Blogs

On May 4-5, 2022, the U.S. Environmental Protection Agency (EPA) Board of Scientific Counselors (BOSC) Executive Committee will meet to review the Office of Research and Development’s (ORD) six Strategic Research Action Plans (StRAP) for fiscal years (FY) 2023-2026. The meetings are open to the public. 87 Fed. Reg. 23861. BOSC will consider comments on the draft StRAPs that are submitted by May 3, 2022. Requests for the draft agenda or making a presentation at the meeting...

On April 13, 2022, the Office of Environmental Health Hazard Assessment (OEHHA) issued a Notice of Modification to Proposed Regulation on Safe Harbor Warnings for Glyphosate and Addition of Documents to Rulemaking File (Notice). OEHHA first proposed this regulation by publishing a Notice of Proposed Rulemaking on July 23, 2021. OEHHA provided a 75-day comment period on the original proposal and its Initial Statement of Reasons (ISOR), including an extension to file comments until...

The U.S.  Food and Drug Administration (FDA) announced on April 22, 2022, the availability of a final guidance for industry entitled “Drug Products, Including Biological Products, that Contain Nanomaterials.” 87 Fed. Reg. 24169. FDA states that the guidance applies to human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form. The guidance discusses both general principles and specific considerations for developing drug...

On April 15, 2022, the U.S. Environmental Protection Agency (EPA) announced final product performance data requirements for products claiming efficacy against certain pests. 87 Fed. Reg. 22464. This action officially incorporates EPA’s already existing product performance standards requirements for certain invertebrate pests into the Code of Federal Regulations (CFR).  EPA states this action also increases the efficiency of its approval process and will save...

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...

On April 20-21, 2022, the U.S. Environmental Protection Agency (EPA) held a virtual public meeting to provide an overview of the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program and give stakeholders an opportunity to provide input. As reported in our March 14, 2022, memorandum on the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA,” the Office of Chemical Safety and...

Bergeson & Campbell, P.C.’s (B&C®) April 20, 2022, webinar “FIFRA Hot Topics” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/7426709986449689102. During this one-hour webinar, Lisa M. Campbell, Partner, B&C, moderated a lively and informative discussion between Edward Messina, Director, U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP), and James V. Aidala, Senior Government Affairs Consultant, B&C, as...

On March 15-17, 2022, the U.S. Environmental Protection Agency (EPA) held a meeting of the Science Advisory Committee on Chemicals (SACC) to peer review EPA’s “Draft TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0” (screening methodology). As reported in our January 24, 2022, memorandum, EPA will use the screening methodology to evaluate potential chemical exposures and associated potential risks to fenceline communities...

The U.S. Environmental Protection Agency (EPA) announced on April 18, 2022, that it will hold a webinar on May 11, 2022, entitled “Data-Driven Solutions to Reducing Animal Use in Ecotoxicity.” Speakers will include: The webinar is co-organized by the People for the Ethical Treatment of Animals (PETA) Science Consortium International, EPA, and the Physicians Committee for Responsible Medicine (PCRM). EPA notes that it does not necessarily endorse the views of the...

The U.S. Environmental Protection Agency (EPA) announced on April 18, 2022, that it will hold a webinar on May 11, 2022, entitled “Data-Driven Solutions to Reducing Animal Use in Ecotoxicity.” Speakers will include: The webinar is co-organized by the People for the Ethical Treatment of Animals (PETA) Science Consortium International, EPA, and the Physicians Committee for Responsible Medicine (PCRM). EPA notes that it does not necessarily endorse the views of the...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On March 9, 2022, U.S. Senators Joni Ernst (R-IA) and Amy Klobuchar (D-MN) introduced the Home Front Energy Independence Act that would ban Russian oil and replace it with the use of biofuels produced in the United States. This bill combines parts of past bills that would make ethanol 15 (E15) available year-round, establish an E15 and Biodiesel Tax Credit, direct the U.S. Environmental Protection Agency (EPA) to finalize...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On March 10, 2022, EPA issued a notice of disclosure to all obligated parties under the Renewable Fuel Standard (RFS) program that have petitioned for a small refinery exemption (SRE) or that have submitted certain RFS compliance reports. EPA will disclose information that is claimed to be, or has been determined to be confidential business information (CBI) from May 21, 2021, through December 31, 2023, to the Government...

The U.S. Environmental Protection Agency (EPA) proposed on April 12, 2022, to prohibit ongoing uses of chrysotile asbestos, the only known form of asbestos currently imported into the United States. 87 Fed. Reg. 21706. EPA proposes under Section 6(a) of the Toxic Substances Control Act (TSCA) to prohibit manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos in bulk or as part of chrysotile asbestos diaphragms used in the chlor-alkali...

The National Nanotechnology Initiative (NNI) announced on April 11, 2022, the release of a video documentary, NNI Retrospective Video: Creating a National Initiative, produced in cooperation with TV Worldwide. According to NNI, the video was made for the 20th NNI grantees conference at the National Science Foundation (NSF). Former President Clinton announced the creation of NNI in January 2000. NSF led the preparation of NNI together with other agencies, including the National Institutes of...

The Senate Committee on Environment and Public Works held a hearing on April 6, 2022, on the U.S. Environmental Protection Agency’s (EPA) proposed fiscal year (FY) 2023 budget. The only witness was EPA Administrator Michael S. Regan. In his written testimony, Regan states that EPA has significant responsibilities under amendments to the Toxic Substances Control Act (TSCA) to ensure the safety of chemicals in or entering commerce and addressing unreasonable risks to...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On March 22, 2022, DOE announced a $34.5 million funding opportunity to improve the science and infrastructure for converting waste streams into bioproducts and biofuels that can benefit the local energy economy. DOE Principal Deputy Assistant Secretary for Energy Efficiency and Renewable Energy (EERE), Kelly Speakes-Backman, stated that “through this investment, we see an opportunity to support the bioeconomy and the...

On March 31, 2022, the National Nanotechnology Initiative (NNI) published a supplement to President Biden’s 2022 budget request. The supplement serves as NNI’s annual report. According to the supplement, NNI has made significant progress toward the five goals of NNI identified in the 2021 NNI Strategic Plan. Furthermore, the nanotechnology research community continues to leverage former NNI investments that established a strong foundation of understanding at the nanoscale to combat...

Register now to join B&C for “FIFRA Hot Topics,” a complimentary webinar covering key priorities of Office of Pesticide Programs (OPP) and what companies should know to avoid market delays. With year one of the Biden Administration’s term in the history books, we have a clearer sense of how EPA is proceeding on all fronts. EPA’s OPP is focusing on long-standing challenges, especially a renewed effort to meet Endangered Species Act (ESA) consultation requirements and...

By Lynn L. Bergeson The Office of Science and Technology Policy (OSTP) published on April 4, 2022, a request for information (RFI) from interested parties on federal programs and activities in support of sustainable chemistry. 87 Fed. Reg. 19539. OSTP notes that “[t]he term “sustainable chemistry” does not have a consensus definition and most uses of the term indicate that it is synonymous with “green chemistry.”” OSTP requests information on the...

Wednesday, April 20, 202212:00 p.m. – 1:00 p.m. (EDT) Register Today Register now to join Bergeson & Campbell, P.C. (B&C®) for “FIFRA Hot Topics,” a complimentary webinar covering key Office of Pesticide Programs (OPP) priorities and what companies should know to avoid market delays. Speakers include: Program:  With year one of the Biden Administration’s term in the history books, we have a clearer sense of how EPA is proceeding on all fronts....

On March 28, 2022, the Biden Administration submitted to Congress President Biden’s budget for fiscal year (FY) 2023. According to the U.S. Environmental Protection Agency’s (EPA) March 28, 2022, press release, the budget makes critical investments, including:...

The European Commission (EC) has begun a public consultation on how the Cosmetic Products Regulation could be improved to ensure human health and the functioning of the internal market. According to the EC, the identified shortcomings include “the lack of coherence between legislations on the definition of nanomaterials.” The EC notes that its October 2020 Chemicals Strategy for Sustainability outlines its goal to protect better the public and the environment against...

As reported in our February 28, 2022, blog item, on February 25, 2022, the U.S. Environmental Protection Agency (EPA) announced that it is revoking the 1980 guidelines and associated procedures for correcting the specific chemical identities of incorrectly described chemical substances submitted to EPA in 1978 using the original reporting form for inclusion on the Toxic Substances Control Act (TSCA) Inventory. 87 Fed. Reg. 10781. On March 25, 2022, the TSCA New Chemicals Coalition...

The U.S. Environmental Protection Agency (EPA) Safer Choice Program announced on March 28, 2022, that it is accepting submissions for its 2022 Safer Choice Partner of the Year Awards. 87 Fed. Reg. 17287. 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, manufacture, selection and use of products with safer chemicals, that further...

The U.S. Environmental Protection Agency (EPA) announced on March 24, 2022, that it has issued a second round of test orders under Section 4 of the Toxic Substances Control Act (TSCA) to obtain additional data on eight of the next 20 chemicals undergoing risk evaluation. EPA states that after reviewing reasonably available data on these chemicals, it determined additional data are needed and is using its TSCA test order authority to require companies to develop and submit...

By Lynn L. Bergeson and Carla N. Hutton On March 23, 2022, the U.S. Environmental Protection Agency (EPA) held a webinar on “Biofuel Premanufacture Notices: New Chemical Risk Assessment and Applications of Tools and Models.” As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. EPA states that to...

The European Chemicals Agency (ECHA) announced on March 22, 2022, that the Committee for Risk Assessment (RAC) recently adopted ten opinions on harmonized classification and labeling (CLH), including an opinion for multi-walled carbon nanotubes (MWCNT). According to the annex to ECHA’s announcement, MWCNTs possess properties that make them useful for industrial applications in new or enhanced materials and products (e.g., tensile strength, electrical and thermal...

On March 23, 2022, the U.S. Environmental Protection Agency (EPA) held a webinar on “Biofuel Premanufacture Notices: New Chemical Risk Assessment and Applications of Tools and Models.” As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. EPA states that to support this effort, it is...

On March 17, 2022, the European Commission (EC) requested that the Scientific Committee on Consumer Safety (SCCS) prepare a scientific opinion on “hydroxyapatite (nano).” As reported in our April 13, 2021, blog item, SCCS issued a final opinion in 2021 stating that having considered the data provided, and other relevant information available in scientific literature, it “cannot conclude on the safety of the hydroxyapatite composed of rod-shaped nanoparticles for use in oral-care...

By Lynn L. Bergeson On March 16, 2022, the House Science, Space, and Technology Subcommittee on Energy held a hearing on “Bioenergy Research and Development for the Fuels and Chemicals of Tomorrow.” According to the hearing charter, the purpose of the hearing was to examine the status of bioenergy research, development, and demonstration (RD&D) activities carried out by the U.S. Department of Energy (DOE). The hearing also considered advancements in bioenergy research and...

By Lynn L. Bergeson As reported in our February 25, 2022, blog item, the U.S. Environmental Protection Agency (EPA) announced on February 25, 2022, the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 10784. On March 10, 2022, EPA the posted the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” The Office of Chemical Safety and Pollution Prevention (OCSPP)...

On March 16, 2022, the House Science, Space, and Technology Subcommittee on Energy will hold a hearing on “Bioenergy Research and Development for the Fuels and Chemicals of Tomorrow.” According to the hearing charter, the purpose of the hearing is to examine the status of bioenergy research, development, and demonstration (RD&D) activities carried out by the U.S. Department of Energy (DOE). The hearing will also consider advancements in bioenergy research and the potential role...

The U.S. Environmental Protection Agency (EPA) announced on March 8, 2022, that it is planning to consolidate several Information Collection Requests (ICR) covering reporting and recordkeeping activities under Section 8 of the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 12954. Before submitting the consolidated ICR to the Office of Management and Budget (OMB) for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection. The...

By Lynn L. Bergeson  On January 31, 2022, U.S. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) and 12 of their colleagues submitted a letter to EPA Administrator, Michael Regan, regarding EPA’s RFS Annual Rules and Proposed RFS Small Refinery Exemption Decision. In the bipartisan letter, Senators Klobuchar and Grassley and their colleagues urge EPA to prioritize the RFS in support of a “homegrown energy future” by: Maintaining the blending requirements for...

By Lynn L. Bergeson and Carla N. Hutton   On March 16, 2022, the House Science, Space, and Technology Subcommittee on Energy will hold a hearing on “Bioenergy Research and Development for the Fuels and Chemicals of Tomorrow.” According to the hearing charter, the purpose of the hearing is to examine the status of bioenergy research, development, and demonstration (RD&D) activities carried out by the U.S. Department of Energy (DOE). The hearing will also consider...

The European Union (EU) Observatory for Nanomaterials (EUON) has launched two calls for tenders to conduct studies on nanomaterials. The first call for tender is on valid in silico modeling tools and read-across approaches, including creating case studies on read-across for specific types of nanomaterials. According to the call for tender, the study proposes to examine the use of these tools for nanomaterials and to draw potential conclusions (for both regulators and industry/small-...

The U.S. Environmental Protection Agency (EPA) announced on March 10, 2022, that registration is now open for the April 19-21, 2022, virtual meeting of the Science Advisory Committee on Chemicals (SACC). During the meeting, SACC will peer review the draft Toxic Substances Control Act (TSCA) Systematic Review Protocol. SACC’s virtual meeting is open to the public, and registration is required. EPA states that the draft Protocol, released in December 2021 for public comment,...

By Lynn L. Bergeson  On February 16, 2022, EPW held a hearing to examine EPA’s RFS program. U.S. Senator and EPW Chairman, Tom Carper (D-DE), made the opening statement, highlighting that EPW had not held an oversight hearing on the RFS since 2016. While Senator Carper demonstrated continued support for the RFS program, he also noted that “[f]or example, the amount of advanced renewable fuel used today in this country is far less than the 36...

On February 25, 2022, the U.S. Environmental Protection Agency (EPA) announced it has issued a response denying the objections filed against its final rule revoking all chlorpyrifos tolerances (Response). EPA issued the August 18, 2021, final rule in response to the Ninth Circuit Court’s Order directing EPA to issue a final rule in response to Pesticide Action Network North America and Natural Resources Defense Council’s 2007 petition, which requested EPA to revoke all...

On March 3, 2022, the White House Office of Science and Technology Policy (OSTP) published a request for information (RFI) to support the development of a federal scientific integrity policy framework. 87 Fed. Reg. 12165. According to OSTP, the framework will include assessment criteria that OSTP and agencies can use to inform, review, and improve the content and implementation of agency scientific integrity policies. To support this framework, OSTP seeks information on: (1) how scientific...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.  On February 22, 2022, U.S. Senator and Chairwoman of the U.S. Senate Committee on Agriculture, Nutrition, and Forestry, Debbie Stabenow (D-MI), and U.S. Senator and Committee member, Amy Klobuchar (D-MN), sent a letter to the U.S. Secretary of Agriculture, Tom Vilsack, requesting improvements to the United States’ biobased economy. Senators Stabenow and Klobuchar’s request focuses particularly on the U.S....

On March 1, 2022, NanoHarmony held the first in a 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. A recording of the March 1, 2022, webinar on the use of TGs in industry is now available. A short survey is available to collect stakeholder viewpoints on the...

The U.S. Environmental Protection Agency (EPA) announced on March 4, 2022, the availability of the latest Toxic Substances Control Act (TSCA) Inventory. EPA states that the 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 summer 2022. According to EPA, the Inventory contains 86,631 chemicals, of which 42,039 are active in U.S commerce. Other updates include new chemical...

By Lynn L. Bergeson  On February 24, 2022, EPA announced the selection of 11 organizations to receive a total of approximately $2 million in funding to divert food waste from landfills by expanding anaerobic digester capacity nationwide. Anaerobic digestion (AD) produces biogas that can be captured and used for energy production and digestate (a fertilizer product) by using microorganisms to break down organic materials, such as food scraps and manure, in the absence of oxygen. By...

By Lynn L. Bergeson  On January 27, 2022, U.S. Senator Shelley Moore Capito (R-WV), Ranking Member of the Senate Environment and Public Works (EPW) Committee, and 14 of her colleagues submitted a letter to the U.S. Environmental Protection Agency (EPA) Administrator, Michael Regan, requesting that EPA reconsider its proposed actions under the Renewable Fuel Standard (RFS) program through the RFS Annual Rules and the Proposed RFS Small Refinery Exemption Decision. Senator Capito and her...

The U.S. Environmental Protection Agency (EPA) announced on February 28, 2022, the implementation of a new process by which the Science Advisory Board (SAB) will assess the science that informs decisions regarding EPA proposed rules. EPA states that the new process “will restore opportunities for peer review and strengthen the independence of” SAB. According to EPA, the new Science Supporting EPA Decisions process strengthens peer review at EPA by: The process is effective...

On February 23, 2022, the U.S. Environmental Protection Agency (EPA) held a webinar on requirements under the Toxic Substances Control Act (TSCA) and the premanufacture notice (PMN) process for biofuels. As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. According to EPA, it has received...

The U.S. Commercial Service, part of the U.S. Department of Commerce’s International Trade Administration, has begun registration for a webinar series designed to inform exporters and manufacturers about potential per- and polyfluoroalkyl substances (PFAS) risks affecting their business: Part I: PFAS Basics: What you need to knowWednesday, March 9, 2022, 1:00 p.m. (EST)The first session will cover the PFAS basics, including where they are found, what health, environmental, and...

On February 24, 2022, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Are nanoplastics hazardous? The way forward to overcome the uncertainties of risk assessment” by Dr. Anita Jemec Kokalj and Dr. Dana Kühnel about defining the criteria to evaluate which properties of nanoplastics should be reported in future studies to decrease uncertainties in their risk assessment. The authors state that nanoplastics “are complex environmental pollutants...

On February 25, 2022, the U.S. Environmental Protection Agency (EPA) announced that it is revoking the 1980 guidelines and associated procedures for correcting the specific chemical identities of incorrectly described chemical substances submitted to EPA in 1978 using the original reporting form for inclusion on the Toxic Substances Control Act (TSCA) Inventory. 87 Fed. Reg. 10781. EPA states that it is providing a final opportunity to use the 1980 guidelines and form to request corrections of...