Blogs

On May 4, 2020, the U.S. Environmental Protection Agency (EPA) published proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMN) and are subject to orders issued by EPA pursuant to TSCA.  85 Fed. Reg. 26419.  The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is...

The International Organization for Standardization (ISO) has published standard ISO/TS 21412:2020, “Nanotechnologies — Nano-object-assembled layers for electrochemical bio-sensing applications — Specification of characteristics and measurement methods.”  The standard specifies the characteristics to be measured of nano-object-assembled layers on electrodes by means of a solution process and of nano-objects constituting the layers for electrochemical applications such as...

By Lynn L. Bergeson On April 29, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) announced a virtual meeting of the Board of Scientific Counselors (BOSC) Chemical Safety for Sustainability and Health and Environmental Risk Assessment (CSS-HERA) Subcommittee. The purpose of the meeting will be to review the draft 2019-2022 Strategic Research Action Plan (StRAP) of the HERA research program. The videoconference meeting will be held over a...

By Lynn L. Bergeson On April 28, 2020, U.S. Representative Abby Finkenauer (D-IA) introduced the Clean Fuels Deployment Act of 2020, which would fund installation and conversion of fuel pump infrastructure to deliver higher blends of biofuel. Co-sponsored by Representatives Angie Craig (D-MN), Don Bacon (R-NE), and Roger Marshall (R-KS), this bipartisan bill creates a clean fuels grant program with $600 million over a six-year period to help biofuel retailers. The plan is to assist retailers to...

By Lynn L. Bergeson On April 24, 2020, the U.S. Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced that it intends to issue a funding opportunity to: Stimulate technology innovation;   Enable manufacturing of cutting-edge products in the United States; and   Improve energy productivity of manufacturing. On behalf of the Advance Manufacturing Office (AMO), this potential funding opportunity aims to advance the Trump...

On April 29, 2020, the U.S. Environmental Protection Agency (EPA) and the Centers for Disease Control and Prevention (CDC) released updated guidance to give assistance to facility operators and families on how to clean and disinfect spaces properly. Developed in cooperation with the White House, the updated guidance provides step-by-step instructions for public spaces, workplaces, businesses, schools, and homes, and falls in line with the Opening up America Again guidelines, the...

 The Ministry of Industry and Trade of the Russian Federation formally announced that the May 1, 2020, deadline to submit substances and mixtures to its chemical inventory is extended to August 1, 2020. Entities exporting products to the Russian Federation should nominate their substances and mixtures to the Russian chemical inventory to ensure continued access to the Russian market.  New substance registration is required for substances or mixtures not on the inventory after the nomination...

On April 24, 2020, the U.S. Environmental Protection Agency (EPA) and U.S. Customs and Border Protection (CBP) announced that the agencies prevented a significant number of shipments of illegal health products from entering the Los Angeles International Airport (LAX) and the San Francisco International Airport (SFO). The products at issue were not registered with EPA, including Virus Shut Out products.  EPA previously announced on March 25, 2020, that EPA and CBP had...

On April 23, 2020, the Supreme Court ruled that pollution traveling indirectly to rivers and streams through groundwater can be covered by the Clean Water Act’s (CWA) permitting requirements.  The case, County of Maui, Hawaii v. Hawaii Wildlife Fund, et al, 590 U.S. (2020), concerned whether pollutants discharged from a point source into groundwater, a non-point source, and then conveyed into navigable waters fall within permitting requirements of the CWA.  In a 6-3 Opinion...

On April 27, 2020, the U.S. Environmental Protection Agency (EPA) released the draft risk evaluation of perchloroethylene.  Perchloroethylene is the last of the first ten chemicals to undergo risk evaluation under the amended Toxic Substances Control Act (TSCA).  EPA’s draft risk evaluation preliminarily found unreasonable risk to workers, occupational non-users, consumers, bystanders, and the environment from certain uses.  EPA states that the primary health risk identified in the draft...

On April 20, 2020, the U.S. Environmental Protection Agency (EPA) announced that EPA Administrator Wheeler has requested that the Science Advisory Board (SAB) provide feedback on research needs concerning SARS-CoV-2 (the virus that causes COVID-19).  This research is intended to help EPA understand and mitigate the environmental and human health impacts from COVID-19, and identifies EPA research that is already underway as well as new EPA research that has been proposed.  EPA issued...

On April 23, 2020, the U.S. Environmental Protection Agency (EPA) announced it is continuing efforts to provide critical information on surface disinfectant products that can be used against SARS-CoV-2, which causes COVID-19.  EPA states that it now has nearly 400 products that have qualified to be effective against SARS-CoV-2.  EPA also published an overview of its actions and resources related to disinfection against the novel coronavirus. EPA’s Office of Chemical Safety and...

By Lynn L. Bergeson On April 22, 2020, the U.S. Department of Energy’s (DOE) Rapid Advancement in Process Intensification Deployment (RAPID) Manufacturing Institute announced the availability of $4 million for five selected projects. The projects align with RAPID’s research focus areas in chemical and commodity processing, renewable bioproducts, natural gas upgrading, modeling and simulation, module manufacturing, and intensified process fundamentals.

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. In March 2020, a paper by master’s degree student Anastasia Prosina titled “Algae-Based Printer Ink as the Way to Foster In-Situ Resource Utilization in Habitation Structures” was published in ResearchGate. Prosina’s paper, submitted to Sasakawa International Center for Space Architecture (SICSA), proposes that the most feasible long-term habitat off-Earth will consist of a 3D printed mixture of algae and regolith, the...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On April 17, 2020, U.S. Department of Agriculture (USDA) Secretary, Sonny Perdue, announced $19 billion to farmers and ranchers as part of its COVID-19 relief program. Aimed at providing critical support in maintaining the integrity of the U.S. food supply chain and ensuring that every American has access to the food needed, the funds will be used not only to directly support farmers and ranchers, but also for USDA purchase and distribution. The...

On April 22, 2020, Assistant Administrator Alexandra Dapolito Dunn stated, on prerecorded remarks posted by the American Bar Association, that the U.S. Environmental Protection Agency (EPA), after the coronavirus crisis subsides, will review whether some of the current requirements to submit notifications or label amendments are necessary.  Some of these requirements have been suspended as part of EPA’s efforts to hasten the process for disinfectants approved for use against SARS-CoV-2,...

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on April 23, 2020, announcing the availability of the draft scope documents for the risk evaluations to be conducted for the remaining seven of the 20 high-priority substances designated in December 2019.  85 Fed. Reg. 22733.  The draft scope document for each chemical substance includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA plans to...

Bergeson & Campbell, P.C. (B&C®) is pleased to release a timely episode of the All Things Chemical™ podcast, “Chemical Distribution in the Time of COVID-19 — A Conversation with Eric R. Byer, NACD.” In this episode, Lynn L. Bergeson, Managing Partner, B&C, and Eric Byer, President and CEO of the National Association of Chemical Distributors (NACD), sat down to discuss current challenges facing small and large chemical distributors, and how NACD member...

The U.S. Environmental Protection Agency (EPA) has postponed the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) peer review virtual meeting scheduled for April 27-30, 2020, due to recent changes in the availability of SACC members for the review.  EPA states that given the importance of the draft risk evaluation for asbestos, it believes that “rescheduling for a time when more members are available is critical and will allow for a more robust...

Register now for the American Bar Association (ABA) webinar “Navigating the Jurisdictional Tightrope Between Biopesticides, Biostimulants, and Related Emerging Technologies” with Bergeson & Campbell P.C. (B&C®) professionals deconstructing the jurisdictional boundaries distinguishing pesticides, biopesticides, plant regulators, biostimulants, and related technologies. The webinar will focus on draft EPA guidance intended to clarify the lines between and among those products that are...

The Nanotechnology Entrepreneurship Network (NEN) aired a special episode of its podcast on March 31, 2020, “Resources for Small Businesses Impacted by COVID-19: A Conversation with Jennifer Shieh.”  The episode features a conversation between Dr. Lisa Friedersdorf, Director of the National Nanotechnology Coordination Office (NNCO), and Dr. Jennifer Shieh, Chief Scientist and Program Manager at the U.S. Small Business Administration (SBA).  Dr. Shieh discusses the resources...

Register now for the American Bar Association (ABA) webinar “Navigating the Jurisdictional Tightrope Between Biopesticides, Biostimulants, and Related Emerging Technologies” with Bergeson & Campbell P.C. (B&C®) professionals deconstructing the jurisdictional boundaries distinguishing pesticides, biopesticides, plant regulators, biostimulants, and related technologies. The webinar will focus on draft EPA guidance intended to clarify the lines between and among those...

On April 17, 2020, the U.S. Environmental Protection Agency (EPA) released the second set of draft scope documents for the seven remaining chemicals designated as high-priority substances for risk evaluation under the Toxic Substances Control Act (TSCA).  As reported in our December 20, 2019, memorandum, EPA designated these chemicals as a high priority for risk evaluation in December 2019.  According to EPA, seeking public input on the conditions of use to be included in the risk...

On May 4, 2022, NanoHarmony will hold a webinar in its series of webinars covering the different phases that an Organization for Economic Cooperation and Development (OECD) test guideline (TG) progresses through during its journey from a science-based initial idea through to use by industry to fulfill regulatory obligations. This webinar will cover phases 2 and 3 of the TG process, technical development and commenting and approval. Speakers will include: Chair Claus Svendsen, United Kingdom...

On April 7, 2020, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Carbon Nanotubes — First nanomaterial of high concern on the SIN List.”  As reported in our November 27, 2019, blog item, ChemSec added carbon nanotubes to the Substitute It Now (SIN) List in November 2019.  According to Dr. Anna Lennquist, Senior Toxicologist, International Chemical Secretariat (ChemSec), ever since ChemSec created the SIN List, there have been...

On April 16, 2020, the U.S. Environmental Protection Agency (EPA) hosted a call on its recently announced plan to reduce the burden for certain stakeholders subject to the Toxic Substances Control Act (TSCA) fees rule requirements for EPA-initiated risk evaluations.  The call covered: How EPA’s plan to initiate a rulemaking to consider proposing exemptions to the current rule’s requirements impacts manufacturers and other businesses;  What the “No Action Assurance” means for...

On April 9, 2020, the Department of Justice (DOJ) announced it had charged a Georgia resident, Rong Sun, a/k/a Vicky Sun with federal criminal charges relating to alleged illegal importation, sales, and mailing of an unregistered pesticide product.  EPA also has taken steps to prevent further imports, sales, and distributions of this product within the United States, announcing in its press release that it prevented several shipments of this product from entering U.S....

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On April 9, 2020, the U.S. Department of Agriculture (USDA) published a report titled “Agricultural Biotechnology Annual,” which argues that under any scenario, the United Kingdom’s (U.K.) separation from the EU (Brexit) is unlikely to change policy or trade in genetically engineered (GE) industries. According to the report prepared by USDA’s Jennifer Wilson, given the fact that the EU is the U.K.’s trading partner...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On April 10, 2020, the European Commission (EC) announced the launch of its new online service that connects crop and food producers with biorefineries. This European Union (EU) project aims to address food waste by enabling crop producers, food processors, and agricultural cooperatives to sell their waste as feedstock for use by two biorefineries in Spain and Italy. The multi-feedstock biorefineries, designed by Agrimax, convert farming and...

By Lynn L. Bergeson On May 6, 2020, the U.S. Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE) will host a virtual meeting of the State Energy Advisory Board (STEAB). The virtual meeting will take place from 12:00 p.m. to 4:00 p.m. (EDT). Interested parties must contact the Board’s Designated Federal Officer, Jay Nathwani, via e-mail or phone at 202-586-9410.

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On April 6, 2020, the U.S. Food and Drug Administration (FDA) published a report that provides options and recommendations for a new methodology to evaluate changes in resource capacity needs of human drug and biosimilar biologic review programs. Titled “Independent Evaluation of the PDUFA and BsUFA Resource Capacity Planning Adjustment Methodology: Evaluation and Recommendations,” the analysis of the methodology was reviewed by an...

The International Organization for Standardization (ISO) has published standard ISO/TS 11308:2020, “Nanotechnologies — Characterization of carbon nanotube samples using thermogravimetric analysis.” The standard provides guidelines for the characterization of carbon nanotube (CNT)-containing samples by thermogravimetric analysis (TGA), performed in either an inert or oxidizing environment. The standard offers guidance on the purity assessment of the CNT samples through a quantitative...

The U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) is hosting the following webinars to educate scientists on the more than 30 federal opportunities available in Research Triangle Park, North Carolina: Thursday, April 16, 2020, 2:00 p.m. to 3:00 p.m. (EDT).  Join the webinar;  Thursday, April 23, 2020, 2:00 p.m.to 3:00 p.m. (EDT).  Join the webinar; and  Thursday, April 30, 2020, 2:00 p.m. to 3:00...

This week, I sat down with Eric Byer, President and CEO of the National Association of Chemical Distributors (NACD). Eric, like many of us these days, is working hard and under extraordinary circumstances ensuring that his member companies are able to continue to distribute much needed chemical products, including sanitizers and other cleaning products, in response to the pandemic.  Our conversation focused on these uniquely “in the moment” issues and a broad range of federal,...

On April 14, 2020, the U.S. Environmental Protection Agency (EPA) announced it is taking further action to help ease the production and availability of EPA-registered disinfectants by temporarily allowing registrants to notify EPA of certain formulation and manufacturing facility changes and immediately release the product for sale without waiting for EPA approval.  This only applies to products on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N).  EPA’s...

On April 6, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of its progress report in meeting its performance measures and goals for pesticide reregistration during fiscal year 2017 (2017 Report).  Section 4(l) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to publish information about EPA’s annual achievements in this area.  The 2017 Report discusses the completion...

The International Organization for Standardization (ISO) has published standard ISO/TS 21237:2020, “Nanotechnologies — Air filter media containing polymeric nanofibres — Specification of characteristics and measurement methods.”  According to ISO, in recent years, air filter media containing nanofibers have been commercialized and widely used by different industries due to their high filtration efficiency, along with a low pressure drop created by the slip flow effect.  ISO...

 The U.S. Environmental Protection Agency (EPA) published on August 11, 2020, its quarterly update of the Toxic Substances Control Act (TSCA) confidential business information (CBI) review statistics.  These data summarize the number of CBI cases under review and results of completed reviews through June 15, 2020: CBI Review Statistics (cases received between June 22, 2016 and June 15, 2020)Cases in which the specific chemical identity is subject to CBI review3,326Cases in which...

The European Union (EU) Observatory for Nanomaterials (EUON) posted an article on April 6, 2020, announcing the availability of a study that found a lack of data on female fertility.  The study, A critical review of studies on the reproductive and developmental toxicity of nanomaterials, was commissioned by the European Chemicals Agency (ECHA) and carried out by DHI A/S and the Danish National Research Center for the Working Environment.  The scope of this project was to...

The U.S. Environmental Protection Agency (EPA) published on April 10, 2020, the quarterly update of the Toxic Substances Control Act (TSCA) confidential business information (CBI) review statistics.  The data summarize the number of CBI cases under review and results of completed reviews through March 1, 2020.  In addition, a spreadsheet showing the details of completed TSCA CBI determinations through March 1, 2020, is available.  EPA states that making this information publicly available...

By Lynn L. Bergeson EPA announced on April 2, 2020, that it sent a letter to all members of Congress to correct the record on its temporary policy regarding enforcement of environmental legal obligations during the COVID-19 pandemic. EPA states that “[a]s should be apparent to anyone who reads the policy, allegations that EPA ‘will cease all enforcement actions during the coronavirus pandemic’ and that the temporary policy ‘absolves polluters of all responsibility’...

By Lynn L. Bergeson On March 3, 2020, EPA announced the availability of a supplemental notice of proposed rulemaking (SNPRM) to the Strengthening Transparency in Regulatory Science proposed rule. EPA notes that the SNPRM “is not a new rulemaking; rather, it provides clarifications on certain terms and aspects of the 2018 proposed rule.” The SNPRM: Proposes that the scope of the rulemaking applies to influential scientific information, as well as significant regulatory decisions;...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On April 9, 2020, EPA issued a final rule amending the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) regulations by extending the 2020 report submission deadline to November 30, 2020. The extension applies to the 2020 submission period only. As many are aware, CDR regulations require manufacturers (including importers) of certain chemical substances to report data on the manufacturing, processing, and use of the chemical...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On April 6, 2020, 15 United States Senators submitted a bipartisan letter to the U.S. Department of Agriculture (USDA) Secretary, Sonny Perdue, requesting the use of its authority to assist the biofuels industry’s economic circumstances brought by the COVID-19 pandemic. Highlighting the negative impacts of the pandemic on farmers and producers who will bear the impact of the decrease in consumption, in the letter, the Senators have also...

On April 3, 2020, the California Department of Pesticide Regulation (DPR) announced it would allow enforcement discretion by County Agricultural Commissioners (CAC) for licensing and certification requirements for pesticide applicators who perform sanitization services to control the spread of COVID-19. DPR states in its announcement that, under normal circumstances, a “Pest Control Business (PCB) must always have a Qualified Applicator License (QAL) holder to supervise pest control...

The U.S. Environmental Protection Agency (EPA) will hold a call on April 16, 2020, from 1:00 p.m. to 2:00 p.m. (EDT) on its recently announced plan to reduce burden for certain stakeholders subject to the Toxic Substances Control Act (TSCA) fees rule requirements for EPA-initiated risk evaluations.  The call will cover: TSCA fees rule requirements and processes associated with EPA-initiated risk evaluations;  EPA’s March 25, 2020, rulemaking announcement and “No...

The National Academies of Sciences, Engineering, and Medicine (National Academies) have published a prepublication copy of A Quadrennial Review of the National Nanotechnology Initiative:  Nanoscience, Applications, and Commercialization.  The National Nanotechnology Coordination Office (NNCO) asked the National Academies to form an ad hoc committee to conduct a quadrennial review of the National Nanotechnology Initiative (NNI) pursuant to the 2003 21st Century...

The U.S. Environmental Protection Agency (EPA) announced on April 8, 2020, that it received a complete manufacturer request for EPA to conduct a risk evaluation of octamethylcyclotetrasiloxane (D4) from Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation through the American Chemistry Council’s Silicones Environmental, Health, and Safety Center.  EPA states that...

The U.S. Environmental Protection Agency (EPA) has placed a March 29, 2022, memorandum correcting the deadline for public comment on the Toxic Substances Control Act (TSCA) Collaborative Research Program to Support New Chemicals. The memorandum states that EPA is clarifying the deadline because the February 25, 2022, Federal Register notice erroneously referenced two different dates. The 60-day comment period on the supporting technical document began when EPA added the document to the...

The U.S. Environmental Protection Agency (EPA) announced on April 6, 2020, that the first set of draft scope documents for the next group of chemicals undergoing risk evaluation under the Toxic Substances Control Act (TSCA) is available for comment.  As reported in our December 20, 2019, memorandum, EPA designated these chemicals as a high priority for risk evaluation in December 2019.  According to EPA, seeking public input on the conditions of use to be included in the risk...