TSCA/FIFRA/TRI

EPA Publishes Final SNURs On Certain Chemical Substances: The U.S. Environmental Protection Agency (EPA) published final significant new use rules (SNUR) on December 18, 2023, for certain chemical substances that were the subject of premanufacture notices (PMN) and are also subject to an Order issued by EPA pursuant to the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 87346. 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 to notify EPA at least 90 days before commencing that activity. Persons may not commence manufacture or processing for the significant new use until they have submitted a Significant New Use Notice (SNUN), and EPA has conducted a review of the SNUN, made an appropriate determination, and has taken such actions as are required by that determination. The final SNURs will be effective February 16, 2024.

EPA Begins TSCA Prioritization Process For Five Chemicals, Requires Reporting On MBOCA: EPA announced on December 18, 2023, that it is beginning the process to prioritize five additional toxic chemicals for risk evaluation under TSCA. 88 Fed. Reg. 87423. The chemicals are acetaldehyde, acrylonitrile, benzenamine, 4,4′-methylene bis(2-chloroaniline) (MBOCA), and vinyl chloride. EPA seeks relevant information, including, but not limited to, the chemical substance’s hazard and exposure potential; the chemical substance’s persistence and bioaccumulation; potentially exposed or susceptible subpopulations relevant to the prioritization; whether there is any storage of the chemical substance near significant sources of drinking water; the chemical substance’s conditions of use or significant changes in conditions of use, including information regarding trade names; the chemical substance’s production volume or significant changes in production volume; and any other information relevant to the potential risks of the chemical substance that might be relevant to the designation of the chemical substance’s priority for risk evaluation. Comments are due March 18, 2024. EPA has opened a chemical-specific docket for each of the five chemicals. On December 26, 2023, EPA required manufacturers (including importers) and processors of MBOCA to submit the records and reports of allegations that this chemical substance causes significant adverse reactions to health or the environment that they are required to maintain and submit to EPA when requested under TSCA. 88 Fed. Reg. 88915. Records are due February 26, 2024. More information is available in our December 27, 2023, memorandum.

EPA Registers Novel Pesticide Technology For Potato Crops: EPA announced on December 22, 2023, that it has registered biopesticide products containing the new active ingredient Ledprona for three years, “a timeframe that is consistent with EPA’s approach to other novel biopesticide products.” Ledprona is a new type of pesticide that relies on a natural mechanism, RNA interference (RNAi), used by plants and insects to protect against disease. EPA notes that this pesticide is “the first sprayable dsRNA pesticide in the world allowed to be used commercially and sprayed on plants.” More information is available in our December 29, 2023, blog item.

EPA Releases 2023 Mercury Inventory Report: On December 26, 2023, EPA announced the availability of the 2023 mercury inventory report. 88 Fed. Reg. 88915. EPA states in its December 21, 2023, press release that the inventory report presents aggregated data from 2021 submitted on imported mercury, mercury manufactured in the United States, imported mercury-added products, mercury-added products made in the United States, and mercury used in manufacturing processes. The inventory report also provides a broad view of U.S. mercury stored, sold, and exported, as well as industry sectors and countries involved in the supply, use, and trade of mercury.

EPA Seeks Nominations Of Ad Hoc Peer Reviewers For Formaldehyde: EPA requested on December 26, 2023, 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 Agency’s evaluation of the risks from formaldehyde being conducted to inform risk management decisions under TSCA and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) programs. 88 Fed. Reg. 88910. EPA states that it expects to ask SACC to consider and review the Office of Pollution, Prevention, and Toxics (OPPT) and the Office of Pesticide Programs (OPP) joint hazard assessments for human and ecological health; and the OPPT exposure and risk characterizations. EPA notes that this SACC peer review is in addition to prior external peer reviews by the National Academies of Science, Engineering, and Medicine (NASEM), EPA’s Human Studies Review Board (HSRB), and SACC. Nominations are due January 25, 2024.

EPA Releases Peer Review Comments On White Paper For Asbestos Part 2 Risk Evaluation: On December 28, 2023, EPA released comments from the letter peer review for its 2023 white paper presenting EPA’s quantitative approach for the human health risk assessment for part 2 of the TSCA risk evaluation for asbestos. According to EPA, the peer review comments will help shape its asbestos part 2 risk evaluation, which the Agency plans to release for public comment in early 2024. More information is available in our January 5, 2024, blog item.

WDOE Petitions EPA To Eliminate Current Allowances For PCBs In Consumer Products: On January 4, 2024, the Washington Department of Ecology (WDOE) submitted a petition to EPA under TSCA Section 21 seeking a rulemaking to eliminate the current allowances for polychlorinated biphenyls (PCB) in consumer products. WDOE states that its research found that when PCBs are found in consumer products, “they are byproducts known to be associated with pigments, paints, or inks used in the manufacturing process.” According to WDOE, “[t]hese inadvertent PCBs currently allowed under TSCA directly expose people and contribute to PCB contamination in the environment.” Under TSCA Section 21, EPA must either grant or deny the petition within 90 days of receipt of the petition. EPA’s response is due April 3, 2024.

EPA Releases Decision Framework To Assess Eye Irritation Or Corrosion In New Chemicals: EPA released on January 8, 2024, a decision framework for identifying eye irritation or corrosion hazards for new chemicals reviewed under TSCA. 89 Fed. Reg. 1093. EPA states that the “New Chemicals Program Decision Framework for Hazard Identification of Eye Irritation and Corrosion” provides a decision framework for use by OPPT’s New Chemicals Division (NCD) to identify eye irritation or corrosion hazards for new chemical substances based on prioritization of reproducible, human-relevant data. EPA notes that the framework supports its mandate under TSCA to promote the development and implementation of New Approach Methodologies (NAM) to reduce, refine, or replace vertebrate animal testing and provide information of equivalent or better scientific quality and relevance for assessing risks of injury to health or the environment. More information is available in our January 9, 2024, memorandum.

EPA Announces Automatic Addition Of Seven Additional PFAS To TRI List Of Chemicals: EPA announced on January 9, 2024, the automatic addition of seven per- and polyfluoroalkyl substances (PFAS) to the list of chemicals covered by the Toxics Release Inventory (TRI). Six PFAS were automatically added for Reporting Year 2024 due to EPA having adopted a final toxicity value during 2023. EPA notes that only these particular salt forms of the acids are added to the list:

• Ammonium perfluorohexanoate; Chemical Abstracts Service Registry Number^® (CAS RN^®) 21615-47-4;

• Lithium bis[(trifluoromethyl)sulfonyl] azanide; CAS RN 90076-65-6;

• Perfluorohexanoic acid (PFHxA); CAS RN 307-24-4;

• Perfluoropropanoic acid (PFPrA); CAS RN 422-64-0;

• Sodium perfluorohexanoate; CAS RN 2923-26-4; and

• 1,1,1-Trifluoro-N-[(trifluoromethyl)sulfonyl] methanesulfonamide; CAS RN 82113-65-3.

Under Section 7321(e) of the Fiscal Year (FY) 2020 National Defense Authorization Act (NDAA), EPA must review confidential business information (CBI) claims before adding a PFAS to the TRI list if the chemical identity is subject to a claim of protection from disclosure. EPA states that it previously identified one PFAS for addition to the TRI list based on the NDAA’s provision to include specific PFAS upon the NDAA’s enactment. Due to CBI claims related to its identity, EPA did not add the PFAS to the TRI list at that time, however. The identity of this chemical was subsequently declassified in an update to the TSCA Chemical Substance Inventory (TSCA Inventory) in February 2023. Because its identity is no longer confidential, EPA added the following chemical to the TRI list:

• Betaines, dimethyl(.gamma.-.omega.-perfluoro-.gamma.-hydro-C8-18-alkyl); CAS RN 2816091-53-7.

Reporting forms will be due by July 1, 2025.

EPA Issues Final SNUR To Prevent Inactive PFAS From Reentering Commerce: On January 11, 2024, EPA issued a final SNUR to prevent companies from starting or resuming the manufacture (including import) or processing of 329 PFAS that are designated as inactive on the TSCA Inventory. 89 Fed. Reg. 1822. The final rule notes that persons subject to the final SNUR are required to notify EPA at least 90 days before commencing any manufacture (including import) or processing of the chemical substance for a significant new use. Once EPA receives a SNUN, EPA must review and make an affirmative determination on the SNUN and take such action as is required by any such determination before the manufacture (including import) or processing for the significant new use can commence. EPA states that such a review “will assess whether the new use may present unreasonable risk to health or the environment and ensure that EPA takes appropriate action as required to protect health or the environment.” The SNUR will take effect March 11, 2024. More information is available in our January 12, 2024, memorandum.

EPA Announces 2024 Annual Pesticide Maintenance Fee Forms Available To Download From EPA Website — Deadline For Paying Is January 16, 2024: FIFRA Section 4(i)(1)(A) requires everyone who holds an active or suspended pesticide registration granted under FIFRA Sections 3 and 24(c) (special local needs) to pay an annual maintenance fee to keep the registration in effect. The maintenance fee requirement does not apply to supplemental distributor registrations, which are identified by a three-element registration number. The instructions, maintenance fee filing form, fee tables, and product listings grouped by company numbers are available to download on EPA’s website. When completed, the filing submission should be e-mailed to maintfee@epa.gov. A paper copy should not be sent to EPA. The fee for 2024 is $4,875 for each registration, the same amount as for FY 2023, up to the maximum fees that can be assessed to a single registrant. Each registrant of a pesticide must pay the annual fee and e-mail the response to EPA by Tuesday, January 16, 2024. Registrations for which the fee is not paid will be canceled, by order and without a hearing. As in years past, payment must be made electronically online at www.pay.gov. More information is available in our January 9, 2024, blog item.

Registration Open For January 18, 2024, Webinar On CDR Tool Preview And Testing Informational Webinar: EPA will hold a webinar on January 18, 2024, from 2:00 p.m. to 4:00 p.m. (EST) for an informational webinar to preview the 2024 Chemical Data Reporting (CDR) tool and learn how to sign up for and participate in the testing period before the tool is formally launched. Under the CDR rule, manufacturers (including importers) of chemicals listed on the TSCA Inventory that meet specific production volume thresholds, generally 25,000 pounds or more at any single site, must report information on the manufacture (including import), processing, and use of those chemicals. Information reported in 2024 will cover activities from 2020 to 2023, with a submission period of June 1 through September 30, 2024. Registration is open. More information is available in our January 10, 2024, blog item.

EPA Will Hold Webinar On PFAS Reporting Requirements On January 25, 2024: EPA will hold a webinar on January 25, 2024, on its October 2023 PFAS reporting rule under TSCA Section 8(a)(7). The rule is a statutory requirement under the FY 2020 NDAA that requires all manufacturers (including importers) of PFAS and PFAS-containing articles in any year since 2011 to report information related to chemical identity, uses, volumes made and processed, byproducts, environmental and health effects, worker exposure, and disposal to EPA. EPA encourages attendees to submit questions in advance to soliman.sarah@epa.gov no later than January 18, 2024. Registration is open. More information on the reporting rule is available in our October 3, 2023, memorandum.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA Extends Deadline To Install Certain New Residential And Light Commercial Air Conditioning And Heat Pump Systems: On December 26, 2023, EPA amended a provision of the Technology Transitions Program under the American Innovation and Manufacturing Act (AIM Act). 88 Fed. Reg. 88825. EPA states that this action allows one additional year, until January 1, 2026, solely for the installation of new residential and light commercial air conditioning and heat pump systems using components manufactured or imported prior to January 1, 2025. According to EPA, the existing January 1, 2025, compliance date for the installation of certain residential and light commercial air conditioning and heat pump systems may result in significant stranded inventory that was intended for new residential construction. EPA is promulgating this action to mitigate the potential for significant stranded inventory in this subsector. In addition, EPA notes that it is clarifying that residential ice makers are not included in the household refrigerator and freezer subsector under the Technology Transitions Rule and are not subject to the restrictions for that subsector. EPA requests comment on all aspects of the rule. The interim final rule was effective December 26, 2023. Comments are due February 9, 2024.

EPA Proposes To Clarify Scope Of “Applicable Requirements” Under State And Federal Operating Permit Programs: EPA proposed on January 9, 2024, to update its Title V operating permit program regulations to reflect more clearly EPA’s existing interpretations and policies concerning when and whether “applicable requirements” established in other Clean Air Act (CAA) programs should be reviewed, modified, and/or implemented through the Title V operating permits program. 89 Fed. Reg. 1150. Specifically, according to EPA, this action clarifies the limited situations in which requirements under the New Source Review (NSR) preconstruction permitting program would be reviewed using EPA’s “unique title V oversight authorities.” Additionally, the proposed rule clarifies that requirements related to an owner or operator’s general duty to prevent accidental releases of hazardous substances are not “applicable requirements” for Title V purposes and are not implemented through Title V. Comments are due March 11, 2024.

EPA Will Propose Waste Emissions Charge For Petroleum And Natural Gas Systems: On January 12, 2024, EPA announced that it will propose a regulation to implement the requirements of the CAA as specified in the Methane Emissions Reduction Program of the Inflation Reduction Act. According to the prepublication version of the proposed rule, this program requires EPA to impose and collect an annual charge on methane emissions that exceed specified waste emissions thresholds from an owner or operator of an applicable facility that reports more than 25,000 metric tons of carbon dioxide equivalent of greenhouse gases (GHG) emitted per year pursuant to the petroleum and natural gas systems source category requirements of the GHG Reporting Rule. EPA states that the proposal would implement calculation procedures, flexibilities, and exemptions related to the waste emissions charge and proposes to establish confidentiality determinations for data elements included in waste emissions charge filings. Publication of the proposed rule in the Federal Register will begin a 45-day comment period.

FDA

FDA Advances Reorganization Proposal: On December 13, 2023, the U.S. Food and Drug Administration (FDA) announced that the efforts to reorganize and create a unified Human Foods Program (HFP) and new Office of Regulatory Affairs (ORA) model is now under review at the U.S. Department of Health and Human Services (HHS), starting the formal external review process. FDA proposes implementation in calendar year 2024 to shift food and field work, combine compliance processes, establish an Office of the Chief Medical Officer (OCMO), strengthening science and preparedness by proposing a combined new Office of Regulatory and Emerging Science, and creating an Office of Enterprise Transformation. Formal implementation will occur after review by the Office of Management and Budget (OMB), Congressional notification, union negotiations, and publication of a formal Federal Register notice.

FDA Opens FSMA Voluntary Qualified Importer Program Portal: On December 13, 2023, FDA confirmed that the Voluntary Qualified Importer Program (VQIP) application portal for fiscal year 2025 would be opened on January 1, 2024. The VQIP, a component of the Food Safety Modernization Act (FSMA), is a voluntary fee-based program that allows for expedited review and importation of human and animal foods into the United States provided that importers meet certain requirements. Additional information is available at the link here.

FDA Revokes Listings For Partially Hydrogenated Oils: On December 14, 2023, FDA confirmed an effective date of December 22, 2023, for a rule that revokes the generally recognized as safe (GRAS) status for partially hydrogenated oils (PHO) in food. 88 Fed. Reg. 86580. The direct final rule also revokes “prior sanctions (i.e., pre-1958 authorization of certain uses) for the use of PHOs in margarine, shortening, and bread, rolls, and buns” based on FDA’s conclusion that these uses of PHOs may be injurious to health. Confirmation of the effective date follows FDA’s rule issued on August 9, 2023. 88 Fed. Reg. 53764.

FDA Issues Updates To Instructions For Serious Adverse Event Reporting Requirement For Cosmetics: On December 14, 2023, FDA issued updates to the instructions for serious adverse event reporting under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

A responsible person is required to report serious adverse events associated with the use of cosmetic products in the United States to FDA within 15 business days. The responsible person must include a copy of the label on or within the retail packaging of such cosmetic product. If the responsible person receives medical or other information about the adverse event within 1 year of the initial report to FDA, they must submit this new information to FDA within 15 business days.

FDA defines the terms “responsible person, and “serious adverse event” at the link here. Serious adverse event reporting requirements, set forth in MoCRA, are enforceable by FDA as of December 29, 2023, but FDA does not intend to enforce these requirements until July 1, 2024.

FDA Issues Final Guidance On Registration And Listing Of Cosmetic Products And Facilities: On December 18, 2023, FDA issued its final guidance for industry on cosmetic product facility registrations and product listings as required under MoCRA. FDA notes that the “… guidance provides recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA,” and includes a frequently asked questions and answer Appendix where FDA notes it is “… being distributed for comment purposes only.” Comments on the final guidance must be submitted by January 18, 2024. The product listing and facility registration requirement entered into force December 29, 2023, but FDA does not intend to enforce these requirements until July 1, 2024.

FDA Launches Cosmetics Direct: On December 18, 2023, FDA announced the launch of its electronic submissions portal, Cosmetics Direct, for cosmetic product listing and facility registration. FDA states that the portal uses the Structured Product Labeling (SPL) authoring tool and contains “… user friendly data entry forms [that perform] initial validations, creates and saves the SPL submission, and submits the SPL to FDA for internal processing without having to use the Electronic Submissions Gateway (ESG).” FDA provides a User’s Guide for additional assistance for those who are not familiar with the SPL authoring tool.

FDA Seeking Comments For Guidance: On January 3, 2024, FDA announced the availability of a draft document named “Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance,” which identifies FDA’s current best practices for the efficient prioritization, development, issuance, and use of guidance documents. 89 Fed. Reg. 380. A copy of the draft document is available at the link here. FDA is accepting comments until March 4, 2024.

FDA Releases Tools And Forms For MoCRA: On January 8, 2024, FDA announced the availability of SPL Xforms, a tool for cosmetic product facility registration and cosmetic product listing mandated by MoCRA. FDA also announced the availability of the paper forms Form FDA 5066 and Form FDA 5067, which are available at the link here. FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the Agency, but electronic submission is not required. FDA does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024.

EDF Files Petition To Remove Solvents From FDA Regulations: On January 10, 2024, FDA announced that the Environmental Defense Fund (EDF), with other parties, filed petitions requesting that FDA amend their food contact regulations to remove certain solvents currently authorized for food contact applications. Specifically, EDF requested that the solvents ethylene dichloride, methylene chloride, and trichloroethylene no longer be permitted for use in color additive applications (21 C.F.R. §§ 73.1, 73.30, 73.345, 73.615), and that benzene, ethylene dichloride, methylene chloride, and trichloroethylene no longer be permitted in food additive applications (21 C.F.R. §§ 172.560, 172.710, 173.230, 173.255, 173.290, and 173.315). Additional information is available at the links here and here.

NANOTECHNOLOGY

NNI Publishes Economic Impact Analysis Of 20 Years Of Nanotechnology Investments: On December 5, 2023, the National Nanotechnology Initiative (NNI) released a report analyzing the economic impact of federal investment in nanotechnology from 2002 to 2022. The report examines the impact of public investment, growth and trends of the market, and the evolving understanding and application of nanotechnology in the United States. It also provides key data for evaluating NNI’s ability to fulfill its mission and illustrates NNI’s successes to date. More information is available in our December 27, 2023, blog item.

EPA Issues Final SNURs For Four Multi-Walled Carbon Nanotubes: On December 18, 2023, EPA issued final SNURs under TSCA for a number of chemical substances that were the subject of PMNs and are also subject to Orders issued by EPA pursuant to TSCA. 88 Fed. Reg. 87346. The SNURs include four chemical substances identified as:

• Multi-walled carbon nanotubes (MWCNT); closed; 4.4-12.8 nanometer (nm) diameter; bundle length 10.6-211.1 micrometer (µm); Grade: Jenotube 6 (PMN P-20-62);

• MWCNTs; closed; 5.1-11.6 nm diameter; bundle length 1.9-552.0 µm; Grade: Jenotube 8 (PMN P-20-63);

• MWCNTs; closed; 7.9-14.2 nm diameter; bundle length 9.4-106.4 µm; Grade: Jenotube 10 (PMN P-20-64); and

• MWCNTs; closed; 17.0-34.7 nm diameter; globular shape; Grade: Jenotube 20 (PMN P-20-65).

The final SNURs will be effective February 16, 2024. After that date, persons who intend to manufacture (including import) or process any of these MWCNTs for an activity that is designated as a significant new use by the SNURs must notify EPA at least 90 days before commencing that activity. More information is available in our December 28, 2023, blog item.

NIOSH Reviews Past Nanotechnology Guidance And Needs For Future Research: On January 3, 2023, the National Institute for Occupational Safety and Health (NIOSH) posted a NIOSH Science Blog item entitled “Looking to the Past and the Future of NIOSH Nanotechnology Guidance.” As the NIOSH Nanotechnology Research Center (NTRC) celebrates its 20th anniversary, it is looking back over two decades of published guidance to help reduce worker exposures to engineered nanomaterials and discussing the needs for future research efforts. According to the blog item, NIOSH continues to seek feedback from the advanced manufacturing industry and provide guidance. Stakeholders can submit suggestions about guidance or research needs to nano@cdc.gov. More information is available in our January 3, 2024, blog item.

Malta Initiative Survey On OECD Test Guidelines And Guidance Documents Closed January 12: The Malta Initiative conducted a survey to collect input on priorities where the Organization for Economic Cooperation and Development (OECD) Test Guidelines (TG) and Guidance Documents (GD) need actions to make them applicable to nanomaterials and other advanced materials. The survey included a preliminary list of suggested topics. The survey closed January 12, 2024.

Nano4EARTH Will Hold Roundtable Discussion On Catalysts On January 24, 2024: Nano4EARTH will hold a roundtable discussion on January 24, 2024, on nanotechnology-enabled catalysts that could help achieve climate goals. The discussion aims to identify fundamental knowledge gaps, needs, and opportunities to advance current climate mitigation goals through the use of nanocatalysts in industrial processes. In-person and virtual registration is open. More information is available in our January 10, 2024, blog item.

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

Bipartisan PFAS Action Act Introduced In The House: On December 14, 2023, Representative Debbie Dingell (D-MI) introduced the PFAS Action Act of 2023 (H.R. 6805), “comprehensive, bipartisan legislation [that would] protect Americans and the environment from harmful forever chemicals known as” PFAS. According to Dingell’s December 14, 2023, press release, the bill would:

• Require EPA to establish a national drinking water standard for perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), and four other PFAS chemicals that protects public health, including the health of vulnerable subpopulations. The press release notes that this provision aligns with EPA’s recent national drinking water standard proposal;

• Accelerate designation of PFOA and PFOS chemicals as hazardous substances and require EPA to determine whether to list other PFAS within five years. According to the press release, the bill reaffirms that “EPA has existing authority to use their discretion regarding liability under CERCLA and rejects liability exemptions for specific industries in line with the introduced bill last Congress”;

• Designate PFOA and PFOS as hazardous air pollutants within 180 days and require EPA to determine whether to list other PFAS within five years;

• Require EPA to place discharge limits on industrial releases of PFAS and provide $200 million annually for wastewater treatment;

• Prohibit unsafe incineration of PFAS wastes and place a moratorium on the introduction of new PFAS into commerce;

• Require comprehensive PFAS health testing;

• Create a voluntary label for PFAS in cookware;

• Assist schools and childcare facilities with addressing PFAS contamination in drinking water; and

• Require manufacturers to provide reference standards for PFAS to help EPA accurately identify and act faster to mitigate the impact of “dangerous forever chemicals.”

PFAS Risk-Communication Strategy Act Introduced In The House: Representative Lizzie Fletcher (D-TX) introduced the PFAS Risk-Communication Strategy Act (H.R. 6808) in the House on December 14, 2023. According to Fletcher’s December 14, 2023, press release, the bill would require EPA to:

• Disseminate information about the risk of PFAS in products, land, air, and water;

• Notify the public about exposure pathways and mitigation measures through outreach and educational resources; and

• Consult with states that have demonstrated effective risk-communication strategies for best practices in developing a national risk-communication strategy.

House Passes Stop Settlement Slush Funds Act Of 2023: On January 11, 2023, the House passed the Stop Settlement Slush Funds Act of 2023 (H.R. 788) by a vote of 211 to 197. The bill would prohibit the federal government from entering into or enforcing a settlement agreement on behalf of the United States that provides for a payment to any person or entity other than the United States. The bill provides exceptions to allow payments that remedy actual harm (including to the environment) caused by the party making the payment or that constitute a payment for services rendered in connection with the case. On January 8, 2024, the White House issued a Statement of Administration Policy opposing passage of the bill, stating that “the legislation is unnecessary and would harm the public interest.” According to the Statement of Administration Policy, the bill “would have adverse effects on the Federal government’s ability to enforce key laws protecting the public, including criminal, bankruptcy, environmental, and civil rights laws such as the Fair Housing Act and the Servicemembers’ Civil Relief Act.”

MISCELLANEOUS

Minnesota Requests Comments On Planned Rules For MPCA’s Determination Of Currently Unavoidable Uses Of PFAS In Products: The Minnesota Pollution Control Agency (MPCA) has published a request for comments (RFC) on planned new rules governing currently unavoidable use (CUU) determinations for products containing PFAS. According to the RFC, the main purpose of the rulemaking is to establish criteria and processes through which MPCA will make decisions on what uses of intentionally added PFAS will qualify as CUUs in products sold, offered for sale, or distributed in Minnesota. Any such determinations must be published by rule by MPCA by January 1, 2032. Comments are due 4:30 p.m. (CST) on March 1, 2024. More information is available in our January 12, 2024, blog item.

Postal Service^TM Proposes New Mailing Standards For Hazardous Materials Outer Packaging And Nonregulated Toxic Materials: The U.S. Postal Service (Postal Service) published a proposed rule on December 15, 2023, that would amend Publication 52, Hazardous, Restricted, and Perishable Mail (Pub 52), by requiring specific outer packaging strength standards when mailing hazardous materials (HAZMAT) or dangerous goods (DG) and remove quantity restrictions for nonregulated toxic materials. 88 Fed. Reg. 86868. The Postal Service proposes to allow mailers to use poly or padded bags as outer packaging for shipments containing lithium batteries installed in the equipment they operate if the shipment does not display hazardous text, markings, or labels as permitted in Pub 52 Sections 349 and 622. Comments are due January 16, 2024. More information is available in our December 27, 2023, blog item.

EPA FY 2023 Enforcement Results Show “Significant Increase” In Enforcement Activity: On December 18, 2023, EPA announced its FY 2023 Enforcement and Compliance Annual Results, showing “significant increases in on-site inspections, new criminal investigations, civil settlements, and cleanup enforcement, as well as record levels of enforcement activity in environmental justice [(EJ)] communities long scarred by pollution.” EPA’s highlights include:

• Conducted more on-site inspections in FY 2023 than since before the pandemic, with 60 percent in communities with EJ concerns;

• Opened 199 criminal investigations in FY 2023, an increase of 70 percent over FY 2022. Concluded 1,789 civil settlements, over 150 more than in FY 2022. Over 55 percent of the cases address facilities in communities with potential EJ concerns, the highest percentage since FY 2014;

• EPA’s FY 2023 enforcement and compliance work resulted in the reduction, treatment, elimination, or minimization of 1.84 billion pounds of pollutants and required violators to pay over $704 million in penalties, fines, and restitution, a 57 percent increase over FY 2022;

• Obtained approximately $1.1 billion from Superfund cleanup and cost recovery settlement agreements and recovery of past and future costs;

• Issued 203 Safe Drinking Water Act (SDWA) orders to public water systems that collectively protected more than 1.9 million people. Eight of the 203 orders were emergency orders to protect almost 2,000 individuals in small, overburdened communities with drinking water that did not meet federal health standards; and

• Conducted 160 on-site inspections at public water systems (PWS) in FY 2023, which is 90 percent more than the prior ten-year average. The resulting 150 cases to correct PWS violations in FY 2023 is an increase of more than 300 percent over the prior ten-year average. 

OIRA Issues Guidance To Increase Public Engagement In Regulatory Review Process:OMB’s Office of Information and Regulatory Affairs (OIRA) announced on December 20, 2023, that it issued final guidance on revisions to its policies and practices regarding meetings with OIRA while regulations are under review (Executive Order 12866 meetings). These meetings offer an opportunity for individuals to provide OIRA with information that may be relevant for the regulatory review process. The guidance describes steps that OIRA is taking to encourage feedback from a broad array of stakeholders through these meetings, including making it easier to request meetings through OIRA’s online portal; providing plain language information to help individuals prepare for these meetings; posting a video how-to guide for how to request meetings (Español); and offering periodic and accessible public trainings on effective participation in these meetings.

GSA Proposes To Amend GSAR To Reduce Single-Use Plastic Packaging: The General Services Administration (GSA) proposed on December 26, 2023, to amend the General Services Administration Acquisition Regulation (GSAR) to add a new provision and clause to identify single-use plastic free (SUP-free) packaging availability for products under the Federal Supply Schedules with the goal of reducing single-use plastic packaging. 88 Fed. Reg. 88856. Comments are due February 26, 2024.

EPA Adjusts Civil Monetary Penalty Amounts: On December 27, 2023, EPA promulgated a final rule to adjust the level of the maximum (and minimum) statutory civil monetary penalty amounts under the statutes EPA administers. 88 Fed. Reg. 89309. EPA states that this action is mandated by the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended through the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act). The 2015 Act prescribes a formula for annually adjusting the statutory maximum (and minimum) amount of civil monetary penalties to reflect inflation, maintain the deterrent effect of statutory civil monetary penalties, and promote compliance with the law. EPA notes that the rule does not establish specific civil monetary penalty amounts EPA may seek in particular cases. EPA calculates those amounts, as appropriate, “based on the facts of particular cases and applicable agency penalty policies.” The final rule was effective December 27, 2023.

EPA Begins Public Comment Period On BMD Model Code And BMD Modeling Output Files For Draft IRIS Toxicological Review Of Inorganic Arsenic: On December 29, 2023, EPA announced a public comment period on the benchmark dose (BMD) model code and BMD modeling output files associated with the draft Integrated Risk Information System Information (IRIS) toxicological review of inorganic arsenic. 88 Fed. Reg. 90182. EPA notes that the public comment period on the draft IRIS inorganic arsenic assessment closed on December 15, 2023. EPA states that after reviewing the comments received on the draft assessment, it is opening an additional public comment period on the BMD model code and the BMD modeling output files that were not accessible by the public during the original comment period due to a technical issue. For submissions received during this public comment period, EPA will only address comments on the BMD model code and BMD modeling output files. Comments are due January 16, 2024. EPA’s Science Advisory Board (SAB) Inorganic Arsenic Review Panel is peer-reviewing EPA’s draft IRIS assessment. It held its first meeting on January 5, 2024, and will hold its second meeting January 24-26, 2024. 88 Fed. Reg. 87765.

OECD Publishes Draft Report On PFAS And Alternatives In Coatings, Paints, And Varnishes: OECD has published a draft report entitled Draft Report on Per- and Polyfluoroalkyl Substances and Alternatives in Coatings, Paints and Varnishes (CPVs): Hazard Profile. OECD intends the draft report to complement its 2022 report, Per- and Polyfluoroalkyl Substances and Alternatives in Coatings, Paints and Varnishes (CPVs), by compiling information on the hazard profile of the fluoropolymers, short-chain PFAS, and non-fluorinated substances identified in terms of hazard classifications from authorities and industry and available assessments from authorities on persistence, bioaccumulation, and environmental and health hazards. OECD conducted the main search for this report from January to July 2022, and it revised the report based on feedback from stakeholders during January to March 2023. More information is available in our January 3, 2024, blog item.

New Paper And Interactive Tool Highlight Impact Of NTP’s RoC: The January 2024 National Institute of Environmental Health Sciences (NIEHS) Environmental Factor includes an item entitled “New paper, interactive tool show research influences public health policies.” According to the item, a December 2023 paper published in Environmental Health Perspectives, “An Approach to Assessing the Influence of Environmental and Occupational Cancer Hazard Identification on Policy Decision-Making,” and an interactive tool demonstrate the impact of the National Toxicology Program’s (NTP) Report on Carcinogens (RoC) on public health policies.

MDEP Begins Accepting Requests For Proposed CUUs Of PFAS: The Maine Department of Environmental Protection (MDEP) is accepting requests for proposals from those seeking CUU determinations. Products or product components with approved instances of CUU will be exempt from the 2030 sales prohibition. Manufacturers may submit proposals individually or collectively. MDEP notes that these determinations will be for uses of PFAS in products within specific industrial sectors and that a separate proposal must be submitted for each individual product category. Proposals are due March 1, 2024, and should be submitted to PFASProducts@maine.gov. More information is available in our January 9, 2024, blog item.

DOI Proposes To Revise Type A Procedures For Natural Resource Damages For Hazardous Substances: The Office of Restoration and Damage Assessment of the U.S. Department of the Interior (DOI) announced on January 5, 2024, that it seeks comments and suggestions from state, Tribal, and federal natural resource co-trustees, other affected parties, and the interested public on revising the simplified Type A procedures in the regulations for conducting natural resource damage assessment and restoration for hazardous substance releases. 89 Fed. Reg. 733. The proposed rule would re-formulate the Type A Rule as a procedural structure for negotiated settlements by using tools tailored to incidents of smaller scale and scope. According to the notice, DOI “believe[s] that this aligns better with the original statutory purpose of providing a streamlined and simplified assessment process as a companion to the more complex Type B Rule — to reduce transaction costs and expedite restoration in a broader range of less complex and contentious cases.” The objective is to formalize beneficial practices that have evolved since the 1997 promulgation of the Type A Rule. Specifically, according to the notice, trustees have used well-established methodologies such as habitat equivalency analysis, resource equivalency analysis, and other relatively simple models to assess natural resource injury in smaller incidents that do not necessarily warrant the more prescriptive Type B procedures. Comments are due March 5, 2024.

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