All Knowledge & Insights By Date

The Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products.  The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded.  FDA notes that it has not established...

The U.S. Environmental Protection Agency (EPA) released on February 19, 2019, an update of the Toxic Substances Control Act (TSCA) Chemical Inventory (TSCA Inventory), which lists chemicals that are “active” versus “inactive” in commerce in the U.S.  EPA’s News Release states that a “key result of the update is that less than half of the total number of chemicals on the current TSCA Inventory (47 percent or 40,655 of the 86,228 chemicals) are currently in commerce.”...

On February 19, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was releasing an update to the Toxic Substances Control Act (TSCA) Inventory listing the chemicals that are actively being manufactured, processed and imported in the United States, which is required under amended TSCA.  Some of the highlights from EPA’s announcement are: Look for our memorandum on this important development tomorrow; it will be posted to our Regulatory Developments...

On February 20, 2019, Inside EPA featured comments by James V. Aidala, Senior Government Affairs Consultant with Bergeson & Campbell, P.C. (B&C®), in the article “New EPA Toxics Chief Seeks To Quell Critics As Agency Implements TSCA.” Jim Aidala, a former EPA toxics chief in the Clinton administration who is now with Bergeson & Campbell, said that Dunn’s confirmation will help the agency navigate its heavy workload in implementing the new law, even as the agency...

On February 18, 2019, the European Union (EU) NanoSafety Cluster (NSC) announced that it is supporting the Malta Initiative by linking various projects with activities developed within the Malta Initiative.  According to NSC’s website, the Malta Initiative began in 2017, when Germany approached the EU Directorate-General (DG) for Research and Innovation to request political and financial support to develop and amend Organization for Economic Cooperation and Development...

Bergeson & Campbell, P.C. (B&C®) is pleased to announce an exciting and important new component to our suite of Toxic Substances Control Act (TSCA) offerings. Our TSCA Tutor™ training platform provides live in-person training at a company’s site, live online training, and pre-recorded webinar training modules — all designed to offer expert, efficient, and essential TSCA training. Companies can mix and match training modules and training approaches to provide the most...

On January 9, 2019, the New York Department of Environmental Conservation (NYDEC) announced it was delaying its enforcement of the New York Household Cleansing Product Information Disclosure Program (NYDP) to October 2, 2019. NYDEC’s announcement was published in the Environmental Notice Bulletin. This article explains the significance of this development....

The February 2019 issue of Computational Toxicology includes an article entitled “Grouping of multi-walled carbon nanotubes to read-across genotoxicity:  A case study to evaluate the applicability of regulatory guidance.”  The article describes a case study, performed by scientists at the European Commission’s (EC) Joint Research Center (JRC), to explore and illustrate read-across of genotoxicity data by following the “Recommendations for nanomaterials applicable to the Guidance on...

The Appropriations Bill that is expected to be signed into law on February 15, 2019, provides funding for the rest of Fiscal Year (FY) 2019 and averts another federal government shutdown.  It does not, however, include either an extension of the Pesticide Registration Improvement Extension Act (PRIA 3) or Reauthorization, widely referred to as PRIA 4.  This omission was a surprise to industry and to the U.S. Environmental Protection Agency (EPA).  On February 13, 2019,...

On February 15, 2019, Inside EPA featured comments by Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), regarding a suit brought against the Trump EPA’s policy barring any recipient of an EPA grant from serving on one of its many scientific advisory committees McFadden’s ruling is not a total victory for EPA, since the agency had argued for dismissal on standing, ripeness and merits grounds. While McFadden dismissed the suit on the merits,...