By Lynn L. Bergeson On July 13, 2020, DOE’s Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs Office (SBIR/STTR Programs Office) issued topics for its FY 2021 SBIR/STTS Phase I Release 1 Funding Opportunity Announcement (FOA). The topics are available online. DOE participating program offices include the Office of Science’s (SC) Office of Advanced Scientific Computing Research (ASCR), Office of Basic Energy Sciences (BES), Office...
August 7, 2020
DOE Selects R&D Projects In The Biomanufacturing Sector
By Lynn L. Bergeson On July 10, 2020, DOE EERE announced that it has selected eight projects totaling more than $5 million to conduct R&D needed to accelerate the U.S. biomanufacturing sector. These projects are a part of the Agile BioFoundry (ABF) consortium and will leverage National Laboratory capabilities to address challenges in biomanufacturing. Each of these ABF selected projects has been invited to collaborate with National Laboratory research facilities to conduct their...
August 7, 2020
USDA Requests Comments On Update To Bioengineered Foods List
By Lynn L. Bergeson On July 24, 2020, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) announced its solicitation for comments and feedback on recommendations to update the List of Bioengineered Foods as it pertains to the National Bioengineered Food Disclosure Standard. Comments are due by August 24, 2020....
August 7, 2020
FDA DHHS Announces 2021 Biosimilar User Fee Rates
By Lynn L. Bergeson On August 4, 2020, the U.S. Food and Drug Administration (FDA) Department of Health and Human Services (DHHS) announced the rates for biosimilar user fees for fiscal year (FY) 2021. The fees assessed are used by FDA for certain activities in connection with biosimilar biological product development, review of applications for approval of biosimilar biological products, and approval of product applications. The established fees will apply from October 1, 2020, through...
August 7, 2020
DOE Announces $64 Million In Funding For H2@Scale Projects
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On July 20, 2020, DOE announced that approximately $64 Million in funding for 18 projects to advance the H2@Scale vision. H2@Scale is a concept that explores the potential for wide-scale hydrogen production and utilization in the United States to enable resiliency of the power generation and transmission sectors while aligning diverse domestic industries, competitiveness, and job creation. Funded through DOE’s Office of Energy Efficiency...
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On July 23, 2020, the National Defense Authorization Act (NDAA) was passed by the U.S. Senate; it includes the bipartisan Sustainable Chemistry Research and Development Act of 2019, led by U.S. Senators Chris Coons (D-DE) and co-sponsored by Senators Susan Collins (R-ME), Amy Klobuchar (D-MN), and Shelley Moore Capito (R-WV). Introduced to the Senate in December 2019, the Sustainable Chemistry Research and Development Act of 2019...
By Lynn L. Bergeson On August 4, 2020, U.S. Senators Joni Ernst (R-IA) and Chuck Grassley (R-IA) voted against Mark Menezes, who is nominated to become Deputy Secretary of Energy. In a statement, both Senators said that “[g]iven the uncertainty with the ‘gap year’ small refinery waivers, the wasted time and resources to score the waivers again, the lack of transparency in the entire process, and most importantly, the toll this has taken on Iowa’s...
This week’s All Things Chemical™ Podcast will be of interest to readers of the TSCAblog™. A brief description of the episode written by Lynn L. Bergeson is below. This week I sat down with Richard E. Engler, Ph.D., B&C’s Director of Chemistry, and all-around TSCA savant. Rich is an organic chemist and a 17-year veteran with the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics, where Rich managed the Green Chemistry Program and...
August 6, 2020
EPA Issues SSURO against EcoShield LLC for Selling an Unregistered Product Claiming Effectiveness against SARS-CoV-2
On August 5, 2020, the U.S. Environmental Protection Agency (EPA) issued a Stop Sale, Use or Removal Order (SSURO) against EcoShield LLC (EcoShield) for selling a clip-on badge product called the Eco AirDoctor Portable that claims to sanitize the air of pathogens. EPA states that the product was being sold and distributed in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) because it is an unregistered pesticide making false disinfectant claims. ...
August 5, 2020
EPA Develops New TSCA Section 5(e) Order Boilerplate and SOP for OECA Input in Developing Consent Orders
As reported in our May 29, 2020, blog item, on May 28, 2020, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) issued a report entitled EPA Toxic Substances Control Act Consent Orders Need Better Coordination. OIG conducted the evaluation to determine what actions EPA took to verify compliance with the requirements of a 2009 Toxic Substances Control Act (TSCA) Premanufacture Notice Consent Order. OIG’s recommendations included that EPA implement a process...
August 4, 2020
EPA Awards $4 Million to Develop New Approaches for Evaluating Chemical Toxicokinetics
On August 3, 2020, the U.S. Environmental Protection Agency (EPA) announced $3,980,782 in funding to five academic research teams to develop New Approach Methods (NAM) for evaluating chemical toxicokinetics. According to EPA, compared to traditional animal testing, NAMs allow researchers better to predict potential hazards for risk assessment purposes without the use of traditional methods that rely on animal testing. EPA is providing a grant of up to $800,000 to each...
July 30, 2020
Suit Regarding Failure to Disclose Information about New Chemicals Could Be Resolved without a Trial
As reported in our March 23, 2020, memorandum, on March 18, 2020, a coalition of non-governmental organizations (NGO) filed suit in the U.S. District Court for the District of Columbia against the U.S. Environmental Protection Agency (EPA), claiming that EPA fails to disclose information about new chemical substances under the Toxic Substances Control Act (TSCA). Environmental Defense Fund v. Wheeler, No. 1:20-cv-762. On July 27, 2020, the parties submitted a joint case...
On July 30, 2020, the U.S. Environmental Protection Agency (EPA) announced it approved amended labels for 13 products based on laboratory testing that shows the products are effective against SARS-CoV-2, the virus that causes COVID-19. These products, and two previously announced products (see our July 7, 2020, blog), are the only products for which EPA has reviewed laboratory testing data and approved label claims specifically against SARS-CoV-2. In January 2020, at the...
As reported in our February 5, 2020, blog item, the American Conference of Governmental Industrial Hygienists (ACGIH®) Threshold Limit Values for Chemical Substances (TLV®-CS) Committee included carbon nanotubes on its 2020 list of chemical substances and other issues under study. Being placed on the under study list indicated that the TLV®-CS Committee had selected carbon nanotubes for development of a threshold limit value (TLV®). ACGIH® has now released...
On July 27, 2020, the U.S. Environmental Protection Agency (EPA) promulgated a final significant use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate chemical substances. 85 Fed. Reg. 45109. The final SNUR requires persons to notify EPA at least 90 days before commencing the manufacture (including import) or processing of these chemical substances for the significant new uses described in the notice. The required significant new use notification...
The Organization for Economic Cooperation and Development (OECD) recently published two guidance documents in its series on testing and assessment:...
The National Academies of Sciences, Engineering, and Medicine (NASEM) are now assembling an ad hoc committee to identify emerging scientific and technological advances from across a broad range of disciplines that the U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) should consider in its research planning to support EPA’s mission for protecting human health and the environment. In addition, according to NASEM, the committee will...
This week’s All Things Chemical™ Podcast will be of interest to readers of the TSCAblog™. A brief description of the episode written by Lynn L. Bergeson is below. This week I sat down with Congressman John M. Shimkus, a Member of the United States House of Representatives for the 15th District of Illinois. As listeners of the podcast know well, Congressman Shimkus is a senior Member of the House Energy and Commerce Committee. In this capacity, Congressman...
On July 23, 2020, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Material manufacturing from nano-scaled particles: moving forward using plants” by Dr. Blaise Tardy, Research Fellow, Bio-Based Colloids and Materials Research Group — Aalto University in Finland. Dr. Tardy notes that bio-based nanomaterials such as nanocellulose “have shown great promise in forming high performance materials, with the potential to replace...
The U.S. Environmental Protection Agency (EPA) is accepting public comments on the experts under consideration for membership on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC). Biographies of the candidates are available in Docket ID EPA-HQ-OPPT-2020-0135. Comments are due August 21, 2020. EPA states that it will use public comments to assist it in selecting multiple members of SACC over the next year. EPA expects to appoint approximately 15...