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May 1, 2023

Monthly Update for May 2023

Bergeson & Campbell, P.C.

VIRTUAL CONFERENCE — Save The Date For “TSCA Reform — Seven Years Later” On June 29, 2023: This essential annual Toxic Substances Control Act (TSCA) event will feature speakers from the U.S. Environmental Protection Agency (EPA), non-governmental organizations, industry stakeholders, and academic leaders providing updates on topics including the interface of science and policy under TSCA, new chemicals, risk evaluation and management, the regulation of articles, and more. Save the date to join Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), the George Washington University Milken Institute School of Public Health, leading experts, and distinguished keynote speakers for a robust exploration of the issues and regulations surrounding TSCA.

WEBINAR — TOP TSCA TOPICS: Cumulative Risk, NAMs, Risk Evaluations, CBI, And More!, May 17, 2023, 11:00 a.m. – 12:00 p.m. (EDT), Via Webinar: Panelists Anna B. Lowit, Ph.D., Senior Science Advisor, Office of Pollution Prevention and Toxics (OPPT), and Richard E. Engler, Ph.D., Director of Chemistry, B&C, will discuss New Approach Methodologies (NAM), cumulative risk assessment (CRA) methodologies, systematic review procedures, new approaches to new chemical reviews, per- and polyfluoroalkyl substances (PFAS) reporting, and confidential business information (CBI) protections. Register now.

ARTICLE — Lynn L. Bergeson, “EPA Can Lead or Get Out of the Way,” The Environmental Forum, May/June 2023: A major task we face in achieving circularity is ensuring that policies remain nimble in addressing environmental and public health challenges. Our suite of laws and their regulatory implementation sometimes reflect an unhelpful resistance to circularity, expressed in policies that are indifferent or antithetical to an efficient transition to true resource economy. Read now.


ARTICLE — Lynn L. Bergeson, “EPA Proposes to Ban Most Uses of Methylene Chloride,” Chemical Processing, May 10, 2023: On May 3, 2023, EPA proposed under Section 6(a) of TSCA to prohibit most uses of methylene chloride. This column summarizes this important initiative.

ARTICLE — Lynn L. Bergeson, “TSCA litigation: The case to watch,” Speciality Chemicals Magazine, May/June 2023: The implementation of the game-changing 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act, amending TSCA, is now a hotbed of legal dispute. Lawsuits challenging key aspects of the law’s implementation are piling up. While all are legally noteworthy, one citizen enforcement case in particular merits attention. As discussed in this article, two recent cases have raised novel issues pertinent to the scope of EPA’s Significant New Use Rule (SNUR) authority under TSCA Section 5 and a more general challenge to the Agency’s right to pre-empt citizen actions if the government is “diligently prosecuting” the act a citizen plaintiff wishes to restrain. The resolution of these cases and both issues will have important implications, making these cases worth watching.

Madison Le Moving From EPA’s New Chemicals Division To Biopesticides Division: In May 2023, Madison Le moved from her position as Director of the New Chemicals Division (NCD) within EPA’s 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 to increase throughput, developed new approaches, and shored up science, policy, and standard operating procedures. More information is available in our April 18, 2023, blog item.

PEER Calls For “Transparent Public Process” For Inhance PFAS SNUNs: On April 20, 2023, the Public Employees for Environmental Responsibility (PEER) issued a press release announcing that, together with the Center for Environmental Health (CEH), it sent a letter to EPA asking it to “fix” the public comment process for 18 significant new use notices (SNUN) for PFAS created by Inhance Technologies in the fluorination of millions of plastic containers. PEER states that “[t]he public comment process is a critical opportunity for stakeholders to provide data and analysis to EPA as it decides whether it will allow Inhance Technologies to continue to use a process that creates highly toxic PFAS during fluorination.” More information is available in our May 2, 2023, blog item.

GAO Finds Progress In EPA’s Process For Assessing And Controlling Toxic Chemicals: 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.” EPA supports the evaluation of such risks through its Integrated Risk Information System (IRIS) and by implementing TSCA. GAO reports that overall ratings for four criteria — leadership commitment, capacity, action plan, and demonstrated progress — remain unchanged since 2021. The overall rating for monitoring increased to partially met. For IRIS, leadership commitment, monitoring, and demonstrated progress increased to partially met. For TSCA, leadership commitment increased to met, and action plan and monitoring increased to partially met. More information is available in our April 27, 2023, blog item.

EPA Holds Preparatory Meeting For SACC Review Of Draft Cumulative Risk Documents: On April 24, 2023, EPA held 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 CRA under TSCA. As reported in our March 1, 2023, memorandum, earlier this year, EPA released for public comment and peer review a set of principles for evaluating cumulative risks under TSCA and an approach for applying those principles to the evaluation of the cumulative risk posed by certain phthalate chemicals undergoing TSCA Section 6 risk evaluation. For more information on the discussion held during the April 24, 2023, meeting, please read our May 3, 2023, memorandum.

EPA Denies Petition Seeking TSCA Section 4 Testing Of PVA: On April 27, 2023, EPA announced that it denied a January 26, 2023, petition from Blueland, Plastic Pollution Coalition, and partners, including Beyond Plastics, Plastic Oceans International, The Shaw Institute, Lonely Whale, 5 Gyres, Global Alliance for Incinerator Alternatives (GAIA), Oceanic Global Foundation, The Last Beach Cleanup, Rio Grande International Study Center, Inland Ocean Coalition, Occidental Arts and Ecology Center, Turtle Island Restoration Network, Friends of the Earth, Surfrider, and Made Safe. 88 Fed. Reg. 25590. The petition, filed under TSCA Section 21, requested that EPA require manufacturers and processors of polyvinyl alcohol (PVA) affiliated with EPA’s Safer Choice certification program to fund and conduct health and environmental safety testing using independent, third-party scientists. The petition also requested, under the Administrative Procedure Act (APA), that EPA update the status of PVA on its Safer Chemical Ingredients List (SCIL) from “green circle” to “gray square” until testing is completed and reviewed by EPA. EPA states that “[a]fter careful consideration,” it has denied the TSCA petition and APA petition requests. More information is available in our May 1, 2023, blog item.

EPA Announces Settlements Resolving Alleged Violations Of Toxic Chemical Reporting By Six New England Companies: EPA announced on May 1, 2023, settlements with six New England companies that resolve alleged violations of the Emergency Planning and Community Right-to-Know Act (EPCRA), which requires companies and organizations to report their use and release of toxic chemicals to EPA’s Toxics Release Inventory (TRI) program. The companies are Franklin Foods of Enosburg Falls, Vermont, Hollingsworth & Vose Company of Groton, Massachusetts, AFC Cable Systems, Inc. of New Bedford, Massachusetts, National Chain Company of Warwick, Rhode Island, Twin Rivers Paper Company of Madawaska, Maine, and Commonwealth Dairy of Brattleboro, Vermont. According to EPA, all six companies “promptly corrected the EPCRA violations after EPA inspections and have filed required reports about their use or generation of toxic chemicals” under the TRI program, “allowing the public and local officials to access data about toxic chemicals used and released in their communities.” EPA notes that each company agreed to pay a civil penalty, improved its compliance with TRI requirements, and cooperated with EPA.

EPA Proposes To Prohibit Most Uses Of Methylene Chloride Under TSCA Section 6(a), Will Hold Webinar On June 7: On May 3, 2023, EPA proposed to prohibit most uses of methylene chloride under TSCA Section 6(a). 88 Fed. Reg. 28284. EPA states in its April 20, 2023, press release that its unreasonable risk determination for methylene chloride was driven by risks associated with workers, occupational non-users (ONU), consumers, and those in close proximity to a consumer use. EPA identified risks for adverse human health effects, including neurotoxicity, liver effects, and cancer from inhalation and dermal exposures to methylene chloride. According to EPA, its proposed risk management rule would “rapidly phase down” manufacturing, processing, and distribution of methylene chloride for all consumer uses and most industrial and commercial uses, most of which would be fully implemented in 15 months. EPA notes that for most of the uses of methylene chloride that it proposes to prohibit, its analysis found that alternative products with similar costs and efficacy to methylene chloride products are generally available. Comments on the proposed rule are due July 3, 2023. EPA notes that under the Paperwork Reduction Act (PRA), “comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before June 2, 2023.” More information is available in our April 25, 2023, memorandum.

EPA announced on May 11, 2023, that it will hold a webinar on June 7, 2023, at 1:00 p.m. (EDT) on its proposed rule. EPA states that it is particularly looking for participation from employers and workers “who can give perspective on the feasibility and efficacy of the proposed requirement for worker protections.” Participants can register as listeners or to make prepared remarks. To provide remarks during the webinar, registration must be completed by May 24, 2023, at 5:00 p.m. (EDT). Registration as a listener can be completed up until the start of the webinar.

EPA Will Extend Compliance Date For DecaBDE PBT Rule, Issues Enforcement Statement: On May 3, 2023, EPA announced its intent to extend the January 6, 2023, compliance date on the prohibition on the processing and distribution of decabromodiphenyl ether (decaBDE) for use in wire and cable insulation in nuclear power generation facilities, and decaBDE-containing wire and cable insulation. EPA also issued a related temporary “Enforcement Statement,” which indicates that it does not intend to pursue violations of this prohibition on processing and distribution of decaBDE-containing wire and cable insulation for use in nuclear power generation facilities, “as long as the entities involved are diligently working to qualify their alternative components in accordance with Nuclear Regulatory Commission regulations and guidance.” EPA also announced a settlement agreement with RSCC Wire & Cable, LLC (RSCC), “the only known supplier of qualified decaBDE-containing wire and cable, regarding TSCA violations.” More information is available in our May 8, 2023, blog item.


PHMSA Requests Feedback On Recycled Plastics Policy: On April 14, 2023, the Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) published a request for feedback on its recycled plastics policy. 88 Fed. Reg. 23140. PHMSA states that it published the notice to solicit information pertaining to how the potential use of recycled plastic resins in the manufacturing of specification packagings may affect hazardous materials transportation safety; ensure transparency of its current policy pertaining to the use of recycled plastics in the manufacturing of specification packagings; seek input on this policy to inform better potential regulatory changes; and gather information for the evaluation of future approval requests and to inform better decisions pertaining to potential regulatory revisions and other related work. Comments are due July 13, 2023. PHMSA notes that in conjunction with the notice, it is considering conducting a webinar to inform the public of its recycled plastics policy if there is sufficient feedback. PHMSA will post information regarding any future webinars on its website. For more information, please read our April 18, 2023, memorandum.

EPA Proposes To Amend MATS For Coal-Fired Power Plants: On April 24, 2023, EPA proposed to amend the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Coal- and Oil-Fired Electric Utility Steam Generating Units (EGU), commonly known as the Mercury and Air Toxics Standards (MATS). 88 Fed. Reg. 24854. Specifically, EPA proposes to amend the surrogate standard for non-mercury (Hg) metal hazardous air pollutants (HAP) (filterable particulate matter (fPM)) for existing coal-fired EGUs; the fPM compliance demonstration requirements; the Hg standard for lignite-fired EGUs; and the definition of startup. EPA states that these proposed amendments are the result of its review of the May 22, 2020, residual risk and technology review of MATS. Comments are due June 23, 2023. EPA notes that under the PRA, comments on the information collection provisions “are best assured of consideration” if OMB receives comments on or before May 24, 2023. EPA held a virtual public hearing on May 9, 2023.

EPA Proposes Amendments To SOCMI NSPS And NESHAP For SOCMI And Group I And II Polymers And Resins Industry: On April 25, 2023, EPA proposed amendments to the New Source Performance Standards (NSPS) that apply to the Synthetic Organic Chemical Manufacturing Industry (SOCMI) and to the NESHAP that apply to the SOCMI (more commonly referred to as the Hazardous Organic NESHAP or HON) and Group I and II Polymers and Resins Industries (P&R I and P&R II). 88 Fed. Reg. 25080. EPA proposes decisions resulting from its technology review of the HON, P&R I, and P&R II, and its eight-year review of the NSPS that apply to the SOCMI. EPA also proposes amendments to the NSPS for equipment leaks of volatile organic compounds (VOC) in SOCMI based on its reconsideration of certain issues raised in an administrative petition for reconsideration. Furthermore, EPA is proposing to strengthen the emission standards for ethylene oxide (EtO) emissions and chloroprene emissions after considering the results of a risk assessment for the HON and Neoprene Production processes subject to P&R I. Lastly, EPA proposes to remove exemptions from standards for periods of startup, shutdown, and malfunction (SSM), to add work practice standards for such periods where appropriate, and to add provisions for electronic reporting. Comments are due June 26, 2023. Under the PRA, comments on the information collection provisions are best assured of consideration if OMB “receives a copy of your comments on or before May 25, 2023.” EPA will hold a virtual public hearing on May 16, 2023.

EPA Announces “First-Ever” Federal CWA Enforcement Action To Address PFAS Discharges: On April 26, 2023, EPA announced that it ordered the Chemours Company to take corrective measures to address pollution from PFAS in stormwater and effluent discharges from the Washington Works facility near Parkersburg. The order on consent also directs Chemours to characterize the extent of PFAS contamination from discharges. According to the EPA order, PFAS levels in the discharges from the facility exceed levels that are set in the facility’s Clean Water Act (CWA) permit.

EPA Will Hold Public Hearing On Proposal To Strengthen Standards For Chemical And Polymers Plants: On April 26, 2023, EPA announced that it will hold a virtual public hearing on May 16, 2023, on its proposal to reduce significantly HAPs from chemical plants, “including the highly toxic chemicals ethylene oxide (EtO) and chloroprene.” According to EPA, the reductions “would dramatically reduce the number of people with elevated air toxics-related cancer risks in communities surrounding the plants that use those two chemicals, especially communities historically overburdened by air toxics pollution, and cut more than 6,000 tons of toxic air pollution a year.”

EPA Proposes Phase 3 GHG Emissions Standards For Heavy-Duty Vehicles: On April 27, 2023, EPA proposed to promulgate new greenhouse gas (GHG) standards for heavy-duty highway vehicles starting in model years (MY) 2028 through 2032 and to revise certain GHG standards for MY 2027 that were established previously under EPA’s GHG Emissions and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles — Phase 2 rule (HD GHG Phase 2). 88 Fed. Reg. 24743. EPA proposes updates to discrete elements of the Averaging Banking and Trading program, including a proposal to eliminate the last MY year of the HD GHG Phase 2 advanced technology incentive program for certain types of electric highway heavy-duty vehicles. EPA proposes to add warranty requirements for batteries and other components of zero-emission vehicles and to require customer-facing battery state-of-health monitors for plug-in hybrid and battery electric vehicles. EPA also proposes additional revisions and clarifying and editorial amendments to certain highway heavy-duty vehicle provisions and certain test procedures for heavy-duty engines. Finally, as part of this action, EPA proposes to revise its regulations addressing preemption of state regulation of new locomotives and new engines used in locomotives. Comments are due June 16, 2023. According to EPA, comments on the information collection provisions submitted to OMB under the PRA “are best assured of consideration” if OMB receives comments by May 30, 2023.

EPA Proposes To Amend Several NESHAPs Regarding Work Practice Standards For PRDs, Emergency Flaring, And Degassing Of Floating Roof Storage Vessels: On July 6, 2020, EPA published the final residual risk and technology review (RTR) conducted for the Ethylene Production source category, which is part of the Generic Maximum Achievable Control Technology (GMACT) Standards NESHAP; on July 7, 2020, EPA published the final RTR conducted for the Organic Liquids Distribution (Non-Gasoline) NESHAP; and on August 12, 2020, EPA published the final RTR conducted for the Miscellaneous Organic Chemical Manufacturing NESHAP. Amendments to the Petroleum Refineries NESHAP were most recently final on February 4, 2020. Subsequently, EPA received and granted various petitions for reconsideration on these NESHAP for, among other things, the provisions related to the work practice standards for pressure relief devices (PRD), emergency flaring, and degassing of floating roof storage vessels. On April 27, 2023, in response to the petitions, EPA proposed amendments to the work practice standards for PRDs, emergency flaring, and degassing of floating roof storage vessels. 88 Fed. Reg. 25574. In addition, EPA proposed other technical corrections and clarifications for each of the rules. EPA states that it will not respond to comments addressing any other issues or any other provisions of the final rule not specifically addressed in this proposed rulemaking. Comments are due June 12, 2023. EPA notes that under the PRA, comments on the information collection provisions are best assured of consideration if OMB receives a copy of the comments on or before May 30, 2023.

EPA Adds Substitutes In Refrigeration And AC Sector And Fire Suppression Sector Under SNAP Program: Pursuant to EPA’s Significant New Alternatives Policy (SNAP) program, EPA published a final rule on April 28, 2023, listing certain substances as acceptable, subject to use conditions, in the refrigeration and air conditioning sector for chillers — comfort cooling, residential dehumidifiers, residential and light commercial air conditioning and heat pumps, and a substance as acceptable, subject to use conditions and narrowed use limits, in very low temperature refrigeration. 88 Fed. Reg. 26382. Through this action, EPA is incorporating by reference standards that establish requirements for electrical air conditioners, heat pumps, and dehumidifiers, laboratory equipment containing refrigerant, safe use of flammable refrigerants, and safe design, construction, installation, and operation of refrigeration systems. Finally, the final rule lists certain substances as acceptable, subject to use conditions, in the fire suppression sector for certain streaming and total flooding uses. The final rule will be effective May 30, 2023.

EPA Proposes Multi-Pollutant Emissions Standards For MYs 2027 And Later Light-Duty And Medium-Duty Vehicles: On May 5, 2023, EPA proposed new, more stringent emissions standards for criteria pollutants and GHGs for light-duty vehicles and Class 2b and 3 (medium-duty) vehicles that would phase-in over MYs 2027 through 203288 Fed. Reg. 29184. In addition, EPA proposed GHG program revisions in several areas, including off-cycle and air conditioning credits, the treatment of upstream emissions associated with zero-emission vehicles and plug-in hybrid electric vehicles in compliance calculations, medium-duty vehicle incentive multipliers, and vehicle certification and compliance. EPA also proposed new standards to control refueling emissions from incomplete medium-duty vehicles, and battery durability and warranty requirements for light-duty and medium-duty plug-in vehicles. EPA also proposed minor amendments to update program requirements related to aftermarket fuel conversions, importing vehicles and engines, evaporative emission test procedures, and test fuel specifications for measuring fuel economy. Comments are due July 5, 2023. EPA notes that comments on the information collection provisions submitted to the OMB under the PRA are best assured of consideration by OMB if OMB receives a copy by June 5, 2023.

EPA Publishes Final Rule Regarding Review Of Standards Of Performance For Automobile And Light Duty Truck Surface Coating Operations: On May 9, 2023, EPA published a final rule amending the NSPS for Automobile and Light Duty Truck Surface Coating Operations pursuant to the review required by the Clean Air Act (CAA). 88 Fed. Reg. 29978. EPA states that it determined that revisions to the NSPS were needed to reflect the degree of emission limitation achievable through the application of the best system of emission reduction (BSER). EPA issued a final amendment, as proposed, in a new NSPS subpart MMa, revised VOC emission limits for prime coat, guide coat, and topcoat operations for affected facilities that commence construction, modification, or reconstruction after May 18, 2022. The final rule was effective May 9, 2023.

EPA Holds Public Hearing For Multi-Pollutant Emissions Standards For MYs 2027 And Later Light-Duty And Medium-Duty Vehicles: EPA held a two-day virtual public hearing on May 9 and May 10, 2023, on its proposal entitled “Multi-Pollutant Emissions Standards for Model Years 2027 and Later Light-Duty and Medium-Duty Vehicles,” which was signed by Administrator Regan on April 11, 2023. EPA is proposing new, more stringent emissions standards for GHG and criteria pollutants for light-duty vehicles and Class 2b and 3 (medium-duty) vehicles that would phase-in over MYs 2027 through 2032.

EPA Will Propose New Carbon Pollution Standards For Fossil Fuel-Fired Power Plants: EPA announced on May 11, 2023, that it will propose new carbon pollution standards for coal and natural gas-fired power plants. EPA states that the technology-based standards it will propose include:

  • Strengthening the current NSPS for newly built fossil fuel-fired stationary combustion turbines (generally natural gas-fired);
  • Establishing emission guidelines for states to follow in limiting carbon pollution from existing fossil fuel-fired steam generating EGUs (including coal, oil, and natural gas-fired units); and
  • Establishing emission guidelines for large, frequently used existing fossil fuel-fired stationary combustion turbines (generally natural gas-fired).

Publication of the proposed rule in the Federal Register will begin a 60-day comment period.

EPA Proposes To Amend NESHAP For Taconite Iron Ore Processing Plants: On May 15, 2023, EPA proposed to amend the NESHAP for Taconite Iron Ore Processing Plants, as required by the CAA. 88 Fed. Reg. 30917. To ensure that all emissions of HAPs from sources in the source category are regulated, EPA proposes emission standards for mercury. In addition, EPA proposes to revise the existing emission standards for hydrogen chloride and hydrogen fluoride. Comments are due June 29, 2023. EPA notes that under the PRA, comments on the information collection provisions are best assured of consideration if OMB receives a copy by June 14, 2023.

EPA Releases Third Volume Of Integrated Review Plan In The Review Of The Lead NAAQS: EPA announced on May 15, 2023, that it made available to the public Volume 3 of the Integrated Review Plan for the Lead National Ambient Air Quality Standards (IRP). 88 Fed. Reg. 30966. EPA notes that the national ambient air quality standards (NAAQS) for lead (Pb) are set to protect the public health and the public welfare from Pb in ambient air. According to EPA, Volume 3 of the IRP is the planning document for quantitative analyses to be considered in the policy assessment, including exposure and risk analyses. Comments are due June 14, 2023.


FDA To Host Webinars On Infant Formula: On April 26, 2023, the U.S. Food and Drug Administration (FDA) announced that it will hold webinars on Wednesday, May 24, 2023, at 2:00 p.m. (EDT), and Wednesday, June 7, 2023, also at 2:00 p.m. (EDT), to provide stakeholders with information on regulatory requirements and considerations for infant formula ingredients and packaging. Registration details are available here.

FDA Announces Meeting For Cosmetic Products: On April 27, 2023, FDA announced a save the date for a virtual public meeting titled Good Manufacturing Practices for Cosmetic Products Listening Session, which will take place on June 1, 2023, from 10:00 a.m. to 4:00 p.m. (EDT)88 Fed. Reg. 25663. The purpose of the listening session is to discuss efforts to develop regulations to establish good manufacturing practices (GMP) for facilities that manufacture or process cosmetic products distributed in the United States. Additional information is available on the meeting page. Submit requests to make oral presentations at the listening session by 6:00 p.m. (EDT), May 18, 2023. Either electronic or written comments on this listening session must be submitted to the docket by July 3, 2023.

FDA Posts Details On International Collaboration: On May 2, 2023, FDA provided details on its collaboration efforts with international organizations. In this conversation, FDA states that “experts engage with international organizations for many important reasons.” FDA further notes that it “…collaborate[s] to strengthen the global food safety system, to ensure safe and fair trade in food, and to encourage the harmonization of science-based food safety standards. The increased safety assurances this involvement provides are particularly important given the volume of imported food we consume in the U.S.” The organizations mentioned in these collaborative efforts include “the World Health Organization (WHO), the Food and Agriculture Organization (FAO) of the United Nations, the World Trade Organization’s Standards and Trade Development Facility (WTO STDF), and the Asia Pacific Economic Cooperation’s (APEC) Food Safety Cooperation Forum (FSCF).”

FDA Seeks Comment On Request To Revoke The Color Additive Listing For Use Of Titanium Dioxide In Food: On May 3, 2023, FDA announced that it has filed a color additive petition (CAP 3C0325), submitted by the Environmental Defense Fund (EDF), CEH, the Center for Food Safety (CFS), the Center for Science in the Public Interest (CSPI), and the Environmental Working Group (EWG). 88 Fed. Reg. 27818. The petition proposes that FDA repeal the color additive regulation for titanium dioxide in 21 C.F.R. Section 73.575, which permits the use of titanium dioxide in foods. FDA states that the petitioners assert that the intended use of titanium dioxide no longer meets the safety standard under 21 C.F.R. Section 70.3(i), “and cite, as evidence, an opinion by the European Food Safety Authority (EFSA) entitled ‘Safety assessment of titanium dioxide (E171) as a food additive’ that was published in May 2021 . . ., and other publications.” FDA invites comments, additional scientific data, and other information related to the issues raised by the petition. FDA states that if it determines that the available data justify repealing Section 73.575 to no longer provide for the safe use of titanium dioxide in foods, it will publish its decision in the Federal Register in accordance with 21 C.F.R. Section 71.20. Comments are due July 3, 2023. More information is available in our May 4, 2023, blog item.


France Extends Due Date For R-Nano Declarations To May 31, 2023: 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), for the 2023 reporting year, “it is important to provide the required characterization methods for your substances.” An extension of the closing date of the declaration, to May 31, 2023, is granted to all the actors. More information is available in our April 22, 2023, blog item.

EUON Extends Deadline For Study Proposals: 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. On April 26, 2023, EUON announced that it extended the deadline for proposals to May 12, 2023.

OECD Tour De Table Includes Information On U.S. Developments On Human Health And Environmental Safety Of Nanomaterials: The Organization for Economic Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials and Advanced Materials — Tour de Table. The Tour de Table compiles information provided by delegations on the occasion of the 22nd meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in June 2022. The Tour de Table lists U.S. developments on the human health and environmental safety of nanomaterials. More information is available in our May 1, 2023, blog item.

EC Committee Begins Public Consultation On Preliminary Opinion On Fullerenes, Hydroxylated Fullerenes, And Hydrated Forms Of Hydroxylated Fullerenes (Nano): The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) has begun a public consultation on its preliminary opinion on fullerenes, hydroxylated fullerenes, and hydrated forms of hydroxylated fullerenes (nano). SCCS states that having assessed the information provided by the notifiers, and the information available from published literature, it “has not been able to conclude on the safety of fullerenes and (hydrated) hydroxylated forms of fullerenes due to a number of uncertainties and data gaps in regard to physicochemical, toxicokinetic and toxicological aspects.” Comments are due June 12, 2023. More information is available in our May 4, 2023, blog item.

JRC Publishes Guidance Document On Implementation Of The EC’s Revised Definition Of Nanomaterials, Launches Free Course On Nanomaterials In EU Legislation: On May 2, 2023, the EC’s Joint Research Center (JRC) announced that it published a guidance document entitled Guidance on the implementation of the Commission Recommendation 2022/C 229/01 on the definition of nanomaterial. JRC states that the new definition will facilitate the formulation of a single nanomaterial definition in EU legislation in the future, including on chemicals, novel food, cosmetics, biocides, or medical devices; “preparat[i‌]ons for updates have already begun in several sectors.” Along with the new guidance document, JRC announced that it has launched a free course on nanomaterials in EU legislation available on the EU Academy. More information is available in our May 9, 2023, blog item.

NNI Announces Webinars On U.S. Government Activities Addressing Micro- And Nanoplastic Issues: The National Nanotechnology Initiative (NNI) will hold two public webinars providing an overview of the key activities of U.S. government agencies in tackling the challenge of plastic waste in the environment. The panel of speakers includes participants in the informal U.S. government nanoplastics interagency interest group that coordinates activities on this subject across the federal agencies, who will provide highlights of agency programs and activities. The first session, on May 22, 2023, will focus on activities of agencies that primarily fund or conduct research. A second session, scheduled for June 6, 2023, will focus on activities of agencies with regulatory responsibilities or that engage in interagency or international collaborations on the subject of micro- and nanoplastics. Registration for the May 22, 2023, is open.


B&C® Biobased And Sustainable Chemicals BlogFor access to a summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to


Senate Republicans Reintroduce Chemical Tax Repeal Act: On April 18, 2023, Senators Ted Cruz (R-TX), John Kennedy (R-LA), Mike Lee (R-UT), and John Barrasso (R-WY) reintroduced the Chemical Tax Repeal Act (S. 1195) to eliminate the Superfund Tax imposed by the Infrastructure Investment and Jobs Act. According to Cruz’s April 18, 2023, press release, the 2021 infrastructure law “imposed roughly $15 billion worth of taxes on 42 different chemicals, critical minerals, and metallic elements that are the building blocks of common household items such as plastics, rubber, concrete, soap, lightbulbs, and electronics.” The press release notes that Cruz previously introduced this bill in 2021.

Senators Reintroduce Bipartisan Legislation To Strengthen Recycling And Composting Efforts: On April 19, 2023, Senators Tom Carper (D-DE), Chair of the Senate Environment and Public Works Committee, Shelley Moore Capito (R-WV), Ranking Member of the Committee, and John Boozman (R-AR), also a member of the Committee, reintroduced two pieces of bipartisan legislation focused on improving recycling and composting systems:

  • The Recycling and Composting Accountability Act (S. 1194) would improve data collection on recycling systems and explore the potential of a national composting strategy. The legislation would require EPA to collect and publish data on recycling and composting rates; and
  • The Recycling Infrastructure and Accessibility Act (S. 1189) would establish a pilot recycling program at EPA. The goal of the program is to fund eligible projects that would significantly improve access to recycling systems in underserved communities through the use of a hub-and-spoke model for recycling infrastructure development.

More information about the bills is available in the Committee’s April 19, 2023, press release. On April 26, 2023, the Committee advanced the bills by a voice vote.

Bill Reintroduced To Create Task Force To Address PFAS: On May 3, 2023, Senator Jeanne Shaheen (D-NH), a senior member of the Senate Armed Services Committee, reintroduced the PFAS Exposure Assessment and Documentation Act (S. 1360). According to Shaheen’s May 3, 2023, press release, the bill would provide blood testing for service members as part of their annual periodic health assessment, as well as for family members and veterans who were stationed at one of the more than 700 military installations with known contamination or suspected releases of PFAS.

Package Of Senate Legislation Would Protect Industries And Municipalities From Liability Claims If PFAS Are Designated As Hazardous Substances: On May 4, 2023, Senator Cynthia Lummis (R-WY) introduced five bills intended to ensure industries and municipalities are not subject to liability claims if EPA designates PFAS compounds as hazardous substances. According to Lummis’s May 4, 2023, press release, the covered entities in these bills either do not contribute to PFAS contamination or are required to use PFAS-containing substances through regulations. The press release states that if EPA issues a final rule designating perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), “entities such as water treatment plants, landfills, farms and ranches would be held liable for PFAS contamination they are not responsible for and entities such as airports, fuel depots and refineries that are required to test use fire suppression foam that contain PFAS would be at risk for litigation.” Each of the five pieces of legislation will address a certain industry targeted by Superfund liability:

  • Agriculture PFAS Liability Protection Act;
  • Airports PFAS Liability Protection Act (S. 1433);
  • Fire Suppression PFAS Liability Protection Act;
  • Resource Management PFAS Liability Protection Act; and
  • Water Systems PFAS Liability Protection Act.

Senate Committee Approves Bipartisan Railway Safety Act: On May 10, 2023, the Senate Committee on Commerce, Science and Transportation approved the bipartisan Railway Safety Act of 2023 (S. 576) following negotiations led by Senator Maria Cantwell (D-WA), Chair of the Committee, sending the legislation to the Senate floor. The Committee’s May 10, 2023, press release notes that the Federal Railroad Administration requires trains carrying large amounts of flammable liquids to comply with speed restrictions in urban areas, improve braking systems to make trains stop faster, conduct a route risk analysis to ensure railroads take the safest route and take steps to mitigate safety and security risks, and ensure railroads have a hazardous materials spill response plan in the event of a derailment. The bill would expand the types of chemicals that trigger these safety requirements “so that trains carrying vinyl chloride and other explosives and toxic materials, including flammable gas, poisonous gas and nuclear material, are subject to the same safety requirements as flammable liquid trains.” The bill would require railroads to notify states about the types and frequency of trains carrying hazardous materials transported through the state boundaries. Additionally, the bill would require DOT to improve railroads’ existing hazardous material response plans by ensuring railroads have: a DOT approved plan explaining how they will respond to a release of dangerous chemicals that high-hazard trains transport; and that railroads have their own hazardous material spill response teams to respond quickly to derailments and support local firefighters.


GAO Recommends Actions To Improve DOD’s Ability To Prevent The Procurement Of Items Containing PFAS: On April 26, 2023, GAO published a report entitled “Persistent Chemicals: Actions Needed to Improve DOD’s Ability to Prevent the Procurement of Items Containing PFAS.” GAO notes that starting April 2023, the Department of Defense (DOD) was prohibited from procuring items in four categories if they contain certain PFAS. GAO evaluated the information available to DOD regarding PFAS in items and the extent to which the April 2023 prohibition aligns with this information; it also evaluated the extent to which DOD has developed an approach to implement the April 2023 prohibition on items containing PFAS. GAO states that it is making it a matter for Congressional consideration to align the item categories specified in the April 2023 prohibition with EPA information. GAO is also making two recommendations to DOD to develop an approach for applying the April 2023 prohibition to the military exchanges and to update its sustainable procurement guidance. According to GAO, DOD concurred with the recommendations. More information is available in our May 3, 2023, blog item.

CDTSC Proposes Adding Microplastics And PPD Derivatives To CCL: The California Department of Toxic Substances Control (CDTSC) announced on April 27, 2023, that it proposes adding two groups of chemicals, microplastics and para-phenylenediamine (PPD) derivatives, to its Candidate Chemicals List (CCL), based on their reported impacts on human health and the environment. CDTSC notes that regulations that add chemicals to the CCL do not directly create any new requirements. They allow CDTSC’s Safer Consumer Products (SCP) Program to select consumer products containing one or more of these chemicals for later evaluation and possible regulation under SCP regulations as a Chemical of Concern in a Priority Product. Manufacturers of a consumer product regulated by SCP must thoroughly evaluate the impacts of a Candidate Chemical before choosing it as a replacement for a Chemical of Concern. CDTSC will hold a virtual workshop on June 27, 2023, regarding microplastics and will also hold a written comment period from June 27, 2023, to July 27, 2023. The PPD derivatives workshop will be held in July 2023 (date to be announced). More information on the workshops is available on CDTSC’s website.

ATSDR Publishes Final Toxicological Profiles For Several Chemicals: In May 2023, the Agency for Toxic Substances and Disease Registry (ATSDR) posted final Toxicology Profiles for chlorodibenzofuransnitrophenols, and n-nitrosodimethylamine (NDMA). Toxicological Profiles succinctly characterize the toxicology and adverse health effects information for the toxic substance described therein. Each peer-reviewed profile identifies and reviews the key literature that describes a substance’s toxicological properties.

EPA Releases Draft National Strategy To Prevent Plastic Pollution: On May 2, 2023, EPA announced the release of the Draft National Strategy to Prevent Plastic Pollution (Draft Strategy) for public comment. 88 Fed. Reg. 27502. EPA states in its April 21, 2023, press release that the Draft Strategy includes “ambitious actions to eliminate the release of plastic and other waste from land-based sources into the environment by 2040.” EPA released the Draft Strategy alongside a new White House Interagency Policy Committee (IPC) on Plastic Pollution and a Circular Economy. The IPC will coordinate federal efforts on plastic pollution, prioritizing public health, economic development, environmental justice, and equity to ensure that the benefits of acting on plastic pollution — including jobs, minimized exposure to harmful chemicals, and clean communities — are available to all. EPA hosted a webinar on May 11, 2023, to provide an overview of the Draft Strategy and the key questions on which EPA seeks comment. Comments on the Draft Strategy are due June 16, 2023. More information on the Draft Strategy is available in our May 2, 2023, memorandum. More information on the May 11, 2023, webinar is available in our May 12, 2023, blog item.

OSHA Will Hold Public Meeting To Discuss Voluntary Protection Programs: The Occupational Safety and Health Administration (OSHA) announced on May 11, 2023, that it will hold a stakeholder meeting on June 15, 2023, in Washington, D.C., to discuss modernizing, improving, and expanding its Voluntary Protection Programs (VPP). OSHA’s VPP recognizes workplaces that demonstrate best practices in safety and health management and serve as industry models. The discussion will include comments and suggestions from the public on recommendations and potential avenues for action. OSHA states that it seeks input from stakeholders, “regardless of whether they’ve had direct, indirect and no involvement with VPP facilities.” OSHA is interested in various perspectives in stakeholders’ answers to questions, such as:

  • Are there leading indicators for measuring future performance of safety and health management systems?
  • How can OSHA encourage more employers to apply to VPP?
  • Aside from current customer experience surveys, how can OSHA solicit more frequent and timely feedback on the program?
  • Beyond the OSHA Challenge, how can the agency increase the use of effective safety and health management systems by companies not in the VPP?
  • How can OSHA improve the program’s quality or integrity?
  • Given OSHA’s limited resources, how can it grow VPP more efficiently?
  • In what ways, can safety and health consensus standards be used to create pathways for companies to participate in the VPP?

NEWMOA Releases Draft PFAS Prevention Model Legislation For Comment, Holds Webinar: The Northeast Waste Management Officials’ Association (NEWMOA) announced in May 2023 the release of its PFAS Prevention Model Act, which is intended to reduce the use of PFAS. The draft legislation presents a menu of policy options for state policy makers to consider. The draft model includes provisions and concepts that reflect current efforts to reduce PFAS use and minimize PFAS releases. NEWMOA states that it has an overarching goal of the “virtual elimination of the environmental releases of PFAS into the environment.” It welcomes comment on all aspects of the draft model legislation, and especially invites comment on:

  • Key definitions, including the definitions for “Intentionally Added PFAS” and “PFAS Added Products”;
  • The provisions in “Currently unavoidable uses of PFAS” in Section 6(c) of the draft model legislation; and
  • The mechanisms for funding the costs of administering the provisions of the draft model legislation, including establishment of the Clearinghouse in Section 4.

Comments on the draft legislation are due June 29, 2023. NEWMOA hosted a webinar on May 10, 2023, to provide an overview of the draft legislation. More information on the draft legislation is available in our May 12, 2023, memorandum.

Canada Proposes To Unmask The Identities Of 132 Substances On The DSL: According to a May 6, 2023, Canada Gazette notice, the Minister of the Environment, pursuant to the Canadian Environmental Protection Act, 1999 (CEPA), intends to unmask the identities of 132 substances currently on Part 3 of the Domestic Substances List (DSL) in accordance with the Approach to disclose confidential information and promote transparency in chemicals. The annexed proposed Order includes the masked names and confidential accession numbers of the substances proposed for unmasking. Canada will take comments into consideration during the development of the final Order. Comments on the proposed Order are due July 5, 2023. More information is available in our May 10, 2023, blog item.

FTC Releases Agenda For May 23, 2023, Workshop On “Talking Trash: Recyclable Claims And The Green Guides”: The Federal Trade Commission (FTC) announced on May 10, 2023, that it released the tentative agenda for its May 23, 2023, workshop on “Talking Trash: Recyclable Claims and the Green Guides.” The workshop will examine FTC’s guidance on “recyclable” advertising claims as part of its ongoing review of the Guides for Use of Environmental Marketing Claims (Green Guides). FTC will webcast the workshop on its website, Registration is not required to watch the webcast. In conjunction with the workshop, FTC states that it is seeking additional public comment. The public will have until June 13, 2023, to submit comments to accommodate those who wish to provide input on the topics discussed at the event. More information on FTC’s review of the Green Guides is available in our December 16, 2022, memorandum.

EPA Requests Comment On Recycling Infrastructure And Market Opportunities Map: EPA announced on May 12, 2023, that it has developed an interactive map of recycling markets that highlights existing recycling infrastructure, per capita generation and recycling of post-consumer materials, and other relevant market factors. 88 Fed. Reg. 30739. According to EPA, the map visually presents data estimates across various phases of the recycling process, including generation, collection, sortation, and end use. EPA’s Office of Land and Emergency Management (OLEM) seeks public comments on the accuracy and completeness of the data, ease of use, graphics, and recommendations on future updates of the map. EPA states that it will collect and analyze the public comments to use as inputs for the next update of the map. Comments are due June 26, 2023.

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