 p.m. (EDT) and March 25, 2020, from 1:00 p.m. to 4:30 p.m. (EDT), both meetings will take place in Arlington, VA. The purpose of the meetings is to develop advice and guidance that promotes R&D leading to the...

By Lynn L. Bergeson On February 25, 2020, the U.S. Patent and Trademark Office (USPTO) announced that nominations are now open for the 2020 National Medal of Technology and Innovation (NMTI) to recognize those who have worked to advance U.S. competitiveness and quality of life and who have strengthened the workforce through technological innovations. The award is presented annually by the President of the United States to leading technological honorees. Applications will be accepted until April...

On March 3, 2020, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a proposed supplemental significant new use rule (SNUR) issued under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances to make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface coatings on articles.  85 Fed. Reg. 12479.  Under the...

On March 4, 2020, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice announcing the availability of its Current Intelligence Bulletin 69:  NIOSH Practices in Occupational Risk Assessment.  85 Fed. Reg. 12786.  The Current Intelligence Bulletin (CIB) describes the process and logic NIOSH uses to conduct risk assessments, including the following steps: Determining what type of hazard is associated with a chemical or...

Effective March 15, 2020, Madison Le will join the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) as Director of the Chemical Control Division (CCD).  Ms. Le will replace Acting Director Lynn Vendinello.  Ms. Le is currently Director of the Fuels Compliance Policy Center within the Office of Air and Radiation.  In that capacity, Ms. Le manages the implementation of EPA’s national fuels programs, including the Renewable Fuel...

On February 28, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a new web portal that is available to the public to search for EPA guidance documents.  The EPA Guidance Portal (Portal) was created under Executive Order 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents,” where agencies are to develop a central web portal for the public to review active guidance documents and the ability to request for modification or...

On March 2, 2020, the U.S. Environmental Protection Agency (EPA) issued a final rule on EPA’s procedures for conducting on-site civil inspections.  This final rule applies to on-site inspections conducted by EPA civil inspectors, federal contractors, and Senior Environmental Employment employees conducting inspections on behalf of EPA.  This rule is effective March 2, 2020. This rule explains how EPA inspectors should conduct on-site civil administrative inspections...

As reported in our February 13, 2020 blog item, the U.S. Environmental Protection Agency (EPA) announced on February 12, 2020, that it is seeking public input on a proposal to incorporate a new nanosilver pesticide product into textiles to combat odors, discoloration, and other signs of wear. The proposed registration decision is for NSPW Nanosilver, and the proposed pesticide product, Polyguard-NSPW Master Batch (Polyguard), will be incorporated into textiles to suppress bacteria, algae,...