Federal Development Update for July 2022


Register Now For “TSCA New Approach Methodologies” On August 3, 2022: Bergeson & Campbell, P.C. (B&C®) is pleased to present “TSCA New Approach Methodologies,” a complimentary one-hour webinar that will highlight examples of the U.S. Environmental Protection Agency’s (EPA) use of non-vertebrate testing strategies, commonly referred to as “new approach methodologies” (NAM), in its evaluation of new and existing chemical substances under the Toxic Substances Control Act (TSCA) Sections 5 and 6. Register now to join Lynn L. Bergeson, Richard E. Engler, Ph.D., James W. Cox, M.S., and Kristie Sullivan, MPH, for this timely and informative webinar.

Recording Available -- TSCA At Six: ELI, B&C, And GWU Conclude Another Fabulous Conference: On June 29, 2022, the Environmental Law Institute (ELI), B&C, and the George Washington University Milken Institute School of Public Health presented “TSCA Reform -- Six Years Later.” This virtual conference marked the sixth TSCA Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Speakers included Lynn R. Goldman, M.D., M.S., M.P.H, Michal Ilana Freedhoff, Ph.D., Madison H. Le, Jeffery T. Morris, Ph.D., Brian Symmes, and Mark A. Hartman. A recording of the conference is available online. More information on this event is available in our July 5, 2022, memorandum.

Balancing Wildlife Protection And Responsible Pesticide Use — A Conversation With EPA’s Jake Li: On this episode of All Things Chemical®, Lynn L. Bergeson, Jake Li, Deputy Assistant Administrator for Pesticide Programs, Office of Chemical Safety and Pollution Prevention (OCSPP), EPA, and James V. Aidala discuss what the Administration is doing to balance wildlife protection and responsible pesticide use, what the federal Interagency Working Group is doing in this regard, and how the Endangered Species Act (ESA) Workplan is helping EPA’s Pesticide Program meet its ESA obligations. Listen now.

Food Pesticide Residues — A Conversation With Sheryl Dolan And Meibao Zhuang, Ph.D.: Lynn L. Bergeson, Sheryl Lindros Dolan, and Meibao Zhuang, Ph.D., sit down for this episode of All Things Chemical to discuss pesticide tolerances, what they are, how EPA develops them, and how well government and industry stakeholders communicate their utility in ensuring a safe and reliable food supply. Listen now.

TSCA/FIFRA/TRI

EPA Receives TSCA Section 21 Petition To Phase Out GHG Pollution: EPA received a petition on June 16, 2022, under Section 21 of TSCA from Daniel M. Galpern on behalf of Donn J. Viviani, John Birks, Richard Heede, Lise Van Susteren, James E. Hansen, Climate Science, Awareness and Solutions, and Climate Protection and Restoration Initiative. The petition requests EPA “to phase out the anthropogenic manufacture, processing, distribution, use, and disposal of greenhouse gas (GHG) emissions, fossil fuels, and fossil fuel emissions.” EPA acknowledged receipt of the petition in a July 5, 2022, letter. Under TSCA Section 21, EPA has 90 days to grant or deny the portions of the petition eligible for TSCA Section 21. If EPA grants the petition, then EPA “will promptly commence an appropriate proceeding.” If EPA denies the petition in whole or in part, then it will publish the reasons for denial in the Federal Register.

EPA’s Spring 2022 Unified Agenda Includes Proposed And Final TSCA And TRI Rules: EPA’s spring 2022 Unified Agenda, published on June 21, 2022, includes a number of proposed and final rulemakings under TSCA or the Toxics Release Inventory (TRI). More information on the rulemakings, including links to our memoranda, is available in our July 8, 2022, blog item.

EPA Proposes SNURs For Certain Chemicals: On June 24, 2022, EPA proposed significant new use rules (SNUR) under TSCA for chemical substances that were the subject of premanufacture notices (PMN) and are also subject to Orders issued by EPA pursuant to TSCA. 87 Fed. Reg. 37783. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required by that determination. Comments are due July 25, 2022.

EPA Announces New Chemical Engineering Initiative Intended To Increase Transparency And Reduce Rework: EPA announced on June 24, 2022, that it is “conducting a broad outreach effort to describe and discuss with stakeholders how the Agency evaluates data provided for new chemicals submissions and common issues that cause EPA to have to reconduct risk assessments (‘rework’) for these submissions.” According to EPA, its goal is to reduce rework of initial risk assessments for new chemicals submissions that is caused by submitters supplementing incomplete initial new chemicals review submissions, contributing to delays in EPA’s review of these chemicals, and stretching already limited resources. EPA notes that it shares an interest with stakeholders in reducing process inefficiencies while also ensuring a protective review of new chemical risks. EPA states that it anticipates this outreach effort will be “particularly helpful” for Low Volume Exemptions (LVE), which constitute about 60 percent of TSCA Section 5 submissions annually. More information is available in our June 27, 2022, memorandum.

EPA Issues Final SNURs For Certain Chemical Substances: On June 27, 2022, EPA issued final SNURs for chemical substances that were the subject of PMNs. 87 Fed. Reg. 37999. The final SNURs require persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use. The final SNURs further require that persons not commence manufacture or processing for the significant new use until they have submitted a Significant New Use Notice (SNUN), and EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken any risk management actions as are required as a result of that determination. The final SNURs will be effective on August 26, 2022.

EPA Publishes Receipt And Status Information For Certain New Chemicals For May 2022: On June 28, 2022, EPA published the receipt and status reports for the period from May 1, 2022, to May 31, 2022. 87 Fed. Reg. 38391. EPA states that it is providing notice of receipt of a PMN, SNUN, or microbial commercial activity notice (MCAN), including an amended notice or test information; an exemption application (Biotech exemption); an application for a test marketing exemption (TME), both pending and/or concluded; a notice of commencement (NOC) of manufacture (including import) for new chemical substances; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. Comments identified by the specific case number provided by EPA are due July 28, 2022.

Final Revision To HBCD Risk Determination Finds HBCD, As A Whole Chemical Substance, Presents An Unreasonable Risk: EPA announced on June 29, 2022, the availability of the final revision to the risk determination for the cyclic aliphatic bromide cluster (HBCD) risk evaluation issued under TSCA. 87 Fed. Reg. 38747. The revision reflects EPA policy changes intended to ensure the public is protected from unreasonable risks from chemicals in a way that is supported by science and the law. EPA states that it determined that “HBCD, as a whole chemical substance, presents an unreasonable risk of injury to health and the environment when evaluated under its conditions of use.” In addition, the revised risk determination does not reflect an assumption that all workers always appropriately wear personal protective equipment (PPE). According to the notice, EPA “understands that there could be occupational safety protections in place at workplace locations; however, not assuming use of PPE reflects EPA’s recognition that unreasonable risk may exist for subpopulations of workers that may be highly exposed because they are not covered by [Occupational Safety and Health Administration (OSHA)] standards, or their employers are out of compliance with OSHA standards, or because OSHA has not issued a permissible exposure limit (PEL) (as is the case for HBCD).” The revised risk determination supersedes the condition of use-specific no unreasonable risk determinations in the September 2020 HBCD risk evaluation and withdraws the associated order included in Section 5.4.1 of the September 2020 HBCD risk evaluation. For more information, please read our June 30, 2022, memorandum.

EPA Publishes Final Scope For Part 2 Of Asbestos Risk Evaluation: EPA published on June 29, 2022, the final scope of the risk evaluation to be conducted for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos. 87 Fed. Reg. 38746. EPA will evaluate the conditions of use of asbestos, including other types of asbestos fibers in addition to chrysotile, that EPA had excluded from Part 1 as legacy uses and associated disposals, as well as any conditions of use of asbestos-containing talc. The final scope of the Part 2 risk evaluation includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations (PESS) that EPA plans to consider in conducting the risk evaluation. More information is available in our July 11, 2022, memorandum.

EPA Issues Annual Progress Report On Pesticide Reregistration Performance Measures And Goals: On July 1, 2022, EPA published a notice announcing the availability of its progress report in meeting its performance measures and goals for pesticide reregistration during fiscal year (FY) 2019 (2019 Report). 87 Fed. Reg. 39517. Section 4(l) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to publish information about EPA’s annual achievements in this area. The 2019 Report discusses the completion of tolerance reassessment and describes the status of various regulatory activities associated with reregistration. The 2019 Report also provides the total number of products reregistered and products registered under the “fast-track” provisions of FIFRA. The report is available at EPA-HQ-OPP-2014-0125. Comments can be submitted on or before August 30, 2022. More information is available in our July 5, 2022, blog.

EPA Amends SNUR Regulations To Protect Workers’ Health: On July 5, 2022, EPA issued a final rule amending the regulations governing significant new uses of chemical substances under TSCA to align with revisions that were made to the OSHA Hazard Communications Standard (HCS) and changes to the OSHA Respiratory Protection Standard and the National Institute for Occupational Safety and Health (NIOSH) respirator certification requirements for the respiratory protection of workers from exposure to chemicals. 87 Fed. Reg. 39756. In addition, EPA is amending the regulations governing SNURs to address issues that have been identified by EPA and raised by stakeholders through public comments. EPA is also making a minor change to reporting requirements for PMNs and other TSCA notifications. EPA states that it “expects these changes to have minimal impact on the costs and burdens of compliance, while updating the significant new use reporting requirements to assist in addressing any potential risks to human health and the environment.” The final rule will be effective on September 6, 2022. More information and a detailed commentary will be available in a forthcoming memorandum that will be posted on our website.

EPA Seeks Input From Small Businesses On Development Of Proposed TSCA Data Reporting Rule: On July 6, 2022, EPA announced that it is inviting small businesses to participate as Small Entity Representatives (SER) for a Small Business Advocacy Review (SBAR) Panel that will focus on EPA’s development of a proposed rule to collect data to inform each step of the TSCA risk evaluation and risk management process. EPA states that the proposed rule would establish a framework of reporting requirements based on a chemical’s status in the TSCA Section 6 Risk Evaluation/Risk Management Lifecycle. Additionally, the new data reporting rule would enhance the exposure-related data collected through the TSCA Chemical Data Reporting (CDR) process. Self-nominations are due July 20, 2022. More information is available in our July 7, 2022, blog item.

EPA Issues A Proposed Consent Decree Regarding Petition Concerning Treated Seeds And Treated Article Exemption: On July 6, 2022, EPA released a proposed consent decree intended to resolve the case, Center for Food Safety, et al. v. U.S. Environmental Protection Agency (3:21-cv-09640-JSC), brought against EPA in the United States District Court for the Northern District of California alleging that EPA has unreasonably delayed responding to a petition for rulemaking relating to the regulatory exemption of pesticide treated seed. 87 Fed. Reg. 40233.In accordance with EPA’s March 18, 2022, memorandum entitled “Consent Decrees and Settlement Agreements to Resolve Environmental Claims Against the Agency,” EPA issued a Federal Register notice providing the proposed consent decree to resolve Center for Food Safety, et al. v. U.S. Environmental Protection Agency and providing a comment period. Comments on the proposed consent decree from persons who are not named as parties to the litigation in question are due on or before August 5, 2022. The public can submit comments at www.regulations.gov in Docket ID Number EPA-HQ-OGC-2022-0511. More information is available in our July 14, 2022, blog.

EPA OIG Finds EPA Was Not Transparent About Changes Made To LCPFAC SNUR After Administrator Signature: On July 7, 2022, EPA Office of Inspector General (OIG) released a report entitled “The EPA Was Not Transparent About Changes Made to a Long-Chain PFAS Rule After Administrator Signature.” OIG evaluated the extent to which EPA followed applicable policies, procedures, and guidance for the changes made to the long-chain perfluoroalkyl carboxylate and perfluoroalkyl sulfonate chemical substances (LCPFAC) SNUR between the EPA Administrator’s signing of the final rule on June 22, 2020, and the publication of the final rule in the Federal Register on July 27, 2020. According to OIG, EPA did not follow all applicable policies, procedures, and guidance when making changes to the LCPFAC SNUR after the Administrator signed it and before it was published in the Federal Register. More information is available in our July 13, 2022, blog item.

GAO Finds Remaining Priority Recommendations For EPA Include Four Priority Recommendations For The IRIS Program: On July 8, 2022, the U.S. Government Accountability Office (GAO) publicly released its 2022 update on its priority open recommendations for EPA. In June 2021, GAO identified 22 priority recommendations for EPA. According to GAO, EPA has since implemented ten of those recommendations. The total number of priority recommendations remaining is 12. These recommendations involve several areas, including assessing and controlling toxic chemicals. Regarding assessing and controlling toxic chemicals, GAO states that EPA’s ability to help protect public health and the environment effectively “depends on credible and timely assessments of risks posed by toxic chemicals,” including per- and polyfluoroalkyl substances (PFAS). According to GAO, by implementing four priority recommendations in this area, EPA would improve its ability to prepare and issue Integrated Risk Information System (IRIS) chemical assessments. More information is available in our July 14, 2022, blog item.

EPA Releases Draft Revisions To Risk Determinations For PCE, NMP, Methylene Chloride, And TCE, Finding That Each, As A Whole Chemical Substance, Presents An Unreasonable Risk Of Injury To Health: EPA recently released draft revisions to the risk determinations for perchloroethylene (PCE) (87 Fed. Reg. 39085 (June 30, 2022)), N-methylpyrrolidone (NMP) (87 Fed. Reg. 39511 (July 1, 2022)), methylene chloride (87 Fed. Reg. 39824 (July 5, 2022)), and trichloroethylene (TCE) (87 Fed. Reg. 40520 (July 7, 2022)). Each draft revision to the risk determinations for these chemicals reflects EPA’s announced policy changes to ensure the public is protected from unreasonable risks from chemicals in a way that is supported by science and the law. In each draft revision, EPA finds that the chemical, as a whole chemical substance, presents an unreasonable risk of injury to health when evaluated under its conditions of use. The following comment deadlines apply: PCE -- August 1, 2022; NMP -- August 1, 2022; methylene chloride -- August 4, 2022; and TCE -- August 8, 2022. More information is available in our July 12, 2022, memorandum.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

Lynn L. Bergeson Authors “Chemical Compliance: Get Ready For Superfund Excise Tax,” Chemical Processing: On November 15, 2021, President Biden signed into law the Infrastructure Investment and Jobs Act (IIJA), reinstating the Superfund excise tax on certain chemical substances under Sections 4661 and 4671 of the Internal Revenue Code (Tax Code). Effective July 1, 2022, the tax many were glad to see expire is back; the first deposit of the tax is due on July 29, 2022. This article discusses the tax and the challenges it poses.

EPA Withdraws Proposed Rule Requiring Control, Capture, And/Or Destruction Of HFCs That Would Otherwise Be Emitted From Manufacture Of HCFCs: On September 29, 2021, EPA issued a proposed rulemaking to require the control, capture, and/or destruction of a hydrofluorocarbon (HFC) that would otherwise be emitted from manufacture of hydrochlorofluorocarbons (HCFC). 86 Fed. Reg. 53916. Specifically, EPA proposed to require companies to control, capture, and/or destroy HFC-23 byproduct generated at plants that manufacture class II ozone-depleting substances regulated under current Clean Air Act (CAA) regulations, such as HCFC-22. According to a June 16, 2022, notice, upon its consideration of comments and based on further action by EPA, “EPA is now withdrawing the proposed requirements described in that proposed rule.” 87 Fed. Reg. 36282. The notice summarizes the proposed rule and provides an explanation for EPA’s decision not to issue a final rule.

EPA Proposes NSPS Review For Industrial Surface Coating Of Plastic Parts For Business Machines: On June 21, 2022, EPA proposed amendments to the Standards of Performance for Industrial Surface Coating of Plastic Parts for Business Machines as the preliminary results of the review of the new source performance standards (NSPS) required by the CAA. 87 Fed. Reg. 36796. Specific to affected facilities that commence construction, modification, or reconstruction after June 21, 2022, EPA proposes, in new subpart TTTa, volatile organic compound (VOC) emission limitations for prime, color, texture, and touch-up coating operations. EPA also proposes in subparts TTTa and TTT to include a requirement for electronic submission of periodic compliance reports. Comments are due August 22, 2022. 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 by July 21, 2022.

EPA Proposes To Amend GHG Reporting Rule: On June 21, 2022, EPA proposed to amend specific provisions in the GHG Reporting Rule to improve the quality and consistency of the data collected under the rule, streamline and improve implementation, and clarify or propose minor updates to certain provisions that have been the subject of questions from reporting entities. 87 Fed. Reg. 36920. According to EPA, the proposed changes would improve understanding of the sector-specific processes or other factors that influence GHG emissions rates, improve verification of collected data, and complement or inform other EPA programs. EPA is also proposing revisions that would improve implementation of the GHG Reporting Rule, such as updates to applicability estimation methodologies, providing flexibility for or simplifying calculation and monitoring methodologies, streamlining recordkeeping and reporting, and other minor technical corrections or clarifications. Comments are due August 22, 2022. EPA notes that under the PRA, comments on the information collection provisions are best assured of consideration if OMB receives a copy of the comments by August 22, 2022.

EPA Publishes Lifetime Drinking Water Health Advisories For Four PFAS: On June 21, 2022, EPA announced the release of health advisories for four PFAS, including interim updated lifetime drinking water health advisories for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS), and final health advisories for hexafluoropropylene oxide (HFPO) dimer acid and its ammonium salt (together referred to as “GenX chemicals”) and perfluorobutane sulfonic acid and its related compound potassium perfluorobutane sulfonate (together referred to as “PFBS”). 87 Fed. Reg. 36848. EPA’s health advisories, which identify the concentration of chemicals in drinking water at or below which adverse health effects are not anticipated to occur, are: 0.004 parts per trillion (ppt) for PFOA, 0.02 ppt for PFOS, 10 ppt for GenX chemicals, and 2,000 ppt for PFBS. EPA notes that health advisories are non-regulatory and reflect EPA’s assessment of the best available peer-reviewed science. The interim updated health advisories for PFOA and PFOS supersede EPA’s 2016 health advisories for PFOA and PFOS.

IRS Issues Procedures To Modify The List Of Substances Subject To The Superfund Tax: As reported in our May 19, 2022, memorandum, the Superfund excise tax on certain chemical substances was reinstated beginning on July 1, 2022, under the IIJA. The Internal Revenue Service (IRS) announced on June 24, 2022, that it has posted frequently asked questions (FAQ) on the Superfund chemical excise tax. The IRS released Revenue Procedure 2022-26, which provides the exclusive procedures for requesting a determination under Section 4672(a)(2) of the Tax Code that a substance be added to or removed from the list of taxable substances under Section 4672(a) of the Tax Code. More information is available in our June 29, 2022, blog item. For information on what you need to know to comply, please see our July 13, 2022, memorandum.

SAB Will Review Draft SAB Reports On NPDWR For PFAS And CCL 5: On June 27, 2022, EPA announced that the Science Advisory Board (SAB) will meet on July 18, 2022, and July 20, 2022, to conduct quality reviews of two draft SAB reports: Review of EPA’s Analyses to Support EPA’s National Primary Drinking Water Rulemaking for PFAS and Review of the EPA’s Draft Fifth Contaminant Candidate List (CCL 5). 87 Fed. Reg. 38150. The SAB quality review process ensures that all draft reports developed by SAB panels, committees, or workgroups are reviewed by the chartered SAB before being prepared in final and transmitted to the EPA Administrator.

Supreme Court Finds EPA Lacked Authority To Issue Clean Power Plan: On June 30, 2022, the Supreme Court issued its decision in West Virginia v. EPA, finding that the “best system of emission reduction” (BSER) identified in the Obama Administration’s Clean Power Plan was not within the authority granted to EPA by Section 111(d) of the CAA. In 2015, EPA issued the Clean Power Plan, concluding that the “best system of emission reduction” for existing coal-fired power plants included a requirement that such facilities reduce their own production of electricity, or subsidize increased generation by natural gas, wind, or solar sources. According to the Court, prior to the Clean Power Plan, EPA had used Section 111(d) only a handful of times since its enactment in 1970. Under the previous Administration, EPA “determined that the interpretive question raised by the Clean Power Plan fell under the major questions doctrine. Under that doctrine, it determined, a clear statement is necessary for a court to conclude that Congress intended to delegate authority ‘of this breadth to regulate a fundamental sector of the economy,’” and it found none. The Court agreed that this was a major questions case and found that the BSERs identified by EPA in the Clean Power Plan were not within the authority granted to EPA in CAA Section 111(d).

PHMSA Requests Information On Electronic Hazard Communication Alternatives: On July 11, 2022, the Pipeline and Hazardous Materials Safety Administration (PHMSA) published a request for information (RFI), seeking input on the potential use of electronic communication as an alternative to current, physical documentation requirements for hazard communication. 87 Fed. Reg. 41179. According to the notice, PHMSA is considering revisions to the Hazardous Materials Regulations (HMR) that would authorize a performance-based electronic communication alternative to the existing physical, paper-based hazard communication requirements. PHMSA states that this revision is meant to facilitate and promote the use of electronic hazard communication. PHMSA anticipates that electronic communication would improve transportation safety, efficiency, and effectiveness by providing electronic access to the same required information currently contained in hazard communication documents. With the RFI, PHMSA seeks input to help determine the most effective mechanisms and potential impediments for implementing electronic hazard communication. The RFI includes two sets of questions: Section A for emergency response and inspection organizations; and Section B for organizations who offer, transport, or facilitate the movement of hazardous materials. Comments are due September 9, 2022.

Congressional Letter Expresses Concerns Over Climate And Environmental Justice Risks Of Chemical Recycling Of Plastics: On July 14, 2022, a bicameral group of 35 members of Congress sent a letter to EPA expressing concerns about “chemical recycling technologies that contribute to the climate crisis and perpetuate environmental injustice in vulnerable communities.” Senator Cory Booker’s (D-NJ) press release states that the letter comes as EPA considers whether to remove existing CAA protections from chemical recycling processes. The letter asks that EPA continue to regulate pyrolysis and gasification units as waste combustion units “so that the most vulnerable communities do not bear even more of a burden from existing facilities.” The letter urges EPA to prioritize solutions that reduce reliance on single-use plastic and move the United States “towards a circular economy through source reduction interventions and improved mechanical recycling as it implements the National Recycling Strategy.”

FDA

FDA Releases Update To 2022 Priority Guidance Topics: The U.S. Food and Drug Administration (FDA) on June 30, 2022, released an updated list of guidance topics that are a priority to complete during 2022. Guidance documents expected this year include:

  • Preparation of Premarket Submission for Food Contact Substances (Chemistry Recommendations); Draft Guidance for Industry;
     
  • Best Practices for Convening a GRAS Panel; Guidance for Industry;
     
  • Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5); Draft Guidance for Industry; and
     
  • Various guidance documents related to the Food Safety Modernization Act (FSMA).
     

FDA Announces Final Guidance For Industry: FDA announced on July 8, 2022, the availability of the final guidance for industry #245 entitled “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.” 87 Fed. Reg. 40846. The final guidance, which is intended to address elements of the hazard analysis and risk-based preventive controls under the FSMA, includes multiple updates from comments received from the draft published in 2018.

Petition To Remove Authorizations For Bisphenol A: On July 11, 2022, FDA announced the filing of a petition by Environmental Defense Fund, Maricel Maffini, Breast Cancer Prevention Partners, Clean Water Action/Clean Water Fund, Consumer Reports, Endocrine Society, Environmental Working Group, Healthy Babies Bright Futures, Linda Birnbaum, and the Nicholas School of the Environment at Duke University, proposing that the food additive regulations be amended to remove or restrict authorizations for the use of bisphenol A (BPA). 87 Fed. Reg. 41079. FDA is seeking comments, additional scientific data, and other information related to the issues raised by the petition, which must be submitted on or before September 9, 2022.

NANOTECHNOLOGY

Presentations Available From 4th Joint Symposium On Nanotechnology: The 4th Joint Symposium on Nanotechnology, organized by the German Federal Institute for Risk Assessment (BfR) and the Fraunhofer Network Nanotechnology (FNT), was held May 30-31, 2022. The conference included presentations on topics such as the use of nanotechnology in textiles and packaging, its application in agriculture, the introduction of nanomaterials into the body, and future-oriented assessment approaches. Presentations from the conference have been posted online.

Canada Publishes Draft Framework For The Risk Assessment Of Manufactured Nanomaterials Under CEPA: On June 17, 2022, Canada published its draft Framework for the Risk Assessment of Manufactured Nanomaterials under the Canadian Environmental Protection Act, 1999 (CEPA) for a 60-day public comment period. The plain language summary states that the framework describes how scientists at Environment and Climate Change Canada (ECCC) and Health Canada (HC) conduct risk assessments on nanomaterials. The draft risk assessment framework outlines approaches and considerations for informing the risk assessment of nanomaterials under CEPA, including both existing nanomaterials on the Domestic Substances List (DSL) and new nanomaterials notified under the New Substances Notification Regulations (Chemicals and Polymers). Comments are due August 16, 2022.

EUON Looking For Topics To Address In Upcoming Studies: On June 17, 2022, the European Union (EU) Observatory for Nanomaterials (EUON) announced that it is looking for topics that could be addressed in its upcoming studies. EUON is looking for study topics that address:

  • Questions related to the health and safety aspects of nanomaterials, including hazard and risk assessment, exposure to nanomaterials, or worker safety and protection;
     
  • Specific issues surrounding the uses of nanomaterials; or
     
  • Information about markets for nanomaterials (e.g., the market for specific materials such as graphene or specific market sectors).
     

Proposals are due July 18, 2022.

NNI Holds Webinar On Nanotechnology Commercialization: Perspectives From A Regional Innovation Ecosystem: On June 28, 2022, the National Nanotechnology Initiative (NNI) held a public webinar on “Nanotechnology Commercialization: Perspectives from a Regional Innovation Ecosystem.” Participants heard from members “of a vibrant nanotechnology innovation ecosystem anchored by the Mid-Atlantic Nanotechnology Hub at the Singh Center for Nanotechnology (part of the National Nanotechnology Coordinated Infrastructure).” The speakers shared their perspectives on topics such as nanotechnology research and development (R&D), the technology development pathway, partnerships, funding, and the importance of resources, such as the federally funded user facilities around the country.

EUON Publishes Nanopinion On Models To Characterize Exposures To Manufactured Nanomaterials In The OECD: On June 28, 2022, EUON published a Nanopinion entitled “Models to Characterize Exposures to Manufactured Nanomaterials in OECD” by Vladimir Murashov, Ph.D., Senior Scientist in the Office of the Director, NIOSH, and John Howard, M.D., Director of NIOSH and Administrator of the World Trade Center Health Program in the U.S. Department of Health and Human Services. The authors describe recently completed international projects conducted under the umbrella of the Organization for Economic Cooperation and Development (OECD). Created in 2007 and led by NIOSH, the OECD Steering Group on Exposure Measurement and Mitigation of Nanomaterials (SG8) addresses the exposure component of the risk assessment and risk management program for manufactured nanomaterials.

OECD Publishes New Test Guidelines For Nanomaterials: On June 30, 2022, OECD published six new Test Guidelines (TG) and ten updated or corrected TGs. The new TGs include the first two harmonized methods for measuring certain nanomaterial-specific physical-chemical properties: Test Guideline 124 on Volume Specific Surface Area of Manufactured Nanomaterials; and Test Guideline 125 on Nanomaterial Particle Size and Size Distribution of Nanomaterials. More information is available in our July 8, 2022, blog item.

Austrian Academy Of Sciences Publishes NanoTrust Dossier On Advanced Materials: The Institute of Technology Assessment of the Austrian Academy of Sciences has published a NanoTrust Dossier entitled “Advanced Materials.” According to the dossier, advanced materials are “materials or material combinations with improved, novel or unique functionalities or properties” and represent a broad class of materials that include semiconductors, biomaterials, and nanomaterials. The dossier concludes that “[a]t present, it is still unclear whether all advanced materials are covered by existing chemical safety regulations. It is therefore necessary to review relevant regulations and corresponding risk assessment tools in this context to anticipate and fill any potential loopholes.”

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.

Lynn L. Bergeson Authors “Environmental Justice And Enforcement In America: What Investors Need To Know,” Financier Worldwide: By any standard, federal enforcement of environmental laws in the United States has been uneven, to say the least. The prevailing perception is that Democrats are “greener” than Republicans when it comes to environmental enforcement. The data are quite scattered, however, and it would seem no party has cornered the environmental protection market. The Trump Administration may be the exception that proves the rule. Most would agree civil and criminal enforcement case numbers were significantly below those of other Administrations, all by design. A raft of other actions taken by the Trump Administration crystallized that environmental enforcement was definitely not top of mind. Priorities today are decidedly different, and investors need to know the implications of the Biden Administration’s commitment to the twin goals of environmental protection and environmental justice. This article explores these topics.

LEGISLATIVE

Senate Committee Holds Hearing On Implementation Of TSCA Amendments: On June 22, 2022, the sixth anniversary of the enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), the Senate Committee on Environment and Public Works held a hearing on “Toxic Substances Control Act Amendments Implementation.” The Committee’s only witness was Michal Freedhoff, Ph.D., Assistant Administrator, OCSPP, EPA. Freedhoff’s written testimony is available online. For more information on the hearing, please see our June 24, 2022, memorandum.

Bipartisan Legislation Would Expand Federal Research On PFAS Contamination: On June 23, 2022, Senator Gary Peters (D-MI) introduced the Federal PFAS Research Evaluation Act (S. 4492). According to Peters’s July 13, 2022, press release, the bill would direct the Director of the National Science Foundation (NSF), in coordination with the EPA Administrator, the Secretary of Defense, the Director of the National Institutes of Health (NIH), and heads of other federal agencies with expertise on PFAS substances to enter into an agreement with the National Academies of Sciences, Engineering, and Medicine to study and report on a federal research agenda that would advance the understanding of PFAS substances. The press release states that the bill “would result in four nonpartisan, consensus reports identifying the research needed to understand human exposure and toxicity estimations of PFAS, and identify management and treatment options for PFAS contamination.”

Bicameral Bill Would Improve Air Quality Monitoring And Protect Frontline Communities: On July 12, 2022, Senator Tammy Duckworth (D-IL) introduced the Public Health Air Quality Act of 2022 (S. 4510). According to Representative Lisa Blunt Rochester’s (D-DE) July 13, 2022, press release, she will introduce a companion bill in the House. The bill would:

  • Require EPA to implement immediate fenceline monitoring for toxic air pollutants at 100 facilities contributing to high local cancer and other health threats from dangerous pollutants like ethylene oxide, chloroprene, and formaldehyde within 18 months for at least a six-year period;
     
  • Ensure that fenceline monitoring and continuous emission monitoring are core components of national emission standards for chemical, petrochemical, and other sources of fugitive toxic air pollution to assure compliance with pollution limits, and so that communities “never again have to wonder what is in their air”;
     
  • Require a “rapid” expansion of the National Ambient Air Quality Standards (NAAQS) or national ambient air monitoring network through the addition of at least 80 new NCore multipollutant monitoring stations in communities where this is most needed to protect people with asthma and other health conditions and from COVId-19. It also requires an additional 100 pollutant-specific monitors to be deployed in unmonitored or under-monitored areas;
     
  • Deploy at least 1,000 new air quality sensors in communities affected by air pollution and complement the NAAQS monitoring network and increase communities’ access to information about air quality; and
     
  • Direct EPA to integrate data collected through these programs into EJSCREEN, EPA’s publicly available environmental justice screening and mapping tool.
     

On July 13, 2022, the Senate Committee on Environment and Public Works held a hearing to examine air quality monitoring legislation, including the Public Health Air Quality Act.

House Will Consider Appropriations Bills: The House is expected to consider six appropriations bills during the week of July 18, 2022, including the appropriations bill for Interior, Environment, and Related Agencies. According to the summary of the bill released by the House Appropriations Committee, the bill would provide $11.5 billion for EPA, an increase of $2 billion above the FY 2022 enacted level. Of this amount, the bill includes:

  • $4.67 billion for EPA’s core science and environmental program work, an increase of $951 million above the FY 2022 enacted level. Within these amounts, the bill includes $126 million in funding for scientific and regulatory work on PFAS needed to establish drinking water and cleanup standards;
     
  • $5.18 billion for State and Tribal Assistance Grants, an increase of $826 million above the FY 2022 enacted level;
     
  • $1.31 billion for Superfund, an increase of $81 million above the FY 2022 enacted level; and
     
  • $301 million for Environmental Justice activities, an increase of $201 million above the FY 2022 level.
     
MISCELLANEOUS

SEC Proposes To Require Enhanced Disclosures By Certain Investment Advisers And Investment Companies About ESG Investment Practices: On June 17, 2022, the Securities and Exchange Commission (SEC) published a proposed rule that would amend rules and forms under both the Investment Advisers Act of 1940 (Advisers Act) and the Investment Company Act of 1940 (Investment Company Act) to require registered investment advisers, certain advisers that are exempt from registration, registered investment companies, and business development companies to provide additional information regarding their environmental, social, and governance (ESG) investment practices. 87 Fed. Reg. 36654. The SEC states that the proposed amendments to these forms and associated rules seek to facilitate enhanced disclosure of ESG issues to clients and shareholders. According to the SEC, it designed the proposed rules and form amendments “to create a consistent, comparable, and decision-useful regulatory framework for ESG advisory services and investment companies to inform and protect investors while facilitating further innovation in this evolving area of the asset management industry.” In addition, the SEC proposes an amendment to Form N-CEN applicable to all Index Funds, as defined in Form N-CEN, to provide identifying information about the index. Comments are due August 16, 2022.

EPA Publishes Initial List Of Programs Covered Under Biden Administration’s Justice40 Initiative: On June 24, 2022, EPA released an initial list of programs covered under the Biden Administration’s Justice40 Initiative, “which aims to deliver 40 percent of the overall benefits of climate, clean energy, affordable and sustainable housing, clean water, and other investments to disadvantaged communities.” EPA’s initial list includes 72 programs covered by the Justice40 Initiative, ranging from EPA’s Lead Risk Reduction Program to the newly created Clean School Bus Program, which was established through the Bipartisan Infrastructure Law. A full list of EPA programs covered by the Justice40 Initiative can be found online.

OSHA Begins Rulemaking Process To Revise Standards For Occupational Exposure To Lead: On June 28, 2022, OSHA published an advance notice of proposed rulemaking (ANPRM) stating that it is considering rulemaking to revise its standards for occupational exposure to lead based on medical findings that adverse health effects in adults can occur at Blood Lead Levels (BLL) lower than the medical removal level (=60 micrograms per deciliter (µg/dL) in general industry, =50 µg/dL in construction) and lower than the level required under current standards for an employee to return to their former job status (<40 µg/dL). 87 Fed. Reg. 38343. OSHA states that it is seeking input on reducing the current BLL triggers in the medical surveillance and medical removal protection provisions of the general industry and construction standards for lead. OSHA is also seeking input about how current ancillary provisions in the lead standards can be modified to reduce worker BLLs. Comments are due August 29, 2022.

EPA OIG Finds Additional Internal Controls Would Improve EPA’s System For Electronic Disclosure Of Environmental Violations: On June 30, 2022, the EPA OIG released a report entitled “Additional Internal Controls Would Improve the EPA’s System for Electronic Disclosure of Environmental Violations.” OIG conducted the evaluation to determine whether EPA’s process for screening self-reported violations through its electronic disclosure, or eDisclosure, system is effective and ensures that significant concerns, such as criminal conduct and potential imminent hazards, are addressed by the Office of Enforcement and Compliance Assurance (OECA). OIG concluded that without national screening guidance, training, effective monitoring, and Central Data Exchange improvements, there is a risk that significant concerns are not being addressed and that the impacts of the EPA’s eDisclosure system will remain limited and unknown. OIG recommends that the OECA Assistant Administrator develop national guidance that includes a process for screening eDisclosure submissions for significant concerns; provide eDisclosure-specific training to EPA headquarters and regions to clarify expectations, establish staff responsibilities, and communicate best practices; develop performance measures for the eDisclosure system, as well as a monitoring plan to track its effectiveness; and assess eDisclosure system functionality to identify and implement improvements. According to OIG, OECA agreed with all four of its recommendations and proposed acceptable corrective actions and estimated completion dates.

GSA Publishes ANPRM Regarding Single-Use Plastics And Packaging: On July 7, 2022, the General Services Administration (GSA) published an ANPRM to seek public feedback pertaining to the use of plastic consumed in both packaging and shipping, as well as other single-use plastics for which the agency contracts. 87 Fed. Reg. 40476. The GSA states that the Center for Biological Diversity, along with 180 signatories, submitted a petition to GSA on February 3, 2022, requesting that it address single-use plastics through rulemaking. This ANPRM, among other things, seeks to understand better the implications of any such rulemaking. According to the GSA, the issues raised in the comments submitted in response to the ANPRM will inform future rulemaking to establish requirements and reporting mechanisms for reducing unnecessary single-use plastic, to include plastic packaging and shipping materials. Comments are due September 6, 2022.

NIOSH Publishes Skin Notation Profiles For Several Chemicals: On July 13, 2022, NIOSH announced the availability of skin notation profiles for dioxane; beta-chloroprene; diacetyl and 2,3-pentanedione; 2,4-toluene diisocyanate, 2,6-toluene diisocyanate, 2,4- and 2,6-toluene diisocyanate mixture; and chlorodiphenyl (54 percent chlorine). 87 Fed. Reg. 41721. Skin notation profiles provide information supplemental to the skin notations in the NIOSH Pocket Guide to Chemical Hazards, including the summary of all relevant data used to aid in determining the hazards associated with skin exposures.

White House Environmental Justice Advisory Council Will Meet In August 2022: On July 7, 2022, EPA announced that the White House Environmental Justice Advisory Council will meet August 3-4, 2022. 87 Fed. Reg. 40529. The meeting discussion will focus on draft recommendations related to climate resilience, the beta version of the Climate and Economic Justice Screening Tool, and the implementation of the Justice40 Initiative. According to the notice, a public comment period relevant to the development of an annual public performance scorecard and the types of indicators or data that would be useful in a scorecard will be considered during the meeting on August 3, 2022. The meeting is open to the public. The Advisory Council is interested in receiving public comments specific to the development of an annual public performance scorecard and the types of indicators or data that would be useful in a scorecard. This scorecard will provide a method for evaluation and accountability to assess the federal government’s progress in addressing current and historic environmental injustice.

ATSDR Seeks Public Nominations Of Substances To Be Evaluated For Toxicological Profile Development: On July 8, 2022, the Agency for Toxic Substances and Disease Registry (ATSDR) announced that is initiating the development of another set of Toxicological Profiles. 87 Fed. Reg. 40843. The notice solicits public nominations of substances for ATSDR to evaluate for Toxicological Profile development. All nominations, whether for substances on the Substance Priority List or for other substances, must be received by August 8, 2022.

OSTP Publishes RFI To Identify Critical Data Gaps And Needs To Inform Federal Strategic Plan For PFAS Research And Development: On July 13, 2022, the White House Office of Science and Technology Policy (OSTP) requested input from all interested parties to identify data gaps in R&D regarding several aspects of PFAS. 87 Fed. Reg. 41749. This information will be used to inform a strategic plan for federal coordination of PFAS R&D and, in compliance with Section 332 of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (NDAA), the interagency strategy team on PFAS will also develop an implementation plan for federal agencies. The RFI states that respondents may provide information for one or as many research goals below as they choose:

  • The removal of PFAS from the environment, in part or in total;
     
  • The safe destruction or degradation of PFAS;
     
  • The development and deployment of safer and more environmentally friendly alternative substances that are functionally similar to those made with PFAS;
     
  • The understanding of sources of environmental PFAS contamination and pathways to exposure for the public; and/or
     
  • The understanding of the toxicity of PFAS to humans and animals.
     

Comments are due August 29, 2022. More information is available in our July 15, 2022, blog item.

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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