AFS Presents Antimicrobial Resistance Session At IBA Annual Conference: On October 31, 2023, the Agriculture and Food Section (AFS) of the International Bar Association (IBA) presented a panel discussion at the IBA 2023 Annual Conference in Paris, France, on antimicrobial resistance (AMR) regulation in the context of one health: how legislation can help reduce AMR. Read more about the session here.

EPA Seeks Public Comment On Whether To Limit The Scope Of The Treated Article Exemption: The U.S. Environmental Protection Agency (EPA) published an advanced notice of proposed rulemaking (ANPRM) on October 12, 2023, soliciting public comment and suggestions on specific issues related to seed treated with conventional pesticides (treated seed) and paint treated with conventional or antimicrobial pesticides (treated paint). 88 Fed. Reg. 70625. According to the ANPRM, EPA is considering whether a rule under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to regulate certain use of treated seed and treated paint products or other administrative action is appropriate considering questions raised by stakeholders. EPA notes in its October 12, 2023, press release that treated seed and treated paint are currently exempt from FIFRA registration requirements if they meet the exemption criteria pursuant to the treated article exemption. EPA requests comment and information from all stakeholders on the use and usage of treated seed, including storage, planting, and disposal of the treated seed, and on whether or to what extent treated seed products are being distributed, sold, and used contrary to treating pesticide and treated seed product labeling instructions. Similarly, EPA requests comment from stakeholders on the addition of labeling requirements on the labels of treated paint products and potential language that should be included in those labels. Comments are due December 11, 2023. More information is available in our November 6, 2023, blog item.

EPA Publishes Instructions For Reporting Asbestos Data: On October 16, 2023, EPA announced the availability of reporting instructions for entities required to report on their use of asbestos under the Toxic Substances Control Act (TSCA). EPA’s July 25, 2023, final rule requires manufacturers (including importers) or processors of asbestos between 2019 and 2022 with annual sales above $500,000 (combined with their parent company) in any of those years to report exposure-related information, including quantities of asbestos manufactured or processed, types of use, and employee data. EPA states that “[i]mportantly, the rule also covers asbestos-containing products (including products that contain asbestos as an impurity, such as asbestos-containing talc) and asbestos that is present as a component of a mixture.” Manufacturers (including importers) and processors subject to the rule must submit all required information to EPA during the three-month data submission period beginning February 24, 2024, and ending May 24, 2024. Reporters must use the asbestos Section 8(a)(1) reporting tool on EPA’s Central Data Exchange (CDX) to submit information. EPA notes that it “will not accept paper submissions or electronic media.”

EPA Proposes To Amend TSCA Risk Evaluation Framework Rule: EPA announced on October 19, 2023, a proposed rule that would amend the procedural framework rule for conducting risk evaluations under TSCA. Published in the Federal Register on October 30, 2023, the proposed rule states that the purpose of risk evaluations under TSCA is to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without considering costs or non-risk factors, including unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA, under conditions of use (COU). 88 Fed. Reg. 74292. EPA states that it has reconsidered the procedural framework rule for conducting such risk evaluations and determined that certain aspects of that framework should be revised to align better with applicable court decisions and the statutory text, to reflect its experience implementing the risk evaluation program following enactment of the 2016 TSCA amendments, and to allow for consideration of future scientific advances in the risk evaluation process without the need to amend further the Agency’s procedural rule. Comments are due December 14, 2023. EPA notes that under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of the comments on or before November 29, 2023. B&C encourages interested parties to review carefully EPA’s proposed rule and to provide comments as appropriate. This is potentially the most impactful TSCA rule proposed to date this year. For more information on the proposed rule, please read our October 30, 2023, memorandum.

EPA Adds PFAS Subject To TRI Reporting To List Of Chemicals Of Special Concern: On October 31, 2023, EPA added per- and polyfluoroalkyl substances (PFAS) subject to reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA) pursuant to the National Defense Authorization Act for Fiscal Year 2020 (NDAA) to the list of Lower Thresholds for Chemicals of Special Concern (chemicals of special concern). 88 Fed. Reg. 74360. The addition of these PFAS to the list of chemicals of special concern means such PFAS are subject to the same reporting requirements as other chemicals of special concern (i.e., it eliminates the use of the de minimis exemption and the option to use Form A and limits the use of range reporting for PFAS). The final rule will remove the availability of the de minimis exemption for purposes of the Supplier Notification Requirements for all chemicals on the list of chemicals of special concern, “help[ing] ensure that purchasers of mixtures and trade name products containing such chemicals are informed of their presence in mixtures and products they purchase to better inform any TRI reporting obligations.” The final rule will be effective November 30, 2023. It will apply for the reporting year beginning January 1, 2024 (reports due July 1, 2025). More information about the proposed rule is available in our December 7, 2022, memorandum.

EPA Proposes To Ban TCE: EPA proposed on October 31, 2023, to ban all uses of trichloroethylene (TCE) after determining that it presents an unreasonable risk of injury to human health under its COUs documented in EPA’s November 2020 risk evaluation and January 2023 revised risk determination pursuant to TSCA. 88 Fed. Reg. 74712. According to EPA’s October 23, 2023, press release, the proposed rule would ban the manufacture, processing, and distribution of TCE for all uses. It would take effect in one year for consumer products and most commercial uses and would implement stringent worker protections on the limited remaining commercial and industrial uses that would be phased down over a longer period. Comments are due December 15, 2023. Under the PRA, comments on the information collection provisions are best assured of consideration if OMB receives a copy of the comments on or before November 30, 2023. More information is available in our November 3, 2023, memorandum.

EPA Grants TSCA Section 21 Petition To Address 6PPD In Tires: On November 2, 2023, EPA announced that it granted a petition filed under TSCA Section 21 to address the use of the chemical N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD) in tires. According to EPA, 6PPD reacts with ozone pollution to form 6PPD-quinone, which may be present in stormwater runoff from parking lots and streets due to the presence of tire wear particles. The runoff may be washed into streams and other bodies of water during rain events, exposing aquatic organisms to 6PPD-quinone. EPA notes that concentrations of 6PPD-quinone in stormwater in the Pacific Northwest were found to be lethal to coho salmon after only a few hours of exposure. EPA intends to publish an ANPRM under TSCA Section 6 by fall 2024 to obtain more information to inform a subsequent regulatory action. EPA states that it also plans to issue a final TSCA Section 8(d) rule to require manufacturers (including importers) of 6PPD to report lists and copies of unpublished health and safety studies to EPA by the end of 2024.

EPA Extends The Comment Period On The Proposed Framework To Assess The Risk To The Effectiveness Of Human And Animal Drugs Posed By Certain Antibacterial Or Antifungal Pesticides: On September 26, 2023, EPA requested comment on a proposed framework to strengthen the assessment of antimicrobial-resistance risks associated with pesticide use. EPA, the U.S. Department of Health and Human Services (HHS), and the U.S. Department of Agriculture (USDA), under the oversight of the White House Executive Office of the President, have published a concept note. EPA states that the concept note is the first step in creating the framework to improve assessments of potential risks to human and animal health where the use of certain pesticides could potentially result in antimicrobial resistance that compromises the effectiveness of medically important antibacterial and antifungal drugs. EPA states that the proposed framework described in the concept note will expand EPA’s current process for assessing the risk that antibacterial or antifungal pesticides may pose to the effectiveness of human and animal antibacterial and antifungal drugs when EPA evaluates pesticides under FIFRA. On November 1, 2023, EPA extended the comment period by 30 days; thus, comments are due by December 13, 2023, and can be submitted by searching docket ID EPA-HQ-OPP-2023-0445 at www.regulations.gov. For more information, please read our November 6, 2023, memorandum.

EPA Requests Nominations For Science Advisory Committee On Chemicals: On November 9, 2023, EPA invited nominations of scientific experts from a diverse range of disciplines to be considered for appointment to the Science Advisory Committee on Chemicals (SACC), established pursuant to TSCA. 88 Fed. Reg. 77308. EPA states that it anticipates appointing new SACC members by mid-2024 due to expiring membership terms. Any interested person or organization may nominate qualified individuals to be considered prospective candidates, and individuals may also self-nominate. Nominations are due December 11, 2023. More information is available in our November 9, 2023, blog item.

EPA Proposes Updates Intended To Strengthen The Safer Choice Standard: EPA announced proposed updates to the Safer Choice Standard on November 13, 2023. According to the November 14, 2023, notice, the proposed changes include a name change to the Safer Choice and Design for the Environment (DfE) Standard (Standard), an update to the packaging criteria, the addition of a Safer Choice certification for cleaning service providers, a provision allowing for preterm partnership termination under exceptional circumstances, and the addition of several product and functional use class requirements. 88 Fed. Reg. 78017. EPA notes that Safer Choice helps consumers, businesses, and purchasers find products that perform and contain ingredients that are safer for human health and the environment and states that DfE is a similar program currently used by EPA to help consumers and commercial buyers identify antimicrobial products that meet the health and safety standards of the typical pesticide registration process required by FIFRA, as well as other EPA DfE criteria. EPA will hold a webinar on December 19, 2023, on its proposed plans for updating the Standard. After EPA’s presentation, there will be time for a question and answer period. EPA asks that comments be submitted in writing after the webinar. Comments on the proposed changes are due January 16, 2024. EPA has posted on its website the proposed changes to the Standard, as well as a “preamble” explaining the proposed changes. More information will be available in a forthcoming memorandum.

Proposed Rule Would Manage Certain HFCs And Substitutes Under AIM Act: EPA proposed on October 19, 2023, to issue regulations to implement certain provisions of the American Innovation and Manufacturing (AIM) Act of 2020. 88 Fed. Reg. 72216. EPA proposes to establish a program for the management of hydrofluorocarbons (HFC) that includes requirements for leak repair and use of automatic leak detection systems for certain equipment using refrigerants containing HFCs and certain substitutes; requirements for the use of reclaimed HFCs in certain sectors or subsectors; the use of recycled HFCs in fire suppression equipment; recovery of HFCs from cylinders; container tracking; and certain recordkeeping, reporting, and labeling requirements. EPA also proposed alternative Resource Conservation and Recovery Act (RCRA) standards for spent ignitable refrigerants being recycled for reuse. Finally, EPA requested advance comment on approaches for establishing requirements for technician training and/or certification. Comments are due December 18, 2023. Under the PRA, comments on the information collection provisions are best ensured of consideration if OMB receives a copy of on or before November 20, 2023.

EPA Issues 2024 HFC Allowances Under AIM Act: On October 19, 2023, EPA issued calendar year 2024 allowances for the production and consumption of HFCs in accordance with the Agency’s regulations. 88 Fed. Reg. 72060. EPA notes that the AIM Act directs it to determine by October 1 of each year the quantity of production and consumption allowances for the following calendar year. EPA also provided notice of separate Agency actions concerning final administrative consequences for certain entities. EPA states that these administrative consequences were applied to withhold, retire, and revoke entities’ remaining calendar year 2023 and newly issued calendar year 2024 allowances in accordance with the administrative consequence regulatory provisions.

EPA Proposes Updates Related To Use Of Ozone-Depleting Substances As Process Agents: EPA proposed on October 19, 2023, to establish recordkeeping and reporting requirements for uses of ozone-depleting substances as process agents and to update definitions to reflect current practice. 88 Fed. Reg. 72027. Codified recordkeeping and reporting requirements would provide clear and consistent notice each year of information EPA collects, aggregates, and reports as a party to the Montreal Protocol on Substances that Deplete the Ozone Layer; effectively monitor these narrow uses in a more routine and consistent manner under the Clean Air Act (CAA); and enhance understanding of emissions of substances harmful to the ozone layer. Comments are due December 4, 2023. Under the PRA, comments on the proposed information collection provisions are best assured of consideration if OMB receives a copy on or before November 20, 2023.

Proposed Consent Decree Would Establish Deadlines For EPA To Review And Revise As Necessary NESHAP For Chemical Manufacturing Area Sources: On October 20, 2023, EPA provided notice of a proposed consent decree in California Communities Against Toxics v. Regan, No. 1:22–cv–1457 (D.D.C.). 88 Fed. Reg. 72478. The proposed consent decree would require that EPA review, and revise as necessary, the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Chemical Manufacturing Area Sources (CMAS), pursuant to CAA Section 112(d)(6), by a date certain. Under the terms of the proposed consent decree, the Administrator would be required to sign a notice of proposed rulemaking for the CMAS source category by November 13, 2024, and a final rule by September 17, 2025. Comments on the proposed consent decree are due November 20, 2023.

EPA Restricts Use Of Certain HFCs Under The AIM Act: EPA published a final rule on October 24, 2023, implementing certain provisions of the AIM Act. 88 Fed. Reg. 73098. The rulemaking restricts the use of HFCs in specific sectors or subsectors in which they are used; establishes a process for submitting technology transitions petitions; establishes recordkeeping and reporting requirements; and addresses certain other elements related to the effective implementation of the AIM Act. These restrictions on the use of HFCs address petitions granted on October 7, 2021, and September 19, 2022. The rule will be effective December 26, 2023.

PHMSA’s OHMS Will Hold Research, Development, And Technology Forum On November 28: The Pipeline and Hazardous Materials Safety Administration’s (PHMSA) Office of Hazardous Materials Safety (OHMS) will hold a public Research, Development & Technology Virtual Forum on Zoom Webinar on November 28, 2023. 88 Fed. Reg. 76889. OHMS will present the results of recently completed projects; brief attendees on new project plans; and obtain stakeholder input on the direction of current and future research topics, including mitigation of climate change, risk management and mitigation, packaging integrity, emerging technology, and technical analysis to aid risk assessment. According to the notice, the forum will enable OHMS to solicit comments related to new research topics that may be considered for inclusion in its future work. OHMS is particularly interested in the research gaps associated with energetic materials (explosives) characterization and transportation; safe transportation of energy products (e.g., crude oil); safe containment and transportation of compressed gases; and safe packaging and transportation of charge storage devices (e.g., lithium-ion batteries) and how these might aid in mitigation of climate change. The forum will also provide opportunities for stakeholder input to identify other research gaps related to the transportation of hazardous materials.

FDA Publishes Guide For New Cosmetic Products Submissions: On October 13, 2023, the U.S. Food and Drug Administration (FDA) published a guidance document titled “Structured Product Labeling (SPL) Implementation Guide with Validation Procedures.” The guidance includes cosmetics product facility registrations and product listings. When FDA begins accepting registrations and listings required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), users may use this guidance to develop SPL-formatted submissions. SPL is an established document sanctioned by health level seven (HL7) for the exchange of product and facility-related information and serves as a foundational reference for regulatory guidance documents and product labeling content exchange.

FDA Issues Update For MoCRA Activities: On November 1, 2023, FDA provided an update on activities related to the new cosmetic product facility registration and cosmetic product listing mandated under MoCRA. The update summarizes the following developments: FDA’s release of draft guidance for cosmetic product facility registrations and product listings, FDA’s request for comments for the electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067), and the publication of the Structured Product Labeling (SPL) Implementation Guide with Validation Procedures (discussed immediately above).

Color Additive Petition Approved For Jagua (Genipin-Glycine) Blue: On November 3, 2023, FDA amended the color additive regulations to include the safe use of jagua (genipin-glycine) blue as a color additive in various food categories at levels consistent with good manufacturing practice (GMP). 88 Fed. Reg. 75490. This action is being taken in response to a color additive petition (CAP) submitted by Exponent, Inc. on behalf of Ecoflora SAS. The color additive regulations at 21 C.F.R. Part 73 will be amended to include this color additive effective on December 4, 2023.

FDA Proposes To Revoke Authorization For Brominated Vegetable Oil: On November 3, 2023, FDA proposed to revoke the authorization for the use of brominated vegetable oil (BVO) in food, giving the reason that “[…] there is no longer a reasonable certainty of no harm from the continued use of BVO in food.” 88 Fed. Reg. 75523. If made final, the action would remove the approval in 21 C.F.R. Section 180.30 that currently permits use of BVO as a food ingredient intended to stabilize flavoring oils in fruit-flavored beverages. FDA cites a 2022 study that indicates BVO “is toxic to the thyroid and results in bioaccumulation of lipid-bound bromine in the body at doses relevant to human exposure.” Electronic or written comments on the proposed rule must be submitted by January 17, 2024.

FDA Updates CFSAN Online Submission Module: On November 6, 2023, FDA announced an update to its CFSAN Online Submission Module (COSM), through which users are able to submit notifications, including Food Additive Petitions (FAP) and Food Contact Notifications (FCN), to FDA’s Office of Food Additive Safety (OFAS). The update introduces three new features:

1. Users may now submit documents directly to OFAS via COSM;
    

2. COSM now allows for secure communication between FDA and users for submissions and amendments to submissions created in COSM; and
    

3. A dynamic user dashboard, displaying the status of the submissions, has been added.

Users should find that electronic submissions are improved with the ability to bypass the Electronic Submission Gateway (ESG) that often proved problematic for industry to navigate.

FDA Adds Tools For FSMA Programs: On November 7, 2023, FDA announced new tools developed for the Accredited Third-Party Certification Program (TPP) and the Laboratory Accreditation for Analyses of Foods (LAAF) Program, both of which were developed under the Food Safety Modernization Act (FSMA). The tools include QR codes and graphical elements that may be used to communicate the status of participants in TPP and LAAF and to promote awareness of the programs. User guidelines that explain how stakeholders may use the QR code and graphic element are available on both the TPP and LAAF Program landing pages.

FDA Delays Enforcement Of Cosmetic Regulations: On November 9, 2023, FDA announced its decision to delay enforcement of the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months until July 1, 2024. 88 Fed. Reg. 77323. FDA is delaying enforcement “to help ensure that owners or operators of cosmetic product facilities and responsible persons for cosmetic products have sufficient time to gather the relevant information required for facility registration and product listing, including obtaining facility registration numbers to associate with cosmetic product listings, obtaining access to the electronic submissions database, and verifying accurate registration and listing information for submission.”

EUON Study Identifies Models And Tools For Computational Safety Assessment Of Nanomaterials: The European Union (EU) Observatory for Nanomaterials (EUON) announced on October 10, 2023, that it published “A study on valid in silico modelling tools and read-across approaches, including creation of case studies on read-across for specific (types of) nanomaterials” that analyzes read-across and in silico approaches as alternative methods to conventional hazard and risk assessments for nanomaterials. According to EUON, the study identifies 190 alternative models and methodologies for hazard and risk assessment of nanomaterials.

NanoHarmony Publishes White Paper On OECD Test Guideline Development: NanoHarmony published on October 13, 2023, a white paper entitled From Science to Regulation: The NanoHarmony White Paper on Test Guideline Development. According to NanoHarmony, for regulations to be effective and for manufacturers to be able to comply with regulatory requirements, Organization for Economic Cooperation and Development’s (OECD) Test Guidelines (TG) need to remain up to date and fit for purpose. The white paper provides eight recommendations in four areas that are intended to help improve the effectiveness of the TG development process of moving new methods from science to regulation more efficiently.

OECD Publishes Reports Concerning Advanced Materials In Series On The Safety Of Manufactured Nanomaterials: OECD has posted two new reports in its Series on the Safety of Manufactured Nanomaterials:

• Advanced Materials Assessment Schemes HARMLESS -- OECD Working Party on Manufactured Nanomaterials (WPMN) Workshop Report (No. 107); and
   

• Early Awareness and Action System for Advanced Materials (Early4AdMa): Pre-regulatory and anticipatory risk governance tool to Advanced Materials (No. 108).

More information is available in our October 27, 2023, blog item.

EU NSC Conducting Survey On Implementation Of Nanosafety In Workplaces: The EU NanoSafety Cluster (NSC) announced on October 24, 2023, that it is conducting a survey on the implementation of nanosafety in workplaces. NSC states that the survey aims to gather insights on the current practices and challenges of implementing nanosafety in workplaces. According to NSC, responses will help shape recommendations for future safety guidelines and protocols. NSC notes that participation will take approximately 15-20 minutes.

NIOSH Report On Approaches To 3D Printing Includes Recommendations For Controls To Protect Users In Makerspaces, Schools, Libraries, And Small Businesses: On November 8, 2023, the National Institute for Occupational Safety and Health (NIOSH) published a report entitled Approaches to safe 3D printing: a guide for makerspace users, schools, libraries, and small businesses. The report summarizes NIOSH’s findings and includes recommendations for controls to protect workers using three-dimensional (3D) printers in makerspaces, schools, libraries, and small businesses.

NNI Nanoinformatics Conference And U.S.-EU NanoEHS COR Workshop Will Be Held In November 2023: The National Nanotechnology Initiative (NNI) Nanoinformatics Conference was held November 15, 2023, immediately before the 11th meeting of the U.S.-EU Nano Environmental, Health, and Safety (NanoEHS) Communities of Research (COR) on November 16-17, 2023. More information is available in our October 20, 2023, blog item.

Registration Open For NNI Symposium Rescheduled For March 5, 2024: NNI has rescheduled its symposium entitled “Enabling the Nanotechnology Revolution: Celebrating the 20^th Anniversary of the 21^st Century Nanotechnology Research and Development Act” to March 5, 2024, at the National Academies of Sciences, Engineering, and Medicine. The symposium will include a poster session for students and postdocs. The abstract submission deadline is December 1, 2023. Selected participants will be notified on January 5, 2024. In-person and virtual registration is open.

Break Free From Plastic Pollution Act Introduced In House And Senate: On October 25, 2023, Representative Jared Huffman (D-CA) and Senator Jeff Merkley (D-OR) introduced the bicameral Break Free from Plastic Pollution Act (H.R. 6053, S. 3127). According to Merkley’s October 25, 2023, press release, the bill would “reduce plastic production, establish ambitious recycling targets, and protect frontline and fenceline communities from the health and environmental burdens of toxic emissions from the plastics industry through reducing production and by changing the incentives of the industry.” The press release states that the bill would “shift the burden of cleanup to the corporations that produce the plastics so they have financial motivation to end the burning and dumping; establish a nationwide deposit return system to address beverage container waste; support reusable and refillable systems; and strengthen environmental justice protections by including the Protecting Communities from Plastics Act.”

House Bill Would Ban BPA, PFAS, And Certain Other Substances In Food Packaging: On October 26, 2023, Representatives Jan Schakowsky (D-IL), Rosa DeLauro (D-CT), and Debbie Dingell (D-MI) introduced the No Toxics in Food Packaging Act of 2023 (H.R. 6105). According to Schakowsky’s October 26, 2023, press release, the bill would ban bisphenol A (BPA), PFAS, ortho-phthalates, styrene, and antimony trioxide from being used in food packaging and processing materials “because science has demonstrated that these chemicals are detrimental to human health -- they can cause cancer and disrupt hormones to name a few effects.”

Bipartisan House Bill Would Curb PFAS Contamination Caused By Defense Facilities: On October 26, 2023, Representatives Jennifer McClellan (D-VA) and Jennifer Kiggans (R-VA) introduced the Department of Defense PFAS Discharge Prevention Act (H.R. 6095), bipartisan legislation intended to protect military personnel and American families from PFAS released from Department of Defense (DoD) facilities. According to McClellan’s October 26, 2023, press release, the bill would:

• Require the Secretary of Defense to request permit revisions to allow for PFAS remediation through carbon filtration at DoD stormwater management outflows; and
   

• Mandate DoD use a small portion of remediation funding for PFAS testing onsite at DoD water management facilities to allow the Department to capture better PFAS before it flows into waterways off base.

California Attorney General Issues Enforcement Advisory Letter To Warn Companies Of Responsibility To Disclose Presence Of PFAS: California Attorney General Rob Bonta announced the release of an enforcement advisory letter on October 17, 2023, to manufacturers, distributors, and sellers of food packaging and cookware, alerting them to their obligations under AB 1200, a recently enacted statute that restricts the presence of PFAS in food packaging and imposes labeling disclosure requirements for cookware. Bonta also issued a consumer alert with tips for reducing PFAS exposures. More information is available in our October 18, 2023, blog item.

OEHHA Modifies Proposed Changes To “Short-Form” Warnings: On October 27, 2023, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a notice proposing changes to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations for “short-form” warnings (Notice). OEHHA first proposed changes to the short-form warning requirements on January 8, 2021, with modifications proposed on December 13, 2021, and April 5, 2022. Industry was harshly critical of OEHHA’s proposal in written comments and during a March 11, 2021, hearing. Industry argued that OEHHA’s proposal was unwarranted and its concerns with the current warning requirements unfounded. Industry stakeholders also expressed frustration with the expected significant resources and costs that implementation of these changes would inspire. On May 20, 2022, OEHHA announced that it would be unable to complete the rulemaking process within the one-year deadline required under California law (Cal. Gov’t Code § 11346.4(b)), and thus the rulemaking would lapse. OEHHAstated in its May 20, 2022, notice entitled“May 2022 Status Update for Clear and Reasonable Warnings -- Short Form: Completion of Proposed Rulemaking” that it “intends to restart the rulemaking process on the short-form with a new regulatory proposal, informed by comments on the previous proposal.” Written comments on the proposed changes are due no later than December 20, 2023. OEHHA also has scheduled a public hearing on December 13, 2023, at 10:00 a.m. (PST). The hearing will be a hybrid format, allowing for in person and remote participation. More information is available in our November 2, 2023, memorandum.

Ninth Circuit Finds Glyphosate Prop 65 Warning Unconstitutional: On November 7, 2023, the Ninth Circuit affirmed the District Court for the Eastern District of California’s June 22, 2020, decision granting summary judgment in favor of Plaintiffs. The Ninth Circuit entered a permanent injunction enjoining the California Attorney General from enforcing Prop 65’s carcinogen warning requirement for the herbicide glyphosate. National Ass’n of Wheat Growers et al. v. Bonta (Opinion).The Ninth Circuit found that requiring the warning was unconstitutional as a violation of First Amendment free speech rights. This case and California Chamber of Commerce v. Council for Educ. and Research on Toxics are important cases with implications for companies facing Prop 65 warning requirements for other substances where the underlying scientific basis for listing also may be unclear and controversial. For more information, please read our November 14, 2023, memorandum.

OIRA Intends Final Revisions To Circular A-4 To Improve Regulatory Analysis: The Biden Administration announced on November 9, 2023, that the Office of Information and Regulatory Affairs (OIRA) issued final revisions to Circular A-4, the government-wide guidance on regulatory analysis. 88 Fed. Reg. 77615. Issued in 2003, Circular A-4 has been updated to help agencies more accurately estimate the impacts of their regulations and, according to the press release, “thereby enable them to craft better regulations which, in turn, means lower costs for consumers; cleaner food, air, and water; less fraud and exploitation; increased workplace safety; more innovation; and a stronger economy.” More information is available in our November 13, 2023, blog item.

EPA Announces Availability Of The Protocol For Nitrate And Nitrite IRIS Assessment (Oral): EPA announced on November 9, 2023, a 30-day public comment period associated with release of the document Protocol for the Nitrate and Nitrite IRIS Assessment (Oral). 88 Fed. Reg. 77310. EPA states that this document communicates the rationale for conducting the human health assessment of nitrate and nitrite, 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 December 11, 2023.

EPA Requests Comment On Draft Revision Of The Technical Guidance For Assessing Environmental Justice In Regulatory Analysis: On November 15, 2023, EPA announced a 60-day public comment period on the draft revision of the Technical Guidance for Assessing Environmental Justice in Regulatory Analysis (Guidance). 88 Fed. Reg. 78358. EPA is updating the Guidance to reflect the state of the science; new peer-reviewed Agency guidance; and new terminology, priorities, and direction, including Executive Order 14096. EPA states that the purpose of the guidance is to outline analytic expectations and discuss technical approaches and methods that can be used by EPA analysts to evaluate environmental justice concerns for regulatory actions. Comments are due January 15, 2024.

WHEJAC Will Meet December 6, 2023: The White House Environmental Justice Advisory Council (WHEJAC) will convene a virtual public meeting on December 6, 2023. Meeting discussions will focus on several topics, including, but not limited to, workgroup activities, proposed recommendations from the WHEJAC for the Council on Environmental Quality (CEQ) and the White House Environmental Justice Interagency Council (IAC), CEQ briefings, and a new formal charge for the WHEJAC. 88 Fed. Reg. 78354. Members of the public who wish to participate during the public comment period must register by 11:59 p.m. (EST) on November 29, 2023. According to the notice, WHEJAC is interested in receiving public comments on the Climate and Economic Justice Screening Tool; the Environmental Justice Scorecard; carbon management; ways that the WHEJAC could recommend advancing environmental justice through a whole-of-government approach; and environmental justice issues affecting Indigenous Peoples and Tribal Nations. Written comments are due December 20, 2023.