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Monthly Federal Developments Memorandum
August 15, 2023

Monthly Update for August 2023

Bergeson & Campbell, P.C.

TSCA/FIFRA/TRI

EPA’s Spring 2023 Unified Agenda Includes TSCA, TRI, And PFAS Rulemakings: The U.S. Environmental Protection Agency’s (EPA) spring 2023 Unified Agenda, published on June 13, 2023, includes a number of proposed and final rulemakings under the Toxic Substances Control Act (TSCA) or the Toxics Release Inventory (TRI), as well as rulemakings concerning per- and polyfluoroalkyl substances (PFAS). More information on the rulemakings, including links to our memoranda, is available in our August 14 and August 15, 2023, blog items.

EPA Announces Release Of Guidance For The Evaluation Of Products For Claims Against Viruses: On July 17, 2023, EPA announced the release of draft guidance for the evaluation of products for claims against viruses. This new guidance provides the framework for registrants who seek to make virucidal claims for antimicrobial products. This draft guidance reiterates recommended test methods and regulatory guidance for the addition of virucidal claims to products that meet the criteria for hard surface disinfection claims consistent with EPA’s Product Performance Test Guidelines; OCSPP 810.2200: Disinfectants for Use on Environmental Surfaces, Guidance for Efficacy Testing guideline and provides recommended test methods and regulatory guidance for the addition of virucidal claims to products that meet the criteria for food/non-food contact sanitizer claims consistent with EPA’s Product Performance Test Guidelines; OCSPP 810.2300: Sanitizers for Use on Hard Surfaces — Efficacy Data Recommendations test guideline. The draft guidance only covers the addition of virucidal claims to a product that has met the criteria for a bactericidal disinfectant and/or sanitizer.

The draft guidance does not cover adding virucidal claims to sterilant products. In addition, this guidance is not intended to cover residual (long-lasting) sanitizer claims. If residual claims are to be added to the product label, visit https://www.epa.gov/pesticide-registration/guidance-products-adding-residual-efficacy-claims. EPA states that the draft guidance is not binding on EPA or any outside parties, and EPA may depart from said guidance where circumstances warrant and without prior notice. Registrants and applicants may propose and submit alternative practices (e.g., modifications to the recommended test methodology) to EPA for assessment. Comments are due to EPA on or before September 15, 2023. For more information on the draft guidance and Bergeson & Campbell, P.C.’s (B&C®) commentary, please read our July 19, 2023, blog.

EPA Extends Comment Period On Proposed SNURs For 18 Chemicals Made From Plastic Waste-Based Feedstocks: On July 19, 2023, EPA announced that it is extending the public comment period for its proposed significant new use rules (SNUR) under TSCA to ensure chemicals made from plastic waste-derived feedstocks are free from certain contaminants before they can be used to make transportation fuels. EPA notes that its decision to extend the public comment period for the SNURs does not impact the date on which use of the substances would be considered a significant new use, which is June 20, 2023. EPA has extended the comment period from July 20, 2023, to August 19, 2023. 88 Fed. Reg. 46726. More information on the proposed SNURs is available in our June 20, 2023, memorandum.

EPA Appoints New Members To SACC: On July 20, 2023, EPA announced that it has appointed nine new members and a new Chair to serve on the Science Advisory Committee on Chemicals (SACC) established under TSCA. SACC members serve staggered terms of appointment, generally of three years. Due to the expiration of eight of the 17 SACC memberships in 2023, EPA sought nominations from the public of prospective members in November 2022, receiving 44 nominations (one was later withdrawn). In March 2023, EPA requested public comments on the 43 nominations. EPA used the public comments to assist it in selecting nine new appointees for a total of 18 SACC members. The new Chair was chosen from the existing SACC members. SACC serves as a scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). It provides independent scientific advice and recommendations to EPA on the scientific basis for risk assessments, methodologies and pollution prevention measures, and approaches for chemicals regulated under TSCA. A list of all current members and their biographies can be found on the SACC website.

EPA Issues Final TSCA Section 8(a) Reporting And Recordkeeping Rule For Asbestos: On July 25, 2023, EPA issued a final rule regarding the reporting and recordkeeping requirements for asbestos under TSCA. 88 Fed. Reg. 47782. EPA states in its July 6, 2023, press release that under the reporting rule, manufacturers (including importers) or processors of asbestos between 2019 and 2022 with annual sales above $500,000 in any of those years are required to report exposure-related information, including quantities of asbestos manufactured or processed, types of use, and employee data. Manufacturers (including importers) and processors subject to the rule will have nine months following the effective date of the final rule to collect and submit all required information to EPA. The final rule will be effective August 24, 2023. There will be a three-month submission period for reporting that will begin six months following the effective date of the final rule. More information is available in our July 12, 2023, memorandum.

Bipartisan Group Of Representatives Calls On EPA To Assess The Risks Of PFAS In Fluorinated Containers: On July 25, 2023, 12 members of the House sent a letter to EPA Administrator Michael Regan urging EPA “to conduct a rigorous, comprehensive, and transparent assessment of the risks of PFAS in fluorinated containers.” According to the letter, the TSCA program “is now facing a major test of this authority from the submission of nine Significant New Use Notices (SNUNs) by Inhance Technologies, a Texas company that fluorinates plastic containers.” The letter states that the Inhance fluorination process “results in the formation of at least 13 individual PFAS, nine of which are long-chain perfluoroalkyl carboxylate (LCPFAC) substances.” The letter asks EPA to answer its questions before September 1, 2023. More information is available in our July 31, 2023, blog item.

EPA Proposes To Ban Uses Of CTC That Have Been Phased Out And Establish WCPP For Uses Not Prohibited: On July 28, 2023, EPA proposed to ban uses of carbon tetrachloride (CTC) that have been phased out and to establish a workplace chemical protection program (WCPP) for uses not prohibited to address the unreasonable risk to human health. 88 Fed. Reg. 49180. EPA proposed to establish workplace safety requirements for most conditions of use (COU), including the COU related to the making of low Global Warming Potential (GWP) hydrofluoroolefins (HFO), to prohibit the manufacture (including import), processing, distribution in commerce, and industrial/commercial use of CTC for COUs where information indicates use of CTC has already been phased out, and to establish recordkeeping and downstream notification requirements. Comments on the proposed rule are due September 11, 2023. EPA notes that under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of the comments on or before August 28, 2023. On August 15, 2023, EPA held a webinar on its proposed rule. More information on the proposed rule is available in our July 26, 2023, memorandum.

TSCA Section 21 Citizen Petition Seeks Prohibition Of 6PPD In Tires: On August 1, 2023, Earthjustice filed a citizen petition under TSCA Section 21 asking EPA to establish regulations prohibiting the manufacturing, processing, use, and distribution of N-(1,3-Dimethylbutyl)-N’-phenyl-p-phenylenediamine (6PPD) (Chemical Abstracts Service Registry Number® (CAS RN®) 793-24-8) for and in tires. Earthjustice filed the petition on behalf of the Yurok Tribe, the Port Gamble S’Klallam Tribe, and the Puyallup Tribe of Indians. According to Earthjustice’s August 1, 2023, press release, “[w]hen 6PPD reacts with ground-level ozone, it breaks down into 6PPD-q — the second most toxic chemical to aquatic species ever evaluated by the EPA.” The Tribes contend that 6PPD in tires poses unreasonable risks to the environment, requiring EPA to regulate the chemical under TSCA.

EPA Releases White Paper On Quantitative Human Health Approach To Be Applied In Risk Evaluation For Asbestos Part 2: On August 3, 2023, EPA announced the availability of and solicited public comment on the document entitled “White Paper: Quantitative Human Health Approach to be Applied in the Risk Evaluation for Asbestos Part 2 — Supplemental Evaluation including Legacy Uses and Associated Disposals of Asbestos” (White Paper) and related charge questions. 88 Fed. Reg. 51309. EPA states that it will be soliciting comments from expert ad hoc reviewers on the quantitative approach described in the White Paper. According to EPA, the White Paper describes the systematic review considerations and criteria for identifying studies for dose-response analysis; includes an evaluation and comparison of existing cancer inhalation unit risks (IUR) and the non-cancer point of departure (POD) with the results of the new systematic review; and a proposal for a cancer IUR and non-cancer POD for use in the Part 2 risk evaluation for asbestos. EPA notes that in addition to the final charge questions and White Paper, public comments received by October 2, 2023, will be provided to the peer reviewers for consideration. EPA expects the letter peer review to begin October 25, 2023, and end November 24, 2023. EPA will consider feedback from the letter peer review in the development of the Part 2 risk evaluation for asbestos, a draft of which will be released subsequently, along with a separate response document. More information will be available in our forthcoming memorandum.

EPA Announces New Webinar Series On The Use Of NAMs To Reduce Animal Testing: EPA is launching a webinar series in collaboration with the PETA Science Consortium International (PSCI), Institute for In Vitro Sciences (IIVS), and the California Department of Pesticide Regulation (CDPR). According to EPA, the quarterly series will focus on the use of new approach methodologies (NAM), or alternative methods to reduce vertebrate animal testing, for risk assessment within EPA and CDPR. The first webinar in the series will take place on August 23, 2023, from 11:00 a.m.-12:30 p.m. (EDT). The webinar will cover recent updates from the Organization for Economic Cooperation and Development (OECD), including information about its developmental neurotoxicity in vitro test battery. Registration is open.

EPA Will Hold SACC Meeting In September To Review Draft Supplement To The 1,4-Dioxane Risk Evaluation: On August 2, 2023, EPA announced a four-day virtual public meeting on September 12-15, 2023, for SACC to review EPA’s 2023 draft supplement to the 1,4-dioxane risk evaluation. 88 Fed. Reg. 43562. EPA provides the following dates for specific activities that are described in the notice:

  • September 1, 2023 — Deadline for submitting a request for special accommodations to allow EPA time to process the request before the meeting;
     
  • September 8, 2023 — Deadline for providing written comments on the draft supplement;
     
  • September 8, 2023 — Deadline for registering to be listed on the meeting agenda to make oral comments during the virtual meeting;
     
  • September 12-15, 2023 — Meeting to be held from 10:00 a.m. to approximately 5:00 p.m. (EDT); and
     
  • September 15, 2023 — Deadline for those not making oral comments to register to receive the links to observe the meeting.

More information on EPA’s draft supplement to the 1,4-dioxane risk evaluation and the draft revised TSCA risk determination for 1,4-dioxane is available in our July 31, 2023, memorandum.

EPA Temporarily Waives Some Requirements Under New CBI Procedures Rule: As reported in our June 12, 2023, memorandum, EPA published on June 7, 2023, a final rule with new and amended requirements concerning the assertion and treatment of confidential business information (CBI) claims for information reported to or otherwise obtained by EPA under TSCA. EPA announced on August 10, 2023, that to ensure the “smoothest possible reporting experience” for TSCA submitters using the new tools, EPA is waiving some of the final rule’s requirements until October 16, 2023. The final rule includes a provision at 40 C.F.R. Section 703.5(f) requiring that all TSCA submissions bearing CBI claims (with limited exceptions) be submitted via EPA’s electronic submission portal, Central Data Exchange (CDX). EPA states that it has been developing additional tools necessary to enable the expanded electronic reporting that are required by Section 703.5(f) by the new rule, which took effect on August 7, 2023. EPA notes that development and testing of these tools will not be complete in time to enable the additional electronic reporting required by Section 703.5(f), however. EPA expects these tools to be available by October 16, 2023. More information is available in our August 14, 2023, blog item.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA Reminds Facility Operators To Prepare For Hazardous Weather Events: On July 18, 2023, EPA issued a press release reminding facility operators of preventing, minimizing, and reporting chemical releases during hazardous weather events. EPA states that facility operators are obligated to maintain safety, minimize releases that do occur, and report chemical releases or oil spills and discharges in a timely manner, as required under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and/or the emergency planning provisions of the Emergency Planning and Community Right-to-Know Act (EPCRA) and/or the National Oil and Hazardous Substances Pollution Contingency Plan. EPA reminds facility owners and operators of the following steps to prepare for hazardous weather:

  • Review procedures for shutting down processes and securing facilities appropriately — especially hazardous chemical storage — or otherwise implement appropriate safe operating procedures;
     
  • Review updated state-federal guidelines for flooding preparedness, available online;
     
  • Ensure all employees are familiar with requirements and procedures to contact the National Response Center at 1-800-424-8802 in case a spill or release occurs; and
     
  • Review local response contacts, including Local Emergency Planning Committees (LEPC) and State Emergency Response Commissions (SERC). A list of these contacts by state is available online.

EPA Establishes Methodology For Allocating HFC Allowances For 2024 And Later Years: On July 20, 2023, EPA published a final rule amending existing regulations to implement certain provisions of the American Innovation and Manufacturing (AIM) Act. 88 Fed. Reg. 46836. The rule establishes the methodology for allocating hydrofluorocarbon (HFC) production and consumption allowances for the calendar years of 2024 through 2028. EPA states that it also amended the consumption baseline to reflect updated data and to make other adjustments based on lessons learned from implementation of the HFC phasedown program thus far, including to: codify the existing approach of how allowances must be expended for import of regulated substances, revise recordkeeping and reporting requirements, and implement other modifications to the existing regulations. The final rule will be effective September 18, 2023, except for amendatory instructions 3 and 13, which will be effective October 1, 2024. The incorporation by reference (IBR) of certain publications listed in the rule is approved by the Director of the Federal Register as of July 20, 2023, and for certain other publications listed in the rule as of October 1, 2024.

EPA Publishes SNPRM For Primary Copper Smelting NESHAP: On July 24, 2023, EPA published a supplemental notice of proposed rulemaking (SNPRM) regarding its 2022 proposed amendments to the national emission standards for hazardous air pollutants (NESHAP) for the Primary Copper Smelting source category. 88 Fed. Reg. 47415. To complete the required technology review for the major source category, EPA proposes additional hazardous air pollutant (HAP) standards for the following pollutants: benzene, toluene, hydrogen chloride, chlorine, polycyclic aromatic hydrocarbons, naphthalene, and dioxin/furans. EPA also proposes revised standards for certain provisions initially proposed in the January 11, 2022, proposal based on additional information gathered since the publication of the 2022 proposed rule. Comments are due September 7, 2023. Under the PRA, comments on the information collection provisions are best assured of consideration if OMB receives a copy of the comments on or before August 23, 2023.

EPA Will Propose To Improve Air Pollution Emissions Data: EPA announced on July 25, 2023, that it will propose updates to its Air Emissions Reporting Requirements rule, including proposing to require reporting of HAPs. According to EPA, the proposal would revise the Air Emissions Reporting Requirements rule, which currently requires states to report emissions of common air pollutants, such as particulate matter, along with pollutants that contribute to their formation, such as ozone-forming volatile organic compounds (VOC). While most states voluntarily report some air toxics emissions data to EPA now, that reporting is not consistent nationwide.

EPA Proposes Amendments To NESHAP For Integrated Iron And Steel Manufacturing Facilities: On July 31, 2023, EPA proposed amendments to the NESHAP for Integrated Iron and Steel Manufacturing Facilities, as required by the Clean Air Act (CAA). 88 Fed. Reg. 49402. EPA states that to complete the required CAA Section 112(d)(6) technology review promulgated on July 13, 2020, it is proposing standards to regulate HAP emissions from five unmeasured fugitive and intermittent particulate (UFIP) sources, some of which are also referred to as “fugitive” sources, that are currently not regulated by the NESHAP, as follows: Bell Leaks, Unplanned Bleeder Valve Openings, Planned Bleeder Valve Openings, Slag Pits, and Beaching. Also, for sinter plants, EPA proposes standards for the following five currently unregulated HAPs: carbonyl sulfide, carbon disulfide, mercury, hydrochloric acid, and hydrogen fluoride; for blast furnace (BF) stoves and basic oxygen process furnaces (BOPF), EPA proposes standards for the following three unregulated pollutants: total hydrocarbons, hydrochloric acid, and dioxins/furans; and for BFs, EPA proposes standards for the following two unregulated pollutants: total hydrocarbons and hydrochloric acid. As an update to the technology review, EPA proposes to revise the current BOPF shop fugitive 20 percent opacity limit to a five percent opacity limit and require specific work practices; revise the current BF casthouse fugitive 20 percent opacity limit to a five percent opacity limit; and revise the current standards for dioxins/furans and polycyclic hydrocarbon for sinter plants. EPA also proposes a fenceline monitoring requirement for chromium, including a requirement that if a monitor exceeds the proposed chromium action level, the facility will need to conduct a root cause analysis and take corrective action to lower emissions. Comments are due September 14, 2023. Under the PRA, comments on the information collection provisions are best assured of consideration if OMB receives a copy of the comments by August 30, 2023.

EPA Proposes To Amend GHG Reporting Rule Requirements For Petroleum And Natural Gas Systems: EPA proposed on August 1, 2023, to amend requirements that apply to the petroleum and natural gas systems source category of the Greenhouse Gas (GHG) Reporting Rule to ensure that reporting is based on empirical data, accurately reflects total methane emissions and waste emissions from applicable facilities, and allows owners and operators of applicable facilities to submit empirical emissions data that appropriately demonstrate the extent to which a charge is owed. 88 Fed. Reg. 50282. EPA states that it is also proposing changes to requirements that apply to the general provisions, general stationary fuel combustion, and petroleum and natural gas systems source categories of the GHG Reporting Rule to improve calculation, monitoring, and reporting of GHG data for petroleum and natural gas systems facilities. This action also proposes to establish and amend confidentiality determinations for the reporting of certain data elements to be added or substantially revised in these proposed amendments. Comments are due October 2, 2023. Under the PRA, comments on the information collection provisions are best assured of consideration if OMB receives a copy of the comments by August 31, 2023.

EPA Releases Preliminary Data For 2022 TRI Reporting Year: EPA announced on August 4, 2023, that it published preliminary TRI data about chemical waste management, including releases, and pollution prevention activities that occurred during 2022 at more than 20,000 industrial and federal facilities across the country. The preliminary data include quantities of chemicals that facilities released into the environment or otherwise managed as waste and also include details about pollution prevention activities initiated by individual facilities during 2022. EPA notes that the dataset contains the data as submitted by facilities and does not include any summary or trend analysis. EPA states that it is conducting additional quality checks to identify suspected reporting errors and follow up with facilities if data quality issues are identified. EPA will update the 2022 preliminary data periodically to reflect revisions to previously submitted data and late submissions. EPA plans to publish a revised version of the dataset in October 2023, which will include late submissions and revisions submitted by facilities. EPA will then use the revised dataset to develop the 2022 TRI National Analysis, which it expects to publish in early 2024.

EPA Proposes Technical Corrections To Hazardous Waste Generator Improvements Rule, Hazardous Waste Pharmaceuticals Rule, And Definition Of Solid Waste Rule: On August 9, 2023, EPA published a proposed rule that would make technical amendments that correct or clarify several parts of the Resource Conservation and Recovery Act (RCRA) hazardous waste regulations. 88 Fed. Reg. 53836. According to EPA, the amendments would correct or clarify specific provisions in the existing hazardous waste regulations that were promulgated in the Hazardous Waste Generator Improvements rule, the Hazardous Waste Pharmaceuticals rule, and the Definition of Solid Waste rule. The proposed rule would also make other minor corrections that fall within the same sections of the hazardous waste regulations but are independent of these three rules. EPA states that examples of the types of corrections being made include, but are not limited to, correcting typographical errors, correcting incorrect or outdated citations, making minor clarifications, and updating addresses. EPA made the technical corrections as a direct final rule on August 9, 2023, without a prior proposed rule “because we view this as a noncontroversial action and anticipate no adverse comment.” 88 Fed. Reg. 54086. If EPA receives no adverse comment, it will not take further action on the proposed rule. The final rule will be effective December 7, 2023, without further notice unless EPA receives adverse comment on the proposed rule by October 10, 2023.

EPA Proposes Revisions To The Air Emissions Reporting Requirements: On August 9, 2023, EPA proposed changes to the Air Emissions Reporting Requirements (AERR). 88 Fed. Reg. 54118. EPA states that the proposed amendments may require changes to current regulations of state, local, and certain Tribal air agencies; would require these agencies to report emissions data using different approaches from current requirements; and would require owners/operators of some facilities to report additional emissions data. More specifically, EPA is proposing to require certain sources report information regarding HAP emissions; certain sources to report criteria air pollutants, their precursors, and HAP; and to require state, local, and certain Tribal air agencies to report prescribed fire data. According to EPA, the proposed revisions would also define a new approach for optional collection by air agencies of such information on HAP by which state, local, and certain Tribal air agencies may implement requirements and report emissions on behalf of owners/operators. The proposed revisions would also make the requirements for point sources consistent for every year; phase in earlier deadlines for point source reporting; and add requirements for reporting fuel use data for certain sources of electrical generation associated with peak electricity demand. The proposed revisions include further changes for reporting on airports, rail yards, commercial marine vessels, locomotives, and nonpoint sources. For owners/operators of facilities that meet criteria described in this proposal, the proposed revisions would require reporting of performance test and performance evaluation data to EPA for all tests conducted after the effective date provided in the final rulemaking. EPA also proposes to clarify that information it collects through the AERR is emission data that are not subject to confidential treatment. Comments are due October 18, 2023. Under the PRA, comments on the information collection request must be received by EPA and OMB on or before September 8, 2023. EPA will hold a virtual public hearing on August 30, 2023.

EPA Seeks Information On Used Drum Management And Reconditioning: On August 11, 2023, EPA published an advance notice of proposed rulemaking (ANPRM) soliciting information and requesting comments to assist in the potential development of non-regulatory and regulatory options that would ensure the proper management of used industrial containers that held hazardous chemicals or hazardous waste, up to and including the drum reconditioning process. 88 Fed. Reg. 54537. EPA states that it plans to use the ANPRM as a preliminary way to explore the regulatory and/or non-regulatory options for dealing with the issues surrounding the management of used containers, such as metal or plastic drums, across their lifecycle, to ensure protection of human health and the environment. According to EPA, management issues across the lifecycle of used containers can occur at industrial facilities, with hazardous waste generators, and with generators of used containers, as well as with transporters and receiving facilities (i.e., drum reconditioners). EPA notes that the ANPRM will refer to any facilities sending used drums/containers to drum reconditioners as “used drum generators.” As a first step for the ANPRM, EPA published a report studying the drum reconditioning industry and documented certain damages such as environmental releases, fires, explosions, and employee injuries that occurred at these facilities. EPA notes that the ANPRM does not propose any regulatory requirements or change any existing regulatory requirements. Comments are due September 25, 2023.

FDA

FDA Releases Inventory Of Unapproved Food Additives And Other Lists: On July 12, 2023, the U.S. Food and Drug Administration (FDA) released a public inventory of food ingredients that the agency has determined to have unsafe uses in food, as well as lists of chemicals currently under the agency’s review. The inventory includes some of FDA’s post-market assessments dating back to 2004, and the lists include substances currently under FDA review (e.g., ingredients considered generally recognized as safe (GRAS), food additives, color additives, food contact substances, and contaminants).

FDA Adds Sesame As A Major Food Allergen: On July 27, 2023, FDA released a statement discussing the addition of sesame, as the ninth major food allergy, on January 1, 2023. FDA notes that sesame is now required to be listed on food labels as a major allergen. FDA raises the issue that it has become aware of manufacturers intentionally adding sesame to products that previously did not contain sesame and are labeling the products to indicate its presence. This keeps manufacturers in compliance with FDA’s law for disclosing the presence of a major food allergen, but limits options for consumers who are allergic to sesame.

FDA Announces Public Meeting To Modernize Recalls Of FDA-Regulated Commodities: On August 2, 2023, FDA announced a free hybrid public meeting to provide a listening session for FDA to hear feedback about topics related to recall modernization for FDA-regulated products. The listening session will take place on September 29, 2023, from 9:00 a.m. to 5:00 p.m. (EDT).

FDA Issues Draft Guidance On Registration And Listing Of Cosmetic Product Facilities And Products: On August 8, 2023, FDA announced the availability of draft guidance to assist with facility registration and product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). 88 Fed. Reg. 53490. FDA intends to make a new electronic portal available in October 2023, and is jointly developing a paper submission form. A facility registration number (FEI) will be required for each facility. FDA is accepting comments until September 7, 2023. Compliance is required by December 29, 2023.

FDA Revokes Use Of Partially Hydrogenated Oils In Foods: On August 9, 2023, FDA published a direct final rule titled “Revocation of Uses of Partially Hydrogenated Oils in Foods,” which amends FDA’s regulations at 21 C.F.R. Parts 161, 164, 184, and 186 to no longer permit use of partially hydrogenated oils (PHO) in various applications. 88 Fed. Reg. 53764. The revocation follows FDA’s determination in June 2015 that PHOs are no longer considered GRAS. 80 Fed. Reg. 34650. The rule revises FDA’s regulations regarding GRAS substances that contain PHOs and revokes prior sanctioned uses of PHOs. FDA states that “[w]e are issuing these amendments directly as a final rule because they are noncontroversial given the public health risks associated with PHOs and the increasing use of PHO alternatives, and we anticipate no significant adverse comments because PHOs were declared no longer GRAS for any use in human food in 2015.” The rule is effective December 22, 2023. FDA is accepting comments until October 23, 2023.

NANOTECHNOLOGY

EC Committee Updates Guidance On The Safety Assessment Of Nanomaterials In Cosmetics: On June 26, 2023, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published the second revision of its Guidance on the Safety Assessment of Nanomaterials in Cosmetics. The Guidance covers the main elements of safety assessment, i.e., general considerations (Section 2), material characterization (Section 3), exposure assessment (Section 4), hazard identification and dose-response characterization (Section 5), and risk assessment (Section 6). More information is available in our August 1, 2023, blog item.

EPA Announces $1.3 Million In Research Funding To Develop Nanosensors To Detect Pesticides And Mitigate Their Impacts: On July 31, 2023, EPA announced that it provided more than $1.3 million in funding to a team of researchers from the University of Wisconsin-Madison to develop nanosensor technology that can detect, monitor, and degrade commonly used pesticides found in water that can harm human health. According to EPA, using funding from the grant, researchers will develop an integrated, portable, sensor-controlled water treatment technology that itself generates the chemicals needed for treatment. More information is available in our July 31, 2023, blog item.

EUON Publishes Study Identifying Status Of Animal-Free Test Methods For Use On Nanomaterials: On August 2, 2023, the European Union (EU) Observatory for Nanomaterials (EUON) announced that it published a study that systematically reviews and assesses alternative methods for the testing of the safety of nanomaterials without the use of animals. According to EUON, the main aim of the study was to collect and provide accurate and transparent information on NAMs available for the human safety assessment of nanomaterials and to create a comprehensive inventory of these methods. EUON states that the study maps the progress of animal-free approaches for testing nanomaterials, identifying methods at various stages of validation. More information is available in our August 8, 2023, blog item.

OECD Will Hold Webinar On Test Guideline No. 126: Determination Of The Hydrophobicity Index Of Nanomaterials Through An Affinity Measurement: On September 20, 2023, OECD will hold a webinar on Test Guideline No. 126: Determination of the Hydrophobicity Index of Nanomaterials Through an Affinity Measurement. The webinar will present the method to determine the hydrophobicity index (Hy) of nanomaterials, through an affinity measurement, described in the OECD Test Guideline (TG) No. 126. Registration is 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://biobasedblog.lawbc.com.

LEGISLATIVE

Senate Bill Would Prohibit Plastic Pollution In Waterways: On July 18, 2023, Senators Dick Durbin (D-IL), Jeff Merkley (D-OR), and Ben Cardin (D-MD) introduced the Plastic Pellet Free Waters Act (S. 2337), which would require EPA to prohibit the discharge of plastic pellets and other pre-production plastic into waterways from facilities and sources that make, use, package, or transport pellets. According to Durbin’s July 18, 2023, press release, the pellets are being consumed by fish and marine life — and in turn, humans — and create additional damage to ecosystems.

House Appropriations Committee Approves FY 2024 Interior, Environment, And Related Agencies Bill: On July 19, 2023, the House Appropriations Committee approved the fiscal year (FY) 2024 bill for the Interior, Environment, and Related Agencies by a vote of 33 to 27. According to the Committee’s July 19, 2023, press release, the bill provides new non-defense discretionary spending totaling $25.417 billion, which is $13.433 billion (35 percent) below the FY 2023 enacted level and $21.371 billion below the President’s budget request. The bill rescinds $9.373 billion in funding provided to EPA, the Presidio Trust, and the Council on Environmental Quality (CEQ) by the Inflation Reduction Act (IRA). The press release notes that the bill includes a $3.962 billion (39 percent) reduction to EPA. The press release states that Republicans adopted several amendments, including one that:

  • “Blocks unnecessary, burdensome regulations” at EPA, including:
    ​
    • The Mercury and Air Toxics Standards (MATS) rule;
       
    • The restriction of rodenticides to prevent animal disease and crop loss on farms;
       
    • Regulations on light, medium, and heavy-duty vehicles; and
       
    • Ethylene oxide regulations until FDA certifies that such regulations will not adversely impact the availability of sterile medical products; and
       
  • Blocks EPA’s efforts to remove natural gas appliances from the EnergySTAR program.

Bipartisan PFAS Alternatives Act Would Remove PFAS From Firefighter Gear: On July 20, 2023, Representative Debbie Dingell (D-MI) introduced the bipartisan Protecting Firefighters and Advancing State-of-the-Art Alternatives Act (PFAS Alternatives Act) (H.R. 4769) “to support development of next-generation PFAS-free turnout gear for firefighters and better protect firefighters from the dangers of their work.” According to Dingell’s July 20, 2023, press release, the PFAS Alternatives Act would:

  • Accelerate the development of PFAS-free turnout gear through research, development, and testing of PFAS-free turnout gear materials;
     
  • Facilitate the development of safer turnout gear materials that reduces the dangers firefighters face, including enhanced protection against primary and secondary exposure to particulates and byproducts of combustion; reduced maintenance that includes contamination resistance and greater ease of cleaning; visible warning indicators to alert firefighters to hazardous exposures or the need for decontamination; and consideration of body composition in turnout gear design;
     
  • Support guidance and training for firefighters on best practices for reducing harmful exposures through the proper wearing, cleaning, and caring for next-generation turnout gear;
     
  • Involve the firefighting industry in the development process by requiring grant applicants to utilize the leadership, experience, and knowledge of firefighters to ensure the next-generation turnout gear will be both effective and practical for the everyday demands of firefighting; and
     
  • Authorize $25 million annually for each of FYs 2024 through 2028 to support the development of new materials, and an additional $2 million annually to support guidance and training.

House Bill Would Regulate Chemicals Used In Fracking Process: On July 20, 2023, Representative Diana DeGette (D-CO) introduced the Fracturing Responsibility and Awareness of Chemicals Act of 2023 (H.R. 4785), which would give EPA the authority to regulate an oil drilling practice known as hydraulic fracking. DeGette’s July 20, 2023, press release states that the legislation “would close a loophole in the Safe Drinking Water Act that prevents EPA from regulating the notorious drilling process that involves injecting huge volumes of toxic chemicals deep into the ground to recover oil and natural gas, potentially contaminating the nation’s water supply and putting the public’s health at risk.” The press release notes that if approved, the bill would not only give EPA the authority to regulate the process going forward, it would also require U.S. fracking companies to disclose publicly the chemicals they are using.

Senate Committee On Appropriations Unanimously Approves FY 2024 Interior-Environment Appropriations Bill: On July 27, 2023, the Senate Committee on Appropriations unanimously approved the FY 2024 Interior-Environment appropriations bill. According to the Committee’s July 27, 2023, press release, the FY 2024 Interior, Environment, and Related Agencies Appropriations Act provides $42.695 billion in total funding. The bill protects the environment, public lands, and Americans’ health, including by delivering essential funding for EPA to protect the environment and people’s health — and increasing funding for EPA’s clean air and climate programs.

MISCELLANEOUS

NASEM Report Recommends Expansion And Standardization Of Plastics Collection And Recycling: The National Academies of Sciences, Engineering, and Medicine (NASEM) announced on July 18, 2023, the release of a report stating that it is in society’s economic and environmental interests to expand and standardize plastics waste collection, increase recycling, and explore new applications for plastics waste in infrastructure. According to the report, recycled plastics are an underutilized resource, and action from the public sector at the federal, state, and local levels will be needed to improve the plastics waste management system in the United States. It also makes specific recommendations for how EPA and the U.S. Department of Transportation (DOT) can promote and sustain a coordinated government response that includes assessments of economically and socially beneficial applications of plastics waste in infrastructure.

OIRA Publishes Guidance On Broadening Public Participation And Community Engagement In The Regulatory Process: On July 19, 2023, OMB’s Office of Information and Regulatory Affairs (OIRA) posted a blog item entitled “Making Voices Heard in the Regulatory Process,” announcing the release of “guidance detailing new steps that Federal agencies should take to make it easier for interested members of the public to voice their views in the regulatory process.” OIRA’s guidance “emphasizes the importance of reaching out to interested members of the public early in the regulatory development process to help build durable, two-way, and trust-based relationships between members of the public and Federal agencies.” According to OIRA, it will work closely with federal agencies in the coming months to identify opportunities for supporting more public participation in the regulatory process. It will also hold a listening session “in a year to take stock — and see how we could be doing better.” More information is available in our July 24, 2023, blog item.

Uhlmann Confirmed As EPA Assistant Administrator For Enforcement And Compliance Assurance: On July 20, 2023, the Senate voted 53 to 46 to confirm David Uhlmann to be Assistant Administrator for the Office of Enforcement and Compliance Assurance (OECA) at EPA. As reported in our September 17, 2021, memorandum, Uhlmann was the Director of the Environmental Policy and Law Program at the University of Michigan Law School. Prior to academia, Uhlmann spent 17 years as a federal prosecutor, including seven years with the U.S. Department of Justice’s Environmental Crimes section. During his opening statement at the September 15, 2021, hearing on his nomination, Uhlmann stressed that his time in academia strengthened his belief in promoting environmental advocacy, noting that he believes that those companies that display ethics, integrity, and environmental stewardship should not be at a competitive disadvantage to those that do not.

EPA Begins Public Comment Period On Draft IRIS Toxicological Review Of PFHxS And Related Salts: On July 24, 2023, EPA announced a 60-day public comment period associated with its release of the draft Integrated Risk Information System (IRIS) Toxicological Review of Perfluorohexane Sulfonate (PFHxS) and Related Salts. 88 Fed. Reg. 47496. EPA states that it released the draft IRIS assessment for public comment in advance of a contractor-led peer review. ERG, a contractor to EPA, will convene a public meeting to discuss the draft report during Step 4 of the IRIS Process. According to EPA, the external peer reviewers will consider public comments submitted in response to the notice and those provided at the public meeting when reviewing the assessment. EPA will consider all comments received when revising the assessment post-peer review. EPA notes that the draft assessment “is not final as described in EPA’s information quality guidelines, and it does not represent, and should not be construed to represent Agency policy or views.” Comments are due September 22, 2023.

EPA Will Accept Comment On Potential Expansion Of Safer Choice And DfE Programs, Announces August 29, 2023, Webinar:On July 25, 2023, EPA announced an opportunity for public input on the potential expansion of the Safer Choice and Design for the Environment (DfE) programs’ certification to new product categories. EPA will hold a listening session webinar on August 29, 2023, and request stakeholder comment on which new product categories Safer Choice and DfE could expand into and how the potential expansion could offer significant benefits to human health and the environment. Comments are due September 11, 2023. For more information on this initiative, please read the full memorandum.

CEQ Proposes Bipartisan Reform Implementation Rule: On July 31, 2023, CEQ proposed the “Bipartisan Permitting Reform Implementation Rule” to revise its regulations for implementing the procedural provisions of the National Environmental Policy Act (NEPA), including to implement the Fiscal Responsibility Act’s amendments to NEPA. 88 Fed. Reg. 49924. CEQ states that it proposes the revisions “to provide for an effective environmental review process that promotes better decision making; ensure full and fair public involvement; provide for an efficient process and regulatory certainty; and provide for sound decision making grounded in science, including consideration of relevant environmental, climate change, and environmental justice effects.” CEQ proposes these changes to align better the provisions with CEQ’s extensive experience implementing NEPA; CEQ’s perspective on how NEPA can best inform agency decision making; longstanding federal agency experience and practice; NEPA’s statutory text and purpose, including making decisions informed by science; and case law interpreting NEPA’s requirements. Comments on the proposed revisions are due September 29, 2023. CEQ will conduct four virtual public meetings for the proposed rule on August 26, 2023, from 1:00 p.m. to 4:00 p.m. (EDT); August 30, 2023, from 5:00 p.m. to 8:00 p.m. (EDT); September 11, 2023, from 1:00 p.m. to 4:00 p.m. (EDT); and September 21, 2023, from 2:00 p.m. to 5:00 p.m. (EDT).

OMB Requests Comment On Proposed Guidance For Assessing Changes In Environmental And Ecosystem Services In Benefit-Cost Analysis: OMB requested comment on August 2, 2023, on proposed guidance for assessing changes in environmental and ecosystem services in benefit-cost analysis. 88 Fed. Reg. 50912. OMB states that it believes that the benefits of the proposed guidance will be substantial. According to OMB, many benefit-cost analyses involve ecosystem services, and standardized guidance on how to assess relevant changes and how to value such services will help promote consistency and predictability in these analyses. The guidance also aims to make incorporating ecosystem-service considerations easier for agencies conducting these analyses, resulting in lower analytic burdens for agencies and more sound analysis. OMB notes that while there are costs associated with performing more robust analyses of ecosystem-service effects, it “believes that the benefits of better analysis and better-informed public discourse resulting from this proposed Guidance are likely to well exceed those costs.” Comments are due September 18, 2023.

OIG Reports That EPA “Lacks Complete Guidance For The New Chemicals Program To Ensure Consistency And Transparency In Decisions”: On August 2, 2023, EPA’s Office of Inspector General (OIG) released a report entitled The EPA Lacks Complete Guidance for the New Chemicals Program to Ensure Consistency and Transparency in Decisions. According to OIG, EPA’s New Chemicals Division (NCD) “lacks assurance that the new chemicals review process operates as intended and achieves its objective to protect human health and the environment.” OIG made four recommendations, including that EPA develop, update, and issue final guidance for the New Chemicals Program; assess and update NCD’s recordkeeping applications, as needed; and address workload issues. EPA agreed to all four recommendations, “which are resolved with corrective actions pending.”

Contrary to the allegations that lead to the investigation, OIG did not “find evidence that employees are rewarded for quickly completing risk assessments that do not find risks instead of with the goal of protecting human health and the environment.” This continues the findings, including the National Archives and Records Administration (NARA) investigation related to recordkeeping, that the allegations of misconduct, including by current and former senior career officials, are not supported. For more information, please read our August 7, 2023, memorandum.

NSTC’s Sustainable Chemistry Strategy Team Releases Sustainable Chemistry Report: On August 3, 2023, the Joint Subcommittee on Environment, Innovation, and Public Health Sustainable Chemistry Strategy Team (Sustainable Chemistry ST) of the National Science and Technology Council (NSTC) published a report entitled Sustainable Chemistry Report: Framing the Federal Landscape. As reported in our January 19, 2021, memorandum, the FY 2021 National Defense Authorization Act (NDAA) included the text of the bipartisan Sustainable Chemistry Research and Development Act of 2019. It established an interagency working group lead by the Office of Science and Technology Policy (OSTP) to coordinate federal programs and activities in support of sustainable chemistry. The report establishes the federal landscape and provides a high-level overview of relevant topical areas around sustainable chemistry. The Sustainable Chemistry ST notes that it is a state-of-science report that includes gaps and opportunities for the federal government. Following the report, the Sustainable Chemistry ST will develop a strategic plan for how the federal government can leverage these opportunities to make significant progress in addressing the identified data gaps. More information will be available in our forthcoming memorandum.

Maine Invites Stakeholder Comment On Rule Concept Draft Language Prohibiting Sale Of Food Packages Containing PFAS: On August 3, 2023, the Maine Department of Environmental Protection (MDEP) announced that it would accept stakeholder comment on its rule concept draft language that would prohibit manufacturers, suppliers, and distributors from offering for sale or for promotional purposes in Maine certain types of food packaging to which PFAS have been intentionally introduced. MDEP states that it has the authority to prohibit the sale of a food package to which PFAS have been intentionally introduced in any amount greater than an incidental presence if MDEP “determines that a safer alternative to the use of PFAS in a specific application to a food package is readily available in sufficient quantity and at a comparable cost, and that the safer alternative performs as well or better than PFAS in the specific application of PFAS to a food package.” MDEP notes that in February 2021, the Washington State Department of Ecology (WDOE) published the Per- and Poly-fluoroalkyl Substances in Food Packaging Alternatives Assessment, identifying four types of food packaging that meet Washington’s statutory criteria for a prohibition. In May 2022, WDOE published a second alternatives assessment report, Safer Alternatives to PFAS in Food Packaging, that identified safer alternatives for all five of the food packaging applications reviewed. MDEP proposes to rely on the conclusions in WDOE’s reports that the safer alternatives identified perform as well as, or better, than PFAS in the specific applications of PFAS to the food package. MDEP requests written comment on this section of the Rule Chapter 80 Concept Draft by August 21, 2023. Stakeholders should e-mail Kerri.Malinowski@maine.gov with their name, affiliation, contact information, and comment in response to MDEP’s request for stakeholder engagement. More information is available in our August 7, 2023, blog item.

ATSDR Requests Nominations For Substances To Be Evaluated For Toxicological Profile Development: On August 8, 2023, the Agency for Toxic Substances and Disease Registry (ATSDR) announced that it is soliciting nominations of substances to be evaluated for an upcoming set of toxicological profiles. 88 Fed. Reg. 53488. ATSDR states that each year, it develops a list of substances to be considered for toxicological profile development. The nomination process includes consideration of all substances on ATSDR’s Substance Priority List (SPL), as well as other substances nominated by the public. Members of the public, government agencies, or private organizations may comment on which substances they are concerned about so that ATSDR may consider this information when developing future toxicological profiles. Comments are due September 7, 2023.

NASEM Releases Peer Review Report Of Draft IRIS Formaldehyde Assessment: NASEM announced the release of its report on August 9, 2023, providing recommendations to EPA for improving its draft IRIS Toxicological Review of Formaldehyde. NASEM states that “[o]verall, the report finds that EPA’s draft assessment follows the advice of prior National Academies reports and that the agency’s findings on hazard and quantitative risk are supported by the evidence identified in the document. The report recommends that EPA revise the document to ensure that users can find and follow the methods used in each step of its assessment for each health outcome.” EPA states in its August 9, 2023, press release that it is “is currently assessing the recommendations provided by the NASEM committee and plans to use the report to revise the draft IRIS formaldehyde assessment prior to finalization.” According to EPA, its program and regional offices intend to use the final assessment as part of the scientific input for developing risk assessments and as scientific information to support future risk management decisions.

NIOSH Requests Comment On Draft IDLH Value Document For Hydrogen Chloride: On August 10, 2023, the National Institute for Occupational Safety and Health (NIOSH) requested public comment and technical review on the draft Immediately Dangerous to Life or Health (IDLH) Value Profile document for the chemical hydrogen chloride (CAS RN 7647-01-0). 88 Fed. Reg. 54319. The IDLH Value Profile provides a detailed summary of the health hazards of acute exposures to high airborne concentrations of the chemical and the rationale for the IDLH value. Comments are due October 10, 2023.

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.

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