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Wrap-Up of Federal and State Chemical Regulatory Developments, September 2023

By Bergeson & Campbell, P.C.
Sep 18, 2023

TSCA/FIFRA/TRI

EPA Posts Resources On Rule To Accelerate Use Of PIPs: The U.S. Environmental Protection Agency (EPA) announced on August 4, 2023, that it is providing resources to help biotechnology developers exercise the full benefits of the exemptions available under the Plant Incorporated Protectants (PIP) exemption rule. These resources are available on EPA’s public website and include the following:

The PIPs Exemption Final Rule went into effect on July 31, 2023. More information is available in our September 7, 2023, blog item.

EPA Issues Third TSCA Test Order For PFAS:EPA announced on August 15, 2023, that it issued the third Toxic Substances Control Act (TSCA) test order requiring testing on per- and polyfluoroalkyl substances (PFAS) under EPA’s National PFAS Testing Strategy. EPA has ordered the Chemours Company FC LLC, E. I. du Pont de Nemours and Company, and 3M Company to conduct and submit testing on 2,3,3,3-Tetrafluoro-2-(heptafluoropropoxy)propanoyl fluoride (HFPO-DAF), “a substance used as a reactant in organic chemical manufacturing.” EPA states that HFPO-DAF is known to be used to make the chemical hexafluoropropylene oxide dimer acid (HFPO-DA) (Chemical Abstracts Service Registry Number® (CAS RN®) 13252-13-6), also known by the trade name GenX. According to EPA, HFPO-DA is used in the production of nonstick coatings, stain repellent, and other consumer and industrial products and was widely used to replace perfluorooctanoic acid (PFOA). EPA notes that more than one million pounds of HFPO-DAF are manufactured each year, according to TSCA Chemical Data Reporting (CDR) rule reports. For more information, please read our August 29, 2023, memorandum.

EPA Announces Latest Update To The TSCA Inventory: On August 16, 2023, EPA announced the availability of the latest TSCA Chemical Substance Inventory. According to EPA, the Inventory contains 86,718 chemicals, of which 42,242 are active in U.S commerce. Other updates to the TSCA Inventory include updates to commercial activity data, unique identifier data, and regulatory flags (e.g., significant new use rules (SNUR) and test orders). EPA states that additionally, “approximately 500 substances are listed with their specific chemical identities after having been moved from the confidential portion of the Inventory to the public portion as part of ongoing TSCA confidential business information (CBI) review plan efforts.” EPA plans the next regular update of the TSCA Inventory for winter 2024.

EPA Releases Beta Version Of ChemExpo, A Tool For Exploring Chemical Use Data Relevant To Exposure Assessment:On August 22, 2023, EPA published ChemExpo, a free, publicly available search and visualization tool for exploring chemical use data relevant to exposure assessment that has been curated from public documents. According to EPA, the interactive web application focuses on data collected by EPA about how chemicals are used in commerce and how they occur in consumer and industrial products. EPA states that the ChemExpo team actively works to curate these data into consumer and occupational product categories, chemical functional categories, and exposure-relevant keywords, as well as to substance identifiers (DTXSID) used by EPA and the CompTox Chemicals Dashboard (Dashboard). The ChemExpo team welcomes any comments or reporting of issues via e-mail at chemexpo.support@epa.gov. EPA will incorporate user feedback into the final version of the application, along with that obtained via formal external peer review. More information is available in our August 24, 2023, blog item.

EPA Expands Alternate PCB Extraction Methods And Amends PCB Cleanup And Disposal Regulations: On August 29, 2023, EPA published a final rule expanding the extraction and determinative methods that can be used to characterize and verify the cleanup of polychlorinated biphenyls (PCB) waste under implementing regulations for PCB-related authority in TSCA. 88 Fed. Reg. 59662. The final rule includes several other amendments to the PCB regulations, including the amendment of the performance-based disposal option for PCB remediation waste; the removal of the provision allowing PCB bulk product waste to be disposed of as roadbed material; the addition of more flexible provisions for cleanup and disposal of waste generated by spills that occur during emergency situations (e.g., hurricanes or floods); harmonization of the general disposal requirements for PCB remediation waste; and other amendments to improve the implementation of the regulations, clarify ambiguity, and correct technical errors. The final rule will be effective February 26, 2024.

EPA Announces Release Of Final Guidance And Methods To Control Public Health Pathogens On Soft Surface Textiles In Non-Residential Settings: On August 29, 2023, EPA announced the release of final guidance and methods for evaluating efficacy claims of antimicrobial products registered to reduce bacteria and viruses on soft surface textiles. EPA states that throughout the guidance, the term “soft surface textile” refers to a soft, porous, or non-porous surface that includes the outer surface of non-clothing fabrics/textiles in clinical and institutional (non-residential) environments where spot treatment is the primary means of disinfection. EPA states the final guidance to support soft surface textile claims, the soft surface textile bacterial method, and the soft surface textile virus method supersede the interim guidance and methods EPA published on December 21, 2022. EPA has also published its response to comments received on the interim guidance and methods, which is available here. This guidance and associated test methods address only products with both soft surface textile disinfectant claims and hard, non-porous surface disinfectant claims for clinical and institutional settings (i.e., products that have only soft surface textile claims are not within the scope of this guidance). EPA also states that the new guidance is not intended to apply to claims on products for use on clothing, frequently laundered items, untreated wood, concrete and other hard porous materials, carpet or rugs, or the backing material/stuffing under the soft surface textile (e.g., beyond what can be visibly observed), and the guidance is not intended to address claims against mycobacterium, fungi, yeasts, or bacterial endospores, nor to address claims of residual efficacy on soft surface textiles. For more information on the final guidance and methods, please read our September 5, 2023, blog.

EPA Holds Webinar On Reviews Of New PFAS And New Uses Of Existing PFAS:EPA held a webinar on September 6, 2023, on its new framework (the Framework) for addressing new PFAS and new uses of existing PFAS under TSCA. According to EPA, the Framework outlines EPA’s planned approach when reviewing new PFAS and new uses of existing PFAS to ensure that, if allowed to enter into commerce, they will not be harmful to human health and the environment. EPA states that the Framework supports the Biden Administration’s commitment to address the impacts of PFAS and advances EPA’s PFAS Strategic Roadmap to confront the human health and environmental risks of PFAS. The Framework outlines EPA’s planned approach when reviewing new PFAS and new uses of PFAS to ensure that, before these chemicals are allowed to enter into commerce, EPA will undertake an extensive evaluation to ensure they pose no harm to human health and the environment. Under TSCA Section 5, EPA is required to review new chemicals, including new PFAS and new uses of PFAS, within 90 days, assess the potential risks to human health and the environment of the chemical, and make one of five possible risk determinations. When potential risks are identified, EPA must take action to mitigate those risks before the chemical can enter commerce. For more information, please read our August 21, 2023, memorandum.

EPA Opens Registration For 2023 Safer Choice Partner Of The Year Awards And Stakeholder Summit: EPA announced on September 7, 2023, that the upcoming 2023 Safer Choice Partner of the Year Awards Ceremony will be held October 2, 2023, and the Partner and Stakeholder Summit will be held October 3-4, 2023. EPA states that during the Partner of the Year Awards Ceremony, it will recognize the 2023 Safer Choice Partners of the Year “for their outstanding achievement in the design, manufacture, selection and use of products that meet the Safer Choice program’s stringent health and environment standards.” The Partner and Stakeholder Summit is a two-day meeting that will include informational sessions, panelist discussions, and networking opportunities with a focus on dialogue and developing solutions, which will help advance the Safer Choice program. Both events will be held at the Cooperative Plaza Conference Center in Arlington, Virginia, with virtual attendance options available. The events are free to attend, but registration is required. Registration is now open.

EPA Calls For Nominations For 2024 Green Chemistry Challenge Awards:announced on September 8, 2023, that it is now accepting nominations for the 2024 Green Chemistry Challenge Awards from companies or institutions that have developed a new green chemistry process or product that helps protect human health and the environment. The awards program highlights green chemistry that helps prevent pollution before it is even created, “making it a preferred approach for providing solutions to some of the nation’s most significant environmental challenges.” Nominations are due to EPA December 8, 2023. An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute will formally judge the 2024 nominations and make recommendations to EPA for the 2024 winners. EPA anticipates giving awards to outstanding green chemistry technologies in six categories in fall 2024. EPA will hold a webinar on September 20, 2023, to educate stakeholders on the Green Chemistry Challenge Awards and the nomination process. Registration for the webinar is open.

EPA Requests Public Comments On Candidates For Letter Peer Review Of White Paper For Asbestos Part 2 Risk Evaluation: On September 14, 2023, EPA requested comment on candidates under consideration to review the “2023 White Paper on the Quantitative Human Health Approach to be Applied in the Risk Evaluation for Asbestos Part 2” under TSCA. EPA states that it will be soliciting comments from the peer reviewers on the quantitative approach to assessing cancer and non-cancer risks for Part 2 of the risk evaluation for asbestos. Biographies of these candidates are available on regulations.gov. Comments are due September 28, 2023.

EPA Will Hold Virtual Training On High Throughput Toxicokinetic Modeling In November 2023: EPA will hold a two-day training on its high throughput toxicokinetic (HTTK) R package as part of its New Approach Methods (NAM) Training Program:

  • Day 1: Presentation and demo: Wednesday, November 8, 2023, 10 a.m. – 12 p.m. (EST); and
  • Day 2: Expert-led hands-on learning activity: Thursday, November 9, 2023, 10 a.m. – 12 p.m. (EST).

EPA’s goal for the two-day training is to familiarize those engaged in chemical exposure assessment, including researchers, regulators, and health and environmental safety professionals, with EPA’s generic and open-source models and data for toxicokinetic, including reverse dosimetry and physiologically based pharmacokinetic (PBPK) modeling for internal dose calculation.

RCRA/CERCLA/CWA/ CAA/PHMSA/SDWA

EPA Releases Initial Nationwide Monitoring Data On 29 PFAS And Lithium: On August 17, 2023, EPA announced the release of the first set of data collected under the fifth Unregulated Contaminant Monitoring Rule (UCMR 5). According to EPA, in the latest action to deliver on EPA’s PFAS Strategic Roadmap, UCMR 5 will provide new data that will improve its understanding of the frequency that 29 PFAS and lithium are found in U.S. drinking water systems, and at what levels. EPA states that the monitoring data on PFAS and lithium will help it make determinations about future actions to protect public health under the Safe Drinking Water Act (SDWA). More information is available in our August 21, 2023, blog item.

PHMSA Announces Second Set Of HMR FAQs For Comment: The U.S. Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) announced on August 18, 2023, that the second set of frequently asked questions (FAQ) based on historical letters of interpretation (LOI) applicable to the Hazardous Materials Regulation (HMR) is available for comment. 88 Fed. Reg. 56702. The second set of FAQs developed under the initiative concern immediate notice of certain hazardous materials incidents and detailed hazardous materials incident reports. The requirements for incident reporting and notification are outlined under Subpart B to Part 171 of the HMR. PHMSA states that specifically, Sections 171.15 and 171.16 address immediate notice of certain hazardous materials incidents and detailed hazardous materials incident reports. Section 171.15 provides criteria requiring immediate notification of unintentional hazardous materials releases to the National Response Center. Each person making a report under Section 171.15 is also required to fill out DOT Form F 5800.1 within 30 days of discovery of the incident as required by Section 171.16. According to PHMSA, “[o]ver the years, [Office of Hazardous Materials Safety (OHMS)] has received more than fifty requests for LOI concerning the provisions of” Section 171.15 and 171.16. Comments are due September 18, 2023.

EPA Announces New Review Of Ozone NAAQS To Reflect The Latest Science: On August 21, 2023, EPA announced a new review of the ozone National Ambient Air Quality Standards (NAAQS) “to ensure the standards reflect the most current, relevant science and protect people’s health from these harmful pollutants.” The press release states that EPA Administrator Michael Regan “reached this decision after carefully considering advice provided by the independent Clean Air Scientific Advisory Committee (CASAC).” In October 2021, EPA announced a reconsideration of the previous Administration’s decision to retain the NAAQS for ozone. EPA will incorporate the ongoing reconsideration into its review and will consider the advice and recommendations of the CASAC. EPA “will move swiftly to execute this new review of the underlying science and the standards — prioritizing transparency, scientific integrity, inclusive public engagement, and environmental justice.” On August 25, 2023, EPA invited stakeholders to assist it in developing and refining the scientific information base for the review of the ozone NAAQS by submitting research studies and data that have been published or accepted for publication since January 1, 2018. 88 Fed. Reg. 58264. All communications and information are due October 24, 2023.

EPA And Department Of The Army Revise Definition Of “Waters Of The United States” To Conform To Supreme Court Decision: On September 8, 2023, EPA and the Department of the Army amended the Code of Federal Regulations to conform the definition of “waters of the United States” to the Supreme Court’s 2023 decision, Sackett v. EPA. 88 Fed. Reg. 61964. The conforming rule amends the provisions of the agencies’ definition of “waters of the United States” that are invalid under the Supreme Court’s interpretation of the Clean Water Act (CWA) in the 2023 decision. While EPA’s and Army’s 2023 rule defining “waters of the United States” was not directly before the Supreme Court, EPA’s August 29, 2023, press release states that “the decision in Sackett made clear that certain aspects of the 2023 rule are invalid.” EPA notes that the amendments issued are limited and change only parts of the 2023 rule that are invalid under Sackett. For example, according to EPA, the final rule removes the significant nexus test from consideration when identifying tributaries and other waters as federally protected. The final rule was effective September 8, 2023.

EPA Proposes To Amend General Provisions For NESHAP: On September 13, 2023, EPA proposed to amend the General Provisions for National Emission Standards for Hazardous Air Pollutants (NESHAP) to address applicability and compliance issues resulting from the addition of a compound to the list of hazardous air pollutants (HAP) under the Clean Air Act (CAA). 88 Fed. Reg. 62711. According to EPA, this action focuses on issues related to newly applicable standards for sources that become major sources solely from the addition of a compound to the CAA HAP list. This action also includes a discussion of the impacts of a newly listed HAP on the federal operating permit program. Comments are due November 13, 2023.

EPA Announces Final Rule Intended To Strengthen Water Protections And Support Clear And Timely Reviews Of Infrastructure And Development Projects: EPA announced on September 14, 2023, a final rule intended to restore the fundamental authority granted by Congress to states, territories, and Tribes to protect water resources that are essential to healthy people and thriving communities. EPA states that its final CWA Section 401 Water Quality Certification Improvement Rule “will support clear, efficient, and focused water quality reviews of infrastructure and development projects that are key to economic growth.” According to EPA, the final rule will realign the scope of Section 401 certification with decades of established practice and restores and strengthens the role of states, territories, and authorized Tribes. The rule will enhance certification review and provide regulatory certainty to advance federally permitted projects. The rule will emphasize that states, territories, and Tribes may only consider the adverse water quality-impacts from the activity. To limit delays, the rule will also provide a clear approach to defining the required contents in a request for certification. More information is available on EPA’s website.

FDA

FDA Releases New Resource For Its Voluntary Qualified Importer Program (VQIP): On July 31, 2023, the U.S. Food and Drug Administration (FDA) released a new online resource, “Preparing for the FDA Voluntary Qualified Importer Program,” to provide eligibility criteria and answer questions before submitting a VQIP application.

FDA Publishes Califf’s Remarks On Dietary Supplements Program: On August 14, 2023, FDA published “Catching Up with Califf: FDA’s Dietary Supplements Program Remains a Critical Priority,” remarks by Robert M. Califf, M.D., Commissioner of Food and Drugs. FDA intends to transform the current organization structure of food program components into a unified Human Foods Program. In his remarks, Commissioner Califf shares details of FDA’s planned reorganization.

FDA Co-Hosts Webinar On Facing Food Safety Challenges: On August 31, 2023, FDA announced a webinar titled “Facing Food Safety Challenges through Culture and Persistence,” that took place on September 13, 2023. The presentation focused on the importance of a strong food safety culture and included experts from the public and private sectors, including Conrad Choiniere, Ph.D., FDA.

NANOTECHNOLOGY

UK Calls For Data On Nanomaterials In Cosmetics: On August 14, 2023, the United Kingdom’s (UK) Office for Product Safety and Standards (OPSS) called for the submission of any scientific information relevant to the safety assessment of nanomaterials used in cosmetics. OPSS invites any interested parties, including academia, manufacturers of cosmetic products/raw materials, and consumer associations, to submit any scientific information relevant to the safety assessment of the following nanomaterials (or surface functionalized variants, alloys, or other related variants) used in cosmetics:

  • Platinum (nano);
  • Copper (nano);
  • Silver (nano), colloidal silver (nano);
  • Gold (nano), colloidal gold (nano), gold thioethyl amino hyaluronic acid (nano);
  • Silica (nano), hydrated silica (nano), silica silyl ate (nano), silica dimethyl silyl ate (nano);
  • Lithium magnesium sodium silicate (nano); and
  • Hydroxyapatite (nano).

Data on silica (nano), hydrated silica (nano), silica silyl ate (nano), and silica dimethyl silylate (nano) are due June 27, 2025. Data on all other substances are due December 22, 2023.

EUON Posts Nanopinion On Nanocrystals Coating By Friction: On August 15, 2023, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Nanocrystals Coating by Friction. A New Approach for Advanced Materials” by Dr. Bentejui Medina-Clavijo, Senior Fellow at the European Organization for Nuclear Research (CERN), and Professor Andrey Chuvilin, head of the Electron Microscopy Laboratory at nanoGUNE. The authors state that friction treatment of surfaces “has the potential to become an industrially viable treatment to improve the properties of manufactured surfaces. … A proper understanding of how they are produced and how to exploit them can represent a competitive advantage for innovative companies.”

2023 Workshop On Nanotechnology Infrastructure Of The Future Held September 12-13, 2023: On September 12-13, 2023, the “2023 Workshop on Nanotechnology Infrastructure of the Future” was held in Washington, D.C., and online. During the workshop, stakeholders provided insights and ideas towards shaping the National Nanotechnology Coordinated Infrastructure (NNCI). Organizers will use stakeholder input to help develop a public-facing white paper recommending a path forward to U.S. government agencies.

Registration Opens For CHIPS Research And Development Office’s Standards Summit On September 26 And 27, 2023: The CHIPS Research and Development Office’s Standards Summit will be held as an in-person and virtual event on September 26 and 27, 2023, from 8:30 a.m. to 5:30 p.m. (EDT). Co-hosted by a number of organizations, including the National Nanotechnology Coordination Office (NNCO), the event will bring together CHIPS for America leaders, standards setting organizations, and industry alliances, domestic and abroad, in the semiconductor domain to identify community priorities for semiconductor and microelectronics standards activities. According to the National Institute of Standards and Technology (NIST), the summit will be a place to foster collaboration, coordination, and innovation within the semiconductor industry’s standards community. The event is intended to facilitate discussions on standards needs, opportunities for standards innovation, and enabling a diverse standards-capable workforce. Registration will close at 11:59 p.m. (EDT) on September 19, 2023. More information is available in our August 30, 2023, blog item.

Registration Opens For Nano4EARTH Roundtable Discussion On Batteries And Energy Storage On September 26, 2023: On September 26, 2023, Nano4EARTH will hold a roundtable discussion on batteries and energy storage. The roundtable will aim to identify fundamental knowledge gaps, needs, and opportunities to advance current electrification goals. The moderated discussion will tackle all aspects of the topic, ranging from research and development (R&D) opportunities to commercialization challenges, by featuring a small group of experts from different sectors and backgrounds. The meeting will be held online and at the NNCO in Washington, D.C. More information is available in our August 22, 2023, blog item.

NNCO Will Host Symposium On “Enabling The Nanotechnology Revolution” On October 10, 2023: On October 10, 2023, NNCO will host a symposium entitled “Enabling the Nanotechnology Revolution: Celebrating the 20th Anniversary of the 21st Century Nanotechnology Research and Development Act” at the National Academies of Sciences, Engineering, and Medicine. According to NNCO, the symposium will be a full-day in-person event with a networking reception afterward. The symposium will include three keynotes and five panels that will each dive into the state of nanotechnology research, commercialization, infrastructure, workforce, and responsible development. In addition, policymakers will discuss how the NNI and the legislation that authorized it came to be, describe the impact of the NNI, and envision the future of nanotechnology and the NNI. Registration is now open.

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

House Bills Would Protect Military Members And Communities From PFAS: On August 22, 2023, Representative Elissa Slotkin (D-MI) introduced a package of bills concerning PFAS:

  • The PFAS Exposure, Assessment and Documentation Act (H.R. 5259), which would require the Department of Defense (DoD) to evaluate service members for exposure to PFAS during physical exams and — if they are exposed — provide a blood test to determine and document their level of exposure;
  • The PFAS Free Military Purchasing Act (H.R. 5260), which would prohibit DoD procurement of certain items containing certain types of PFAS, including cookware, floor wax, cleaning products, carpeting and upholstery, and food packaging materials;
  • The PFAS Training For DoD Providers and Service Members Act (H.R. 5261), which would require DoD to provide each of its medical providers with mandatory training regarding the potential health effects of PFAS;
  • The PFAS Cleanup Transparency Act (H.R. 5262), which would require DoD to post on a publicly available website timely and regularly updated information on the status of cleanup at sites; and
  • The PFAS Strictest Standard Act (H.R. 5263), which would require DoD to abide by most stringent standards among state or federal PFAS standards in cleanup efforts.

Bipartisan House Bills Would Help Airports Clean Up PFAS: On September 8, 2023, Representative Salud Carbajal (D-CA) introduced two bipartisan bills aimed at helping curb the threat of PFAS in communities near regional airports:

  • The Pollution-Free Aviation Sites (PFAS) Act (H.R. 5356), which would create a new transition fund within the U.S. DOT to provide grants to airports needing support to replace PFAS foams with fluorine-free alternatives; and
  • The Save our Airports Reporting Act (H.R. 5355), which requires the Federal Aviation Administration to provide a progress report every six months on its efforts to transition to the use of PFAS-free firefighting foams.

MISCELLANEOUS

EPA’s National Enforcement And Compliance Initiatives For 2024-2027 Include Addressing PFAS And Chemical Accident Risk Reduction: On August 17, 2023, EPA announced its National Enforcement and Compliance Initiatives (NECI) for 2024-2027, “including for the first time initiatives to mitigate climate change, address exposure to PFAS contamination, and protect communities from cancer-causing coal ash.” To advance the Biden Administration’s commitment to protect disadvantaged communities, EPA states that it also will integrate environmental justice considerations into each of its NECIs. The 2024-2027 NECIs are:

  • Mitigating climate change;
  • Addressing exposure to PFAS;
  • Protecting communities from coal ash contamination;
  • Reducing air toxics in overburdened communities;
  • Increasing compliance with drinking water standards; and
  • Chemical accident risk reduction.

More information is available in our August 22, 2023, blog item.

SAB Meeting Will Include Review Of EPA’s Draft IRIS Toxicological Review Of Hexavalent Chromium: EPA announced on August 21, 2023, that the Science Advisory Board (SAB) will meet September 21-22, 2023. 88 Fed. Reg. 56820. According to the announcement, the purpose of the meeting is to receive briefings from EPA; discuss a proposed SAB project to provide advice to EPA on environmental justice analysis; conduct quality reviews of three draft SAB reports, including Review of EPA’s draft IRIS Toxicological Review of Hexavalent Chromium; discuss a draft SAB commentary on Volume Requirements for 2023 and Beyond under the Renewable Fuel Standard Program (RIN 2060-AV14); and discuss recommendations received from the SAB Work Group for Review of Science Supporting EPA Decisions concerning SAB review of EPA planned regulatory actions.

CPSC Publishes Supplemental Guidance For CPSC Chronic Hazard Guidelines For Public Comment: On August 24, 2023, the U.S. Consumer Product Safety Commission (CPSC) announced the availability of proposed supplemental guidance for its Chronic Hazard Guidelines. 88 Fed. Reg. 57947. The supplements are draft supplemental guidance for the use of benchmark dose methodology in risk assessment, and draft supplemental guidance for the analysis of uncertainty and variability in risk assessment. CPSC requests comments from the public on the proposed supplemental guidance. Comments are due October 23, 2023.

EPA Announces Availability Of IRIS Protocol For Vanadium And Compounds (Inhalation): On August 28, 2023, EPA announced a 30-day public comment period associated with release of the document, Protocol for the Vanadium and Compounds (Inhalation) IRIS Assessment. 88 Fed. Reg. 58578. EPA states that this document communicates the rationale for conducting the Integrated Risk Information System (IRIS) assessment of vanadium and compounds (inhalation), 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 September 27, 2023.

ATSDR Begins Comment Period On Draft Toxicological Profiles And Draft Interaction Profile: On August 30, 2023, the Agency for Toxic Substances and Disease Registry (ATSDR) announced the opening of a docket to obtain comments on drafts of five updated toxicological profiles and one draft interaction profile: creosote, nickel, 1,2-dichloroethene, vinyl acetate, acrylonitrile, and the interaction profile for selected metallic ions. 88 Fed. Reg. 59927. ATSDR states that it prepared the drafts based on current understanding of the health effects and availability of new studies and other information since their initial release. ATSDR notes that it considers key studies during the profile development process, using a systematic review approach. To that end, 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. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion in the profile. Comments are due November 28, 2023.

EPA Launches New Cancer Prevention Website: EPA announced on September 13, 2023, that as part of the Biden Cancer Moonshot, EPA launched a new website “highlighting its activities to help prevent cancer by reducing exposures to carcinogens in our everyday lives.” Upcoming EPA actions to prevent cancer risk by reducing exposure to carcinogens include:

  • Several regulatory efforts to reduce unreasonable risks associated with chemicals evaluated under TSCA with cancer risks, including:
    • Trichlorethylene (TCE), which is used as a refrigerant and degreasing solvent for metal equipment (proposed rule estimated to be published fall 2023); and
    • 1-Bromopropane, which is used as a solvent in vapor degreasing, adhesives, and other products (proposed rule estimated to be published fall 2023).
  • By September 2023, EPA will update its website for indoor air quality with secondhand smoke messaging and resources from federal agencies and other credible sources regarding smoking cessation. Secondhand exposure to tobacco and marijuana smoke as well as e-cigarettes can impact indoor air quality and pose health risks.

EPA Issues Phase II FOIA Final Rule: EPA issued on September 14, 2023, its Phase II Freedom of Information Act (FOIA) final rule updating and modernizing EPA’s FOIA regulations. 88 Fed. Reg. 63020. According to EPA’s September 7, 2023, press release, the final rule “promote[s] transparency and accountability, make[s] FOIA more affordable, and expedite[s] access to information to communities potentially experiencing disproportionate and adverse human health or environmental effects.” The final rule establishes a new standard, in addition to the existing “compelling need” standard, for expediting EPA’s response to FOIA requests for records when there is a pressing need to inform a community that is potentially experiencing disproportionately high and adverse human health or environmental effects. EPA will also waive fees for such FOIA requests. The final rule removes barriers by raising the threshold for when requesters will be charged fees, benefiting all requesters, as well as making other changes to bring EPA’s fee rates and other regulatory provisions into compliance with the FOIA statute, government wide policy, and relevant case law. Additionally, EPA updated the FOIA fee rates and will no longer charge any fees to a requester if the Agency accumulates less than $250 of chargeable fees. The final rule will be effective November 13, 2023.

NSF Will Hold Public Listening Sessions On NSTC Framework For Federal Scientific Integrity Policy And Practice: The U.S. National Science Foundation (NSF), on behalf of the federal agencies and departments participating on the National Science and Technology Council (NSTC) Subcommittee on Scientific Integrity (the Subcommittee), is organizing two virtual listening sessions to hear from members of the public about recommendations, issues, and concerns related to federal department and agency implementation of the NSTC Framework for Federal Scientific Integrity Policy and Practice (the Framework). 88 Fed. Reg. 60713. The Subcommittee is supporting the development of scientific integrity policies at federal departments and agencies and seeks public input on the development and implementation of these policies and associated procedures and practices. According to the notice, perspectives gathered during the virtual listening sessions will inform: (1) federal agencies’ finalization of Scientific Integrity Policies, in response to the Framework and its implementation memorandum from the White House Office of Science and Technology Policy (OSTP); (2) federal agency processes, procedures, and practices related to scientific integrity; and (3) other elements of federal implementation of the Framework. The first listening session was held September 15, 2023, 1:00 p.m. – 3:00 p.m. (EDT) and the second will be held September 20, 2023, 5:00 p.m. – 7:00 p.m. (EDT). Registration is now open. More information on the Framework is available in our January 19, 2023, blog item.

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