Recent Federal Developments for February 2024
TSCA/FIFRA/TRI
EPA Announces Automatic Addition Of Seven Additional PFAS To TRI List Of Chemicals: The U.S. Environmental Protection Agency (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). EPA states that as of January 1, 2024, facilities that are subject to reporting requirements for these chemicals should begin tracking their activities involving these PFAS as required by Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA). Reporting forms will be due by July 1, 2025. EPA notes that these seven newly added PFAS, along with the previous 189 TRI-listed PFAS, are also subject to EPA’s action in October 2023 to classify all PFAS subject to TRI reporting as chemicals of special concern. Among other impacts, this removes the use of a reporting exemption that allowed facilities to avoid reporting information on PFAS when those chemicals were used in small concentrations. More information is available in our October 24, 2023, blog item.
EPA Extends Review Period For CBI Claims For The Identity Of Chemicals On The TSCA Inventory: EPA announced on January 24, 2024, that it is extending the review period for confidential business information (CBI) claims for specific identity of all active chemical substances listed on the confidential portion of the Toxic Substances Control Act (TSCA) Inventory submitted to EPA under TSCA. 89 Fed. Reg. 4605. EPA states that it “has determined that an extension of the statutory review period for the review of CBI claims under TSCA are necessary to allow the Agency to complete the required reviews under TSCA.” According to EPA, the additional time is necessary “given the volume of submissions that require review, information technology issues, and other legal and administrative delays that have affected the review process.” EPA extended the review period to February 19, 2025. As this extended deadline approaches, EPA may further extend the deadline as necessary to complete the reviews.
EPA Will Hold Webinar On February 20, 2024, On Five Chemicals Undergoing TSCA Prioritization: On January 31, 2024, EPA announced that it will hold a webinar on February 20, 2024, at 1:00 – 4:00 p.m. (EST) on the five chemicals currently undergoing prioritization under TSCA. EPA states that the webinar is open to all, “but EPA is particularly interested in learning more about how these chemicals are used and how people could potentially be exposed at different points in a chemical’s lifecycle. EPA is also interested in hearing from members of communities who may be impacted by chemical exposures.” Registration is open. More information is available in our February 9, 2024, blog item.
EPA Accepting Comments On Candidates For TSCA SACC Membership: EPA announced on January 31, 2024, a 30-day public comment period on candidates currently under consideration for membership on the TSCA Science Advisory Committee on Chemicals (SACC). EPA notes that there are currently 18 SACC members, with eight membership terms that will soon expire. The expiring membership terms are eligible for reappointments. Therefore, up to eight new appointments or a mix of reappointments and new appointments are possible during this membership cycle. EPA will use comments received to assist it in making SACC membership decisions by June 2024. Biographies for all interested and available candidates under consideration are available in docket EPA-HQ-OPPT-2023-0521. In addition, biographies for current SACC members are available on the TSCA SACC website.
EPA Releases Guidance To Clarify How It Will Evaluate “Absence Of An Ingredient” Claims For Pesticides: On February 1, 2024, EPA released guidance to clarify how it will evaluate “absence of an ingredient” claims for pesticide products regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA states that it is aware that the regulated community seeks clarity on whether and how “absence of an ingredient” claims can be made lawfully on FIFRA-regulated product labels. For more information on EPA’s guidance, please see our February 8, 2024, blog item.
EPA Releases Final TSCA Fees Rule: On February 8, 2024, EPA announced its final amendments to the 2018 final rule that established fees for the administration of TSCA. The final rule includes changes to the fee amounts and EPA’s total costs for administering TSCA; exemptions for entities subject to the EPA-initiated risk evaluation fees; exemptions for test rule fee activities; modifications to the self-identification and reporting requirements of EPA-initiated risk evaluation and test rule fees; modifications to EPA’s proposed methodology for the production-volume-based fee allocation for EPA-initiated risk evaluation fees in any scenario in which a consortium is not formed; expanded fee requirements to companies required to submit information for test orders; modifications to the fee payment obligations of processors subject to test orders and enforceable consent agreements (ECA); and extended timeframes for certain fee payments and notices. The final rule will be effective 60 days after publication in the Federal Register. EPA has posted a pre-publication version of the rule. More information is available in our February 14, 2024, memorandum.
EPA Announces Experts For Letter Peer Review Of TCEP Draft Risk Evaluation: EPA announced on February 14, 2024, the list of ten scientific experts selected to review the 2023 draft risk evaluation for tris(2-chloroethyl) phosphate (TCEP) under TSCA. Biographies of these experts are available in docket EPA-HQ-OPPT-2023-0265. EPA states that it will hold a virtual public meeting on March 5, 2024, to review the documents and draft charge questions being posed to the reviewers and address any questions from reviewers and the public regarding the scope and clarity of the questions. EPA notes that the meeting “also gives the public the opportunity to ask questions about the documents with the letter peer reviewers present.” Registration is open until March 1, 2024, to attend the meeting. EPA expects the letter peer review to begin on March 13, 2024. More information on EPA’s draft risk evaluation is available in our December 21, 2023, memorandum.
EPA Releases New Methodology To Detect Low Levels Of PFAS In HDPE Containers: On February 15, 2024, EPA released a new methodology for detecting 32 PFAS in high-density polyethylene (HDPE) containers. According to EPA, the method can accurately identify PFAS contamination at levels as low as 0.002 parts per billion (ppb) (or 2 parts per trillion (ppt)). EPA states that in releasing this method to the public, it “is enabling the industries that utilize HDPE containers, including container manufacturers, to test the containers before use, preventing PFAS contamination of pesticides and other products stored in HDPE plastic containers.” EPA notes that the method also has wide applicability for other industries, as it can be modified to test for PFAS in additional solid samples such as fabric, packaging paper, and more. More information will be available in a forthcoming memorandum.
Deadline For Filing Annual Pesticide Production Reports — March 1, 2024: The March 1, 2024, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2023 reporting year is fast approaching. Pursuant to FIFRA Section 7(c)(1) (7 U.S.C. § 136e(c)(1)), “Any producer operating an establishment registered under [Section 7] shall inform the Administrator within 30 days after it is registered of the types and amounts of pesticides and, if applicable, active ingredients used in producing pesticides” and this information “shall be kept current and submitted to the Administrator annually as required.” Reports must be submitted on or before March 1 annually for the prior reporting year’s production and distribution. The report, filed through the submittal of EPA Form 3540-16: Pesticide Report for Pesticide-Producing and Device-Producing Establishments, must include the name and address of the producing establishment; and pesticide production information, such as product registration number, product name, and amounts produced and distributed. The annual report is always required, even when no products are produced or distributed. More information regarding the submission of the annual pesticide production reports is available in our January 31, 2024, blog item.
RCRA/CERCLA/CWA/CAA/PHMSA/SDWA
EPA Proposes Waste Emissions Charge For Petroleum And Natural Gas Systems: On January 26, 2024, EPA proposed a regulation to implement the requirements of the Clean Air Act (CAA) as specified in the Methane Emissions Reduction Program of the Inflation Reduction Act. 89 Fed. Reg. 5318. According to the notice, 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. 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. Comments are due March 11, 2024. EPA states 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 by February 26, 2024.
EPA Releases Draft 6PPD-Quinone Water Testing Method For Widespread Use: EPA announced on January 30, 2024, the publication of a draft testing method (EPA Method 1634) that will enable government agencies, Tribes, and other groups to determine where and when 6PPD-quinone is present in local stormwater and surface waters. As reported in our November 3, 2023, blog item, 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. 6PPD reacts with ozone in the air to form 6PPD-quinone. EPA notes that Agency-funded research in 2020 found 6PPD-quinone to be linked to the deaths of coho salmon in urban Puget Sound streams. Runoff containing 6PPD-quinone is washed from parking lots and streets into streams and other bodies of water. More information is available in our February 5, 2024, blog item.
EPA Proposes To Modify The Definition Of Hazardous Waste And Add Multiple PFAS As Hazardous Constituents: EPA announced on February 1, 2024, two proposed rules that will add to its comprehensive approach to tackling PFAS pollution and the commercial bottom line for hundreds of businesses facing costs for cleanup. The first proposed rule would modify the definition of hazardous waste as it applies to cleanups at permitted hazardous waste facilities. 89 Fed. Reg. 8598. EPA states that this modification “would assure that EPA’s regulations clearly reflect EPA’s and authorized states’ authority to require cleanup of the full range of substances that the Resource Conservation and Recovery Act (RCRA) intended, including emerging chemicals of concern, such as PFAS, that may present substantial hazards, at permitted facilities.” Comments are due March 11, 2024. The second proposed rule would amend the RCRA regulations to add multiple PFAS compounds as hazardous constituents. 89 Fed. Reg. 8606. According to EPA, these PFAS “would be added to the list of substances identified for consideration in facility assessments and, where necessary, further investigation and cleanup through the corrective action process at hazardous waste treatment, storage and disposal facilities [TSDF].” Comments on the second proposed rule are due April 8, 2024. More information on the proposed rules is available in our February 5, 2024, memorandum.
EPA Will Lower Primary (Health-Based) Annual PM2.5 Standard: EPA announced on February 7, 2024, a final rule that will lower the National Ambient Air Quality Standards (NAAQS) for fine particle pollution, also known as fine particulate matter (PM2.5). EPA will lower the primary (health-based) annual PM2.5 standard from 12 micrograms per cubic meter (μg/m3) to 9.0 μg/m3 to reflect new science on harms caused by particle pollution. EPA is retaining the current primary 24-hour PM2.5 standard and the primary 24-hour PM10 standard. EPA also is not changing the secondary 24-hour PM2.5 standard, secondary annual PM2.5 standard, and secondary 24-hour PM10 standard at this time. EPA is also revising other key aspects related to the PM NAAQS, including revisions to the Air Quality Index (AQI) and monitoring requirements for the PM NAAQS. The final rule will take effect 60 days after publication in the Federal Register. More information is available on EPA’s website.
EPA Announces Availability Of Integrated Science Assessment For Lead: EPA announced on February 7, 2024, the availability of a final document entitled Integrated Science Assessment for Lead (EPA/600/R–23/375). 89 Fed. Reg. 8425. The Center for Public Health and Environmental Assessment within EPA’s Office of Research and Development (ORD) prepared the document as part of the review of the primary (health-based) and secondary (welfare-based) lead NAAQS and represents an update of the 2013 Integrated Science Assessment (ISA) for Lead (EPA/600/R–10/075F). The final lead ISA, in conjunction with additional technical and policy assessments, will provide the scientific foundation for EPA’s decisions on the adequacy of the current lead NAAQS and, if appropriate, on potential alternative standards.
Draft Inventory Of U.S. Greenhouse Gas Emissions And Sinks: 1990-2022 Available For Comment: EPA announced on February 14, 2024, the availability of the Draft Inventory of U.S. Greenhouse Gas Emissions and Sinks: 1990-2022 for public review. 89 Fed. Reg. 11275. EPA requests recommendations for improving the overall quality of the inventory report to be issued in final in April 2024, as well as subsequent inventory reports. Comments are due March 15, 2024. EPA states that it will consider comments received after that date for the next edition of this report.
FDA
FDA Launches Traceability Video Series: On January 24, 2024, the U.S. Food and Drug Administration (FDA) published the first video in an educational series focused on how food companies’ use of tech-enabled traceability can enhance food safety and protect consumers from foodborne illness. The first video, available at the link here, focuses on Supply Chain Technology and builds on key themes from the 2021 FDA New Era of Smarter Food Safety Low- or No-Cost Tech-Enabled Traceability Challenge. Additional information is available at the link here.
FDA Announces Priorities For 2024: On January 25, 2024, FDA announced the following five new priority topics:
- Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry;
- Action Levels for Lead in Food Intended for Babies and Young Children: Guidance for Industry;
- The Food Traceability Rule: Questions and Answers; Draft Guidance for Industry;
- Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 12: Preventive Controls for Chemical Hazards: Draft Guidance for Industry; and
- Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2): Draft Guidance for Industry.
FDA expects to publish guidance for each of these topics by the end of December 2024. A list of other topics FDA is considering releasing guidance documents on is available at the link here.
FDA Releases Draft Guidance For Conducting Remote Regulatory Assessments: On January 26, 2024, FDA announced the availability of a revised draft guidance for industry entitled “Conducting Remote Regulatory Assessments—Question and Answers.” 89 Fed. Reg. 5244. The draft guidance, describing FDA’s current thinking regarding its use of remote regulatory assessments (RRA), has been updated to address public comments and recent amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA). It is FDA’s view that “use of both mandatory and voluntary RRAs, as applicable, for all types of FDA-regulated products is in the interest of the public health,” and the draft guidance is issued “to provide further transparency to stakeholders about the circumstances in which mandatory and voluntary RRAs may be used.” A full copy of the draft guidance is available at the link here. FDA is accepting comments until March 26, 2024.
FDA Releases Video About What FDA Does And Does Not Approve: On January 26, 2024, FDA released a video and companion web page listing ten facts about products that are, and are not, regulated by FDA. The list of facts focuses on common consumer products, such as dietary supplements, sunscreen, and cosmetics. Additional information, on a page titled “Rumor Control,” is available at the link here. These resources provide insight that many entering into this space may find beneficial, especially in the exploration of new potential markets regulated by FDA.
FDA Releases Draft Hazard Analysis And Risk-Based Preventive Controls For Human Food Guidance: On February 2, 2024, FDA announced the availability of a revised draft Introduction and a revised draft Appendix 1 within a multichapter guidance for industry entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food.” 89 Fed. Reg. 7315. This multichapter draft guidance is one component of the Food Safety Modernization Act (FSMA). This multichapter draft guidance, when final, will explain FDA’s current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under the rule entitled ‘‘Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.’’ FDA states that it “revised the draft Introduction and draft Appendix 1: Known or Reasonably Foreseeable Hazards (‘Potential Hazards’) to address comments submitted on drafts that we made available in 2016. This draft guidance is not final nor is it in effect at this time.” FDA is accepting comment until June 3, 2024.
NANOTECHNOLOGY
OECD Tour De Table Includes Information On U.S. Developments On The Safety Of Manufactured Nanomaterials: The Organization for Economic Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials and Advanced Materials — Tour de Table. The Tour de Table compiles information provided by delegations on the occasion of the 23rd meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in June 2023. The Tour de Table lists U.S. developments on the human health and environmental safety of nanomaterials. More information is available in our February 13, 2024, blog item.
NIOSH Collaborates Globally On Workplace Safety Of Nanomaterials: On February 1, 2024, the National Institute for Occupational Safety and Health (NIOSH) posted a NIOSH Science Blog item entitled “NIOSH Global Collaborations on Workplace Safety of Nanomaterials.” According to the blog item, NIOSH’s global collaboration efforts “build on the strong NIOSH [Nanotechnology Research Center (NTRC)] research and guidance efforts contributing to the global technical information and guidance about protecting workers and aim to facilitate international collaborations for research and for development and dissemination of guidance and training to protect workers not only nationally, but also worldwide from the potential risks of manufactured nanomaterials.” More information is available in our February 9, 2024, blog item.
NNI Holds Webinar On Nanometrology For Food, Agriculture, And Environment: The National Nanotechnology Coordination Office (NNCO) is organizing a series of National Nanotechnology Initiative (NNI) webinars on nanometrology, metrological challenges, and recent advances in three topical areas: food, agriculture, and environment; nanoscale medical and pharmaceutical products; and electronics. The second webinar in the series, Nanometrology for Food, Agriculture, and Environment, was held February 2, 2024.
EUON Announces New Tender Notices Published By ECHA: The European Union (EU) Observatory for Nanomaterials (EUON) announced on February 5, 2024, that the European Chemicals Agency (ECHA) has published two new ex-ante publicity notices for two service contracts:
More information is available in our February 5, 2024, blog item.
ECHA Survey On Nano-Agrochemicals Will Close February 29, 2024: ECHA has commissioned, as part of EUON’s activities, a study on the collection and review of information on nanomaterial-based and nano-enabled plant protection products, biocidal products, and fertilizing products. The study includes a systematic literature and documentary review on nanoforms of (active) substances and delivery systems of the corresponding formulations used in biocidal products, plant protection products, and/or fertilizing products. The study also involves the collection of information from key stakeholders across the EU (and beyond) through questionnaires and interviews. The survey will close February 29, 2024, at 18:00 (CET).
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
Senate Legislation Introduced To Research The Impact Microplastics Have On Healthy Farming Practices: On January 18, 2024, Senator Jeff Merkley (D-OR) introduced the Research for Healthy Soils Act (S. 3623) to research the impact of microplastics on biosolids and the overall health and safety of farming practices. Merkley’s January 18, 2024, press release states that biosolids “are a valuable product of the wastewater treatment process that can be applied as fertilizer to agricultural land to add nutrients to the soil and improve soil structure.” According to the press release, “studies have shown that biosolids may contain microplastics, with a recent study estimating that land application of biosolids in the U.S. could annually release 785-1,080 trillion microplastics into the environment.” Additional research is needed to understand the amount of microplastics in biosolids to understand better the potential impacts on soil health, crops, public health, and the environment. The bill would authorize the U.S. Department of Agriculture (USDA) to make grants available to study the incidence and impacts of microplastics in biosolids on farmland. Representative Marie Gluesenkamp Perez (D-WA) introduced companion legislation in the House on July 28, 2023.
Senate Committee Holds Hearing On TSCA Implementation: The Senate Environment and Public Works Committee held a hearing on January 24, 2024, on “Oversight of Toxic Substances Control Act Amendments Implementation.” Michal Freedhoff, Ph.D., Assistant Administrator (AA) of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) was the Committee’s sole witness. Committee Chair Tom Carper (D-DE) and Ranking Member Shelley Moore Capito (R-WV) provided opening statements. On the whole, no new ground was broken, and the takeaway is that everyone — EPA, the Hill, and industry — remains frustrated with TSCA’s implementation, but for very different reasons. More information and an insightful commentary is available in our January 29, 2024, memorandum.
Bipartisan Legislation Would Improve Soil Health And Sustainability On Farms: On January 25, 2024, Representative Don Beyer (D-VA) introduced the Innovative Practices for Soil Health Act (H.R. 7076), bipartisan legislation intended to improve soil health on farms and support sustainable alternatives to annual agriculture by improving USDA conservation programs to ensure they are better able to support farmers who incorporate perennial systems and agroforestry into their operations. According to Beyer’s January 25, 2024, press release, annual crops and monoculture cropping require tilling that disrupts the natural soil structure and can lead to increased erosion and a reliance on fertilizers and pesticides. The press release states that “[p]erennial and agroforestry systems require less soil disturbance — improving soil structure, preventing erosion, increasing ecosystem nutrient retention, and promoting carbon sequestration.”
No IRIS Act Introduced In Congress: On February 1, 2024, Senator John Kennedy (R-LA) introduced the No Industrial Restrictions In Secret Act (No IRIS Act) (S. 3724) to prevent EPA from using data from the Integrated Risk Information System (IRIS) “to make rules against America’s chemical manufacturing industry.” According to Kennedy’s February 1, 2024, press release, the bill would prohibit the federal government from using IRIS to inform its rulemakings unless Congress “explicitly authorizes the program.” Representative Glenn Grothman (R-WI) introduced companion legislation (H.R. 7284) in the House on February 7, 2024.
PFAS Accountability Act Would Amend TSCA To Create A Federal Cause Of Action: Representative Madeleine Dean (D-PA) reintroduced the PFAS Accountability Act (H.R. 7194) on February 1, 2024. According to Dean’s February 1, 2024, press release, the bill would create a federal cause of action and allow courts to award medical monitoring for victims of PFAS exposure. Senator Kirsten Gillibrand (D-NY) reintroduced the bill (S. 3725) in the Senate on February 1, 2024. Gillibrand’s February 1, 2024, press release states that the bill would:
- Establish a cause of action under TSCA for those who have been significantly exposed to PFAS against manufacturers. An individual would be considered significantly exposed if they demonstrate that they were present in an area where PFAS was released for at least one year or get blood testing done that demonstrates PFAS exposure;
- Make it easier for courts to award medical monitoring for victims of significant PFAS exposure: A court would be able to award medical monitoring if, as a result of significant exposure, the individual or class has suffered an increased risk of developing a disease associated with exposure to PFAS and there is a reasonable basis for the individual or class to undergo periodic medical monitoring for diseases associated with PFAS exposure. Medical monitoring programs for victims of hazardous exposures are used for early detection and treatment of adverse health conditions related to the exposure; and
- Incentivize industry to fund PFAS safety research. A court would be permitted to order new or additional epidemiological, toxicological, or other studies or investigations of new PFAS as part of a medical monitoring remedy.
Sound Science For Farmers Act Introduced In The Senate: On February 1, 2024, Senate Ted Budd (R-NC) introduced the Sound Science for Farmers Act (S. 3719). According to Budd’s February 1, 2024, press release, the bill creates accountability and scientific quality standards for EPA assessments, risk evaluations, and regulatory actions for existing chemicals that “impact America’s farmers and producers.” The press release states that the bill would:
- Require EPA to provide assessments, evaluations, or regulations to other agencies (including USDA, FDA, and the Small Business Administration (SBA)), for at least 90 days and follow Executive Order and docketing requirements for interagency comments; and
- Ensure a full, open peer review of EPA draft or final assessments, evaluations, or regulations with an impact on agriculture, including for scientific quality, transparency, reproducibility of key results, effects on the agricultural sector, and consideration of real-world exposure.
MISCELLANEOUS
Multistate Coalition Supports EPA’s Proposed Revisions To The Safer Choice Standard: As reported in our December 5, 2023, memorandum, EPA proposed updates to the Safer Choice Standard on November 14, 2023, that 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. On January 16, 2024, California Attorney General Rob Bonta announced that, alongside a coalition of 12 attorneys general, he submitted a comment letter that:
- Supports EPA’s proposed revisions to its Safer Choice Standard;
- Recommends that EPA not allow products with plastic primary packaging to use the Safer Choice label or DfE logo;
- Recommends that if EPA does allow products with plastic primary packaging to use the label and logo, EPA should prohibit the use of chemical recycling in meeting the proposed standard’s plastic packaging recycled content requirements; and
- Calls on EPA to exclude any products or packaging that contain any PFAS, “whether intentionally introduced or not.”
ATSDR Announces Availability Of Draft Toxicological Profiles: The Agency for Toxic Substances and Disease Registry (ATSDR) announced on January 19, 2024, the opening of a docket to obtain comments on drafts of two updated toxicological profiles: chloroform and chloroethane. ATSDR states that all toxicological profiles issued as “Drafts for Public Comment” represent the result of its “evidence-based evaluations of the available literature to provide important toxicological information on priority hazardous substances to the public and health professionals.” ATSDR considers key studies during the profile development process, using a systematic review approach. ATSDR seeks public comments and additional information or reports on studies about the health effects of these substances for review and potential inclusion in the profiles. Written comments are due April 18, 2024. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion in the profiles.
EPA Releases Draft Updates To Its Scientific Integrity Policy For Public Comment: On January 24, 2024, EPA began a 30-day public comment period on the draft updates to its Scientific Integrity Policy (Policy). 89 Fed. Reg. 4606. EPA states that in accordance with the requirements of the 2021 Presidential Memorandum on Restoring Trust in Government Through Scientific Integrity and Evidence-based Policymaking, it is revising its Policy. The updated Policy will adopt a new federal definition of scientific integrity and “meaningfully strengthen several policy elements that will help ensure a culture of scientific integrity at the Agency.” EPA notes that it will incorporate the model scientific integrity policy from the National Science and Technology Council’s A Framework for Federal Scientific Integrity Policy and Practice (2023), lessons learned over the years, and the results of previous surveys of EPA staff on scientific integrity. Comments are due February 23, 2024. More information is available in our February 2, 2024, memorandum.
OSHA Publishes Directive On PSM Of Highly Hazardous Chemicals: On January 26, 2024, the Occupational Safety and Health Administration (OSHA) published Directive CPL 02-01-065, establishing OSHA’s enforcement policy for its standard for Process Safety Management (PSM) of Highly Hazardous Chemicals, 29 C.F.R. Section 1910.119 (PSM standard), and references to it in 29 C.F.R. Sections 1926.64 and 1910.109. The Directive instructs OSHA enforcement personnel on the agency’s interpretations of those standards. The Directive cancels the OSHA Instruction CPL 02-02-045A (REVISED), September 13, 1994, and provides enforcement policy concerning the application of occupational safety and health standards in facilities with PSM-covered processes. Significant modifications include:
- Removal of the Appendix A PQV Audit Checklist in the OSHA Instruction CPL 02-02-045A (REVISED), September 13, 1994; and
- Incorporation of existing OSHA PSM enforcement policies into a question and response format.
EPA Accepting Applications For 2024 Safer Choice Partner Of The Year Awards: EPA announced on January 31, 2024, that it has begun accepting applications for the 2024 Safer Choice Partner of the Year Awards. 89 Fed. Reg. 6116. EPA states in its press release that, “[i]n support of the Biden-Harris Administration’s goals, EPA especially encourages submission of award applications that show how the applicant’s work involving products with safer chemical ingredients promotes environmental justice, bolsters resilience to the impacts of climate change, results in cleaner air or water, improves drinking water quality or advances innovation in packaging.” Submissions are due April 25, 2024. EPA will recognize award winners at a ceremony later in 2024.
Protocol For The Uranium IRIS Assessment (Oral) Available For Public Comment: EPA announced on February 14, 2024, a 30-day public comment period for the Protocol for the Uranium IRIS Assessment (Oral). 89 Fed. Reg. 11275. EPA states that this document “communicates the rationale for conducting the human health assessment of natural and/or depleted uranium via oral exposure, 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 March 15, 2024.
EPA Will Hold External Peer Review Meeting On Draft IRIS Toxicological Review Of PFHxS And Related Salts: The draft IRIS toxicological review of perfluorohexanesulfonic acid (PFHxS) and related salts is undergoing independent external scientific peer review managed by ERG, a contractor to EPA. ERG is organizing a public peer review meeting that will take place virtually via Zoom over three days:
- February 26, 2024, 10:00 a.m. to 4:00 p.m. (EST);
- February 27, 2024, 10:00 a.m. to 4:00 p.m. (EST); and
- March 1, 2024, 11:00 a.m. to 2:00 p.m. (EST).
Members of the public may attend as observers. Time will be set aside for oral public comments on the first day of the peer review meeting. Stakeholders must register through links on EPA’s website to attend the peer review meeting as an observer or to register to make an oral comment.
EPA Releases 2023 Update To Equity Action Plan: EPA announced on February 14, 2024, the release of the 2023 update to its Equity Action Plan, as part of the Biden-Harris Administration’s whole-of-government equity agenda. Following robust engagement with community stakeholders, EPA states that it identified eight priority strategies, including four previously identified priorities carried forward from the 2022 Equity Action Plan and four newly identified strategies to support communities that have been historically underserved, as well as all communities across the United States:
- Improve Access for Communities to Federal Assistance;
- Reduce Cumulative Impacts and Health Disparities;
- Strengthen EPA’s Civil Rights Compliance Program;
- Protect Children from Exposures to Environmental Harms;
- Address Inequitable Access to Resources for Rural Communities;
- Ensure Public Access to EPA Programs and Address Environmental Harms for People with Disabilities;
- Strengthen Community-Based Participatory Science to Achieve Environmental Equity; and
- Improve Data and Analytic Capacity to Better Identify and Remove Barriers.
This Update is provided as a complimentary service to our clients and is for informational purposes. This Update may be copied or quoted, provided proper attribution is given. The contents are not intended and cannot be considered as legal advice.