Category: General

July 21, 2022

Tips for Working with Foreign Regulators in China — A Conversation with David Cragin, Ph.D.

Download transcript. This week, I sat down with David Cragin, Ph.D., DABT®, Quality Assurance and External Affairs Director for a large multinational pharmaceutical company, to discuss his experience living and working in China. For many listeners, working with foreign regulators can be particularly challenging for a variety of reasons, including language barriers, cultural differences, and differing regulatory standards. Dave shares his experience working in China and explains his...
July 19, 2022

OECD Publishes Project Report on Chemical Accidents Involving Nanomaterials

The Organization for Economic Cooperation and Development (OECD) has published a document entitled Chemical Accidents Involving Nanomaterials: Potential Risks and Review of Prevention, Preparedness and Response Measures — Project Report. Part of OECD’s series on chemical accidents, the document presents the outcome from a project of the OECD Working Party on Chemical Accidents (WPCA) that aimed to investigate safety issues related to the prevention of, preparedness for, and response to...
July 19, 2022

EPA Will Hold Kick-Off Meeting on TSCA New Chemical Engineering Initiative to Increase Transparency and Reduce Rework

The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will hold a webinar on Wednesday, July 27, 2022, from 1:00 - 2:00 p.m. (EDT). During the webinar, EPA will provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) before taking questions from the audience. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how...
July 18, 2022

EPA Receives TSCA Section 21 Petition to Phase Out GHG Pollution

The U.S. Environmental Protection Agency (EPA) received a petition on June 16, 2022, under Section 21 of the Toxic Substances Control Act (TSCA) from Daniel M. Galpern on behalf of Donn J. Viviani, John Birks, Richard Heede, Lise Van Susteren, James E. Hansen, Climate Science, Awareness and Solutions, and Climate Protection and Restoration Initiative. The petition requests EPA “to phase out the anthropogenic manufacture, processing, distribution, use, and disposal of greenhouse gas (GHG)...
July 16, 2022

OSTP Publishes RFI on Identifying Critical Data Gaps and Needs to Inform Federal Strategic Plan for PFAS R&D

On July 13, 2022, the White House Office of Science and Technology Policy (OSTP) requested input from all interested parties to identify data gaps in research and development (R&D) regarding several aspects of per- and polyfluoroalkyl substances (PFAS). 87 Fed. Reg. 41749. This information will be used to inform a strategic plan for federal coordination of PFAS R&D and, in compliance with Section 332 of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal...
July 15, 2022

Austrian Academy of Sciences Publishes NanoTrust Dossier on Advanced Materials

The Institute of Technology Assessment of the Austrian Academy of Sciences has published a NanoTrust Dossier entitled “Advanced Materials.” According to the dossier, advanced materials are “materials or material combinations with improved, novel or unique functionalities or properties” and represent a broad class of materials that include semiconductors, biomaterials, and nanomaterials. The dossier states that in many cases, novel materials offer solutions to environmental...
July 14, 2022

ELI Summer School Series 2022: Law & Policy of Products Regulation, July 14, 2022, 12:00 p.m. – 2:00 p.m. EDT, Washington, D.C., and via webinar

The lifecycle of industrial, agricultural, and antimicrobial chemical products, especially those embedded in consumer products, has gained increased public attention. Regulators are looking at the entire product lifecycle, including post-discard of a product at the end of its useful life, as well as toxicity data. Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), presented on chemical product regulation matters including risk communication,...
July 14, 2022

GAO Finds Remaining Priority Recommendations for EPA Include Four Priority Recommendations for the IRIS Program

On July 8, 2022, the U.S. Government Accountability Office (GAO) publicly released its 2022 update on its priority open recommendations for the U.S. Environmental Protection Agency (EPA). In June 2021, GAO identified 22 priority recommendations for EPA. According to GAO, EPA has since implemented ten of those recommendations by requiring states to report quarterly to EPA on the number of lead service lines in each public water system in the state and providing direction to staff on...
July 13, 2022

EPA OIG Finds EPA Was Not Transparent about Changes Made to LCPFAC SNUR after Administrator Signature

On July 7, 2022, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report entitled “The EPA Was Not Transparent About Changes Made to a Long-Chain PFAS Rule After Administrator Signature.” OIG evaluated the extent to which EPA followed applicable policies, procedures, and guidance for the changes made to the long-chain perfluoroalkyl carboxylate and perfluoroalkyl sulfonate chemical substances (LCPFAC) significant new use rule (SNUR) between the EPA...
July 13, 2022

Superfund Tax on Chemicals: What You Need to Know to Comply

As reported in our May 19, 2022, memorandum, the Superfund excise tax on certain chemical substances was reinstated beginning on July 1, 2022, under the Infrastructure Investment and Jobs Act. The newly reinstated tax has caught many off guard, and most subject to the tax are struggling with computing and reporting the tax. We offer some guidance below and stand ready to assist. Overview There are two separate Superfund chemical excise taxes: a tax on the sale or use of “taxable...