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 Lowit, Senior Science Advisor, Office of Pollution Prevention and Toxics (OPPT), and Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), will discuss New Approach Methodologies (NAM), cumulative risk assessment methodologies, systematic review procedures, new approaches to new chemical reviews, per- and polyfluoroalkyl substances (PFAS) reporting, and confidential business information (CBI) protections. Register now.
RECORDED WEBINAR ON-DEMAND — “Extended Producer Responsibility (EPR) Regulations”: Panelists discuss the history and evolution of EPR legislation, expected developments that will affect the chemical and chemical product industry, and what companies need to know to prepare for these changes. Panelists included 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. Watch now.
EVENT — Catherine M. Croke, DBA To Speak At HCPA IMPACT2023: B&C and The Acta Group (Acta®) are proud to be sponsors of IMPACT2023, the Household & Commercial Products Association’s (HCPA) Mid-Year Meeting. On Friday, May 5, 2023, Catherine M. Croke, DBA, Director of Product Stewardship and Regulatory Affairs, B&C and Acta, will present “Product Stewardship in a Regulated World” during the Regulatory Affairs Council session. Dr. Croke will review specific rules and bans on substances, specific rules and bans on a single chemical, and general voluntary disclosures and “green” seals and certificates. For more information and to register, visit the IMPACT2023 website.
PODCAST — The East Palestine Train Derailment: Behind the Scenes with Three Former Government Officials: Lynn L. Bergeson sits down with James V. Aidala and Dennis R. Deziel, both Senior Government Affairs Advisors with B&C, and Richard E. Engler, Ph.D., to discuss what happens when the call comes in reporting on a major incident, how U.S. Environmental Protection Agency (EPA) officials plan for the unexpected, key challenges in communicating risk information about chemicals to the public, and their thoughts on restoring trust in what the government reports during major incidents. Listen now or read the transcript.
PODCAST — Modernization of Cosmetic Regulations Act of 2022 — A Conversation with Karin F. Baron: On this episode of ALL Things Chemical®, Lynn L. Bergeson and Karin F. Baron, MSPH, Director of Hazard Communication and International Registration Strategy, B&C, address the newly enacted Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA is intended to modernize the regulation of cosmetics and imposes sweeping changes on the review and regulation of cosmetics about which our listeners need to know. Listen now.
PUBLISHED BOOK — Lynn L. Bergeson And Bethami Auerbach Co-Edit Chemical Risk Governance Volume Of The Elgar Encyclopedia Of Environmental Law: B&C is pleased to announce the publication of Chemical Risk Governance, Volume XII of the Elgar Encyclopedia of Environmental Law. Lynn L. Bergeson and Bethami Auerbach, Of Counsel with B&C, edited the volume, along with Adam D.K. Abelkop, Associate Professor and Director of Legal Writing, University of San Francisco School of Law, and Lucas Bergkamp, Senior Policy Adviser, European Governance & Sustainability Center. This volume provides expert analysis of the foundations, main concepts, and substantive and procedural requirements of selected chemical law regimes as they pertain to the environment. Ms. Bergeson and Ms. Auerbach also co-authored, along with colleagues Lisa R. Burchi, and Carla N. Hutton, Chapter 13: Case Studies in Regulatory Concepts, a thorough review of types of chemicals, exposures, and the regulation of chemicals in products and manufacturing. Purchase online.
TSCA/FIFRA/TRI
EPA Announces Rule Proposal To Update The Pesticide Application Exclusion Zone Requirements Under The 2015 Agriculture Worker Protection Standard: On March 13, 2023, 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. Comments are due on or before May 12, 2023. For more information, please read our March 16, 2023, blog.
EPA Announces Toxic Chemical Releases In 2021 Remained Below Pre-Pandemic Levels: EPA announced on March 16, 2023, the release of its 2021 Toxics Release Inventory (TRI) National Analysis, which shows that environmental releases of TRI chemicals from facilities covered by the program remained below pre-pandemic levels and releases in 2021 are ten percent lower than 2012 releases, even with an eight percent increase from 2020 to 2021. Additionally, in 2021, facilities managed 89 percent of their TRI chemical waste through preferred practices such as recycling, energy recovery, and treatment, while reporting that they released 11 percent of their TRI chemical waste into the environment. The 2021 TRI National Analysis summarizes TRI chemical waste management activities, including releases, that occurred during calendar year 2021. According to EPA, more than 21,000 facilities submitted reports on 531 chemicals requiring TRI reporting that they released into the environment or otherwise managed as waste.
EPA Releases Additional Data On Ongoing Uses Of Chrysotile Asbestos: On March 17, 2023, EPA released additional data related to the proposed risk management rule for chrysotile asbestos for public comment. 88 Fed. Reg. 16389. According to EPA’s March 16, 2023, press release, these data concern chrysotile asbestos diaphragms used in the chlor-alkali industry and chrysotile asbestos-containing sheet gaskets used in chemical production. EPA states that it may use the data in the development of the final rule, including the proposed chrysotile asbestos prohibition compliance dates for these uses. EPA requests public comment on any data in the docket that were received during and after the proposed rule public comment period and about how EPA should consider it during the development of the final rule. Comments are due April 17, 2023.
EPA Releases Congressional Justification For FY 2024 Budget: 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 (TSCA):
- By September 30, 2026, complete at least eight high-priority substance TSCA risk evaluations annually within statutory timelines compared to the FY 2020 baseline of one;
- By September 30, 2026, initiate all TSCA risk management actions within 45 days of the completion of a final existing chemical risk evaluation; and
- By September 30, 2026, review 90 percent of risk management actions for past TSCA new chemical substances reported to the 2020 Chemical Data Reporting (CDR) Rule compared to the FY 2021 baseline of none.
More information on activities for the Chemical Risk Review and Reduction (CRRR) Program is available in our March 22, 2023, blog item. A summary of funding provided for the Safer Choice, Environmentally Preferable Purchasing (EPP) and Green Chemistry Programs is available in our March 24, 2023, blog item. More information on the Senate Committee on Environment and Public Works’ March 22, 2023, hearing on EPA’s proposed budget is available in our March 23, 2023, memorandum. A summary of the House Appropriations Subcommittee for Interior, Environment, and Related Agencies’ March 28, 2023, hearing on the budget request for EPA is available in our March 30, 2023, memorandum.
EPA Seeks Nominations For Ad Hoc Expert Reviewers For Review Of Draft Supplement To The 1,4-Dioxane Risk Evaluation: 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 submit the draft supplement to the SACC for peer review and is scheduling a four-day virtual public meeting for the SACC to consider and review the draft supplement in September 2023. Nominations are due April 24, 2023. More information is available in our April 3, 2023, blog item.
EPA Is Accepting Applications For The 2023 Safer Choice Partner Of The Year Awards: On March 27, 2023, 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. Similar achievement in the design, manufacture, selection, and use of Design for the Environment (DfE)-certified products will also make an organization eligible for the Partner of the Year Awards. The DfE program is a companion program to Safer Choice and certifies antimicrobial products. Submissions are due May 31, 2023. More information on the 2023 Safer Choice Partner of the Year Awards, including the application form, submission process, and past winners, is available on EPA’s website. More information is available in our March 29, 2023, blog item.
EPA’s New Chemicals Program Holds Second Webinar In Series On Standardized Approach For MMOs In New And Modified CAMs: On March 30, 2023, EPA’s New Chemicals Program (NCP) held the second of a two-part webinar series on EPA’s new standardized process to assess risk and apply mitigation measures, as appropriate, for mixed metal oxides (MMO), including new and modified cathode active materials (CAM). As described in EPA’s slides, the webinar focused on “one of the most time consuming parts of the new chemical review process for MMOs CAMs,” the human health risk assessment. The risk assessment includes the following steps: understanding the chemical; understanding exposure; understanding hazard; and determining risk. NCP follows EPA’s Guidance for Risk Assessment. For risks to humans, EPA looks at risks to workers, general population, and consumers; risk through dermal, oral (drinking water and fish ingestion), and inhalation routes; and whether the chemical substance is a carcinogen. More information is available in our April 6, 2023, memorandum.
EPA Publishes “First Ever” CDR National Review: EPA announced on March 31, 2023, publication of the “first ever” CDR National Review, a web-based, interactive report with comprehensive analysis of data submitted during the 2020 CDR reporting cycle. According to EPA, the National Review “increases public awareness of chemicals being manufactured in communities and helps EPA and a variety of stakeholders (including citizens and communities, other regulatory agencies, industry, researchers and nongovernmental organizations) evaluate and understand information including the types, quantities and uses of chemicals produced domestically or imported” into the United States. EPA is hosting a public webinar on April 18, 2023, highlighting the findings and trends from the 2020 CDR National Review and explaining the new interactive features of the National Review website. More information on the CDR National Review will be available in our forthcoming memorandum.
Court Dismisses Private-Citizen Suit Against Inhance: 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 PFAS when fluorinating plastic containers. According to the court’s April 6, 2023, opinion, Inhance filed a motion to dismiss the case brought by CEH and PEER, “arguing that the TSCA’s diligent-prosecution bar requires dismissal of this separate action.” The court found that CEH and PEER failed to prove that the U.S. Department of Justice (DOJ) is not “diligently prosecuting” the action. The court granted Inhance’s motion, dismissing the case without prejudice. According to an April 7, 2023, PEER press release, PEER and CEH will now move to intervene in DOJ’s suit in the U.S. District Court for the Eastern District of Pennsylvania. More information is available in our April 11, 2023, blog item.
Non-Governmental Organization (NGO) Seeks Review Of TSCA Section 5 Order For A New Chemical Substance: 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 TSCA Section 5. According to the petition, the August 11, 2022, Order authorizes Chevron U.S.A. Inc. to manufacture, process, distribute in commerce, use, or dispose of certain new chemical substances. The press release states that EPA approved the new chemicals to make fuels “despite finding that the resulting air pollution would pose a cancer risk 250,000 times greater than what the agency typically considers unreasonable.” More information is available in our April 17, 2023, blog item.
EPA Issues SNURs For Certain Chemical Substances: On April 11, 2023, EPA issued final significant new use rules (SNUR) under TSCA for chemical substances that were the subject of premanufacture notices (PMN). 88 Fed. Reg. 21480. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required by that determination. The SNURs will be effective June 12, 2023.
EPA Will Hold Virtual Preparatory Meeting For SACC Review Of Draft Documents Related To Cumulative Risk Assessment Under TSCA: EPA will hold a virtual public preparatory meeting for 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 TSCA. Registration for the virtual preparatory meeting is open. To participate as a listen-only attendee, registration will be open up to the end of the meeting. Requests to make brief oral comments can be submitted when registering and will be accepted until April 21, 2023. More information is available in our April 14, 2023, blog item.
EPA Will Hold GenRA Training On May 23, 2023: 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.” Specifically targeted for decision-makers, EPA has divided the training into two parts to accommodate a variety of interests and schedules. Registration for one or both sessions is free but required.
- Session 1 (Presentation and Questions and Answers (Q&A)) 11:00 a.m. – 12:30 p.m. (EDT)
This session will provide an overview of GenRA content and function with opportunities for participation and Q&A.
- Session 2 (Breakout Sessions) 12:30 – 1:30 p.m. (EDT)
This session will break participants into breakout rooms to work on exercises in small groups, aided by facilitators.
RCRA/CERCLA/CWA/CAA/PHMSA/SDWA
EPA Holds CERCLA PFAS Enforcement Listening Session: On March 14, 2023, EPA held the first of two public listening sessions to receive individual input related to concerns about potential liability under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). According to EPA’s March 2, 2023, press release, EPA will review and consider the input received in drafting a “CERCLA per- and polyfluoroalkyl substances (PFAS) enforcement discretion and settlement policy to the extent that PFAS cleanup enforcement efforts occur under CERCLA.” EPA posted recordings of the March 14, 2023, and March 23, 2023, session. A summary of the March 14, 2023, listening session is available in our March 17, 2023, memorandum.
EPA Amends NSPS For Industrial Surface Coating Of Plastic Parts For Business Machines: On March 27, 2023, EPA published a final rule amending the new source performance standards (NSPS) for Industrial Surface Coating of Plastic Parts for Business Machines pursuant to the review required by the Clean Air Act (CAA). 88 Fed. Reg. 18056. According to EPA, for affected facilities that commence construction, modification, or reconstruction after June 21, 2022, EPA is, in a new subpart, issuing final volatile organic compound (VOC) emission limitations for prime, color, texture, and touch-up coating operations, as well as a final requirement for electronic submission of periodic compliance reports. The final rule was effective March 27, 2023. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of March 27, 2023.
EPA Proposes First-Ever National Drinking Water Standard For Six PFAS: On March 29, 2023, EPA proposed the first-ever national drinking water standard for six PFAS in the latest action under EPA’s PFAS Strategic Roadmap. 88 Fed. Reg. 18638. The proposed National Primary Drinking Water Regulation (NPDWR) would regulate perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) as individual contaminants and will regulate four other PFAS — perfluorononanoic acid (PFNA), perfluorohexane sulfonic acid (PFHxS), perfluorobutane sulfonic acid (PFBS), and hexafluoropropylene oxide dimer acid (GenX chemicals) — as a mixture. EPA’s proposal includes:
- An enforceable maximum contaminant level (MCL) for PFOA and PFOS: EPA proposes to regulate PFOA and PFOS at a level that “can be reliably measured, which is 4 parts per trillion” (4.0 nanograms/liter (ng/L)); and
- An enforceable limit on a combination of PFNA, PFHxS, PFBS, and GenX chemicals: The proposed rule would place limits on any mixture containing one or more of PFNA, PFHxS, PFBS, and/or GenX chemicals. According to EPA, for these PFAS, water systems would use an approach called a hazard index, defined in the proposed rule, to determine if the combined levels of these PFAS pose a potential risk.
Comments must be received on or before May 30, 2023. Comments on the information collection provisions submitted to the Office of Management and Budget (OMB) are best assured of consideration by OMB if OMB receives a copy of your comments on or before April 28, 2023. EPA will hold a public hearing on May 4, 2023. More information is available in our March 16, 2023, memorandum.
EPA Publishes Draft Integrated Science Assessment For Lead: On March 31, 2023, EPA announced a 60-day public comment period for the draft document entitled “Integrated Science Assessment for Lead (External Review Draft).” 88 Fed. Reg. 19302. The draft document was prepared by the Center for Public Health and Environmental Assessment (CPHEA) within EPA’s Office of Research and Development (ORD) as part of the review of the primary (health-based) and secondary (welfare-based) Lead (Pb) National Ambient Air Quality Standards (NAAQS). EPA released the draft document to seek review by the Clean Air Scientific Advisory Committee (CASAC) and input from the public. Comments are due May 30, 2023.
EPA Will Propose To Strengthen Mercury And Air Toxics Standards For Power Plants: EPA announced on April 5, 2023, that it will propose to strengthen and update the Mercury and Air Toxics Standards (MATS) for coal-fired power plants, “achieving important hazardous air pollutant emissions reductions and ensuring standards reflect the latest advancements in pollution control technologies.” EPA states that the proposed rule, the most significant update since MATS was first issued in February 2012, fulfills EPA’s responsibility under the CAA to review emission standards periodically. EPA notes that earlier this year, it reaffirmed the scientific, economic, and legal underpinnings of the standards, “reversing a rule issued by the previous administration that undermined the legal basis for these vital health protections.”
EPA Will Propose To Reduce HAPs From Chemical Plants Significantly, Require Fenceline Monitoring: EPA announced on April 6, 2023, that it will issue a proposed rule to reduce significantly hazardous air pollutants (HAP) from chemical plants, “including the highly toxic chemicals ethylene oxide (EtO) and chloroprene.” EPA’s fact sheet states that the proposed rule would significantly strengthen and update several CAA regulations that apply to a variety of equipment and processes used to make synthetic organic chemicals and a variety of processes used in polymers and resins production, including neoprene production. According to EPA, the proposal would “dramatically reduce air toxics-related cancer risks for people who live near approximately 200 plants across the country that make synthetic organic chemicals.” EPA notes that as an “added measure of protection for people who live near the facilities the proposal covers,” the proposed rule would require plants to conduct fenceline monitoring if they use, produce, store, or emit any of six key air toxics — EtO, chloroprene, benzene, 1,3-butadiene, ethylene dichloride, and vinyl chloride. If annual average air concentrations of the chemicals are higher than an “action level” at the fenceline, owners and operators would have to find the source and make repairs. The proposed action levels vary depending on the chemical. For EtO, EPA will propose an action level of 0.2 micrograms per cubic meter of air. For chloroprene, the proposed action level will be 0.3 micrograms per cubic meter of air. Publication of the proposed rule in the Federal Register will begin a 60-day comment period. EPA will hold a virtual public hearing 21 days after publication. EPA notes that it has a consent decree deadline to issue a final rule by March 29, 2024.
EPA Seeks Input On Standards Of Performance For New Stationary Sources And Emission Guidelines For Existing Sources: Other Solid Waste Incineration Units Review: EPA announced on April 6, 2023, that it is inviting small businesses, small governments, and small not-for-profit organizations to participate as Small Entity Representatives (SER) for a Small Business Advocacy Review (SBAR) Panel. EPA states that the panel will focus on EPA’s development of a rule, “Standards of Performance for New Stationary Sources and Emission Guidelines for Existing Sources: Other Solid Waste Incineration Units Review,” that would revise standards and other regulatory requirements for other solid waste incineration (OSWI) units such as very small municipal waste combustion (VSMWC) and institutional waste incineration (IWI) units. Self-nominations are due April 20, 2023.
EPA Proposes New Standards Intended To Protect Public Health, Reduce Exposure To EtO: EPA announced on April 11, 2023, that it will propose new health protections to reduce exposure to EtO, including more stringent air emissions standards and additional protections for workers who are exposed to the gas used to sterilize medical devices and certain spices. Under EPA’s CAA authority, EPA issued a proposed rule outlining new requirements for 86 commercial sterilizers across the country. 88 Fed. Reg. 22790. If issued in final, the proposal would reduce EtO emissions from these facilities by 80 percent, bringing emission levels down so that risk falls below EPA’s CAA benchmark for elevated cancer risk. Comments on the proposed amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Commercial Sterilization Facilities source category are due June 12, 2023. EPA notes that under the Paperwork Reduction Act (PRA), “comments on the information collection provisions are best assured of consideration if [OMB] receives a copy of your comments on or before May 15, 2023.” EPA will hold virtual public hearings on May 2 and May 3, 2023.
EPA also proposed a comprehensive set of new mitigation measures intended to decrease risk for workers who use EtO to sterilize products and for other people in communities near sterilization facilities. 88 Fed. Reg. 22447. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA approves the use of pesticides subject to certain controls through a registration decision, including antimicrobial pesticides like EtO. EPA proposes to increase control measures on the use of EtO in the Proposed Interim Decision, such as:
- Prohibiting certain uses of EtO where alternatives exist, including use in museums, archival settings, beekeeping, some cosmetics, and musical instruments;
- Reducing the amount of EtO that may be applied for medical device sterilization while meeting applicable standards for sterility assurance;
- Requiring engineering controls that reduce worker exposures to EtO, such as automation or emissions capture technology; and
- Mandating personal protective equipment (PPE) in sterilization facilities when EtO is detected using state-of-the-art monitoring technology.
Comments are due June 12, 2023. EPA states that it will also host a public webinar on May 1, 2023, at 8:00 p.m. (EDT) to discuss proposed actions to reduce exposure to EtO from commercial sterilization facilities and healthcare facilities.
EPA Announces Decisions To Deny Two Petitions Submitted Under AIM Act: EPA published a notice on April 11, 2023, to alert the public to and provide explanation of its decisions to deny two petitions submitted under the American Innovation and Manufacturing (AIM) Act of 2020. 88 Fed. Reg. 21579. The first petition requests that EPA provide an exemption for the use of certain regulated substances in pain relief sprays and the second petition requests that EPA subject gas canisters of certain regulated substances to import restrictions established under the [Hydrofluorocarbon (HFC)] Allocation Framework Rule. These petitions were submitted to EPA pursuant to its authority under the Act to promulgate rules that restrict, fully, partially, or on a graduated schedule, the use of a regulated substance in the sector or subsector in which the regulated substance is used.
EPA Will Propose “Strongest-Ever” Pollution Standards For Cars And Trucks: On April 12, 2023, EPA announced that it will propose new federal vehicle emissions standards “that will accelerate the ongoing transition to a clean vehicles future and tackle the climate crisis”:
- The Multi-Pollutant Emissions Standards for Model Years (MY) 2027 and Later Light-Duty and Medium Duty Vehicles builds on EPA’s existing emissions standards for passenger cars and light trucks for MYs 2023 through 2026. According to EPA, the proposal “retains the proven regulatory design of previous EPA standards for light-duty vehicles, but leverages advances in clean car technology to further reduce both climate pollution and smog- and soot-forming emissions.” Publication of the proposed rule in the Federal Register will begin a 60-day comment period; and
- The Greenhouse Gas Standards for Heavy-Duty Vehicles — Phase 3 would apply to heavy-duty vocational vehicles (such as delivery trucks, refuse haulers or dump trucks, public utility trucks, transit, shuttle, and school buses) and trucks typically used to haul freight. According to EPA, these standards would complement the criteria pollutant standards for MY 2027 and beyond heavy-duty vehicles that EPA issued in final in December 2022 and represent the third phase of EPA’s Clean Trucks Plan. Publication of the proposed rule in the Federal Register will begin a 50-day comment period. EPA will hold a public hearing on May 2 and 3, 2023. 88 Fed. Reg. 23388.
PHMSA Will Hold Public Meeting For ERG2024: The Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) announced on April 12, 2023, that it will hold a public meeting to solicit input on the development of the 2024 edition of the Emergency Response Guidebook (ERG2024). 88 Fed. Reg. 22089. According to PHMSA, the meeting will include a discussion of the methodology used to determine the appropriate response protective distances for poisonous vapors resulting from spills involving dangerous goods considered toxic by inhalation in the 2020 Edition of the ERG “Green Pages,” as requested by stakeholders. To pursue its objective of continually improving the ERG, PHMSA will solicit comments related to new methodologies and considerations for future editions of the ERG. Additionally, the meeting will include discussions on the outcomes of field experiments, ongoing research efforts to understand better environmental effects on airborne toxic gas concentrations, and updates to be published in the ERG2024. The meeting will take place virtually on Microsoft Teams on May 16, 2023. Registration is open.
EPA Publishes ANPRM Seeking Information To Assist In Consideration Of Future CERCLA Regulations Regarding PFAS: EPA published an advance notice of proposed rulemaking (ANPRM) on April 13, 2023, seeking information to assist in the consideration of potential development of future regulations pertaining to PFAS under CERCLA. 88 Fed. Reg. 22399. EPA states that it seeks input and data regarding potential future hazardous substance designation under CERCLA of seven PFAS, besides PFOA and PFOS, and their salts and structural isomers, or some subset thereof; precursors to PFOA, PFOS, and seven other PFAS; and/or categories of PFAS. 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 your comments” by May 15, 2023. More information is available in our April 13, 2023, memorandum.
FDA
FDA Provides Information On Implementation Of Cosmetic Regulation: On March 27, 2023, the U.S. Food and Drug Administration (FDA) published a web page for MoCRA, noting that MoCRA is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act (FFDCA) was passed in 1938. The web page includes background information, lists products that may be exempt from MoCRA (e.g., drugs and devices), and provides a link to the webinar held in April 2023 regarding the new regulation.
FDA No Longer Accepting Voluntary Cosmetics Submissions: Effective March 27, 2023, FDA notes it will no longer accept submission to the Voluntary Cosmetic Registration Program (VCRP) as a result of FDA’s plans to develop a program for submission of the facility registrations and product listings mandated by MoCRA. FDA requests that cosmetics companies wait to register until the new system is available. MoCRA is the most significant expansion of the FDA’s authority to regulate cosmetics since the FFDCA was passed in 1938. MoCRA, is enacted as part of the Consolidated Appropriates Act, 2023. FDA provides on its website an overview of the new requirements, and includes with this notice, its first action stemming from its enactment. Cosmetic companies are encouraged to engage with FDA as the elements of this regulation are developed.
FDA Presents Webinar For Identifying Contaminants In Food: FDA presented a webinar titled “Identification of Persistent Organic Pollutants in Foods: Method Development and Automation” on April 13, 2023. The presentation focused on new instrumentation and analytical methods for the quantitation of legacy Persistent Organic Pollutants (POP), some of which are also being evaluated for PFAS determinations.
FSMA Importers Portal Closing On May 31, 2023: FDA reminded importers that the Food Safety Modernization Act (FSMA) Voluntary Qualified Importer Program (VQIP) portal opened on January 1, 2023, and will close on May 31, 2023. VQIP is a voluntary fee-based program that provides qualified importers expedited review and importation of human and animal foods into the United States.
FDA Proposes Rule For Salt Substitutes: On April 10, 2023, FDA issued draft guidance titled “Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods.” 88 Fed. Reg. 21148. The proposed rule, if issued in final, would, in FDA’s view, “help support a healthier food supply by providing flexibility to facilitate industry innovation in the production of standardized food lower in sodium while maintaining the basic nature and essential characteristics of the foods.” FDA is accepting comments until August 8, 2023.
FDA Issues Revised Beer Can Labeling Guidance: On April 6, 2023, FDA issued a revised guidance document, titled “Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration: Guidance for Industry” (available at the link here), to add sesame to mandatory label information for beer. Sesame was identified as a major food allergen on April 23, 2021, as part of the food Allergy Safety, Treatment, Education and Research (FASTER) Act.
FDA Announces Webcast On New Era Of Smarter Food Safety Core Element 2: FDA intends to hold a webcast on May 11, 2023. The webcast is a live stream from the “Food Safety Summit: Measure What You Treasure.” This webcast is part of a continuing series “Collaborating on Culture in the New Era of Smarter Food Safety,” that began in 2021 and aims to focus on food safety culture as part of FDA’s New Era of Smarter Food Safety.
NANOTECHNOLOGY
EUON Issues Call For Study Proposals: The European Union (EU) Observatory for Nanomaterials (EUON) has issued a call for study proposals. EUON will assess all proposals, and if selected, they will be carried out through EUON’s existing procurement channels. EUON will post the outcome and study reports on its website. EUON states that it usually conducts two studies each year to address knowledge gaps on nanomaterials. EUON notes that studies are based on desk research and surveys and should not require laboratory research. Proposals are due April 27, 2023. More information is available in our March 16, 2023, blog item.
EUON Posts Nanopinions On Graphene Electronic Tattoos And How To Monitor The Crystal Defect Structure In Nanomaterials: EUON has posted two Nanopinions:
- “Graphene Electronic Tattoos,” posted on February 20, 2023, by Dr. Dmitry Kireev; and
- “A Reliable and Non-Destructive Experimental Technique Can Monitor the Crystal Defect Structure in Nanomaterials,” posted on March 14, 2023, by Professor Jenő Gubicza.
More information is available in our March 21, 2023, blog item.
EC Committee Issues Final Opinion On Hydroxyapatite (Nano) In Oral Cosmetic Products: The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published its final opinion on hydroxyapatite (nano) on March 23, 2023. According to the final opinion, based on the data provided, SCCS considers hydroxyapatite (nano) safe when used at concentrations up to ten percent in toothpaste, and up to 0.465 percent in mouthwash. The final opinion notes that this safety evaluation applies only to hydroxyapatite (nano) with the following characteristics: composed of rod-shaped particles of which at least 95.8 percent (in particle number) have an aspect ratio less than three, and the remaining 4.2 percent have an aspect ratio not exceeding 4.9; and the particles are not coated or surface modified. SCCS notes that its final opinion is not applicable to hydroxyapatite (nano) composed of needle-shaped particles. The final opinion states: “Although the use of hydroxyapatite (nano) is indicated also for breath spray, no data were provided to allow assessment of consumer safety from inhalation exposure. Therefore, this Opinion is not applicable to sprayable products that might lead to exposure of the consumer’s lungs to nanoparticles by inhalation.”
White House OSTP Publishes RFI On NNI EHS Research Strategy; NNI Will Hold Public Meeting: 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 states that it is interested in public input to inform an updated nanotechnology EHS research strategy, “specifically a strategy that focuses on the use of science-based risk analysis and risk management to protect public health and the environment while also fostering the technological advancements that benefit society.” Comments are due on or before 5:00 p.m. (EDT) on June 2, 2023. More information is available in our April 6, 2023, blog item.
NNI will hold a public meeting May 31-June 1, 2023, to discuss the revision of the 2011 EHS Research Strategy. NNI encourages individuals, NGOs, 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. More information is available in our March 28, 2023, blog item.
Paper Proposes Further Actions To Harmonize Testing Of Nanomaterials For EU Regulatory Requirements: 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 EU regulatory areas. For each information requirement, experts identified potential needs for further action to accommodate guidance and test guidelines to nanomaterials. More information is available in our April 11, 2023, blog item.
USDA Researchers Develop Natural, Washable, Antimicrobial Cleaning Wipes Using Nanocomposite Raw Cotton Fiber: 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.” More information on the antimicrobial wipes is available in an article in Molecules entitled “Washable Antimicrobial Wipes Fabricated from a Blend of Nanocomposite Raw Cotton Fiber.”
BIOBASED/RENEWABLE PRODUCTS/SUSTAINABILITY
B&C® Biobased And Sustainable Chemicals Blog: For access to a summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to https://biobasedblog.lawbc.com.
LEGISLATIVE
Bill Would Support U.S. Battery Industry By Eliminating Superfund Chemical Tax On Lead Oxide, Antimony, And Sulfuric Acid: On March 14, 2023, Representative Daniel Meuser (R-PA) introduced the USA Batteries Act (H.R. 1594), which would eliminate the Superfund chemical tax on lead oxide, antimony, and sulfuric acid. According to Meuser’s April 5, 2023, press release, these chemicals are the primary inputs used in lead batteries. According to the press release, the lead battery industry “includes many small businesses employing 25,000 Americans across 38 states with an annual economic impact of $23.6 billion. By repealing the Superfund chemical tax, we will help ensure the American battery industry continues to thrive.”
Bipartisan Legislation Intends To Protect Consumers From PFAS: On March 15, 2023, Senator Gary Peters (D-MI) introduced the Protecting Consumers from PFAS Act (S. 820), which would add the Consumer Product Safety Commission (CPSC) to the list of federal agencies required to participate on the PFAS Interagency Working Group. According to Peters’ March 16, 2023, press release, CPSC is currently represented on the PFAS Interagency Working Group, but is not required to be by law. The press release states that as public awareness and understanding of PFAS continue to grow and evolve, the bill “would take a commonsense step to ensure the best interests of consumers are accounted for and future federal efforts to address PFAS are conducted using a product safety lens.”
Bill Would Promote Environmental Justice By Cleaning Up 100 Hardest High Communities: On March 21, 2023, Representative Diana DeGette (D-CO) introduced the Protection from Cumulative Emissions and Underenforcement of Environmental Law Act of 2023 (H.R. 1673). According to DeGette’s March 21, 2023, press release, the legislation would require EPA to identify 100 low-income or predominantly minority communities in the United States that have been suffering from a disproportionately high number of environmental law violations. Once identified, the legislation would require EPA to work directly with state and local officials in each of those communities to clean them up. The bill would also, “for the first time ever,” require EPA to consider how multiple sources of pollution in, and around, a particular community can impact the health of residents there.
Bicameral Legislation Would Amend TSCA To Ban Asbestos: On March 30, 2023, the Alan Reinstein Ban Asbestos Now Act of 2023 (H.R. 2402, S. 1069) was introduced in the House and Senate. According to Senator Jeff Merkley’s (D-OR) March 30, 2023, press release, the bill would ban the importation and use of all six of the recognized asbestos fibers, plus winchite and richterite, “expanding on the EPA’s recent proposed rulemaking, which will only ban one.” The bill would amend TSCA to prohibit the manufacture, processing, use, and distribution in commerce of commercial asbestos and mixtures and articles containing commercial asbestos.
Bill Would End Federal Taxes On PFAS Remediation: On April 13, 2023, Representative Chris Pappas introduced the No Taxation on PFAS Remediation Act (H.R. 2615), which would remove federal taxes on PFAS contamination reimbursements. According to Pappas’ April 13, 2023, press release, Pappas heard from constituents with private wells who used New Hampshire’s PFAS Rebate Program for out-of-pocket costs to address PFAS contamination in their water. The press release notes that these individuals spent their own money and received a rebate but were later informed the state’s payment would be considered taxable income by the Internal Revenue Service (IRS). Pappas’s legislation would address this issue by removing PFAS contamination reimbursements as taxable income.
MISCELLANEOUS
Petition Filed To Add Cellulose Acetate To List Of Chemical Substances Subject To Superfund Excise Tax: 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 petition covers cellulose acetate (DS = 1.5-2.0), “commonly referred to as cellulose diacetate. Cellulose acetate in this range generally has similar properties. The petition uses the lowest end of the range cellulose acetate DS = 1.5 to demonstrate that >20% of the substance is made from taxable chemicals, and the midpoint cellulose acetate DS = 1.75 to calculate the tax rate for the entire range.” Comments and requests for a public hearing are due May 15, 2023.
EPA Accepting Comment On Protocol For Naphthalene IRIS Assessment: EPA announced on March 17, 2023, a 30-day public comment period associated with release of the Protocol for the Naphthalene IRIS Assessment. 88 Fed. Reg. 16442. EPA states that this document communicates the rationale for conducting the Integrated Risk Information System (IRIS) assessment of naphthalene, describes screening criteria to identify relevant literature, outlines the approach for evaluating study quality, and describes the methods for dose-response analysis. Comments are due April 17, 2023.
IRS Proposes Regulations Regarding Superfund Tax On Chemicals, Extends Temporary Relief Related To Penalty For Failure To Deposit Excise Taxes: On March 29, 2023, the 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 4672 of the Internal Revenue Code to amend the Environmental Tax Regulations (26 C.F.R. Part 52). The NPRM states that Section 4661(a) imposes an excise tax on the sale or use of “taxable chemicals” by manufacturers, producers, or importers, and that Section 4662 provides definitions and special rules for applying the Section 4661 tax. Section 4671(a) imposes an excise tax on the sale or use of “taxable substances” by importers, and Section 4672 provides definitions and special rules for applying the Section 4671 tax. The NPRM states that the proposed regulations provide guidance on the application of the reinstated Superfund chemical taxes. The proposed regulations affect manufacturers, producers, and importers that sell or use taxable chemicals and importers that sell or use taxable substances. Comments on the NRPM and requests for a public hearing are due May 30, 2023. More information on the proposed regulations is available in our April 4, 2023, memorandum.
Although not addressed in the NPRM, the IRS recently issued Notice 2023-28, extending the temporary relief provided in Notice 2022-15, 2022-18 I.R.B. 1043, regarding deposits of Superfund chemical taxes. According to Notice 2023-28, the extended relief is available in connection with deposits of the Superfund chemical taxes for semimonthly periods in the second, third, and fourth calendar quarters of 2023. The notice also extends the temporary relief provided in Section 3(b) of Notice 2022-15 related to the authority of the IRS to withdraw a taxpayer’s right to use the deposit safe harbor rules of Section 40.6302(c)-1(b)(2), through the second calendar quarter of 2024.
President Biden Signs EO On Modernizing Regulatory Review: On April 6, 2023, President Joseph Biden signed Executive Order (EO) 14094 on “Modernizing Regulatory Review.” 88 Fed. Reg. 21879. According to an April 6, 2023, blog item by the Office of Information and Regulatory Affairs (OIRA), the EO will focus OIRA and agency resources where they are most beneficial by increasing the threshold to $200 million from $100 million in annual effects and directing that it be adjusted for gross domestic product (GDP) growth every three years. OIRA states that “[t]his change will help return the number of regulations subject to more rigorous review to levels consistent with earlier administrations.” The EO also takes steps intended to encourage greater public participation when developing regulations, “particularly by individuals who may feel the largest effects of regulations but have not previously participated in the regulatory process.” OIRA notes that it has already been engaging with members of the public to seek feedback on ways to improve public participation in the regulatory process.
EPA Publishes Final IRIS Assessment Of PFHxA And Related Salts: EPA’s IRIS Program has posted the final IRIS Toxicological Review of Perfluorohexanoic Acid (PFHxA) and Related Salts. According to EPA, the final IRIS assessment of PFHxA can be used to support a variety of decision-making needs across EPA’s program offices, regions, and state agencies.
EPA Releases Draft IRIS Assessment Of PFDA And Related Salts For Public Comment: On April 10, 2023, EPA announced the availability of the draft IRIS Toxicological Review of Perfluorodecanoic Acid (PFDA) and Related Salts. 88 Fed. Reg. 21189. EPA states that it is releasing this draft IRIS assessment for public comment in advance of a contract-led peer review. EPA will provide public comments received to the external peer reviewers. The external peer reviewers will consider public comments submitted in response to this notice and comments provided at a future public peer review meeting. EPA will consider all comments received when revising the document post-peer review. EPA notes that the draft assessment is not final as described in EPA’s information quality guidelines, and it does not represent, and should not be construed to represent Agency policy or views. Comments are due June 9, 2023.EPA Publishes New Online Resource To Help Prevent Heavy Metal Exposures In Children: EPA announced on April 14, 2023, the release of an online resource guide that connects the public to a suite of federal, state, and local resources in multiple languages on preventing heavy metal exposures from cultural products. EPA states that children and those who are pregnant are especially vulnerable to the health risks posed by exposure to heavy metals in certain products that may lead to long-term health risks. According to EPA, the resource “fulfills one of the many promised goals outlined in the 2022 EPA Strategy to Reduce Lead Exposures and Disparities in U.S. Communities, a strategy designed to reduce lead exposure in communities overburdened by pollution and advance the Biden-Harris Administration’s commitment to environmental justice and equity.”
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