The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 28, 2020, extending the comment and reporting period on the preliminary lists of manufacturers (including importers) subject to fees associated with EPA-initiated risk evaluations under the Toxic Substances Control Act (TSCA). 85 Fed. Reg. 32036. The new due date is June 15, 2020. EPA states that it is extending the comment period in response to stakeholder feedback and to...
On May 20, 2020, the U.S. Environmental Protection Agency (EPA) issued a press release announcing a final agreement with Swix Sport USA (Swix) resolving Toxic Substances Control Act (TSCA) violations associated with the importation of noncompliant ski wax products containing per- and polyfluoroalkyl substances (PFAS). According to the press release, Swix agrees to pay a fine and develop a $1 million educational program to raise awareness in ski communities about PFAS chemicals in...
May 27, 2020
EU NanoSafety Cluster Publishes Final Report of (nano) TiO2 Safety Communication Task Force
On May 26, 2020, the European Union (EU) NanoSafety Cluster announced the publication of the final report of the (nano) TiO2 safety communication Task Force. The goal of the task force was to provide scientific input to the ongoing classification of titanium dioxide (TiO2). The Task Force ran from January 2018 to January 2019, collecting information regarding the classification of TiO2 and information on TiO2 hazard potential from available...
May 22, 2020
Study Analyzes Existing Research on Dermal Absorption of Nanomaterials Used in Consumer Products and at Workplaces
The European Union (EU) Observatory for Nanomaterials (EUON) announced on May 20, 2020, that a recent study has analyzed existing research on whether nanomaterials used in consumer products and at workplaces are absorbed through the skin. The study was commissioned by EUON and carried out by the RPA consortium of Triskelion and the Dutch National Institute for Public Health and the Environment (RIVM). According to EUON, the study found that the lack of standardized,...
The U.S. Environmental Protection Agency (EPA) recently published its 2020 Annual Plan for Chemical Risk Evaluations under TSCA (Annual Plan). Section 26(n) of the Toxic Substances Control Act (TSCA) requires EPA to publish an annual plan at the beginning of each calendar year that identifies the chemical substances for which EPA expects to initiate or complete risk evaluations that year and the resources necessary for their completion, describes the status of each risk evaluation that has...
May 22, 2020
“TSCA Reform — Four Years Later” Virtual Seminar
From the current impacts of the Toxic Substances Control Act (TSCA) on science policies to challenges faced by industry, Lautenberg Implementation continues to evolve even four years after becoming law. B&C, The Environmental Law Institute (ELI), and the George Washington University (GWU) Milken Institute School of Public Health are pleased to present “TSCA Reform — Four Years Later,” a complimentary virtual seminar bringing together government and industry officials to...
By Lynn L. Bergeson On May 14, 2020, the American Cleaning Institute (ACI), a BRAG member, announced that the U.S. Environmental Protection Agency (EPA) approved eight cleaning product ingredients submitted by ACI for inclusion in EPA’s Safer Chemical Ingredients List (SCIL). EPA’s Safer Choice Program focuses on assisting consumers, businesses, and purchasers to find products that perform and contain ingredients that are safer for human health and the environment. SCIL is a list of...
By Lynn L. Bergeson The U.S. Air Force (USAF) Research Laboratory is sponsoring a $1 million challenge for synthetic biology solutions to reduce the cost and improve the quality for aerospace thermosets. This scientific challenge is focused on the use of biotechnology to create products or product precursors required by USAF. Interested parties must submit white papers on the viability of the approach to bio-synthesize two molecules A and B needed for aerospace thermosets. This...
May 22, 2020
U.S. Senators Introduce Bipartisan Bioeconomy Act
By Lynn L. Bergeson On May 15, 2020, U.S. Senators Cory Gardner (R-CO), Kirsten Gillibrand (D-NY), Ed Markey (D-MA), and Marco Rubio (R-FL) introduced the Bioeconomy Research and Development Act of 2020, creating a federal research initiative to ensure continued United States leadership in engineering biology. The National Engineering Biology Research and Development Initiative would focus on the advancement of societal well-being, national security, sustainability, and economic productivity and...
By Lynn L. Bergeson On May 18, 2020, USDA issued its final rule for the Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program (9003 Program), which incorporates the statutory definition changes as required in the Agricultural Act of 2018 (Farm Bill) and adopts the interim rule published on June 14, 2015. The 9003 Program replaces the Biorefinery Assistance Program (BAP), which guaranteed loans to fund the development, construction, and retrofitting of...
May 20, 2020
“TSCA Reform — Four Years Later” Provides a Virtual Update on Where Lautenberg Implementation Stands Today
A virtual day-long symposium presented by the Environmental Law Institute (ELI), Bergeson & Campbell, P.C. (B&C®), and the George Washington University Milken Institute School of Public Health Free and Open to the PublicWednesday, June 24, 20209:30 a.m. – 4:30 p.m. (EDT) Register Online B&C, ELI, and the George Washington University Milken Institute School of Public Health are pleased to present “TSCA Reform — Four Years Later.” This complimentary...
On May 20, 2020, the Senate Environment and Public Works Committee held an oversight hearing on the U.S. Environmental Protection Agency (EPA). EPA Administrator Andrew Wheeler was the only witness. During the hearing, Senator Jeff Merkley (D-OR) questioned Wheeler about the risk evaluations being done under the amended Toxic Substances Control Act (TSCA), particularly the risk evaluation of asbestos. Wheeler acknowledged that EPA probably will not meet the June 22, 2020, deadline for...
May 20, 2020
Find B&C’s Updates And Analysis Of Chemical Regulatory Impacts Of COVID-19 In One Place
From new product or new use approvals, to impact on chemical supply chains, Bergeson & Campbell, P.C. (B&C®) monitors key federal and international chemical legislative and regulatory initiatives to keep firm clients and friends informed. We have compiled a comprehensive and frequently updated listing of our content related to the coronavirus crisis that we hope will serve as a useful, one-click source of information: www.lawbc.com/uploads/docs/COVID-19.pdf....
As we noted in our May 15, 2020, blog item “NGOs Ask EPA to Revise Draft Scope Documents to Comply with TSCA and EPA Regulations,” Environmental Defense Fund (EDF), Earthjustice, Natural Resources Defense Council (NRDC), and Safer Chemicals, Healthy Families filed comments on May 13, 2020, stating that the U.S. Environmental Protection Agency’s (EPA) 20 draft scope documents released on April 9 and April 23, 2020, fail to meet Toxic Substances Control Act (TSCA) and EPA...
On May 15, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is issuing its third temporary modification to Pesticide Registration (PR) Notice 98-10 to include food-contact surface sanitizer products containing the active ingredient (AI) isopropyl alcohol. This new temporary amendment permits all the registration modifications outlined in the March and April modifications, while also expanding the criteria for the types of products that qualify for the provisions of...
The Science Advisory Board (SAB) of the U.S. Environmental Protection Agency (EPA) announced that it will convene the Chartered SAB meeting on May 20, 2020, to review and discuss the draft report prepared by the SAB COVID-19 Review Panel. The draft report, SAB Technical Review of EPA’s Identification of Research Needs to Address the Environmental and Human Health Impacts of COVID-19, was funded by the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act. This...
On May 18, 2020, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued the much-anticipated final Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule. 85 Fed. Reg. 29790. The rule is intended to update and modernize USDA’s biotechnology regulations under the Plant Protection Act. The final rule amends the regulations regarding the movement (importation, interstate movement, and environmental release) of...
Environmental Defense Fund (EDF), Earthjustice, Natural Resources Defense Council (NRDC), and Safer Chemicals, Healthy Families filed comments on May 13, 2020, stating that the U.S. Environmental Protection Agency’s (EPA) 20 draft scope documents released on April 9 and April 23, 2020, fail to meet Toxic Substances Control Act (TSCA) and EPA regulatory requirements. According to EDF’s May 14, 2020, blog item, the non-governmental organizations (NGO) called on EPA to revise the...
May 15, 2020
New Reporting Procedure For Co-Manufacturers Under TSCA CDR Rule May Catch Certain Manufacturers Off
By Lynn L. Bergeson One of several changes to the Toxic Substance Control Act (TSCA) Chemical Data Reporting (CDR) rule, issued in final on April 9, 2020, is that in the 2020 cycle, EPA has changed the way that toll manufacturing must be reported. In this cycle, EPA will not accept reporting from only the contracting manufacturer in situations where a company contracts with another company (i.e., a toll manufacturer) for the production of chemicals....
By Lynn L. Bergeson On May 12, 2020, the U.S. Food and Drug Administration (FDA) announced the release of an update to its Purple Book: Database of FDA-Licensed Biological Products (Purple Book). The update adds all FDA-licensed biological products, including products approved in the new drug applications (NDAs) that were deemed to be licenses (transition biological products). This update also includes a new feature allowing users to download reports. Historical reports now include highlighted...
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On May 12, 2020, a bill was introduced in the U.S. House of Representatives, which would make emergency supplemental appropriations for the fiscal year ending on September 30, 2020. Titled the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act), this bill addresses various issues, many of which have been worsened by the COVID-19 pandemic. Some of these issues include provisions of revenue, health, retirement,...
By Lynn L. Bergeson On May 11, 2020, a total of 70 Mayors from various cities in the United States submitted a letter to Andrew Wheeler, U.S. Environmental Protection Agency (EPA) Administrator, criticizing the decision not to uphold the Renewable Fuel Standard (RFS) and not to reject proposed waivers under Section 211(o)(7) of the Clean Air Act. The Mayors state that this decision on waivers is already causing damage to the economy and will continue...
On May 12, 2020, the U.S. Environmental Protection Agency (EPA) announced additional procedures for registrants to add new disinfectant products to EPA’s List N: Disinfectants for Use Against SARS-CoV-2 that are considered to be safe and effective for use against SARS-CoV-2, the virus that causes COVID-19. EPA states that it intends to expedite reviews of certain Pesticide Registration Improvement Extension Act (PRIA 4) submissions for products intended for use against the...
May 14, 2020
EPA Will Hold Webinar on CDR Requirements on May 19
The U.S. Environmental Protection Agency (EPA) will host a webinar on May 19, 2020, from 1:00 to 3:00 p.m. (EDT) to provide an overview of the 2020 Chemical Data Reporting (CDR) requirements. The 2020 CDR submission period is from June 1, 2020, to November 30, 2020. The webinar will include information about the revised reporting requirements, including: The webinar will also introduce the updated e-CDRweb reporting tool. EPA notes that the presentation will...
May 13, 2020
New Reporting Procedure for Co-Manufacturers under TSCA CDR Rule May Catch Certain Manufacturers Off Guard
One of several changes to the Toxic Substance Control Act (TSCA) Chemical Data Reporting (CDR) Rule, issued in final on April 9, 2020, is that in the 2020 cycle, the U.S. Environmental Protection Agency (EPA) has changed the way that toll manufacturing must be reported. In this cycle, EPA will not accept reporting from only the contracting manufacturer in situations where a company contracts with another company (i.e., a toll manufacturer) for the production of chemicals. ...
May 13, 2020
WHO Publishes Principles and Methods to Assess Risk of Immunotoxicity Associated with Exposure to Nanomaterials
On April 12, 2020, the World Health Organization (WHO) published Environmental Health Criteria 244: Principles and methods to assess the risk of immunotoxicity associated with exposure to nanomaterials. WHO states that the document presents an overview of the current knowledge and evidence on principles and basic mechanisms of immunotoxicity caused by engineered nanomaterials (ENM). The document provides guidance on principles and methods for hazard and risk assessment of...
May 13, 2020
EPA’s Updated Small Manufacturer Definition Will Apply to CDR Reporting Period Beginning June 1
On May 12, 2020, the U.S. Environmental Protection Agency (EPA) released the signed final rule updating the definition of small manufacturers, including a new definition of what is considered a small government, used to determine reporting and recordkeeping requirements under the Toxic Substances Control Act (TSCA). According to EPA, the updated definitions will reduce reporting burdens on chemical manufacturers and small governments while maintaining the agency’s ability to receive the...
The U.S. Environmental Protection Agency (EPA) announced on May 11, 2020, that the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) will meet from June 8 to 11, 2020, to peer review the draft risk evaluation for asbestos. The public meeting will be virtual, with participation by phone and webcast only. There will be no in-person gathering for this meeting. EPA postponed the previously announced virtual meeting for SACC to review...
As reported in our April 8, 2020, blog item, the National Academies of Sciences, Engineering, and Medicine (National Academies) 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)...
May 8, 2020
EUON Publishes Nanopinion on ECETOC’s NanoApp
On May 5, 2020, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “NanoApp helps navigate legal obligations under REACH.” Olivier de Matos, Secretary General of the European Center for Ecotoxicology and Toxicology (ECETOC), describes the web-based app that was designed to help registrants follow the European Chemicals Agency’s (ECHA) guidance on sets of nanoforms. According to de Matos, the app primarily covers the “Appendix for...
May 8, 2020
Register Now For The “TSCA Reform — Four Years Later,” Virtual Symposium, Wednesday, June 24, 2020,
By Lynn L. Bergeson B&C, the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health are pleased to present "TSCA Reform — Four Years Later," on June 24, 2020. This complimentary virtual conference marks the fourth Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Speakers...
May 8, 2020
Richard E. Engler, Ph.D., Presents “TSCA New Chemicals” During GlobalChem Webinar Series, May 13, 20
By Lynn L. Bergeson The 2020 GlobalChem webinar series addresses major developments in chemicals management and provides participants a chance to engage with policymakers and other key experts throughout the chemical industry value chain. On May 13, 2020, at 12:00 p.m. (EDT), Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), will present during the “TSCA New Chemicals” webinar. Other presenters include Lynn Dekleva, Ph.D., Associate Deputy...
On April 29, 2020, the U.S. District Court for the District of Utah issued a temporary restraining order (TRO) to halt the sale of a fraudulent coronavirus (COVID-19) treatment. The U.S. Department of Justice (DOJ) announced the court’s decision in an effort to halt the sale of silver products fraudulently claimed to prevent and cure COVID-19. DOJ filed a civil complaint on April 27, 2020, against defendants Gordon Pedersen of Cedar Hills, Utah and his companies, My...
The American Industrial Hygiene Association (AIHA) announced on May 1, 2020, the availability of industry-specific guidelines and resources intended to help employers and employees get back to work safely. Guidelines are available for at-home service providers, retail, restaurant, hair and nail salon, and construction industries, general office settings, gyms and workout facilities and rideshare, taxi, limo, and other passenger driver-for hire. The guidelines include...
May 6, 2020
EPA Approves Experimental Use Permit for Field Testing of Genetically Modified Aedes aegypti Mosquitoes
On May 1, 2020, the U.S. Environmental Protection Agency granted an experimental use permit (EUP) to Oxitec Ltd. (Oxitec) to field test the use of genetically engineered Aedes aegypti mosquitoes as a way to reduce populations that serve as a vector for a variety of diseases including Zika virus. The EUP is designed to test the effectiveness of genetically engineered Aedes aegypti mosquitoes as a way to reduce mosquito populations in specific locations with monitoring...
The 2020 GlobalChem webinar series addresses major developments in chemicals management and provides participants a chance to engage with policymakers and other key experts throughout the chemical industry value chain. On May 13, 2020, at 12:00 p.m. (EDT), Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), will present during the “TSCA New Chemicals” webinar. Other presenters include Lynn Dekleva, Ph.D.,...
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 4, 2020, announcing the availability of and soliciting public comment on the draft Toxic Substances Control Act (TSCA) risk evaluation of perchloroethylene. 85 Fed. Reg. 26464. EPA states that it is also submitting the same document to the TSCA Science Advisory Committee on Chemicals (SACC) for peer review and is announcing that there will be two virtual public meetings of the TSCA SACC, with...
May 4, 2020
EPA Proposes SNUR for Carbon Nanotubes (Generic)
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...
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...
April 29, 2020
EPA and CBP Announce the Prevention of Shipments of Unregistered “Virus Shut Out” Product Imported into California
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...
April 24, 2020
EPA Announces Its Continued Efforts to Provide Critical Information on Safe Disinfectant Use During COVID-19 Crisis
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....