Last week, press reported that the U.S. Food and Drug Administration (FDA) would assess distilleries making hand sanitizer $14,060 in fees as Monograph Drug Facilities (MDF) under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021. Several days later, on December 31, 2020, the Department of Health and Human Services (HHS) Office of Public Affairs tweeted a statement from Brian Harrison, HHS Chief of Staff. According to the...
January 5, 2021
EPA Provides Companies Opportunity to Submit, Amend, or Withdraw Filings under TSCA Active-Inactive Rule
The U.S. Environmental Protection Agency (EPA) announced on January 5, 2021, that it is reopening the reporting period under the Toxic Substances Control Act (TSCA) Inventory notification active-inactive rule where companies identified chemicals that were manufactured, imported, or processed in the United States during the ten-year time period ending on June 21, 2016. As reported in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules,” the final TSCA Inventory...
January 4, 2021
ACGIH® TLV®-CS Committee Seeks Information on Carbon Nanotubes
The American Conference of Governmental Industrial Hygienists (ACGIH®) Threshold Limit Values for Chemical Substances (TLV®-CS) Committee has included carbon nanotubes on its 2021 list of chemical substances and other issues under study. Being placed on the under study list indicates that the TLV®-CS Committee has selected carbon nanotubes for development of a threshold limit value (TLV®). ACGIH® describes TLVs® as health-based values representing the...
The U.S. Environmental Protection Agency (EPA) released on December 30, 2020, the final risk evaluation for asbestos, part 1: chrysotile asbestos. Of the six use categories evaluated (chlor-alkali diaphragms, sheet gaskets, other gaskets, oilfield brake blocks, aftermarket automotive brakes/linings, and other vehicle friction products), EPA states that it found that there is unreasonable risk to workers, occupational non-users (ONU), consumers, and/or bystanders within each of the six...
January 2, 2021
Dan Utech Is EPA’s Incoming Chief of Staff
Dan Utech, Incoming Chief of Staff for the U.S. Environmental Protection Agency (EPA), announced to EPA on January 21, 2021, that until Michael Regan, Secretary of the North Carolina Department of Environmental Quality, is confirmed as EPA Administrator, Jane Nishida will serve as Acting Administrator. In his announcement, Utech notes that on January 20, 2021, President Biden signed an Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the...
B&C Publishes 2021 Forecast: 2021 brings a new Administration to Washington, D.C. and Bergeson & Campbell, P.C.’s (B&C®) Forecast of the key chemical law and policy developments we are likely to see in 2021 is available now. The PDF version delivers 83 pages of detailed and helpful content regarding what to expect concerning regulatory programs and regions, including the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the...
January 1, 2021
WEBINAR—What To Expect When You’re Electing (a New President), January 28, 2021, 1:00 p.m. EST
Bergeson & Campbell, P.C. (B&C®) is pleased to present “What To Expect When You’re Electing (a New President),” a webinar focusing on the incoming Biden Administration, including what policies and initiatives can be expected in the next four years and how any likely regulatory directions may affect our clients. Registration is now open.
December 30, 2020
OECD Will Hold Webinar on Aquatic and Sediment Ecotoxicity Testing of Nanomaterials
On January 26, 2021, the Organization for Economic Cooperation and Development (OECD) will hold a webinar on Guidance Document on Aquatic and Sediment Toxicological Testing of Nanomaterials (No. 317). The webinar will discuss the scope and use of the guidance document, which addresses practical aspects of carrying out valid tests on nanomaterials, and modifications or additions to OECD Test Guidelines procedures intended to improve the accuracy of test...
December 30, 2020
EPA Releases Report Compiling Letter Peer Review Comments on Revised Draft Risk Evaluation of PV29
On December 21, 2020, the U.S. Environmental Protection Agency (EPA) announced that a report compiling the letter peer reviewers’ comments on the revised draft Toxic Substances Control Act (TSCA) risk evaluation of C.I. Pigment Violet 29 (PV29) is now available in Docket EPA-HQ-OPPT-2018-0604. EPA states that it is in the process of reviewing the letter peer reviewers’ comments and will use the feedback received from the peer review and public comments to inform the final risk...
December 30, 2020
EPA Intends Proposed Rule to Increase Flexibility and Reduce Burdens under TSCA Fees Program
On December 21, 2020, the U.S. Environmental Protection Agency (EPA) released a proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule. According to EPA, the proposed rule “reflects real-world situations, narrows the broad scope of current requirements, significantly reduces the burden on American businesses, and increases the flexibility for surrounding TSCA fees requirements.” Under TSCA, EPA collects fees from chemical manufacturers and...