B&C® Biobased and Sustainable Chemicals Blog

By Lynn L. Bergeson EPA announced on June 1, 2020, the availability of the latest Toxic Substances Control Act (TSCA) Inventory. EPA notes that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. EPA plans the next regular update of the Inventory for early 2021. According to EPA, the Inventory contains 86,405 chemicals, of which 41,587 are active in the United States commerce. Other updates...

By Lynn L. Bergeson On May 29, 2020, the U.S. Environmental Protection Agency (EPA) issued a pre-publication version of a proposed anti-backsliding determination that no additional measures are necessary pursuant to the Clean Air Act (CAA) Section 211(v) to mitigate the adverse air quality impacts of renewable fuel volumes required under CAA Section 211(o). The proposed determination will be published in the Federal Register for a 30-day comment period. CAA Section 211 requires EPA to...

By Lynn L. Bergeson On May 21, 2020, the U.S. Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced the availability of approximately $21.3 million in funding for 106 Phase I small business innovation projects. The funds, announced by U.S. Secretary of Energy Dan Brouillette, are part of DOE’s $53 million available for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) research and development projects. The...

By Lynn L. Bergeson On May 22, 2020, EPA’s Office of Pesticide Programs (OPP) announced the opening of a 15-day comment period on its proposal to register a new active ingredient and biopesticide product. The biopesticide product, PHC-91398, would contain Ea peptide 91398, the new active ingredient that was derived from naturally occurring bacterium and induces natural plant defenses. The plant’s reaction to the peptide “activates a hypersensitive response in treated plants,...

By Lynn L. Bergeson On May 28, 2020, the U.S. Environmental Protection Agency (EPA) announced the issuance of the final rule amending the definition of small manufacturer, including a new definition for small government in accordance with the Toxic Substances Control Act (TSCA). Effective June 29, 2020, these amendments affect certain reporting and recordkeeping requirements in the Chemical Data Reporting (CDR) rule under TSCA....

By Lynn L. Bergeson On May 21, 2020, U.S. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) introduced a bill directing the U.S. Department of Agriculture (USDA) Secretary to establish a renewable feedstock reimbursement program. Aiming to support biofuel producers that have been negatively affected by the COVID-19 pandemic, this bill can be cited as the Renewable Fuel Feedstock Reimbursement Act of 2020. Under the reimbursement program, biofuel producers will be reimbursed for their...

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...

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...

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...

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...

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...

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...

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...

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...

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...

 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...

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...

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...

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...

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 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: Webinar participants will learn about OCSPP’s role in protecting human health and the environment, OCSPP’s newly formed worksite located in Research Triangle Park, and the more than 30 scientific positions for which OCSPP is...

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,...

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...

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...

By Lynn L. Bergeson EPA announced on March 26, 2020, a temporary policy regarding enforcement of environmental legal obligations during the COVID-19 pandemic. EPA states that its temporary enforcement discretion policy applies to civil violations during the COVID-19 outbreak. The policy addresses different categories of noncompliance differently. For example, according to EPA, it “does not expect to seek penalties for noncompliance with routine monitoring and reporting obligations that are...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On March 31, 2020, the U.S. Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced its intention to replace eXCHANGE for a new system for funding opportunity announcements (FOA) and application submissions. Starting in Fiscal Year 2021, parties interested in responding to EERE’s opportunities will use the EERE Program Information Center (EPIC). As DOE EERE transitions into EPIC, it is currently...

By Lynn L. Bergeson On April 1, 2020, the U.S. Department of Agriculture (USDA) requested written stakeholder input on objectives and opportunities leading to research goals and informed product goals to facilitate transformative breakthroughs that enable U.S. agriculture to meet its goal of increasing agricultural production by 40 percent by 2050....

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On April 1, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is now accepting nominations of scientific experts to be considered for appointment to its Science Advisory Board (SAB) and four SAB standing committees. EPA is seeking candidates from a wide range of disciplines including analytical chemistry, forestry, modeling, toxicology, and benefit-cost analysis, among many others. The four SAB standing committees seeking...

The Acta Group (Acta®) announced today the launch of CDR Cross-Check™, an ingenious yet simple tool developed and offered by Acta to assist companies in preparing for the 2020 Chemical Data Reporting (CDR) required by the U.S. Environmental Protection Agency (EPA). CDR Cross-Check utilizes the most recent CDR listing information publicly available provided by EPA (currently, 2016 lists) to identify whether all or some of a company’s inventory of chemical substances are subject to...

By Lynn L. Bergeson Effective March 29, 2020, Yvette T. Collazo will be the new Director of EPA’s Office of Pollution Prevention and Toxics (OPPT). Ms. Collazo previously worked for the U.S. Department of Energy (DOE), where she led activities related to federal contracts and agreements of more than $250 million for the cleanup of radiological, industrial, and groundwater hazards resulting from decades of nuclear material production at DOE’s Savannah River facility. Ms. Collazo also...

By Lynn L. Bergeson On March 25, 2020, the U.S. Department of Energy (DOE) announced a meeting of the Biological and Environmental Research Advisory Committee (BERAC). The meeting will be held digitally via webcast on April 16, 2020, from 9:00 a.m. to 5:00 p.m. (EDT). Information on how to access the meeting will be posted here. Tentative agenda topics include: BERAC business and discussion; News from the Biological Systems Science and Climate and Environmental Sciences...

The U.S. Environmental Protection Agency (EPA) announced on March 25, 2020, that it will consider a proposed rule that would look at potential exemptions to the Toxic Substances Control Act (TSCA) fees rule in response to stakeholder concerns about implementation challenges.  EPA states that by considering a proposal to narrow the broad scope of the current requirements, it “could significantly reduce burden on potentially thousands of businesses across the country while...

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on March 23, 2020, announcing that the EPA Safer Choice program is accepting submissions for its 2020 Safer Choice Partner of the Year Awards.  85 Fed. Reg. 16334.   EPA states that it developed the Partner of the Year Awards to recognize the leadership contributions of Safer Choice partners and stakeholders who, over the past year, have shown achievement in the design,...

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on March 20, 2020, inviting the public to nominate scientific experts from a diverse range of disciplines to be considered for appointment to the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC).  85 Fed. Reg. 16094.  EPA is seeking nominations of individuals who have demonstrated high levels of expertise in scientific and/or technical fields relevant to...

By Lynn L. Bergeson The Product Stewardship Society is now accepting nominations for officials from member companies to serve on its Board of Directors. The Board establishes the organization’s strategic direction and goals, and monitors progress toward reaching those goals. Nominees must be members in good standing; self-nominations are allowed. “Our Board members are leaders in a diverse range of business sectors. We are looking for leaders who have a passion for the Society and...