Blogs

On May 3, 2023, the Senate Appropriations Subcommittee on Interior, Environment, and Related Agencies will hold a hearing entitled “A Review of the President’s Fiscal Year 2024 Budget Request for the Environmental Protection Agency.” The only scheduled witness is Michael S. Regan, Administrator of the U.S. Environmental Protection Agency (EPA). On May 10, 2023, the House Energy and Commerce Subcommittee on the Environment, Manufacturing, and Critical Materials will hold a hearing on “The...

By Lynn L. Bergeson and Carla N. Hutton   The Office of Management and Budget (OMB) published a request for information (RFI) on April 27, 2023, seeking public input on existing or potential bioeconomy-related industries and products that are established, emerging, or currently embedded in existing industry/manufacturing processes. 88 Fed. Reg. 25711. As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order (EO) creating a...

As reported in our March 16, 2023, blog item, on March 14, 2023, the European Union (EU) Observatory for Nanomaterials (EUON) issued a call for study proposals. EUON is looking for studies on: Questions related to the health and safety aspects of nanomaterials, including hazard and risk assessment, exposure to nanomaterials, or worker safety and protection; Specific issues surrounding the uses of nanomaterials; or Information about markets for nanomaterials (e.g., the market for...

On April 20, 2023, the U.S. Government Accountability Office (GAO) issued its updated High Risk List, which highlights 37 areas across the federal government that are vulnerable to waste, fraud, abuse, and mismanagement, or that need broad reform. The High Risk List includes “Transforming EPA’s Process for Assessing and Controlling Toxic Chemicals.” GAO states that the U.S. Environmental Protection Agency’s (EPA) ability to implement its mission of protecting public health and the...

By Lynn L. Bergeson and Carla N. Hutton   On April 25, 2023, the Council of the European Union (EU) announced that it approved the conclusions on the opportunities of the bioeconomy in light of current challenges, with special emphasis on rural areas. Using biomass to produce food, materials, and energy can help boost rural communities, increase competitiveness, and combat many of the challenges facing the EU. According to the press release, in their conclusions, ministers...

The Senate Committee on Environment and Public Works will hold a hearing on April 27, 2023, on “Impacts of Plastic Production and Disposal on Environmental Justice Communities.” Witnesses will include: Philip Landrigan, M.D., Director, Global Public Health Program and Global Observatory on Planetary Health, Schiller Institute for Integrated Science and Society; Sharon Lavigne, Founder, Rise St. James, Earth Island Institute; Chris Tandazo, Community Organizer, New Jersey Environmental...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Government Accountability Office (GAO) published a “Science & Tech Spotlight” on synthetic biology on April 17, 2023. GAO defines synthetic biology as “a multidisciplinary field of biotechnology that involves engineering the genetic material of organisms -- such as viruses, bacteria, yeast, plants, or animals -- to have new characteristics.” According to GAO, scientists are currently exploring the use of...

In France, under Decree No. 2012-232, companies that manufacture, import, and/or distribute a “substance with nanoparticle status” in an amount of at least 100 grams per year must submit an annual report with substance identity, quantity, and use information. According to the R-Nano website, managed by the French Agency for Food, Environmental and Occupational Health and Safety (ANSES), the declaration form has evolved since 2022 to require the completion of certain fields in accordance...

Maine enacted An Act To Stop Perfluoroalkyl and Polyfluoroalkyl Substances Pollution in July 2021. Under the bill, manufacturers of products with intentionally added per- and polyfluoroalkyl substances (PFAS) were required to report the presence of the intentionally added PFAS in those products to the Maine Department of Environmental Protection (MDEP) beginning January 1, 2023. As reported in our February 17, 2023, memorandum, on February 14, 2023, MDEP announced a much anticipated...

By Lynn L. Bergeson and Carla N. Hutton   On April 5, 2023, the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) issued a report on the food safety aspects of cell-based food, which is animal agricultural products grown directly from cell cultures. FAO, in collaboration with WHO, developed the report to engage with respective members and relevant stakeholders “by proactively sharing the current knowledge to identify concrete ways to...

May 17, 202311:00 a.m. - 12:00 p.m. EDTREGISTER NOW The U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) has advanced groundbreaking science policy initiatives in furtherance of implementation of the Toxic Substances Control Act (TSCA). As EPA advances New Approach Methodologies (NAM), cumulative risk assessment methodologies, and systematic review procedures, chemical stakeholders must understand directionally how these initiatives are influencing...

In May 2023, Madison Le will move from her position as Director of the New Chemicals Division (NCD) within the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) to the Office of Pesticide Programs’ Biopesticides Division. As reported in our March 4, 2020, blog item, Le joined OPPT as Director of the then Chemical Control Division in 2020, a particularly challenging time. During her time as head of NCD, NCD has increased staffing, allowing it...

Earthjustice announced on April 7, 2023, that Cherokee Concerned Citizens, a community group in Pascagoula, Mississippi, filed suit in the U.S. Court of Appeals for the District of Columbia Circuit for review of an Order for a New Chemical Substance under Section 5 of the Toxic Substances Control Act (TSCA), signed by the U.S. Environmental Protection Agency (EPA). According to the petition, the August 11, 2022, Order authorizes Chevron U.S.A. Inc. to manufacture, process,...

 The U.S. Environmental Protection Agency (EPA) will hold a virtual public preparatory meeting for the Science Advisory Committee on Chemicals (SACC) members, ad hoc reviewers, and the public to comment on and ask questions regarding the scope and clarity of the draft charge questions to be used for the May 8-11, 2023, review of two draft documents related to cumulative risk assessment under the Toxic Substances Control Act (TSCA). As reported in our March 1,...

The U.S. Department of Agriculture (USDA) announced on April 11, 2023, that its Agricultural Research Service (ARS) recently developed sustainable, machine-washable antimicrobial wipes that can be used at least 30 times for cleaning hard and nonporous surfaces. According to USDA, ARS researchers developed the antimicrobial wipes “by using raw cotton fiber that naturally produced silver nanoparticles inside the fiber in the presence of a silver precursor.” USDA states that the...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Agriculture (USDA) announced on April 11, 2023, that its Agricultural Research Service (ARS) recently developed sustainable, machine-washable antimicrobial wipes that can be used at least 30 times for cleaning hard and nonporous surfaces. According to USDA, ARS researchers developed the antimicrobial wipes “by using raw cotton fiber that naturally produced silver nanoparticles inside the fiber in the presence of a silver...

The U.S. Department of Agriculture (USDA) announced on April 11, 2023, that its Agricultural Research Service (ARS) recently developed sustainable, machine-washable antimicrobial wipes that can be used at least 30 times for cleaning hard and nonporous surfaces. According to USDA, ARS researchers developed the antimicrobial wipes “by using raw cotton fiber that naturally produced silver nanoparticles inside the fiber in the presence of a silver precursor.” USDA states that the...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on April 10, 2023, that it is inviting public comment on a draft Environmental Assessment (EA) and draft Plant Pest Risk Assessment (PPRA). 88 Fed. Reg. 21602. APHIS states that it produced these documents in response to a petition from Pioneer Hi-Bred International, Inc. seeking deregulation of a corn variety developed using genetic...

On April 6, 2023, NanoHarmony announced publication of a paper in Regulatory Toxicology and Pharmacology entitled “Towards harmonisation of testing of nanomaterials for EU regulatory requirements on chemical safety — A proposal for further actions.” The paper provides an overview of the information requirements across different European Union (EU) regulatory areas. For each information requirement, experts identified potential needs for further action to accommodate...

On April 6, 2023, the U.S. District Court for the District of Columbia dismissed a suit brought by the Center for Environmental Health (CEH) and Public Employees for Environmental Responsibility (PEER) to prevent Inhance Technologies USA (Inhance) from generating per- and polyfluoroalkyl substances (PFAS) when fluorinating plastic containers. As reported in our January 6, 2023, blog item, CEH and PEER sought a court order restraining Inhance from continued manufacture of PFAS in violation of a...

By Lynn L. Bergeson and Carla N. Hutton   On March 23, 2023, the U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced the release of its 2023 Multi-Year Program Plan (MYPP). The MYPP is used as an operational guide, setting forth BETO’s mission, goals, and strategic approach. It also serves as a resource to help manage and coordinate BETO’s activities and communicate its strategy to stakeholders and the public. The new plan identifies...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Government Accountability Office (GAO) publicly released a report on March 27, 2023, entitled Sustainable Aviation Fuel: Agencies Should Track Progress toward Ambitious Federal Goals. According to GAO, sustainable aviation fuel (SAF) production and use in the United States have increased in recent years; this fuel is now used by airlines at two major commercial airports in California. GAO states that while U.S. production reached 15.8...

The White House Office of Science and Technology Policy (OSTP) published a request for information (RFI) on April 5, 2023, seeking public input in updating the National Nanotechnology Initiative (NNI) Environmental, Health, and Safety (EHS) Research Strategy. 88 Fed. Reg. 20194. OSTP is soliciting public input from a wide variety of stakeholders, including individuals, industry, academia, research laboratories, nonprofits, and think tanks. OSTP states that it is interested in public input...

By Lynn L. Bergeson and Carla N. Hutton   President Joseph Biden’s September 12, 2022, Executive Order (EO) creating a National Biotechnology and Biomanufacturing Initiative directs the U.S. Department of Commerce’s (DOC) Bureau of Economic Analysis (BEA) to assess “the feasibility, scope, and costs of developing a national measurement of the economic contributions of the bioeconomy.” As reported in our March 30, 2023, blog item, BEA released a March 2023 report on...

The U.S. Environmental Protection Agency (EPA) will hold training on May 23, 2023, on Generalized Read-Across (GenRA), a publicly available tool that uses an automated approach to make reproducible read-across predictions of toxicity. EPA states that read-across “is a commonly used data gap filling technique whereby endpoint information for one substance is used to predict the same endpoint for another substance, supported by structural or other feature similarities.” According to EPA,...

By Lynn L. Bergeson and Carla N. Hutton   As part of the National Biotechnology and Biomanufacturing Initiative, the U.S. Department of Defense (DOD) announced in September 2022 an investment of $1.2 billion in bioindustrial domestic manufacturing infrastructure to catalyze the establishment of a domestic bioindustrial manufacturing base accessible to U.S. innovators. As reported in our March 30, 2023, blog item, on March 22, 2023, DOD released its Biomanufacturing Strategy to guide these...

The U.S. Environmental Protection Agency (EPA) announced on March 23, 2023, that it is seeking public nominations of scientific and technical experts that EPA can consider for service as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with the peer review of the “2023 Draft Supplement to the 1,4-Dioxane Risk Evaluation.” 88 Fed. Reg. 17566. EPA states that it will release the draft supplement for public review and comment in June 2023. EPA also plans to...

By Lynn L. Bergeson and Carla N. Hutton As reported in our March 30, 2023, blog item, on March 22, 2023, the White House Office of Science and Technology Policy (OSTP) released a new report, Bold Goals for U.S. Biotechnology and Biomanufacturing: Harnessing Research and Development to Further Societal Goals. The report includes five sections, each presenting goals that highlight what could be possible with the power of biology. The goals set ambitious national targets for the next two decades to...

Bergeson & Campbell, P.C.’s (B&C®) March 22, 2023, webinar, “Extended Producer Responsibility (EPR) Regulations,” is now available for on-demand viewing. During this one-hour webinar LeRoy (Lee) C. Paddock, Distinguished Professorial Lecturer of Environmental Law at the George Washington University Law School; Edith G. Nagy, Regulatory Consultant, B&C; and Lynn L. Bergeson, Managing Partner, B&C, discuss the history and evolution of EPR legislation,...

On March 29, 2023, the Internal Revenue Service (IRS) published a notice of proposed rulemaking (NPRM) relating to the Superfund excise taxes imposed on certain chemicals and certain imported substances, effective July 1, 2022. 88 Fed. Reg. 18446. There are two separate Superfund chemical excise taxes: a tax on the sale or use of “taxable chemicals” and a tax on the sale or use of imported “taxable substances.” The NPRM contains proposed regulations under Sections 4661, 4662, 4671, and...

By Lynn L. Bergeson and Carla N. Hutton   To celebrate its 125th anniversary, ASTM International invited case study submissions from committee members to highlight standards that have made a significant impact in society. One of the winning entries is on a set of standards for biodegradable plastic from Committee D20 on Plastics. According to ASTM International’s article, standard test methods for determining the biobased content of solid, liquid, and gaseous samples using radiocarbon...

April 3-5, 2023, Washington D.C. Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are proud to be sponsors of and presenting during the 2023 GlobalChem Conference. This three-day event offers authoritative speakers, in-depth sessions, and a chance to meet and reconnect with industry peers and key government representatives. Highlights from the diverse and substantive program planned for GlobalChem attendees include: New Chemicals Breakout Session -- In...

By Lynn L. Bergeson and Carla N. Hutton   As reported in our September 13, 2022, blog item, President Joseph Biden signed an Executive Order (EO) on September 12, 2022, creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” On March 22, 2023, the White House Office of Science and Technology Policy (OSTP) published a fact sheet announcing “new bold goals and priorities...

On March 27, 2023, the U.S. Environmental Protection Agency (EPA) announced that its Safer Choice program is accepting submissions for its 2023 Safer Choice Partner of the Year Awards. 88 Fed. Reg. 18135. The Safer Choice program certifies products containing ingredients that have met the program’s specific and rigorous human health and environmental toxicological criteria. According to EPA, the Safer Choice program allows companies to use its label on certified products that contain safer...

By Lynn L. Bergeson and Carla N. Hutton   On March 27, 2023, the U.S. Environmental Protection Agency (EPA) announced that its Safer Choice program is accepting submissions for its 2023 Safer Choice Partner of the Year Awards. 88 Fed. Reg. 18135. The Safer Choice program certifies products containing ingredients that have met the program’s specific and rigorous human health and environmental toxicological criteria. According to EPA, the Safer Choice program allows companies to use its...

The National Nanotechnology Initiative (NNI) will hold a public meeting May 31-June 1, 2023, to discuss the revision of the 2011 National Nanotechnology Initiative Environmental, Health, and Safety Research Strategy (EHS Research Strategy). NNI encourages individuals, non-governmental organizations (NGO), academic and research institutions, and the private sector interested in the responsible development of nanotechnology to attend and contribute to creating an updated EHS Research Strategy....

On March 28, 2023, the House Appropriations Subcommittee on Interior, Environment, and Related Agencies will hold a hearing on the fiscal year (FY) 2024 budget request for the U.S. Environmental Protection Agency (EPA). As reported in our March 22, 2023, blog item, EPA has posted the justification for its FY 2024 appropriation estimates for the Committee on Appropriations (Congressional Justification (CJ)). According to the CJ, EPA’s...

The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published its final opinion on hydroxyapatite (nano) on March 23, 2023. As reported in our April 13, 2021, blog item, SCCS released a final opinion in 2021 on the safety of hydroxyapatite (nano) when used in leave-on and rinse-off dermal and oral cosmetic products according to the maximum concentrations and specifications reported, taking into account reasonably foreseeable exposure...

The U.S. Environmental Protection Agency (EPA) has posted the justification for its fiscal year (FY) 2024 appropriation estimates for the Committee on Appropriations (Congressional Justification (CJ)). According to the CJ, work in the Pollution Prevention (P2) Program supports Objective 7.2: Promote Pollution Prevention (P2) under Goal 7: Ensure Safety of Chemicals for People and the Environment. The FY 2024 budget includes $29 million and 69.2 full-time equivalents...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Environmental Protection Agency (EPA) has posted the justification for its fiscal year (FY) 2024 appropriation estimates for the Committee on Appropriations (Congressional Justification (CJ)). According to the CJ, work in the Pollution Prevention (P2) Program supports Objective 7.2: Promote Pollution Prevention (P2) under Goal 7: Ensure Safety of Chemicals for People and the Environment. The FY 2024 budget includes $29 million and 69.2...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on March 23, 2023, the availability of a draft guide detailing the information requirements and process for submitting permit applications for microorganisms developed using genetic engineering. The draft Guide for Submitting Permit Applications for Microorganisms Developed Using Genetic Engineering under 7 CFR Part 340 is intended to assist developers with preparing a...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on March 23, 2023, the availability of a draft guide detailing the information requirements and process for submitting permit applications for microorganisms developed using genetic engineering. The draft Guide for Submitting Permit Applications for Microorganisms Developed Using Genetic Engineering under 7 CFR Part 340 is intended to...

The U.S. Environmental Protection Agency (EPA) has posted the justification for its fiscal year (FY) 2024 appropriation estimates for the Committee on Appropriations (Congressional Justification (CJ)). According to the CJ, EPA’s FY 2024 budget includes $470.7 million and 1,677 full-time equivalents (FTE) for Objective 7.1, “Ensure Chemical and Pesticide Safety.” The CJ includes the following target dates for actions under the Toxic Substances Control Act...

The European Union (EU) Observatory for Nanomaterials (EUON) has posted two Nanopinions: “Graphene Electronic Tattoos,” posted on February 20, 2023, by Dr. Dmitry Kireev. “Graphene Electronic Tattoos (GETs) are a type of skin-wearable electronic device that can be used for personalized healthcare by transmitting the bio-electrical activity of the human body in the measurable electrical signal. […] The GETs are optically transparent, lightweight, and flexible, making them adhere and...

The Internal Revenue Service (IRS) announced on March 16, 2023, that it received a petition requesting that cellulose acetate (degree of substitution (DS) = 1.5-2.0) be added to the list of taxable substances under Section 4672(a) of the Internal Revenue Code. 88 Fed. Reg. 16307. The petitioner is Celanese Ltd., an exporter of cellulose acetate (DS = 1.5-2.0). According to the notice, cellulose acetate (DS = 1.5-2.0) “is made from cellulose (wood pulp) and methane. The production process...

By Lynn L. Bergeson and Carla N. Hutton   That National Academies of Sciences, Engineering, and Medicine (NASEM) hosted an October 2022 workshop on successes and challenges in biomanufacturing. The workshop brought together biomanufacturing stakeholders across industry, academia, and government with expertise across diverse fields, including United States-based and international speakers. According to NASEM, discussions spanned the breadth of biomanufacturing contexts and applications,...

The Senate Committee on Environment and Public Works will hold a hearing on March 22, 2023, on the proposed fiscal year (FY) 2024 budget for the U.S. Environmental Protection Agency (EPA). The only listed witness is EPA Administrator Michael Regan. As reported in our March 14, 2023, blog item, the budget requests over $12 billion in discretionary budget authority for EPA, a $1.9 billion or 19 percent increase from the FY 2023 enacted level. Highlights of the FY 2024...

On March 17, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a final rule amending the Chemical Data Reporting (CDR) rule.  According to EPA, the amendments are intended to reduce the burden for certain CDR reporters, improve the quality of CDR data collected, and align reporting requirements with the Frank R. Lautenberg Chemical Safety for the 21st Century Act’s (Lautenberg Act) amendments to the Toxic Substances Control Act (TSCA).  EPA...

On March 13, 2023, the U.S. Environmental Protection Agency (EPA) issued a proposed rule that would update the pesticide Application Exclusion Zone (AEZ) requirements under the 2015 Agricultural Worker Protection Standard (WPS). 88 Fed. Reg. 15346. The proposed rule is available at EPA-HQ-OPP-2022-0133, and comments on the proposed rule are due on or before May 12, 2023. Application Exclusion Zone According to EPA’s press release, the WPS regulations offer protections to...

The European Union (EU) Observatory for Nanomaterials (EUON) has issued a call for study proposals. EUON is looking for studies on: Questions related to the health and safety aspects of nanomaterials, including hazard and risk assessment, exposure to nanomaterials, or worker safety and protection; Specific issues surrounding the uses of nanomaterials; or Information about markets for nanomaterials (e.g., the market for specific materials such as graphene or specific market sectors)....