TSCA/FIFRA/TRI
EPA Seeks Comment On Proposed Settlement Agreement To Conclude A TSCA Rulemaking Regulating Lead Wheel Weights, Publishes ANPRM Regarding Lead Wheel Weights: On March 13, 2024, the U.S. Environmental Protection Agency (EPA) published notice of a proposed settlement agreement to address a petition for writ of mandamus filed by the Ecology Center, the Center for Environmental Health, United Parents Against Lead & Other Environmental Hazards, and the Sierra Club in the United States Court of Appeals for the Ninth Circuit (Ecology Center v. EPA, No. 23-70158 (9th Cir.)). 89 Fed. Reg. 18408. Under the proposed settlement agreement, EPA will:
- Publish an advance notice of proposed rulemaking (ANPRM) concerning lead for wheel-balancing weights (lead wheel weights); and
- By December 31, 2024, either sign a proposed rule regulating lead wheel weights pursuant to 15 U.S.C. Section 2605(a) and sign a final rule or otherwise take final action on the proposed rule by September 30, 2025, or sign a determination not to proceed with a rulemaking regulating lead wheel weights.
Comments on the proposed settlement agreement were due April 12, 2024. EPA published on April 3, 2024, an ANPRM regarding lead wheel weights. 89 Fed. Reg. 22972. EPA requests comments and information to assist in the potential development of regulations for the manufacture (including importing), processing (including recycling), and distribution in commerce of lead for lead wheel weights under the Toxic Substances Control Act (TSCA). Comments on the ANPRM are due May 3, 2024.
EPA Calls For Nominations Of Peer Reviewers For Draft Risk Evaluation Of 1,1-DCA: On March 21, 2024, EPA called for nominations of scientific and technical experts to review the draft risk evaluation for 1,1-dichloroethane (1,1-DCA) conducted under TSCA. 89 Fed. Reg. 20201. EPA will solicit comments from the experts on the approach and methodologies used in the draft risk evaluation. EPA states that it will release the draft risk evaluation for public review and comment in spring 2024 through a separate Federal Register notice and subsequently will provide the selected peer reviewers with the draft risk evaluation for letter peer review in summer 2024. Nominations were due April 11, 2024.
EPA Announces That Toxic Releases Declined 21 Percent In Ten Years Based On 2022 TRI Data: On March 21, 2024, EPA announced the release of its 2022 Toxics Release Inventory (TRI) National Analysis showing that environmental releases of TRI chemicals from facilities covered by the program were 21 percent lower in 2022 compared to 2013, including a 26 percent decrease in air releases. According to EPA, during this ten-year period, releases from manufacturing facilities decreased by nine percent while the value added to the U.S. economy from manufacturing increased by 14 percent. EPA notes that while overall releases increased by one percent from 2021 to 2022, there was a 6.5 percent increase in the number of pollution prevention activities reported under the TRI program compared to 2021.
EPA Issues Fourth TSCA Test Order For PFAS:EPA announced on March 25, 2024, that it has issued the fourth TSCA test order requiring testing on per- and polyfluoroalkyl substances (PFAS) under its National PFAS Testing Strategy. According to EPA, the action requires the 3M Company and Wacker Chemical Corporation to conduct and submit testing on the physical-chemical properties of 2-(N-Methylperfluoro-1-octanesulfonamido)ethanol (NMeFOSE) (Chemical Abstracts Service Registry Number® (CAS RN®) 24448-09-7), including testing on the health effects following inhalation of this chemical. According to EPA, NMeFOSE “has been used widely in product, including clothing and carpet treatments as well as furniture coatings (paint and varnish).” EPA states that NMeFOSE has been found in the air and in biosolids, a byproduct of the water treatment processes often used on agricultural fields as fertilizer. EPA notes that studies have demonstrated that NMeFOSE can accumulate in indoor dust and air, as well as in outdoor environmental media. More information will be available in a forthcoming memorandum.
EPA Proposes To Require Submission Of Health And Safety Studies For 16 Chemicals Being Considered For TSCA Risk Evaluation: EPA published on March 26, 2024, a proposed rule requiring manufacturers (including importers) of 16 chemical substances to submit copies and lists of certain unpublished health and safety studies to EPA. 89 Fed. Reg. 20918. EPA identified 15 of the chemical substances as potential candidates for prioritization through a screening process based on a combination of hazard, exposure (including uses), and persistence and bioaccumulation characteristics. EPA also included the N-(1,3-Dimethylbutyl)-N’-phenyl-p-phenylenediamine (6PPD) transformation product 2-anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone) due to a response to a recent citizen’s petition filed under Section 21 of TSCA on 6PPD and 6PPD-quinone. According to the proposed rule, health and safety studies sought by this action will help inform EPA’s responsibilities pursuant to TSCA, including prioritization, risk evaluation, and risk management. Comments are due May 28, 2024. For more information on the proposed rule, please read the full memorandum.
EPA Bans Ongoing Uses Of Chrysotile Asbestos: On March 28, 2024, EPA issued a final rule under TSCA to address to the extent necessary the unreasonable risk of injury to health presented by chrysotile asbestos based on the risks posed by certain conditions of use (COU). 89 Fed. Reg. 21970. The final rule will be effective May 28, 2024. This rule is not just about asbestos; it reflects how EPA will manage risks for existing chemical substances EPA identifies as high-priority substances under TSCA Section 6. For more information on the final rule and our insightful commentary, please read the full memorandum.
GAO Will Review EPA’s Practices For Managing And Accessing The Performance Of Its New Chemicals Review Program: EPA provided notice of disclosure on April 2, 2024, to all potentially affected businesses under TSCA that submitted information to EPA pursuant to TSCA Section 5 that it will disclose information to the U.S. Government Accountability Office (GAO). 89 Fed. Reg 22713. According to the notice, GAO is initiating a review of EPA’s practices for managing and accessing the performance of EPA’s New Chemicals Review program under TSCA Section 5. To do so, GAO has requested access to records, data, and documents submitted to EPA pursuant to TSCA, the Pollution Prevention Act (PPA), and other applicable statutes administered by EPA’s Office of Pollution Prevention and Toxics (OPPT) from October 1, 2021, through the date of the notice. EPA states that the requested information may include submissions that have been claimed as, or have been determined to be, confidential business information (CBI). More information is available in our April 3, 2024, blog item.
EPA Announces End Dates For Sales, Distribution, And Use Of Existing Stocks On Over-The-Top Uses Of Dicamba: On April 3, 2024, EPA issued a Federal Register notice providing notice of its issuance of an Existing Stocks Order and announcing the end dates for sales, distribution, and use of existing stocks on over-the-top (OTT) uses of dicamba subject to the Order. 89 Fed. Reg. 23010. This announcement follows the February 14, 2024, Existing Stocks Order for Dicamba Products Previously Registered for Over-the-Top Use on Dicamba-Tolerant Cotton and Soybean (Existing Stocks Order), and the revised Existing Stocks Order issued on March 12, 2024, which were in response to the February 6, 2024, ruling by the U.S. District Court of Arizona vacating the 2020 registrations for OTT dicamba products. More information is available in our April 15, 2024, blog.
EPA Proposes SNURs For Certain Chemical Substances: On April 8, 2024, EPA proposed significant new use rules (SNUR) for certain chemical substances that were the subject of premanufacture notices (PMN). 89 Fed. Reg. 24398. EPA states that the chemical substances received “not likely to present an unreasonable risk” determinations pursuant to TSCA. 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 proposed as a significant new use to notify EPA at least 90 days before commencing that activity. EPA notes that the manufacture or processing for the significant new use may not commence until EPA has conducted a review of the required notification, made an appropriate determination regarding that notification, and taken such actions as required by that determination. Comments on the proposed SNURs are due May 8, 2024.
EPA Denies Petition To Eliminate Current Allowances For PCBs In Consumer Products: EPA announced on April 9, 2024, its denial of the Washington Department of Ecology’s (WDOE) petition under TSCA Section 21 seeking a rulemaking to eliminate the current allowances for polychlorinated biphenyls (PCB) in consumer products. 89 Fed. Reg. 24824. EPA states that it “shares the petitioner’s concerns regarding risks to human health and the environment posed by PCBs, and the Agency continues to work towards better understanding and reducing exposures to PCBs.” EPA notes that WDOE failed to point with any specificity to deficiencies in the Agency’s 1984 final rule and determination of no unreasonable risk under TSCA, however. As a result, according to EPA, “the petitioner has not provided adequate justification — based on the rulemaking process and record for the 1984 final rule and information provided or otherwise available to the Agency — to support reassessing the limits on allowable inadvertent PCBs in consumer products.” EPA “finds that the petition is insufficiently specific, and that the petitioner did not meet their burden under TSCA of establishing that it is necessary to amend the 1984 final rule.”
Non-governmental Organizations Petition EPA To Remove PFAS Immediately From Fluorinated Plastic Containers: The Public Employees for Environmental Responsibility (PEER) announced on April 11, 2024, that a coalition of public health groups filed a petition under TSCA Section 21 seeking to stop immediately the manufacture and distribution of “hundreds of millions of plastic containers with dangerous levels of per- and polyfluoroalkyl substances (PFAS) that leach from these containers into household products and the environment.” Petitioners ask EPA to use its TSCA Section 6 authority to prohibit immediately the production of three toxic long-chain PFAS — perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA) — during this fluorination process. As reported in our March 25, 2024, memorandum, on March 21, 2024, the U.S. Court of Appeals for the Fifth Circuit vacated EPA’s December 2023 orders prohibiting Inhance Technologies, L.L.C. (Inhance) from manufacturing or processing PFAS during its fluorination process. PEER notes that the court recognized that EPA has the power to regulate the fluorination process that creates PFAS under a different provision of TSCA, Section 6, “which directs that when EPA has determined that a chemical ‘presents an unreasonable risk of injury to health or the environment,’ it ‘shall’ act ‘to the extent necessary so that [it] no longer presents such risk.’” This is the action that the petitioners seek.
EPA Releases Draft Part 2 Risk Evaluation For Asbestos For Public Comment: EPA announced on April 15, 2024, that it released a draft of the TSCA Risk Evaluation for Asbestos, Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos for public comment. EPA states that in Part 2, it is evaluating legacy uses and associated disposals of asbestos, including chrysotile asbestos and five additional asbestos fiber types. EPA notes that legacy uses are uses where manufacturing, processing, or distribution have ended, but there may still be asbestos present, such as floor and ceiling tiles, pipe wraps, insulation, and heat-protective textiles containing asbestos. According to EPA, it “has preliminarily determined that disturbing and handling asbestos associated with legacy uses, and asbestos as a whole chemical, poses unreasonable risk to human health.” EPA is scheduled to announce the availability of the draft risk evaluation in the Federal Register on April 16, 2024, beginning a 60-day comment period. EPA will host a public webinar providing an overview of the risk evaluation on May 13, 2024, at 3:00 p.m. (EDT). To provide a comment during the webinar, please e-mail Chloe Durand (Durand.Chloe@epa.gov) no later than May 7, 2024. More information will be available in a forthcoming memorandum.
RCRA/CERCLA/CWA/CAA/PHMSA/SDWA
EPA Announces Multi-Pollutant Emission Standards For Model Years 2027 And Later Light-Duty And Medium-Duty Vehicles: EPA announced on March 20, 2024, a final rule, Multi-Pollutant Emissions Standards for Model Years 2027 and Later Light-Duty and Medium-Duty Vehicles, that sets new, more protective standards to reduce further harmful air pollutant emissions from light-duty and medium-duty vehicles starting with model year 2027. According to EPA, the final rule builds upon its final standards for federal greenhouse gas (GHG) emissions standards for passenger cars and light trucks for model years 2023 through 2026 and “leverages advances in clean car technology to unlock benefits to Americans ranging from improving public health through reducing smog- and soot-forming pollution from vehicles, to reducing climate pollution, to saving drivers money through reduced fuel and maintenance costs.” The standards will phase in over model years 2027 through 2032. The final rule will take effect 60 days after publication in the Federal Register.
EPA Issues Final Rule Regarding CWA Hazardous Substance Facility Response Plans: On March 28, 2024, EPA issued a final rule regarding facility response plan requirements for worst case discharges of Clean Water Act (CWA) hazardous substances for onshore non-transportation-related facilities that could reasonably be expected to cause substantial harm to the environment by discharging a CWA hazardous substance into or on the navigable waters, adjoining shorelines, or exclusive economic zone. 89 Fed. Reg. 21924, The facility response plan requirements apply to facilities that could reasonably be expected to cause substantial harm to the environment, based on their location. These include facilities with a maximum on-site quantity of a CWA hazardous substance that meets or exceeds threshold quantities, located within a 0.5-mile radius of navigable water or conveyance to navigable water, and that meets one or more substantial harm criteria. The final rule will be effective May 28, 2024. Regulated facilities are required to submit response plans to EPA within 36 months after the effective date of the rule.
EPA Announces Final GHG Pollution Prevention Standards For Heavy-Duty Vehicles: EPA announced on March 29, 2024, final national GHG pollution standards for heavy-duty vehicles, such as freight trucks and buses, for model years 2027 through 2032. According to EPA, the standards are technology-neutral and performance-based, allowing each manufacturer to choose what set of emissions control technologies is best suited for them and the needs of their customers. The new standards apply to heavy-duty vocational vehicles (such as delivery trucks, refuse haulers, public utility trucks, and transit, shuttle, and school buses) and tractors (such as day cabs and sleeper cabs on tractor-trailer trucks). EPA notes that relative to the proposed rule, the final rule provides more time in the early model years of the program for the development of vehicle technologies and deployment of charging and refueling infrastructure. EPA states that the final rule also includes flexibilities that will assist manufacturers in meeting the standards in the early years of the program while preserving incentives for early adoption of advanced technologies. The final rule will take effect 60 days after publication in the Federal Register.
EPA Amends NESHAP For Integrated Iron And Steel Manufacturing Facilities: EPA published final amendments on April 3, 2024, to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Integrated Iron and Steel Manufacturing Facilities to regulate hazardous air pollutant (HAP) emissions. 89 Fed. Reg. 23294. EPA states that the amendments include: HAP from unmeasured fugitive and intermittent particulate (UFIP) sources previously not regulated by the NESHAP; previously unregulated HAP for sinter plants: previously unregulated pollutants for blast furnace (BF) stoves and basic oxygen process furnaces (BOPF) primary control devices; and previously unregulated pollutants for BF primary control devices. EPA also issued a final update to the technology review for this source category. The final rule will be effective June 3, 2024. The incorporation by reference of material publications listed in the rule is approved by the Director of the Federal Register beginning June 3, 2024. The incorporation by reference of certain other material listed in the rule was approved by the Director of the Federal Register as of July 13, 2020.
EPA Amends Ethylene Production, Miscellaneous Organic Chemical Manufacturing, Organic Liquids Distribution (Non-Gasoline), And Petroleum Refineries NESHAP: On July 6, 2020, EPA issued 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 Standards NESHAP; on July 7, 2020, EPA issued the final RTR conducted for the Organic Liquids Distribution (Non-Gasoline) NESHAP; and on August 12, 2020, EPA issued the final RTR conducted for the Miscellaneous Organic Chemical Manufacturing NESHAP. EPA most recently amended the Petroleum Refinery Sector NESHAP 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 4, 2024, EPA published a final rule removing the force majeure exemption for PRDs and emergency flaring, incorporating clarifications for the degassing requirements for floating roof storage vessels, and addressing other corrections and clarifications. 89 Fed. Reg. 23840. The final rule was effective April 4, 2024. The incorporation by reference of certain material listed in the rule was approved by the Director of the Federal Register as of August 12, 2020.
EPA Issues Final RTR For Commercial Sterilization Facilities: On April 5, 2024, EPA issued the final RTR conducted for the Commercial Sterilization Facilities NESHAP source category. 89 Fed. Reg. 24090. EPA states that it is issuing final decisions concerning the RTR, including definitions for affected sources, emission standards for previously unregulated sources, amendments pursuant to the risk review to address ethylene oxide (EtO) emissions from certain sterilization chamber vents (SCV), aeration room vents (ARV), chamber exhaust vents (CEV), and room air emissions, and amendments pursuant to the technology review for certain SCVs and ARVs. In addition, EPA is taking final action to correct and clarify regulatory provisions related to emissions during periods of startup, shutdown, and malfunction (SSM), including removing exemptions for periods of SSM. EPA is also requiring owners and operators to demonstrate compliance through the use of EtO continuous emissions monitoring systems (CEMS), with exceptions for very small users of EtO; add provisions for electronic reporting of performance test results and other reports; and include other technical revisions to improve consistency and clarity. EPA states that it estimates that these final amendments will reduce EtO emissions from this source category by approximately 21 tons per year (tpy). The final rule was effective April 5, 2024. The incorporation by reference of certain material listed in the rule is approved by the Director of the Federal Register April 5, 2024. The incorporation by reference of certain other material listed in the rule was approved by the Director of the Federal Register before February 27, 2021.
EPA Announces Final Rule To Strengthen Standards For Synthetic Organic Chemical Plants And Polymers And Resins Plants: EPA announced on April 9, 2024, a final rule that it states will significantly reduce emissions of toxic air pollution from chemical plants, “including the potent air toxics ethylene oxide (EtO) and chloroprene.” The final rule amends the New Source Performance Standards (NSPS) that apply to the Synthetic Organic Chemical Manufacturing Industry (SOCMI) and amendments 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 (P&R I and P&R II, respectively) Industries. EPA states that it is issuing final decisions resulting from its technology review of the HON and the P&R I and P&R II NESHAP, and its review of the NSPS that apply to the SOCMI. EPA is also amending 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 issuing final emission standards for EtO emissions and chloroprene emissions after considering the results of a risk assessment for the HON and for Neoprene Production processes subject to the P&R I NESHAP and is issuing a final fenceline monitoring work practice standard for certain HAP. Lastly, EPA is removing exemptions from standards for SSM periods, adding work practice standards for such periods where appropriate, issuing final standards for previously unregulated HAP, and adding provisions for electronic reporting of performance test reports and periodic reports. The final rule will be effective 60 days after publication in the Federal Register.
EPA Announces Settlement With Sasol Chemicals For Alleged Chemical Accident Prevention Violations: EPA announced on April 9, 2024, that it reached a final settlement with Sasol Chemicals (Sasol) over alleged violations of the chemical accident prevention provisions of the Clean Air Act (CAA) at the Company’s facility in Westlake, Louisiana. Under the settlement, Sasol will pay more than $1.4 million in civil penalties and correct violations related to an October 2022 fire at the facility, as well as those found during a compliance evaluation in 2021.
EPA Releases Updated Interim Guidance On Destroying And Disposing Of Certain PFAS And PFAS-Containing Materials, Will Hold 180-Day Comment Period: EPA announced on April 9, 2024, the release of an updated “Interim Guidance on the Destruction and Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances and Materials Containing Perfluoroalkyl and Polyfluoroalkyl Substances.” According to EPA, the updated guidance “reflects the latest, best available science to provide information that managers of PFAS wastes can use to evaluate the most appropriate destruction, disposal, or storage method among those currently available.” EPA notes that the guidance recommends that decision-makers “prioritize the use of technologies with the lowest potential for environmental release, to better protect people and communities from PFAS exposures.” EPA will accept comments on the updated interim guidance for 180 days following publication of a notice of availability for public comment in the Federal Register. The updated interim guidance does not establish requirements for destruction or disposal of PFAS materials. More information on the updated interim guidance will be available in a forthcoming memorandum.
EPA Releases First-Ever Drinking Water Standards For PFAS: EPA announced on April 10, 2024, the final National Primary Drinking Water Regulation (NPDWR) for six PFAS. The NPDWR establishes Maximum Contaminant Levels (MCL) for six PFAS in drinking water: PFOA, perfluorooctane sulfonic acid (PFOS), perfluorohexane sulfonic acid (PFHxS), PFNA, and hexafluoropropylene oxide dimer acid (HFPO-DA) as contaminants with individual MCLs, and PFAS mixtures containing at least two or more of PFHxS, PFNA, HFPO-DA, and perfluorobutane sulfonic acid (PFBS) using a Hazard Index (HI) MCL to account for the combined and co-occurring levels of these PFAS in drinking water. EPA also issued final health-based, non-enforceable Maximum Contaminant Level Goals (MCLG) for these PFAS. EPA’s general fact sheet states that the final rule sets the following levels:
| Chemical | MCLG | MCL |
| PFOA | 0 | 4.0 parts per trillion (ppt) |
| PFOS | 0 | 4.0 ppt |
| PFNA | 10 ppt | 10 ppt |
| PFHxS | 10 ppt | 10 ppt |
| HFPO-DA (GenX chemicals) | 10 ppt | 10 ppt |
| Mixture of two or more: PFNA, PFHxS, HFPO-DA, and PFBS | HI of 1 | HI of 1 |
The final rule will take effect 60 days after publication in the Federal Register. EPA has posted a pre-publication version of the final rule. More information will be available in a forthcoming memorandum.
PHMSA Amends HMR To Maintain Harmonization With International Standards: The Pipeline and Hazardous Materials Safety Administration (PHMSA) issued a final rule on April 10, 2024, amending the Hazardous Materials Regulations (HMR) to maintain alignment with international regulations and standards by adopting various amendments, including changes to proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, air transport quantity limitations, and vessel stowage requirements. 89 Fed. Reg. 25434. PHMSA states that it is also withdrawing the unpublished November 28, 2022, Notice of Enforcement Policy Regarding International Standards on the use of select updated international standards in complying with the HMR during the pendency of this rulemaking. The final rule will be effective May 10, 2024. The voluntary compliance date was January 1, 2023. The delayed compliance date is April 10, 2025. The incorporation by reference of certain publications listed in this rule is approved by the Director of the Federal Register on May 10, 2024.
EPA Publishes Annual U.S. GHG Inventory: EPA announced on April 11, 2024, the release of its latest annual Inventory of U.S. GHG Emissions and Sinks (GHG Inventory), which presents a national-level overview of annual GHG emissions from 1990 to 2022. According to EPA, net U.S. GHG emissions were 5,489 million metric tons of carbon dioxide equivalent in 2022, a 1.3 percent increase in emissions from 2021. EPA states that the increase is largely due to higher energy use in 2022, reflecting the continued rebound in economic activity following the height of the coronavirus pandemic. Emissions have declined 17 percent overall since 2005, however, reflecting the combined impacts of several factors, including energy market trends, technological changes including energy efficiency improvements, and the carbon intensity of energy fuel choices.
FDA
FDA Issues Import Alert For Foods Contaminated With PFAS: On March 20, 2024, the U.S. Food and Drug Administration (FDA) issued Import Alert 99-48, titled “Detention without Physical Examination of Foods Due to Chemical Contamination.” It reminds shareholders of FDA’s authority to prevent entry of food products into the United States if they are believed to be contaminated with a broad range of human-made chemicals, including benzene, dioxins, and PCBs, and PFAS, among others. FDA notes that food products found with levels of chemical contaminants that may pose a risk to human health may be subject to detention without physical examination under this Import Alert. To remove a firm/product from this Import Alert, evidence should be provided to FDA to demonstrate adequately that the firm has resolved the conditions that gave rise to the appearance of the violation, so that FDA will have confidence that future products will be in compliance. Additional information is available here.
FDA Issues Final Rule For Revoking FCN Authorizations: On March 22, 2024, FDA issued a final rule titled “Food Additives: Food Contact Substance Notification That Is No Longer Effective.” 89 Fed. Reg. 20306. The final rule identifies additional grounds for FDA to revoke food contact notification (FCN) authorizations and broadens opportunities for market participants to comment prior to a final determination. Under 21 C.F.R. Section 170.105, FDA now may only determine that an FCN is no longer effective based on safety concerns. The final rule authorizes FDA to consider additional factors such as abandonment by the FCN holder or information available to FDA that a manufacturer or supplier has stopped producing, supplying, or using a food contact substance (FCS) for the intended use. The final rule is effective on May 24, 2024.
FDA Hosts Meeting On Data And Technology: On March 25, 2024, FDA announced that it will hold a meeting on April 24, 2024, from 10:00 a.m. to 4:00 pm (EDT). The meeting, part of The New Era of Smarter Food Safety initiative, “is designed to help the agency improve its understanding of how we can leverage data and technology to exponentially advance food safety and achieve better health outcomes.” The morning session will include presentations from FDA describing the current thinking on various technological activities. The afternoon session is reserved for public comments to provide an opportunity for stakeholders to share feedback on how and where advances in data and technology can be leveraged to accelerate significantly FDA’s ability to improve public health outcomes. The April 24 public meeting is a virtual event. Registration is free and will be open through the day of the meeting. Persons interested in attending the public meeting and receiving related meeting materials in advance of the meeting must register. Registration information is available here.
FDA Announces That VQIP Portal Will Close On May 31, 2024, For FY 2025 Benefits: On March 26, 2024, FDA announced the application window for its Voluntary Qualified Importer Program (VQIP) portal for fiscal year (FY) 2025 will close on May 31, 2024. The VQIP allows importers an expedited process for importing human and animal foods and is part of the Food Safety Modernization Act (FSMA). The submission portal for the Notice of Intent to Participate in the VQIP is typically January 1 – May 31. The application process includes a user fee. More information is available here and here.
FDA Publishes Consumer Update: On April 2, 2024, FDA published a consumer update, titled “Is Food Safe if it Has Chemicals?,” on the safety of food additives and the use of chemicals in food. FDA notes that the presence of chemicals in food is not what determines whether food is safe to eat, and that FDA evaluates and monitors chemicals in regulated food to ensure they do not pose a health risk. This publication, along with other FDA campaigns, aligns its intent to be more transparent on food chemical safety.
FDA Releases Data On Testing Talc-Containing Cosmetics: On April 5, 2024, FDA announced results from its sampling assessment of talc-containing cosmetics for the presence of asbestos as required under the Modernization of Cosmetics Regulations Act of 2022 (MoCRA). More information is available in our April 9, 2024, memorandum.
FDA Announces Webinar On Food Safety Culture: On April 9, 2024, FDA announced that a webinar titled “The Journey Continues” will be held on May 9, 2024, from 5:15 p.m. to 6:30 p.m. (ET). The webinar is the last in an 11-part series titled “Collaborating on Culture in the New Era of Smarter Food Safety.” Registration information is available here.
NANOTECHNOLOGY
EC Amends Cosmetics Regulation, Prohibiting And Restricting Certain Nanomaterials: On March 15, 2024, the European Commission (EC) published in the Official Journal of the European Union an amendment to the Cosmetics Regulation. The following nanomaterials have been added to Annex II (substances prohibited in cosmetic products). From February 1, 2025, cosmetic products containing these substances shall not be placed on the European Union (EU) market. From November 1, 2025, cosmetic products containing these substances shall not be made available on the EU market:
- Styrene/Acrylates copolymer (nano) and Sodium Styrene/Acrylates copolymer (nano);
- Copper (nano) and Colloidal Copper (nano);
- Colloidal silver (nano);
- Gold (nano), Colloidal Gold (nano), Gold Thioethylamino Hyaluronic Acid (nano), and Acetyl heptapeptide-9 Colloidal gold (nano); and
- Platinum (nano), Colloidal Platinum (nano), and Acetyl tetrapeptide-17 Colloidal Platinum (nano).
The following nanomaterial has been added to Annex III (substances that are banned except under the conditions indicated). From February 1, 2025, cosmetic products containing this substance and not complying with the restrictions shall not be placed on the EU market. From November 1, 2025, cosmetic products containing that substance shall not be made available on the EU market:
- Hydroxyapatite (nano).
OECD Issues Report On First WPMN Workshop On NanoCarriers: The Organisation for Economic Co-operation and Development (OECD) published the report of the first Working Party on Manufactured Nanomaterials (WPMN) workshop on NanoCarriers. The aims of the June 14-15, 2023, workshop were to discuss NanoCarriers used in different applications (cosmetic, pharmaceutical, and agricultural) and to use OECD’s Early Awareness and Action System for Advanced Materials (Early4AdMa) to identify knowledge gaps and signals of possible concerns regarding both their safety and their sustainability. More information is available in our March 25, 2024, blog item.
NIOSH Science Blog Item Highlights 20 Years Of NTRC’s Field Studies Team: The National Institute for Occupational Safety and Health (NIOSH) published an April 1, 2024, NIOSH Science Blog item entitled “Celebrating 20 Years of Research: Highlights From NIOSH’s Nanotechnology Research Center’s Field Studies Team.” The blog item describes how the NIOSH Nanotechnology Research Center’s (NTRC) Field Studies Team evaluates advanced materials and processes in workplaces ranging from large manufacturers, research and development labs, and government facilities, to schools, libraries, and other non-industrial settings. More information is available in our April 2, 2024, blog item.
EPA Describes Future Of Its Nanotechnology Research: EPA posted a research update on April 2, 2024, entitled “Advancing Environmental Safety: Celebrating 20 years of Nanotechnology Research at EPA.” According to the item, future directions for EPA research include:
- Nanopesticides: Create an identification framework for pesticides containing carbonaceous nanomaterials; determine physical and chemical properties and transport in the environment; and determine environmental impact on watersheds;
- Nano-printers: Continue work on quantification of additive manufacturing/three-dimensional (3D) printing incidental nanoparticle emissions and realistic estimates for exposure to aerosols and volatile organic compounds;
- NaKnowBase database: Continue inclusion of novel EPA data, enhance improved data interoperability of nanomaterials environmental health and safety data with federal partners;
- Nanosensors: Detection and remediation of drinking water and air pollutants and use of nanosensors for identification of Contaminants of Immediate and Emerging Concern (CIEC), such as PFAS;
- Nanoplastics: Detection, characterization, fate, transport, and human and aquatic life toxicity; and
- Capacity building of future expertise through training students, hiring post-doctoral scientists, and supporting research grants to build the next generation of EPA researchers.
NNI Holds Webinar On Metrology Of Nanoparticles In Electronics: The National Nanotechnology Coordination Office (NNCO) is organizing a series of National Nanotechnology Initiative (NNI) webinars on nanometrology, metrological challenges, and recent advances in three topical areas: food, agriculture, and environment; nanoscale medical and pharmaceutical products; and nanoparticles in electronics. The fourth webinar in the series, Metrology of Nanoparticles in Electronics, was held April 5, 2024. The webinar covered recent advances and current challenges in the synthesis, characterization, and application of nanoparticles in electronics.
ARS Researchers Discover Ability Of Cotton Gin Waste To Transform Silver Ions Into Silver Nanoparticles: The U.S. Department of Agriculture’s (USDA) Agricultural Research Service (ARS) announced on April 9, 2024, that ARS researchers published a study revealing the ability of cotton gin waste to synthesize and generate silver nanoparticles in the presence of silver ions. Using a simple heat treatment of cotton gin waste materials in water containing silver ions, the researchers produced silver nanoparticles without needing additional chemical agents. According to ARS, a provisional patent application on the self-embedding silver nanoparticle biomass waste compositions has been filed.
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://www.lawbc.com/brand/bioblog/.
LEGISLATIVE
Bicameral Bill Would Direct DHHS To Compensate Firefighters Suffering From Injuries Or Who Have Died From PFAS-Related Conditions: On March 21, 2024, Representative Darren Soto (D-FL) and Senator Cory Booker (D-NJ) introduced legislation (H.R. 7788, S. 4013) to compensate firefighters who suffer from injuries or have died from PFAS-related conditions. According to Soto’s March 21, 2024, press release, the Firefighter PFAS Injury Compensation Act directs the U.S. Department of Health and Human Services (DHHS) to establish a program under which eligible firefighters can file a claim to seek timely, uniform, and adequate compensation. Firefighters who have served two or more years and can provide evidence of injury would be eligible to file a claim. In the case of a death related to PFAS exposure, one heir of a deceased firefighter would be eligible to submit a claim.
Bipartisan Bill Would Prohibit Federal Agencies From Purchasing Products Containing PFAS: On March 21, 2024, Representative Chris Pappas (D-NH) introduced the PFAS-Free Procurement Act (H.R. 7775) alongside Representatives Mike Lawler (R-NY) Bill Posey (R-FL), Brian Fitzpatrick (R-PA), Katie Porter (D-CA), Haley Stevens (D-MI), and Marie Gluesenkamp Perez (D-WA). Pappas’s March 21, 2024, press release states that the bipartisan legislation would prohibit federal agencies from the procurement of items containing PFOS or PFOA and prioritize the procurement of products not containing PFAS.
House Bill Would Require USDA And Farm Stakeholders To Review EPA Rules: On April 9, 2024, Representative Brad Finstad (R-MN) introduced the EPA Accountability to Farm Country Act (H.R. 7900), legislation that would require USDA and farmer stakeholders to review rules and regulations proposed by EPA that may impact the agricultural sector and provide recommendations on how to limit the impact. According to Finstad’s April 10, 2024, press release, the bill would:
- Require the Secretary of Agriculture to review any proposed rule or regulation published by EPA that may have a major economic impact on the agriculture industry or affect a substantial number of agriculture entities;
- If the proposed rule or regulation is found by the Secretary of Agriculture to have a major economic impact or effect on the agricultural sector, require the Secretary to convene a panel composed of agency officials, as well as four active producers from different geographic areas of the United States, to analyze the regulation and submit a report that describes the panel’s findings and recommendations related to how EPA can limit the impact of the rule to USDA, EPA, and the House and Senate Agriculture Committees; and
- If the EPA Administrator fails to implement the recommendations given by the panel, the rule would be unable to be issued in final.
MISCELLANEOUS
EPA Proposes Revisions To Standards For OB/OD Of Waste Explosives: On March 20, 2024, EPA proposed to revise regulations that allow for the open burning and detonation (OB/OD) of waste explosives. 89 Fed. Reg. 19952. The proposed rule states that this variance to the prohibition on the open burning of hazardous waste was established at a time when there were no alternatives for the safe treatment of waste explosives. Recent findings from the National Academy of Sciences, Engineering, and Medicine (NASEM) and EPA have identified safe alternatives that are potentially applicable to treat some energetic/explosive waste streams, however. According to the proposed rule, the revisions would reduce OB/OD of waste explosives and increase control of air emissions through improved implementation of existing requirements that facilities must evaluate and use safe and available alternative technologies in lieu of OB/OD. Comments are due May 20, 2024. 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 April 19, 2024.”
Minnesota Publishes New Information Concerning PFAS In Products: On March 26, 2024, The Minnesota Pollution Control Agency (MPCA) announced that it has published new information concerning PFAS in products. This information includes:
- Recommendations on how to dispose of products that may contain PFAS when they reach the end of their useful life; and
- Details on the types of products that will be subject to PFAS prohibitions in January 2025. At that time, Minnesota will prohibit intentionally added PFAS in products from 11 categories under Amara’s Law.
MPCA will publish details on other product categories in response to questions it has received. More information is available in our March 28, 2024, blog item.
EPA Requests Nominations Of Candidates For SAB IRIS Chloroform Review Panel: On March 29, 2024, EPA’s Science Advisory Board (SAB) requested public nominations of scientific experts to form a panel to review the draft EPA document entitled Integrated Risk Information System (IRIS) Toxicological Review of Chloroform (inhalation). 89 Fed. Reg. 22143. The draft IRIS cancer and non-cancer assessment includes a hazard identification analysis, which summarizes the available evidence on health effects that may be associated with environmental or occupational exposure, and dose-response analysis that characterizes the quantitative relationship between chloroform inhalation exposure and each credible health hazard. Nominations are due April 19, 2024.
California DPR Announces Webinar To Be Held On April 23, 2024, To Discuss Proposed Registration Fee Increase: On March 29, 2024, the California Department of Pesticide Regulation (DPR) announced it will hold a webinar on Tuesday, April 23, 2024, at 10:00 a.m. (PDT) to discuss and receive feedback from registrants and other stakeholders on its intent to increase registration fees to a level that, according to DPR, supports the current and future business needs of the pesticide registration program. For more information, please read our April 1, 2024, blog.
EPA Launches New Website To Improve Transparency In Permitting: On April 2, 2024, EPA announced the launch of a new website, epa.gov/permits, a centralized web-based platform for information about federal environmental permitting. EPA states that it highlights EPA’s permitting and environmental review programs and shares information on related statutes and environmental justice initiatives. In support of EPA’s commitments under Title 41 of the Fixing America’s Surface Transportation Act (FAST-41), it also displays the status of EPA permits for large scale infrastructure projects covered by this statute. EPA notes that the website is a resource for the public, permit applicants, and federal agency partners.
Biden-Harris Administration Announces Action To Cut PFAS From U.S. Government Custodial Contracts: EPA announced on April 8, 2024, that it is directing government contractors to purchase cleaning products for federal buildings that are free of PFAS. This change is the result of a collaboration between EPA and the U.S. General Services Administration (GSA) to implement President Biden’s Federal Sustainability Plan, which directs federal agencies to prioritize the purchase of sustainable products and services, including products without added PFAS. The change is reflected in GSA’s custodial specification. Contractors will be required to use products certified to ecolabels such as EPA’s Safer Choice that meet strict criteria for human health and the environment by using effective, safer chemical alternatives, as well as certain Green Seal® certifications. More information is available in our April 12, 2024, blog item.
OIRA Completes Review Of Final Rule Updating The HCS: On April 8, 2024, OMB’s Office of Information and Regulatory Affairs (OIRA) completed its review of a final rule that would amend the Hazard Communication Standard (HCS). As reported in our February 16, 2021, memorandum, on February 16, 2021, the U.S. Occupational Safety and Health Administration (OSHA) published a proposed rule that would amend the HCS, the federal-level regulation that sets forth the classification, labeling, Safety Data Sheet (SDS), and training requirements for hazardous chemicals intended to be used, handled, or stored in workplaces. The current HCS is based on the third revised edition (Rev 3) of the United Nations (UN) Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The proposed changes included updating the HCS to align with the seventh revised edition (Rev 7) of GHS. The transition period proposed was one year for chemical manufacturers, importers, and distributors of substances and two years for chemical manufacturers, importers, and distributors of mixtures after the effective final rule is published. The final rule is not yet publicly available.
FRA Establishes Train Crew Size Safety Requirements: The U.S. Department of Transportation’s (DOT) Federal Railroad Administration (FRA) published a final rule on April 9, 2024, establishing minimum safety requirements for the size of train crews depending on the type of operation. 89 Fed. Reg. 25052. FRA states that the final rule requires railroad operations to have a minimum of two crewmembers except for certain identified one-person train crew operations that do not pose significant safety risks to railroad employees, the public, or the environment. The final rule includes requirements for railroads seeking to continue certain existing one-person train crew operations and a special approval process for railroads seeking to initiate certain new one-person train crew operations. The final rule also requires each railroad receiving special approval for a one-person train crew operation to submit to FRA an annual report summarizing the safety of the operation. The final rule will be effective June 10, 2024.
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