Blogs

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...

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...

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...

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...

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...

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...

The Organization for Economic Cooperation and Development (OECD) published a report entitled Moving Towards a Safe(r) Innovation Approach (SIA) for More Sustainable Nanomaterials and Nano-enabled Products.  According to the Executive Summary, the report “presents common working descriptions to ensure a common understanding of concepts such as: Safe(r) Innovation Approach and its elements, Safe(r)-by-Design and Regulatory Preparedness.”  The report compiles existing risk...

The U.S. Environmental Protection Agency (EPA) has posted a Compliance Advisory entitled “Applicability of the Toxic Substances Control Act to Chemicals made from Petroleum and Renewable Sources Used as Fuels and Fuel Additives and Distillates.”  The Compliance Advisory states that EPA is reaffirming that chemical substances used as fuels, fuel additives, and distillates made from either petroleum or renewable sources are subject to the Toxic Substances Control Act (TSCA).  Anyone who...

The Organization for Economic Cooperation and Development (OECD) has posted a report entitled Ability of biopersistent/biodurable manufactured nanomaterials (MNs) to induce lysosomal membrane permeabilization (LMP) as a prediction of their long-term toxic effects.  The report describes “the expanding knowledge on the implications and biological significance of lysosomal and autophagy dysfunction and the subsequent assembly and activation of inflammasome NLRP3 induced by biodurable...

On December 22, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of new interim guidance on destroying and disposing of certain perfluoroalkyl and polyfluoroalkyl substances (PFAS) and PFAS-containing materials for public comment.  85 Fed. Reg. 83554.  The interim guidance outlines the current state of the science on techniques and treatments that may be used to destroy or dispose of PFAS and PFAS-containing materials from non-consumer products,...

In 2016, the Organization for Economic Cooperation and Development’s (OECD) Working Party on Manufactured Nanomaterials (WPMN) included the Advancing Adverse Outcome Pathway (AOP) Development for Nanomaterial Risk Assessment and Categorization (NanoAOP) project in its program of work.  The objective of the project is to contribute to the future development and application of AOPs for manufactured nanomaterial regulatory decision making by following the principles established by the OECD...

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...

On December 16, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a draft compliance guide that outlines which imported articles are covered by EPA’s July 2020 final significant new use rule (SNUR) that prohibits companies from manufacturing, importing, processing, or using certain long-chain per- and polyfluoroalkyl substances (PFAS) without prior EPA review and approval.  85 FR 81466.  The draft guide will be “the official compliance guide for...

On December 10, 2020, the U.S. Environmental Protection Agency (EPA) announced a new policy that will allow registrants of antimicrobial pesticide products voluntarily to disclose all inert ingredients more efficiently in response to the request of retailers, states, and industry. Registrants who wish to disclose all inert ingredient can choose to do so in three ways under the new policy: On the product label as part of the full ingredient statement or on the product’s back...

On December 14, 2020, the U.S. Environmental Protection Agency (EPA) released the final risk evaluation for perchloroethylene.  The final risk evaluation determined that there are unreasonable risks to workers, occupational non-users (ONU), consumers, and bystanders from 59 out of 61 conditions of uses: Consumers and Bystanders:  EPA found unreasonable risks to consumers and bystanders from all consumer uses of perchloroethylene.  Common consumer uses include as a dry...

The European Union (EU) Observatory for Nanomaterials (EUON) is conducting a web satisfaction survey.  EUON provides information on the safety, innovation, research, and uses of nanomaterials on the EU market.  It is intended for stakeholders developing policies in the area, consumers, industry representatives, and non-governmental organizations.  EUON is funded by the European Commission (EC) and hosted and maintained by the European Chemicals Agency (ECHA).  Information from the survey...

On December 7, 2020, the U.S. Environmental Protection Agency (EPA) issued for comment the Proposed Interim Decision (PID) for chlorpyrifos.  85 Fed. Reg. 78849.  EPA announced it is proposing new risk mitigation measures to address potential human and environmental risks identified in EPA’s September 2020 draft risk assessments.  The PID proposes the following measures: Label amendments limiting application to address potential drinking water risks of...

On December 1, 2020, the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) announced the results of an assessment of R-Nano, France’s national reporting scheme for substances in nanoparticle form.  In 2013, France began requiring companies that manufacture, import, and/or distribute a “substance with nanoparticle status” in an amount of at least 100 grams per year to submit an annual report with substance identity, quantity, and use...

The U.S. Environmental Protection Agency (EPA) announced on December 8, 2020, that it received a complete manufacturer request to conduct a risk evaluation of octahydro-tetramethyl-naphthalenyl-ethanone (OTNE), a category of chemical substances consisting of four inseparable individual isomers.  International Flavors and Fragrances, Inc., Privi Organics USA Corporation, and DRT America, Inc. formally requested the risk evaluation through the OTNE Consortium managed by B&C® Consortia...

On November 25, 2020, the U.S. Environmental Protection Agency (EPA) released updates to the interim final list of manufacturers and importers subject to fees for the next 20 chemicals undergoing risk evaluation under Section 6(b) of the Toxic Substances Control Act.  According to EPA, “[t]he updated list includes additional manufacturers not identified on the final list of companies and removes manufacturers that self-identified in error or imported the chemical solely for the...