Wrap-Up of Federal and State Chemical Regulatory Developments, September 2024

TSCA/FIFRA/TRI

EPA Updates Safer Choice And DfE Standard: The U.S. Environmental Protection Agency (EPA) announced on August 8, 2024, the availability of the final updated Safer Choice and Design for the Environment (DfE) Standard (the Standard). 89 Fed. Reg. 64915. According to EPA, the update includes a name change to the title of the Standard, a revision to the packaging criteria, a new certification for cleaning service providers, a new provision allowing for preterm partnership termination under exceptional circumstances, and the addition of several product and functional use class requirements. EPA states that “Safer Choice helps consumers, businesses, and purchasers find products that perform and contain ingredients that are safer for human health and the environment.” DfE is a similar program that helps consumers and commercial buyers identify antimicrobial products that meet the health and safety standards of the normal pesticide registration process required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as well as other EPA DfE criteria. The Standard was effective August 8, 2024. EPA has posted both the current Standard and a version that reflects the final changes. For more information, please read the full memorandum.

EPA Authors Describe Categorization Approach To PFAS To Identify Potential Candidates For Testing And Human Health Assessments: On August 18, 2024, Computational Toxicology published an article entitled “Development of chemical categories for per- and polyfluoroalkyl substances (PFAS) and the proof-of-concept approach to the identification of potential candidates for tiered toxicological testing and human health assessment.” Co-authored by members of EPA’s Center for Computational Toxicology & Exposure (CCTE) and Office of Chemical Safety and Pollution Prevention (OCSPP), the study “describes the approach taken to further refine a relevant PFAS landscape to EPA from which an initial set of structural categories were derived.” More information is available in our August 21, 2024, blog item.

EPA Will Hold Webinars On Next Round Of Chemicals To Be Considered For Prioritization Under TSCA: EPA will hold two virtual public meetings, on September 30 and October 1, 2024, to provide information regarding existing chemical pre-prioritization and prioritization activities under the Toxic Substances Control Act (TSCA). 89 Fed. Reg. 68894. During the webinars, EPA will explain the prioritization process and provide an overview of information that it may use to inform the considerations that ultimately support a high- or low-priority substance designation, such as information on conditions of use and health effects resulting from exposure to the chemicals of interest. In addition, EPA will present the list of candidate chemical substances currently being considered for future prioritization actions for stakeholders to comment on the information available that EPA may use to determine which chemical substances may undergo prioritization in the near term. Registrations are due September 25, 2024, to receive the webcast meeting link and audio teleconference information before the meeting and to make oral comments during the meeting. Following the public webinars, written comments may be submitted during a 30-day public comment period that will open following the second public webinar on October 1, 2024.

EPA Releases Draft Risk Evaluation For DINP For Public Comment: EPA announced on September 3, 2024, the release of the draft risk evaluation for diisononyl phthalate (DINP) under TSCA for public comment. 89 Fed. Reg. 71270. EPA states in its August 30, 2024, press release that it preliminarily determined that two industrial uses and one consumer use “significantly contribute to the unreasonable risk of DINP out of the 45 uses evaluated.” EPA preliminarily determined that DINP has the potential to cause developmental toxicity and harm the liver and that it could cause cancer at higher levels of exposure. EPA notes that it also preliminarily determined that DINP does not pose unreasonable risk of injury to the general population or pose unreasonable risk to the environment. EPA will host a public webinar on September 26, 2024, at 2:00 p.m. (EDT) to provide an overview of the risk evaluation and an opportunity for participants to share comments. According to EPA’s August 30 press release, requests to make comments during the webinar are due by September 23, 2024, at 5:00 p.m. (EDT). Requests for accommodations are due by September 19, 2024, at 5:00 p.m. (EDT). Comments on the draft risk evaluation are due November 4, 2024. More information will be available in a forthcoming memorandum.

EPA Postpones Submission Period For TSCA Section 8(a)(7) Reporting On PFAS: EPA published a direct final rule on September 5, 2024, that will amend the TSCA regulation with reporting and recordkeeping requirements for PFAS to make a “one-time modification” to change the data submission period from November 12, 2024, through May 8, 2025, to July 11, 2025, through January 11, 2026. 89 Fed. Reg. 72336. For any reporter who is reporting exclusively as an article importer and is also considered a small manufacturer, the submission period will begin on July 11, 2025, and last for 12 months: July 11, 2025, through July 11, 2026. EPA is also taking action to correct an inadvertent error in the rulemaking by revising the text “published study reports” under the requirement to submit Organisation for Economic Co-operation and Development’s (OECD) Harmonised Templates (OHT) to the correct requirement of submitting OHTs for “unpublished study reports.” EPA states that there are no other changes to the reporting and recordkeeping requirements in the existing rule. The direct final rule will be effective November 4, 2024. If EPA receives adverse comment by October 7, 2024, it will publish a timely withdrawal in the Federal Register informing the public that the direct final rule will not take effect. EPA published a separate notice that will serve as the proposed rule to amend the beginning of the submission period if adverse comments are received on the direct final rule. 89 Fed. Reg. 72362. More information is available in our September 4, 2024, blog item.

EPA Reports Issues With Submitting CBI In CDX For CDR Reporting: The Chemical Data Reporting (CDR) rule requires manufacturers (including importers) to report data to EPA every four years. The 2024 submission period began June 1, 2024, and will end September 30, 2024. The CDR rule requires all companies to report data electronically using e-CDRweb through EPA’s Central Data Exchange (CDX) system. CDR reporting in CDX is currently malfunctioning, however. EPA has issued two alerts:

• If a reporter is claiming more than one chemical as confidential business information (CBI) and is using the reporting tool’s copy functionality to substantiate multiple chemicals, “chemical specific substantiation questions/response may disappear from the application and PDF.” EPA asks reporters to “delay using the substantiation copy functionality for chemicals being claimed as CBI until after an update is deployed, expected on 9/20.”

• If a reporter claimed a secondary submitter as confidential, the generated PDF is not accurately displaying that claim. EPA asks reporters to delay submitting the form “until after an update is deployed, expected on 9/20.”

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

Three States Petition EPA To Designate Four PFAS As HAPs: On August 29, 2024, the North Carolina Department of Environmental Quality (NCDEQ) announced that together with the New Mexico Environment Department (NMED) and the New Jersey Department of Environmental Protection (NJDEP), it petitioned EPA to add the following PFAS as hazardous air pollutants (HAP):

• Perflurooctanoic acid (PFOA);

• Perfluorooctane sulfonic acid (PFOS);

• Hexafluoropropylene oxide-dimer acid (HFPO-DA or GenX); and

• Perfluorononanoic acid (PFNA).

The states note that EPA has not established an air pollution control program for PFAS. According to the states, PFAS emissions in ambient air remain “largely unmeasured and unregulated.” The states argue that these PFAS “are known to cause or may reasonably be anticipated to cause adverse effects to human health or adverse environmental effects,” allowing EPA to make the necessary findings to list them as HAPs under Section 112(b)(3)(B) of the Clean Air Act (CAA). The states also “encourage EPA to use the results of its research and analyses on the toxicity, fate and transport, and prevalence of PFAS to add other PFAS compounds to the list of HAPs.”

EPA Adds Electronic Reporting Provisions To NESHAP For RICE, NSPS For Stationary CI And Stationary SI Internal Combustion Engines: On August 30, 2024, EPA amended the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Reciprocating Internal Combustion Engines (RICE), the New Source Performance Standards (NSPS) for Stationary Compression Ignition (CI) Internal Combustion Engines, and the NSPS for Stationary Spark Ignition (SI) Internal Combustion Engines, to add electronic reporting provisions. 89 Fed. Reg. 70505. According to EPA, the addition of electronic reporting provisions will provide for simplified reporting by sources and enhance availability of data on sources to EPA and the public. In addition, EPA made a small number of revisions to these rules to clarify and correct inadvertent and other minor errors in the Code of Federal Regulations (CFR), particularly related to tables. The rule was effective on August 30, 2024.

EPA Issues Enforcement Alert To Address Illegal Import Of HFCs Into The United States: EPA announced on September 6, 2024, that it issued an Enforcement Alert regarding its work under the American Innovation and Manufacturing (AIM) Act to phase down production and consumption of hydrofluorocarbons (HFC). According to EPA, the new alert provides information on common compliance issues observed with the importation of bulk HFCs and highlights recent civil and criminal enforcement actions. EPA states that the alert is intended to help address the climate crisis and ensure that companies comply with the law and take the necessary steps to avoid potential EPA enforcement actions.

EPA Removes Vacated Provisions On Disposable Cylinder Ban And Cylinder Tracking: On September 11, 2024, EPA published a final rule removing regulations from the CFR that have been vacated by the U.S. Court of Appeals for the District of Columbia Circuit related to the prohibition of disposable cylinders and tracking of cylinders of HFCs. 89 Fed. Reg. 73588. The final rule was effective September 11, 2024.

EPA Proposes Framework To Review Application-Specific Allowances Under The AIM Act: On September 16, 2024, EPA proposed a framework to assess the eligibility of six applications to receive priority access to allowances allocated pursuant to the AIM Act. 89 Fed. Reg. 75898. EPA proposed whether to renew each of the six applications that currently receives application-specific allowances; revisions to the Technology Transitions regulations as relevant to the specific applications under review; a procedural process for submitting a petition to designate a new application as eligible for priority access to allowances; narrow revisions to the methodology used to allocate allowances to application-specific allowance holders for calendar years 2026 and beyond; and limited revisions to existing regulations. EPA also proposed to authorize an entity to produce regulated substances for export. Lastly, EPA proposed certain confidentiality determinations for newly reported information if this rulemaking is promulgated as proposed. Comments are due October 31, 2024.

FDA

FDA Posts Discussion Paper On Development Of An Enhanced Systematic Process For Its Post-Market Assessment Of Chemicals In Food; Comments Due December 6, 2024: As reported in our August 7, 2024, blog item, the U.S. Food and Drug Administration (FDA) announced on August 1, 2024, that it will hold a public meeting on September 25, 2024, on the development of an enhanced systematic process for its post-market assessment of chemicals in food. 89 Fed. Reg. 65633. FDA has posted a Discussion Paper Development of an Enhanced Systematic Process for the FDA’s Post-Market Assessment of Chemicals in Food (Discussion Paper). The Discussion Paper “broadly outlines a general approach for such a systematic process that would allow the FDA to proactively identify and target chemicals currently in the food supply for assessment in a structured manner based on risk.” The purpose of the Discussion Paper is to obtain public comment on the process to assist FDA in developing the post-market chemicals program that it will establish under the new FDA Human Foods Program. Comments regarding the questions in the Discussion Paper should be submitted to Regulations.gov Docket No. FDA-2024-N-3609 by December 6, 2024. More information is available in our August 22, 2024, blog item.

PCRM NURA Program Will Hold Webinar Series On Human-Based Methods In FDA Submissions: The Physicians Committee for Responsible Medicine (PCRM) New Approach Methodologies (NAM) Use for Regulatory Application (NURA) program will hold a series of webinars on human-based methods in FDA submissions. In the webinar series, NURA will feature leaders in human-relevant nonanimal methods to demonstrate medical product safety and efficacy:

• September 10, 2024, at 1:00 p.m. (EDT): Case Study #1: The Utilization of Human-on-a-Chip Systems for Regulatory Submissions for Neurological Conditions. The materials for this webinar are available here;

• September 25, 2024, 10:00 a.m. (EDT): RosetteArray^® Platform for Quantitative High-Throughput Screening of Human Developmental Neurotoxicity. Register; and

• October 10, 2024, at 1:00 p.m. (EDT): Case Study #2: Vanda Pharmaceuticals Inc. Uses NAMs in Lieu of Animal Study. Register.

FDA Provides Update For FSMA Food Traceability Rule: On September 4, 2024, Jim Jones, the FDA Deputy Commissioner for Human Foods, provided an update discussing the Food Safety Modernization Act’s (FSMA) Food Traceability Final Rule. Jones noted that FDA has “heard broad support for the rule and its benefits” but also “concerns from industry” about implementation. To help support implementation, FDA worked with the Reagan-Udall Foundation to host three roundtable discussions on the Food Traceability Rule. A summary of the discussions is available here.

NANOTECHNOLOGY

EPA Proposes SNUR For Graphene Nanoplatelets (Generic): On August 20, 2024, EPA proposed SNURs under TSCA for chemical substances, including graphene nanoplatelets (generic), that were the subject of premanufacture notices (PMN) and a Microbial Commercial Activity Notice (MCAN) and are also subject to a TSCA Order. 89 Fed. Reg. 67368. The SNURs would require persons who intend to manufacture (defined by statute to include import) or process any of the chemical substances for an activity that is proposed as a significant new use by the rule to notify EPA at least 90 days before commencing that activity. According to EPA, the PMN for graphene nanoplatelets (generic) states that the generic (non-confidential) use will be as an additive for paint coatings. EPA states that based on comparison to analogous chemical substances, it has identified concerns for lung effects and systemic effects. EPA issued the Order under TSCA Sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. The proposed SNUR would designate as a significant new use the absence of the protective measures included in the Order and listed in the proposed SNUR. Comments are due September 19, 2024. More information is available in our August 20, 2024, blog item.

NASEM Holds Virtual Town Hall On September 5 As Part Of Its Quadrennial Review Of The NNI: As part of its quadrennial review of the National Nanotechnology Initiative (NNI), the National Academies of Sciences, Engineering, and Medicine (NASEM) held a virtual town hall on September 5, 2024, for stakeholders to share their thoughts on the future of nanotechnology in the United States. The overall objective of NASEM’s review is to identify opportunities and barriers to broadening access to nanotechnology research and development (R&D) infrastructure in the United States. More information is available in our August 22, 2024, blog item.

NIOSH Blog Item Highlights NTRC’s Toxicology And Internal Dose Team: The National Institute for Occupational Safety and Health (NIOSH) posted a blog item on September 10, 2024, entitled “NTRC Marks 20 Years of Studying Nanotoxicology: Highlights from the Toxicology and Internal Dose Team” that reviews the Nanotechnology Research Center’s (NTRC) achievements in the field of nanotechnology. The blog item highlights where NTRC started, where it is now, NTRC’s partnerships, and its work modeling workplace exposure to assess toxicity. More information is available in our September 12, 2024, blog item.

Registration Opens For NNI Webinar On Nanometrology For Continuous And Automated Manufacturing: The National Nanotechnology Coordination Office (NNCO) is organizing a series of NNI webinars on nanometrology, metrological challenges, and recent advances in three topical areas: food, agriculture, and the environment; nanoscale medical and pharmaceutical products; and nanoparticles in electronics. Registration is open for the fifth webinar in the series, “Nanometrology for Continuous and Automated Manufacturing.” The October 4, 2024, webinar will describe challenges related to in-line and at-line measurements in continuous systems and measurements made in automated systems. The sixth webinar in the series, “Nanometrology Involving Big Data, AI, and Modeling,” will be held November 1, 2024. Recordings of the webinars from earlier this year can be found on NNI’s website. More information is available in our September 11, 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 House Bills Would Speed Up PFAS Clean-Up Efforts And Reduce Use Of PFAS In Cleaning Products Used By DOD: On August 2, 2024, Representative Elissa Slotkin (D-MI) introduced the Accelerating DOD PFAS Cleanups Act (H.R. 9286) with Representative Jen Kiggans (R-VA) and the Prioritizing PFAS-Free Cleaning Products Act (H.R. 9288) with Representative Nancy Mace (R-SC). According to Slotkin’s August 9, 2024, press release, H.R. 9286 would:

• Require the U.S. Department of Defense (DOD) to expedite the implementation of “interim remedies” or “early actions” to mitigate the spread of PFAS-contaminated groundwater from military installations to off-base sources of groundwater or surface water;

• Require DOD to publish the results of its evaluations, including any potential actions it has identified and a schedule for the implementation of such actions; and

• Require DOD to identify private and public water wells with concentrations of PFAS that exceed the maximum contamination level established under the recently announced National Primary Drinking Water Standard for PFAS and to provide alternative drinking water to households and communities served by the contaminated wells.

The press release states that H.R. 9288 would:

• Require DOD to prioritize the purchase of PFAS-free cleaning products for use on military installations and other DOD buildings; and

• Require the Secretary to procure only PFAS-free cleaning products certified by the existing Safer Choice Program (or similar certification programs), to the maximum extent practicable.

The press release notes that a version of the Prioritizing PFAS-Free Cleaning Products Act was included in the National Defense Authorization Act for Fiscal Year 2025 approved by the House Armed Services Committee earlier this year.

House Subcommittee Holds Legislative Hearing On Evaluating FDA Human Foods And Tobacco Programs: On September 10, 2024, the House Energy and Commerce Subcommittee on Health held a legislative hearing on “Evaluating FDA Human Foods and Tobacco Programs.” The Subcommittee heard from the following witnesses:

• James “Jim” Jones, Deputy Commissioner for Human Foods, FDA; and

• Brian King, Ph.D., Director, Center for Tobacco Products, FDA.

The September 3, 2024, hearing announcement lists the following legislative proposals for discussion:

• H.R. 1462, Defending Against Imitations and Replacements of Yogurt, Milk, and Cheese to Promote Regular Intake of Dairy Everyday (DAIRY PRIDE) Act;

• H.R. 1750, Defending Domestic Orange Juice Production Act of 2023;

• H.R. 1803, Codifying Useful Regulatory Definitions (CURD) Act;

• H.R. 2901, Food Labeling Modernization Act of 2023;

• H.R. 4764, The Honey Identification Verification and Enforcement (HIVE) Act;

• H.R. 6512, Stephen Hacala Poppy Seed Safety Act;

• H.R. 6770, Improving Newborns’ Food and Nutrition Testing Safety (INFANTS) Act of 2023;

• H.R. 7563, The Food Traceability Enhancement Act;

• H.R. 9425, Tobacco User Fee Modernization Act of 2024; and

• H.R. 9443, Federal and State Food Safety Information Sharing Act of 2024.

MISCELLANEOUS

U.S. Chamber Of Commerce Releases Report Examining Impact Of Essential Fluorochemistries: In August 2024, the U.S. Chamber of Commerce released a report entitled Essential Chemistries: Providing Benefits Across the U.S. Economy that “examines the dependence of seven critical U.S. sectors, including aerospace manufacturing, data centers, defense equipment and systems, energy transition, health care, mobility, and semiconductors on essential fluorochemistries,” including PFAS. Third-party experts in environmental and economic policy engaged by the Chamber evaluated the economic and fiscal impacts of specific sectors reliant on essential fluorochemistries across the U.S. economy. The report primarily addresses the key uses of fluoropolymers, fluorinated gases (f-gases), and other fluorinated substances, such as heat transfer fluids. More information is available in our September 12, 2024, blog item.

EWG Roadmap Provides Comprehensive Plan On How Next President Can Address PFAS: On August 15, 2024, the Environmental Working Group (EWG) proposed a comprehensive plan for steps the next presidential administration should take to address PFAS. The priority actions EWG suggests for agencies include:

• DOD: Ensure safe drinking water for affected communities, end PFAS use in firefighting foam, and increase funding for cleanup efforts;

• EPA: Double funding for PFAS programs, enhance protection for air, water, and food, and enforce stricter controls on industrial discharges; and

• FDA: Permanently ban PFAS in food packaging, set limits on PFAS in foods, and assess safer alternatives for drugs and medical devices.

Canada Begins 60-Day Comment Period On Computational Tool For Chemical Screening And Prioritization: As part of its implementation of the modernized Canadian Environmental Protection Act, 1999 (CEPA), on August 17, 2024, Health Canada published a Canada Gazette notice announcing the availability of its Science Approach Document — Chemical Screening and Prioritization: Health Canada’s Automated Workflow for Prioritization (HAWPr). The science approach document (SciAD) describes the scientific approach that Canada applied to more than 25,000 chemicals on the Domestic Substances List (DSL) to prioritize their risk to human health based on their inherent hazard properties, current use in products, and quantities in commerce. Preliminary results for the use of the HAWPr on the DSL substances are available as a supporting document to this approach. Canada is providing a public consultation on the SciAD in advance of using this information in prioritization activities to allow the public to comment and provide additional information on the approach and its application to the DSL. Comments are due October 16, 2024.

EPA Announces Availability Of Final IRIS Assessment Of Formaldehyde (Inhalation): EPA announced on August 20, 2024, the posting of the final IRIS Toxicological Review of Formaldehyde (Inhalation). According to EPA, “[t]he assessment finds that formaldehyde inhalation for a lifetime can result in various noncancer health effects, including sensory irritation, respiratory tract pathology, male reproductive toxicity, decreased pulmonary function, increased frequency of current asthma symptoms or difficulty controlling asthma, and increased allergic responses, and other potential health effects.” EPA notes that children with allergies or asthma may be especially vulnerable. The assessment includes a new Reference Concentration (RfC) based on evidence of decreased pulmonary function, increased frequency of current asthma symptoms or difficulty controlling asthma, and increased allergic responses. EPA states that the assessment “also concludes that formaldehyde is ‘carcinogenic to humans,’ EPA’s strongest cancer classification, based on evidence demonstrating that it causes nasal cancers and myeloid leukemia.” EPA has developed an estimate of increased cancer risk from lifetime inhalation exposure. This cancer inhalation unit risk (IUR) is based on nasal cancer.

DPR Announces Updated CalPEST Launch Date: On August 20, 2024, the California Department of Pesticide Regulation (DPR) announced it will launch its electronic pesticide registration system, the California Pesticide Electronic Submission Tracking (CalPEST), on September 24, 2024. The launch of CalPEST will convert its paper-based pesticide registration process to a streamlined electronic system. According to DPR, it is conducting the final stages of testing and has identified areas for improvement in system functionality and security that must be addressed prior to launch. The original launch date of August 27, 2024, was updated to September 24, 2024. More information on the launch of CalPEST is available in our August 23, 2024, blog item.

Petitions Filed To Add Several Chemicals To List Of Taxable Substances; Comments Due November 4, 2024: On September 3, 2024, the Internal Revenue Service (IRS) announced that petitions have been filed to add the following chemicals to the list of taxable substances:

Comments and requests for a public hearing are due November 4, 2024. More information is available in our September 11, 2024, blog item.

White House OSTP Releases PFAS Federal R&D Strategic Plan: The White House Office of Science and Technology Policy (OSTP) announced on September 3, 2024, the release of its Per- and Polyfluoroalkyl Substances (PFAS) Federal Research and Development Strategic Plan (Strategic Plan). Prepared by the Joint Subcommittee on Environment, Innovation, and Public Health PFAS Strategy Team (PFAS ST) of the National Science and Technology Council, the Strategic Plan provides a federal strategy and implementation plan for addressing the strategic areas identified in the 2023 PFAS Report. The Strategic Plan is intended to be a companion document to the PFAS Report. The activities described in the Strategic Plan are reviewed through the Office of Management and Budget (OMB) annual budget process and subject to available resources. More information on the Strategic Plan will be available in a forthcoming memorandum.

EPA Issues Final Policy For Meaningful Engagement And Public Participation In Agency Decision-Making Processes: On September 5, 2024, EPA announced the release of the final Achieving Health and Environmental Protection Through EPA’s Meaningful Engagement Policy. The new policy outlines updates on how the Agency intends to engage with the public and provide meaningful public participation opportunities in all of its programs and regions. According to EPA, the policy “highlights three steps to help EPA staff design appropriate and effective processes for meaningful engagement and public participation for a particular action or situation, recognizing that engagement processes will need to be tailored to meet different program or decision contexts, and the people we serve”:

• Understanding EPA actions and key issues the public can inform;

• Identifying the expected level of participation using EPA’s public participation spectrum; and

• Identifying the appropriate engagement tools and practices using EPA’s public participation model.

SEC Announces Settlement With Keurig For Statements Regarding The Recyclability Of K-Cups: The U.S. Securities and Exchange Commission (SEC) announced on September 10, 2024, that it charged Keurig Dr Pepper Inc. (Keurig^®) with making inaccurate statements regarding the recyclability of its K-Cup^® single use beverage pods. The SEC found that Keurig violated Section 13(a) of the Securities Exchange Act of 1934 and Rule 13a-1 thereunder. Without admitting or denying the findings in the order, Keurig agreed to a cease-and-desist order and to pay a civil penalty of $1.5 million. More information is available in our September 10, 2024, blog item.

USDA Updates Guideline On Substantiating Animal-Raising Or Environment-Related Labeling Claims: The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) announced on September 10, 2024, the availability of an updated version of its guideline on documentation needed to support animal-raising or environment-related claims on meat or poultry product labeling. 89 Fed. Reg. 73253. According to FSIS, the updated guideline includes changes made in response to updated scientific information, FSIS sampling data, askFSIS questions, public comments, petitions, and other meetings with USDA stakeholders. FSIS “strongly encourages” the use of third-party certification to substantiate animal-raising or environment-related claims. FSIS states that third-party certification of animal-raising or environment-related claims “helps ensure that such claims are truthful and not misleading by having an independent organization verify that standards are being met on the farm for the raising of animals and the use of environmentally supportive practices.” The guidance document identifies criteria that ensure a third-party certification organization is credible and reliable. Comments are due November 12, 2024.

EPA Will Hold September 19, 2024, Webinar On “A Safer Choice For Cleaning: Increasing Access To Products With Safer Ingredients”: EPA will hold a webinar on September 19, 2024, on “A Safer Choice for Cleaning: Increasing Access to Products with Safer Ingredients.” Jennie Romer, EPA Deputy Assistant Administrator for Pollution Prevention, will host a webinar on how EPA’s Safer Choice program helps people find and have access to cleaning and other products made with safer ingredients and how the program works in partnership with a broad range of stakeholders to prevent pollution. More information is available in our August 30, 2024, blog item.

ORD And NICEATM Will Hold Workshop On Advancing Quantitative Analysis In Human Health Assessments Through Probabilistic Methods: On October 7-8, 2024, EPA’s Office of Research and Development (ORD), in conjunction with the National Toxicology Program’s (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), is convening a workshop to facilitate discussion of probabilistic methods in human health risk assessment. The workshop will provide an overview of past implementation of probabilistic methods in risk assessments, highlight ongoing research, and discuss the needs and challenges of regular use of these methods. The workshop will take place as a hybrid meeting (both in person at the EPA Research Triangle Park (RTP) campus in North Carolina and virtually) and is open to all members of the public. For those participating in person, a poster session will be conducted with abstract submissions available during registration. In-person participation will be capped at the first 150 participants and poster abstracts will be capped at the first 40 submissions.

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