Monthly Update for November 2021
B&C Launches FIFRA Tutor™ Online, On-Demand Regulatory Training: Bergeson & Campbell, P.C. (B&C®) is pleased to announce that FIFRA Tutor™ regulatory training courses are now available at www.FIFRAtutor.com. Professionals can preview and enroll in on-demand classes to complete at their own pace and timing. FIFRA Tutor joins B&C’s existing TSCA Tutor® training courses in offering efficient and essential training for chemical regulatory professionals, and a third training program, HazCom GHS Tutor, is planned for 2022. These courses are intended to provide on-demand knowledge to assist with the strategic planning that is critical to global product development. More information is available here.
Product Sustainability Webinar Series: Part 2, November 17, 2021, Via Webinar: Chemical Watch presents part two of the Product Sustainability Webinar Series looking at the current state of plastics recycling. This webinar will explore the rapidly evolving regulatory constraints on materials management. Speakers, including B&C Managing Partner Lynn L. Bergeson, will share practical experience and observations about strategies for developing effective recycling programs that achieve the desired results.
Exploring The Environmental Footprint Of The Digital Economy — A Conversation With David Rejeski: In the recent All Things Chemical® episode Exploring the Environmental Footprint of the Digital Economy — A Conversation with David Rejeski, Lynn L. Bergeson and David Rejeski, Visiting Scholar with the Environmental Law Institute (ELI), discuss David’s work with the Project on the Energy and Environmental Implications of the Digital Economy. With support from the Alfred P. Sloan Foundation, ELI, the Yale School of the Environment, and the Center for Law, Energy & the Environment at UC Berkeley, the Project is shedding much-needed light on the true environmental and energy implications of the digital economy, focusing on blockchain technologies, sharing platforms, artificial intelligence, and other technologies.
Higher Education, Management, And Climate Change — A Conversation With Kurt Landgraf: Lynn L. Bergeson was recently joined by Kurt M. Landgraf, former Chairman and CEO of DuPont Pharmaceuticals Company and most recently former President of Washington College located in Chestertown, Maryland, for an episode of All Things Chemical. Kurt’s extraordinarily diverse background includes a mix of pharmaceutical management issues, higher education, and observations on preparing students for careers in environmental disciplines, resulting in a fascinating conversation.
2022 Forecast — Hitting Inboxes The First Week Of January: B&C and The Acta Group (Acta®) professionals are hard at work reporting and interpreting the many developments that will shape the agenda for chemicals and chemical products in the coming year. Our perennially anticipated Forecast document will be sent to clients and friends in the first week of January 2022.
EPA Proposes To Add 12 Chemicals To List Of TRI Chemicals: On October 18, 2021, the U.S. Environmental Protection Agency (EPA) proposed to add 12 chemicals to the list of toxic chemicals subject to the reporting requirements under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). 86 Fed. Reg. 57614. EPA states that it believes that each of the 12 chemicals meets the EPCRA criteria. The 12 chemicals that EPA is proposing to add are:
|N-Hydroxyethylethylenediamine;||Tris(1,3-dichloro-2-propyl) phosphate; and|
|Nitrilotriacetic acid trisodium salt;||Tris(dimethylphenol) phosphate|
Based on available bioaccumulation and persistence data, EPA believes that one chemical, 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran, should be classified as a persistent, bioaccumulative, and toxic (PBT) chemical and designated as a chemical of special concern with a 100-pound reporting threshold. Comments are due December 17, 2021.
EPA Releases Updated 2020 TRI Data: On October 21, 2021, EPA announced that it has made available updated 2020 Toxics Release Inventory (TRI) data about chemical releases, chemical waste management, and pollution prevention activities that took place during 2020 at more than 21,000 federal and industrial facilities throughout the United States and its territories. EPA states that this dataset builds on the preliminary data released in July 2021. It includes revised and late submissions from facilities, and additional data quality checks by EPA. EPA notes that the data released also include the first-ever reporting on the 172 per- and polyfluoroalkyl substances (PFAS) added to TRI by the 2020 National Defense Authorization Act (NDAA). EPA’s full analysis of the 2020 data will be published in early 2022 in the reporting year 2020 TRI National Analysis, and will examine different aspects of the data, including trends in releases, other waste management practices, and pollution prevention activities.
EPA Publishes Receipt And Status Information For September 2021 For Certain New Chemicals: On October 22, 2021, EPA published the receipt and status reports for the period from September 1, 2021, to September 30, 2021. 86 Fed. Reg. 58658. EPA is providing notice of receipt of a premanufacture notice (PMN), significant new use notice (SNUN) or microbial commercial activity notice (MCAN) (including an amended notice or test information); an exemption application under 40 C.F.R. Part 725 (Biotech exemption); an application for a test marketing exemption (TME), both pending and/or concluded; a notice of commencement (NOC) to 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. EPA also provides information on its website about cases reviewed under the amended Toxic Substances Control Act (TSCA), including the Section 5 PMN/SNUN/MCAN and exemption notices received, the date of receipt, the final EPA determination on the notice, and the effective date of EPA’s determination for PMN/SNUN/MCAN notices on its website. Comments identified by the specific case number provided in the Federal Register notice must be received by November 22, 2021.
EPA Proposes To Expand Options For Extraction And Determinative Methods Used To Characterize And Verify PCB Waste Cleanup: On October 22, 2021, EPA proposed to expand the available options for extraction and determinative methods used to characterize and verify the cleanup of polychlorinated biphenyls (PCB) waste under TSCA regulations. 86 Fed. Reg. 58730. According to EPA, the proposed changes are expected to reduce greatly the amount of solvent used in PCB extraction processes, thereby conserving resources and reducing waste. In addition, the proposed changes are expected to result in quicker, more efficient, and less costly cleanups while still being equally protective of human health and the environment. EPA also proposes to amend the performance-based disposal option for PCB remediation waste; to remove the provision allowing PCB bulk product waste to be disposed as roadbed material; to add more flexible provisions for cleanup and disposal of waste generated by spills that occur during emergency situations (e.g., hurricanes or floods); and to harmonize the general disposal requirements for PCB remediation waste. Comments are due December 21, 2021. The notice states that under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy on or before November 22, 2021.
EPA Publishes Statements Of Findings For August 2021 For Certain New Chemicals Or Significant New Uses: On October 25, 2021, EPA published its statements of findings made after reviewing notices submitted under TSCA Section 5(a) that certain new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment. 86 Fed. Reg. 58908. The notice presents statements of findings made by EPA during the period from August 1, 2021, to August 31, 2021.
EPA OIG Will Evaluate Process For Changes Made To Final SNUR For LCPFAC And Perfluoroalkyl Sulfonate Chemical Substances: According to an October 25, 2021, project notification memorandum, the EPA Office of Inspector General (OIG) plans to begin an evaluation to determine the extent to which EPA followed applicable policies, procedures, and guidance for the changes made to the significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate chemical substances 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. The memorandum states that the anticipated benefits of the evaluation include greater assurance that EPA “has controls in place to maintain the integrity of signed final rules prior to final publication in the Federal Register.”
EPA OIG Plans To Begin Fieldwork On Audit Of EPA’s Process For Conducting New Chemical Reviews: According to an October 26, 2021, project notification memorandum, OIG plans to begin fieldwork on an audit of EPA’s process for conducting reviews of new chemicals under TSCA. The memorandum states that the audit “is self-initiated based on OIG’s oversight plan for fiscal year [(FY)] 2022 and to address complaints submitted to the OIG Hotline.” The audit also addresses the following FY 2022 top management challenge for EPA: ensuring safe use of chemicals. OIG states that its objective is to determine the extent to which EPA uses and complies with applicable records management requirements, quality assurance requirements, and employee performance standards to review and approve new chemicals under TSCA to manage human health and environmental risks. More information is available in our November 3, 2021, blog item.
EPA Requests Nominations Of Individuals With Experience In Systematic Review Or Exposures To Fenceline Communities For SACC: On October 27, 2021, EPA requested public nominations of scientific experts to consider for service as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with two peer review topics anticipated for early 2022: the draft EPA TSCA Systematic Review Protocol and the draft EPA TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities. 86 Fed. Reg. 59382. EPA states that any interested person or organization may nominate qualified individuals to be considered prospective candidates for these reviews. Individuals may also self-nominate. Nominations are due November 17, 2021. More information is available in our October 27, 2021, blog item.
Comments On Proposed Extension Of PIP (3:1) Compliance Dates Due December 27, 2021: On October 28, 2021, EPA proposed to amend the regulations applicable to phenol, isopropylated phosphate (3:1) (PIP (3:1)) promulgated under TSCA. 86 Fed. Reg. 59684. Specifically, EPA is proposing to extend the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles until October 31, 2024, along with the associated recordkeeping requirements for manufacturers, processors, and distributors of PIP (3:1)-containing articles. EPA also announced its intention to commence a new rulemaking effort on PIP (3:1) and four other PBT chemicals that have been regulated under TSCA Section 6(h). EPA states that it is anticipating issuing a proposal to this end in 2023. Comments on the proposed rule are due December 27, 2021. More information is available in our October 25, 2021, memorandum, “EPA Proposes Further Extension of Compliance Dates for PIP (3:1)-Containing Articles.”
EPA Denies TSCA Section 21 Petition Regarding Chemical Mixtures In Cigarettes: On October 29, 2021, EPA announced its response to a petition submitted under TSCA Section 21 seeking a rule requiring cigarette manufacturers to eliminate the hazardous chemicals used and to develop new product designs that eliminate or reduce the cigarette butt disposal risks to the environment. 86 Fed. Reg. 59931. EPA states that it finds that the petitioner has not met its burden as defined in TSCA Sections 6(a) and 21(b)(1) “because cigarettes are not a product that can be regulated under TSCA section 6(a).”
EPA Revises Mercury Inventory Reporting Rule To Remove Reporting Exemption: On November 8, 2021, EPA published a final rule revising the regulations associated with persons who must report data to the mercury inventory established under TSCA. 86 Fed. Reg. 61708. The revisions implement an order issued by the U.S. Court of Appeals for the Second Circuit on June 5, 2020, that vacated the exemption at 40 C.F.R. Section 713.7(b)(2) for persons who import pre-assembled products that contain a mercury-added component. As a result, such persons are now required to report pursuant to 40 C.F.R. Section 713.7(b). EPA states that the rule is effectuating the vacatur ordered by the Second Circuit by making necessary amendments to the corresponding text in 40 C.F.R. Section 713.7(b). The final rule will be effective on December 8, 2021. EPA states in its November 2, 2021, press release that the final rule “offers impacted communities adequate notice of the amended reporting requirements, as the deadline for reporting 2021 data is July 1, 2022.” EPA will update the mercury inventory reporting rule compliance guide and other supporting materials to reflect these new reporting requirements.
EPA Issues Final SNURs On Certain Chemical Substances: On November 15, 2021, EPA issued final SNURs under TSCA for chemical substances that were the subject of PMNs. 86 Fed. Reg. 62917. The 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 by the SNURs. The SNURs further require that persons not commence manufacture or processing for the significant new use until they have submitted a SNUN and EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken any risk management actions that are required as a result of that determination. The SNURs will take effect on January 14, 2022.
EPA Invites Small Entities To Participate In SBAR Panel On Proposed PFAS NPDWR: On October 19, 2021, EPA announced that it is inviting small entities, including qualifying businesses, not-for-profit organizations, and local governments, to participate as Small Entity Representatives (SER) for a Small Business Advocacy Review (SBAR) Panel that will focus on EPA’s effort to develop a National Primary Drinking Water Regulation (NPDWR) for certain per- and polyfluoroalkyl substances (PFAS). NPDWRs are legally enforceable maximum contaminant levels (MCL) or treatment techniques that apply to public water systems. The SBAR Panel will include federal representatives from the Small Business Administration (SBA), OMB, and EPA. The panel members ask a selected group of SERs to provide advice and recommendations on behalf of their company, community, or organization to inform the panel members about the potential impacts of the proposed rule on small entities. Self-nominations were due November 2, 2021.
EPA Will Act Upon Petition By Initiating Two RCRA Rulemakings To Address PFAS: On October 26, 2021, EPA announced that it is acting upon a petition from New Mexico Governor Michelle Lujan Grisham (D) to address PFAS under the Resource Conservation and Recovery Act (RCRA). EPA states that in responding to the petition, it outlined plans to initiate the rulemaking process for two new RCRA actions, “reflecting the agency’s focus on using best available science and leveraging authorities to combat this shared challenge.” First, EPA will initiate the process to propose adding four PFAS as RCRA Hazardous Constituents under Appendix VIII, by evaluating the existing data for these chemicals and establishing a record to support such a proposed rule. The four PFAS that EPA will evaluate are perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), perfluorobutane sulfonic acid (PFBS), and GenX. The second rulemaking effort will clarify in EPA’s regulations that the RCRA Corrective Action Program has the authority to require investigation and cleanup for wastes that meet the statutory definition of hazardous waste, as defined under RCRA Section 1004(5). According to EPA, this modification would clarify that emerging contaminants such as PFAS can be cleaned up through the RCRA corrective action process.
EPA To Propose Sharp Reductions In Methane Emissions: On November 2, 2021, EPA announced that it will propose “comprehensive new protections to sharply reduce pollution from the oil and natural gas industry — including, for the first time, reductions from existing sources nationwide.” According to EPA, key features of the proposed rule include:
- A comprehensive monitoring program for new and existing well sites and compressor stations;
- A compliance option that allows owners and operators the flexibility to use advanced technology that can find major leaks more rapidly and at lower cost than ever before;
- A zero-emissions standard for new and existing pneumatic controllers (with a limited alternative standard for sites in Alaska), certain types of which account for approximately 30 percent of current methane emissions from the oil and natural gas sector;
- Standards to eliminate venting of associated gas, and require capture and sale of gas where a sales line is available, at new and existing oil wells;
- Proposed performance standards and presumptive standards for other new and existing sources, including storage tanks, pneumatic pumps, and compressors; and
- A requirement that states meaningfully engage with overburdened and underserved communities, among other stakeholders, in developing state plans.
EPA also is requesting information on additional sources of methane that it should consider in developing a supplemental proposal to reduce emissions even further. In addition, EPA is taking comment on how to structure a community monitoring program that would empower the public to detect and report large emission events for appropriate follow-up by owners and operators for possible further development in a supplemental proposal. EPA intends to issue the supplemental proposal in 2022, and to issue a final rule before the end of 2022. Publication of the proposed rule in the Federal Register will begin a 60-day comment period. Under the PRA, comments on the information collection provisions are best assured of consideration if OMB receives a copy of the comments 30 days after publication in the Federal Register.
EPA Extends Comment Period On ANPRM Regarding Potential Future Regulation Addressing Pyrolysis And Gasification Units: On November 5, 2021, EPA extended the comment period on its September 5, 2021, advance notice of proposed rulemaking (ANPRM) soliciting information and requesting comments to assist in the potential development of regulations for pyrolysis and gasification units that are used to convert solid or semi-solid feedstocks to useful products such as energy, fuels, and chemical commodities. 86 Fed. Reg. 61102. EPA has received several inquiries about regulations under Section 129 of the Clean Air Act (CAA) for solid waste incineration units and the applicability of such regulations to pyrolysis and gasification units for a variety of process and feedstock types. Based on these requests and the differences in language pertaining to pyrolysis among the CAA Section 129 rules, EPA believes that there is confusion in the regulated community regarding the applicability of CAA Section 129 to pyrolysis and gasification units. Information and comments are due December 23, 2021.
EPA And DOI Recommit To Federal Partnership In Support Of Urban Waters: On November 9, 2021, EPA, the U.S. Department of the Interior (DOI), 13 other federal agencies, and non-governmental partners commemorated a decade of accomplishments under the Urban Waters Federal Partnership while pledging their recommitment to the partnership. According to EPA’s press release, 20 partnership locations across the country are advancing economic, public health, environmental, and social benefits by enhancing community connections to water. The Partnership also provides support to hundreds of additional underserved communities with seed funding for local projects and public education through the Urban Waters Learning Network.
EPA Requests Nominations For National Drinking Water Advisory Council Microbial And Disinfection Byproducts Rule Revisions Working Group: EPA has requested that the National Drinking Water Advisory Council (NDWAC) provide it with advice and recommendations on key issues related to potential revisions to the following Microbial and Disinfection Byproducts (MDBP) rules: Stage 1 and Stage 2 Disinfectants and Disinfection Byproducts Rules; Surface Water Treatment Rule; Interim Enhanced Surface Water Treatment Rule; and Long-Term 1 Enhanced Surface Water Treatment Rule. To support the work of NDWAC, EPA asked that it form a Microbial and Disinfection Byproducts Rule Revisions Working Group that would include stakeholders with a variety of backgrounds and expertise. The working group would explore specific issues and identify potential MDBP rule revisions options for NDWAC to consider in making its recommendations to EPA. On November 12, 2021, EPA solicited nominations of qualified individuals to serve on the working group. 86 Fed. Reg. 62767. EPA states that it anticipates the working group will be active approximately from spring 2022 through mid-2023. Nominations are due December 13, 2021.
EPA Centralizes Collection Of Continuous Release Reports: On November 12, 2021, EPA issued a technical amendment to modify the submission location for Continuous Release Reports under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). 86 Fed. Reg. 62736. Reports are currently submitted to respective EPA regional offices; with the technical amendment, EPA will instead require all future such reports to be submitted to the appropriate EPA Headquarters (HQ) office. EPA also corrected a typographical spelling error, corrected citations within the section, and amended the listed authority. The final rule was effective on November 12, 2021.
EPA Requests Nominations Of Candidates For CASAC Ozone Panel: On November 15, 2021, EPA requested public nominations of scientific experts for the Clean Air Scientific Advisory Committee (CASAC) Ozone Panel. 86 Fed. Reg. 63024. According to the notice, the panel will provide advice through the chartered CASAC on policy-relevant science for EPA’s reconsideration of the Ozone National Ambient Air Quality Standards (NAAQS). Nominations are due December 6, 2021.
FDA Issues Non-Substantive Updates To FCN Guidance: In October 2021, the U.S. Food and Drug Administration (FDA) issued updated final guidance for the “Preparation of Food Contact Substance Notifications (Toxicology Recommendations): Guidance for Industry” and the “Preparation of Food Contact Substance Notifications (Administrative): Guidance for Industry.” Each guidance document was updated to “include Paperwork Reduction Act information and non-substantive formatting or editorial revisions.”
FDA Announces Webinar Series: On October 18, 2021, FDA announced that it would host a series of webinars that will explore a “…collaborative exchange of ideas and experience related to the importance of a robust food safety culture in helping to ensure safe food production.” The webinars aim to explore one of the core elements in FDA’s New Era of Smarter Food Safety Initiative announced in July 2020. The first webinar on November 4, 2021, was entitled “Key Concepts in Addressing Food Safety Culture as a Science – Not a Slogan,” and the recording is available here.
FDA Issues Asbestos Test Results For Cosmetic Products: On October 25, 2021, FDA released test results for the agency’s recent sampling of talc-containing products for the presence of asbestos. The test results, for samples analyzed via polarized light microscopy (PLM) and transmission electron microscopy (TEM), indicate that asbestos was not detected in the cosmetic products.
FDA Issues Proposed SUNSET Rule: On October 29, 2021, the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking to withdraw or repeal the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) final rule in its entirety. 86 Fed. Reg. 59906. The SUNSET final rule was issued on January 19, 2021, and scheduled to take effect on March 22, 2021. The Administration delayed the effective date, pending judicial review, until March 22, 2022. The rule raises many procedural concerns on the potential impact to multiple stakeholders, including FDA. The concerns include the potential inadvertent expiration of key regulations, including newer requirements under the Food Safety Modernization Act (FSMA) and decades old regulations on color additives. The notice states that comments on the adverse impact were disregarded in error when the final rule was issued. Comments on the proposed rule are being accepted until December 28, 2021.
ANSES Publishes Health Risk Assessment Guide For Nanomaterials In Food: On October 11, 2021, the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) announced the release of a scientific guide to assess the risks posed by nanomaterials in food. ANSES will initially test its methodology on engineered nanomaterials previously identified in the first phase of the expert appraisal, depending on data availability. According to ANSES, at this stage, titanium dioxide appears to have the best-documented exposure and hazard data, allowing a full risk assessment to be conducted. More information is available in our October 19, 2021, blog item.
Honorable Mentions In EPA’s Cleaner Indoor Air During Wildfires Challenge Include Concept Using Nanomaterial Coating: On October 26, 2021, EPA announced the winners of its Cleaner Indoor Air During Wildfires Challenge. The honorable mention awardees include Metalmark Clean Air Device, “[a] device that uses a novel nanomaterial coating on a filter to enable destruction of captured particulate matter [(PM)] when the filter is heated to high temperature.” More information is available in our November 5, 2021, blog item.
Registration Opens For Webinar On “What We Know About NanoEHS: Risk Assessment And Risk Management”: Registration has opened for a November 16, 2021, webinar held by the National Nanotechnology Initiative (NNI) on “What We Know about NanoEHS: Risk Assessment and Risk Management.” The webinar’s speakers will explore the impact of advances in risk assessment and risk management on the safe and responsible development of nanotechnology.
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 http://blog.braginfo.org.
Lynn L. Bergeson Authors “Is Extended Producer Responsibility On The Rise For Packaging?” For Chemical Processing:On July 13, 2021, Maine became the first state to enact Extended Producer Responsibility (EPR) legislation for packaging. On August 6, 2021, Oregon followed, enacting a similar EPR law applicable to packaging. Other states are poised to pass similar legislation. This article discusses the concept of EPR and summarizes the state legislation.
Senate Committee Releases FY 2022 EPA Appropriations Bill: On October 18, 2021, the Senate Appropriations Committee released nine appropriations bills for FY 2022, including the bill for the Department of the Interior, Environment, and Related Agencies. According to the bill summary, the bill provides $10.54 billion for EPA, $1.3 billion more than FY 2021. The bill summary states that increased funding for EPA’s clean air and climate program, as well as its compliance and enforcement efforts, will enable EPA to tackle climate change and support clean air and clean water for communities across the country. To ensure that all communities can benefit, these resources are paired with an agency-wide expansion in environmental justice (EJ) efforts, from $12 million in funding to over $200 million, including $100 million for EJ grants. The bill includes major investments in drinking and waste water infrastructure: $2.86 billion for the Drinking Water and Clean Water State Revolving Funds, an increase of $100 million; $72 million for lead pipe replacement grants, an increase of $50 million; and $80 million for innovative water infrastructure loans through the Water Infrastructure Finance and Innovation Act (WIFIA), an increase of $15 million. The bill will protect health and spur economic growth by helping clean up contaminated lands and pollution through $1.33 billion for EPA’s Superfund program, an increase of $100 million for cleanup at sites on the National Priorities List; $126 million for brownfields grants, an increase of $35 million; and $142 million for diesel engine clean up grants, an increase of $52 million.
House Select Committee Holds Hearing On Business Perspectives On Climate Action: On October 20, 2021, The House Select Committee on the Climate Crisis held a hybrid hearing on “Good for Business: Private Sector Perspectives on Climate Action.” The Committee heard from Gilbert Campbell, Founder and Chief Executive Officer (CEO), Volt Energy Utility; Corley Kenna, Head of Communications and Policy, Patagonia; David Edsey, Climate Director, Technical Underwriting, Zurich North America; and Mark W. Menezes, Former Deputy Secretary of Energy, U.S. Department of Energy; Former Chief Counsel for Energy and Environment, House Energy and Commerce Committee.
Senate Committee Holds Hearing On “Evaluating The Federal Response To The Persistence And Impacts Of PFAS Chemicals On Our Environment”: On October 20, 2021, the Senate Committee on Environment and Public Works held a hearing on “Evaluating the Federal Response to the Persistence and Impacts of PFAS Chemicals on our Environment.” The sole witness called before the Committee was EPA Assistant Administrator for the Office of Water, Radhika Fox. The focus of the hearing was to address the recently released EPA Strategic Roadmap for PFAS. More information on EPA’s Strategic Roadmap is available in our October 19, 2021, memorandum, which is discussed below in the Miscellaneous section. More information on this hearing is available in our October 21, 2021, memorandum.
House Committee Holds Hearing On “TSCA And Public Health: Fulfilling The Promise Of The Lautenberg Act”: The House Energy and Commerce Subcommittee on Environment and Climate Change held a hearing on October 27, 2021, on “TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act.” The October 25, 2021, briefing memorandum notes that the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Lautenberg Act) comprehensively amended TSCA, “including key reforms to increase EPA’s authority to mandate testing, require EPA to make affirmative decisions about the safety of new chemicals, and require the evaluation, and where merited, the regulation of existing chemicals.”
Dr. Michal Ilana Freedhoff, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP), was the Subcommittee’s only witness. In her testimony, she emphasized several critical building blocks of a sustainable TSCA program. More information regarding Dr. Freedhoff’s testimony is available in our October 28, 2021, memorandum.
Infrastructure Bill Includes Provisions Important To Chemical And Agriculture Sectors: On November 8, 2021, the Infrastructure Investment and Jobs Act (H.R. 3684) was presented to President Biden for signature. The House passed the bill on November 5, 2021, by a vote of 228 to 206, and the Senate passed the bill on August 10, 2021, by a vote of 69 to 30. The bill contains many important provisions. We highlight in our memorandum some of the provisions in the 1,039-page bill that we believe our clients and friends may find interesting. Passing and enacting the Infrastructure Investment and Jobs Act is without question a landmark bipartisan achievement for modernizing infrastructure in the U.S. The $1.2 trillion, 1,039-page Act includes hundreds of new programs and initiatives with significant investments that touch almost every aspect of the U.S. economy. Fully understanding the implications for the chemical and agricultural sectors will take time and indeed many aspects of the Act will take years to implement and longer to see meaningful results. Investment in sustainable manufacturing, pollution prevention, climate change resilience, environmental remediation, even personal protective equipment (PPE) policy, will have consequences for the chemical and agriculture industries, as well as manufacturing writ large. B&C will continue to provide in-depth analysis and identify opportunities moving forward.
Biden Administration Announces Multi-Agency Plan To Confront PFAS Pollution; EPA Releases Strategic Roadmap: On October 18, 2021, the Biden Administration announced a multi-agency plan to address PFAS contamination nationwide. According to the White House, agencies, including EPA, the Department of Defense (DOD), FDA, the U.S. Department of Agriculture (USDA), the Department of Homeland Security (DHS), and HHS, will take actions to prevent PFAS from being released into the air, drinking systems, and food supply and to expand cleanup efforts to remediate the impacts of PFAS pollution. To facilitate the coordination of PFAS response activities across the government, Biden Administration officials convened a first meeting of the newly-formed Interagency Policy Committee on PFAS, under the leadership of White House Council on Environmental Quality (CEQ) Chair Brenda Mallory. During the meeting, agency leaders discussed their progress and plans for addressing PFAS contamination and reducing the risks to American families. The Interagency Policy Committee on PFAS will work to coordinate and help develop new policy strategies to support research, remediation, and removal of PFAS in communities across the country.
EPA announced the release of its PFAS Strategic Roadmap: EPA’s Commitments to Action 2021-2024 (Strategic Roadmap), which sets timelines by which EPA plans to take specific actions during the first term of the Biden Administration. EPA states that the Strategic Roadmap is the result of a “thorough analysis” conducted by the EPA Council on PFAS established by EPA Administrator Michael Regan in April 2021. The Strategic Roadmap is centered on three guiding strategies: increase investments in research; leverage authorities to take action now to restrict PFAS chemicals from being released into the environment; and accelerate the cleanup of PFAS contamination. According to EPA, over the coming weeks, it will be working to partner for progress on PFAS. More information is available in our October 19, 2021, memorandum.
EPA And USDA Announce Winners Of Next Gen Fertilizer Innovations Challenge: On October 19, 2021, EPA announced the winners of the Next Gen Fertilizer Innovations Challenge, the second of a two-part, joint EPA-U.S. Department of Agriculture (USDA) Partnership and Competition on Enhanced Efficiency Fertilizers (EEF) to Advance Agricultural Sustainability in the United States. The goal of the competition is to improve the efficiency of fertilizers to increase crop yields while reducing the impacts of fertilizers on the environment. According to EPA, the winners submitted concepts for novel technologies that can reduce the environmental effects of nitrogen and phosphorus from modern agriculture while maintaining or increasing crop yields. The winning solutions use nanoparticles that require less fertilizer and release nutrients on demand to growing plants, and then biodegrade into harmless substances or even nutrients; support greater plant growth from the same or less fertilizer application; and other approaches.
FTC Amends Energy Labeling Rule For Central Air Conditioners: On October 20, 2021, the Federal Trade Commission (FTC) published a final rule that amends the Energy Labeling Rule to update the comparability ranges and sample labels for central air conditioners. 86 Fed. Reg. 57985. The amendments will be effective January 1, 2023. The notice states that manufacturers may begin using the new range information prior to that date, in a manner consistent with the Department of Energy (DOE) guidance now that FTC has issued the final updates to appendices H and I.
EPA Releases Final GenX Human Health Toxicity Assessment: On October 25, 2021, EPA announced the release of its final human health toxicity assessment for GenX chemicals, which are part of the PFAS group. According to EPA, in certain locations, GenX chemicals have been found in surface water, groundwater, drinking water, rainwater, and the air. EPA’s final assessment for GenX chemicals focuses solely on the potential human health effects associated with oral exposure. EPA states that issuing the final toxicity assessment gives it the opportunity to share and exchange information with its state and Tribal co-regulators “who are working with their communities to confront this complex environmental challenge.” The final 2021 GenX chemicals assessment uses the state-of-the-art systematic review process, incorporates new data available since 2018, and applies revised uncertainty factors. EPA notes that these changes resulted in a lower, more protective toxicity value for GenX chemicals relative to its 2018 draft toxicity assessment.
EPA Seeks Comment On Draft Strategy To Reduce Lead Exposures And Disparities In U.S. Communities: On October 28, 2021, EPA published a notice of availability and request for comments on its Draft Strategy to Reduce Lead Exposures and Disparities in U.S. Communities (Lead Strategy). 86 Fed. Reg. 59711. EPA states that it developed the Lead Strategy to reduce further lead exposures in communities, and particularly those with EJ concerns. Adverse effects on intellect, ability to pay attention, and academic achievement have been linked to very low levels of lead in children’s blood. According to the notice, EPA will focus on eliminating the disparities in blood lead levels by taking targeted actions informed by scientific information to prevent exposures that could lead to lifelong impacts on social and economic achievement. Following the public comment period, EPA will revise and implement the Lead Strategy. Comments are due January 26, 2022.
FTC Updates Procedures For Responding To Petitions For Rulemaking: On October 29, 2021, FTC published a final rule updating its procedures for responding to petitions for rulemaking. 86 Fed. Reg. 59851. According to FTC, the changes will provide increased transparency and promote public participation in the rulemaking process. Pursuant to the amendments, FTC will provide notice and an opportunity for public comment on petitions for the issuance, amendment, or repeal of regulations. FTC states that the rules also provide greater guidance to the public on the procedures for filing petitions and the types of material that may be submitted in support of a petition. The rule was effective October 29, 2021.
Federal Agencies Reaffirm Commitment To Protecting Endangered Species, Providing Effective Pest Control Tools, And Regulating Pesticide Use In A Fair, Transparent, And Predictable Manner: On November 3, 2021, EPA, the White House CEQ, USDA, the U.S. Department of Commerce, and DOI “reaffirm[ed] their commitment to working together and with stakeholders to protect endangered species, provide effective pest control tools, and regulate pesticide use in a fair, transparent, and predictable manner.” According to EPA’s November 3, 2021, press release, on October 15, 2021, all five agencies met as part of the Interagency Working Group (IWG) created under the 2018 Farm Bill to discuss improvements to the consultation process for pesticide registration and registration review under Section 7 of the Endangered Species Act (ESA). EPA states that the group’s first meeting resulted in specific commitments to improve the pesticide consultation process for endangered species and engaging stakeholders, including by capitalizing on the strong interest among stakeholders for a workable process. More information is available in our blog item.
OSHA Publishes ETS On Vaccination And Testing; Fifth Circuit Stays ETS Pending Review: On November 5, 2021, the Occupational Safety and Health Administration (OSHA) issued an emergency temporary standard (ETS) to protect unvaccinated employees of large employers (100 or more employees) from the risk of contracting COVID-19 “by strongly encouraging vaccination.” 86 Fed. Reg. 61402. Covered employers must develop, implement, and enforce a mandatory COVID-19 vaccination policy, with an exception for employers that instead adopt a policy requiring employees to either get vaccinated or elect to undergo regular COVID-19 testing and wear a face covering at work in lieu of vaccination. In its November 4, 2021, press release, OSHA states that the emergency temporary standard covers employers with 100 or more employees — firm or company-wide — and provides options for compliance. The ETS requires employers to provide paid time to workers to get vaccinated and to allow for paid leave to recover from any side effects. The ETS also requires employers to do the following:
- Determine the vaccination status of each employee, obtain acceptable proof of vaccination status from vaccinated employees, and maintain records and a roster of each employee’s vaccination status;
- Require employees to provide prompt notice when they test positive for COVID-19 or receive a COVID-19 diagnosis. Employers must then remove the employee from the workplace, regardless of vaccination status; employers must not allow them to return to work until they meet required criteria;
- Ensure each worker who is not fully vaccinated is tested for COVID-19 at least weekly (if the worker is in the workplace at least once a week) or within seven days before returning to work (if the worker is away from the workplace for a week or longer); and
- n Ensure that, in most circumstances, each employee who has not been fully vaccinated wears a face covering when indoors or when occupying a vehicle with another person for work purposes.
Although the ETS was effective November 5, 2021, OSHA states that it also serves as a proposal for a final standard. OSHA seeks comment on all aspects of the ETS and whether it should be adopted as a final standard. Comments are due December 6, 2021.
After OSHA issued the ETS, a number of petitioners, including covered employers, states, religious groups, and individual citizens, filed suit in the federal courts of appeals, moving to stay and permanently enjoin OSHA’s mandate. On November 12, 2021, the U.S. Court of Appeals for the Fifth Circuit granted petitioners’ motion for a stay pending judicial review. The court ordered that OSHA take no steps to implement or enforce the ETS until further court order. In its decision, the court states that in seeking to make health policy, OSHA “runs afoul” of the Occupation Safety and Health Act “from which it draws its power and, likely, violates the constitutional structure that safeguards our collective liberty.”
EPA Announces Public Meetings Of SAB PFAS Review Panel: On November 10, 2021, EPA announced that the EPA Science Advisory Board (SAB) PFAS Review Panel will hold four public meetings to review and provide comments on the health effects data to inform the derivation of proposed Maximum Contaminant Level Goals (MCLG) for PFOA and PFOS; the analysis of health risk reduction benefits of potential decreases in drinking water concentrations of PFOA and PFOS; and approaches to assess the cumulative risk among mixtures of PFAS. 86 Fed. Reg. 62526. The public meetings of the SAB PFAS Review Panel will be held on December 16, 2021; January 4, 2022; January 6, 2022; and January 7, 2022. Prior to the meetings, the agenda and other meeting materials for each meeting will be placed on the SAB website.
ATSDR And CDC Seek More Participants In PFAS Study: On November 10, 2021, the Agency for Toxic Substances and Disease Registry (ATSDR) and the Centers for Disease Control and Prevention (CDC) announced that they need more participants in a study designed to understand better the extent of exposure to PFAS in drinking water near the Pease International Tradeport in Portsmouth, New Hampshire (the Pease Study). On November 16, 2021, Pease Study staff will be on hand at the Food Court on Pease to screen for eligibility, schedule appointments, and answer questions from the community. ATSDR states that the Pease Study “will expand our scientific understanding of PFAS by looking at the association between health outcomes and PFAS exposure from drinking water.”
Board Of Scientific Counselors Executive Committee Will Deliberate EPA’s Charge Questions On PFAS: On November 12, 2021, EPA announced that the Board of Scientific Counselors (BOSC) Executive Committee (EC) will meet on November 23 and December 8, 2021. 86 Fed. Reg. 62811. Proposed agenda items for the meeting include, but are not limited to, deliberation on EPA’s charge questions on PFAS. The agenda and other meeting materials will be posted on BOSC’s website. Comments must be received by November 22, 2021, to be considered by the EC. EPA will accept requests for the draft agenda or making a presentation at the meeting until November 22, 2021. BOSC is a federal advisory committee that provides advice and recommendations to EPA’s Office of Research and Development on technical and management issues of its research programs.
EPA Releases 2021 National Recycling Strategy: EPA released on November 15, 2021, the 2021 National Recycling Strategy to tackle major recycling challenges and to create a stronger, more resilient, and cost-effective municipal solid waste recycling system. According to EPA, the 2021 Strategy is the first time its recycling strategy will address the climate impacts of producing, using, and disposing of materials and focus on the human health and environmental impacts of waste and waste-related facilities in overburdened communities, reflecting its commitment to delivering EJ. The National Recycling Strategy includes five strategic objectives with specific actions to strengthen the U.S. recycling system:
- Improve markets for recycled commodities through market development, analysis, manufacturing, and research;
- Increase collection of recyclable materials and improve recycling infrastructure through analysis, funding, product design, and processing efficiencies;
- Reduce contamination in the recycled materials stream through outreach and education to the public on the value of proper recycling;
- Enhance policies and programs to support recyclability and recycling through strengthened federal and international coordination, analysis, research on product pricing, and sharing of best practices; and
- Standardize measurement and increase data collection through coordinated recycling definitions, measures, targets, and performance indicators.
In addition, the Strategy focuses on how EPA will move forward in the following areas: increasing equitable access for overburdened communities; reducing climate impacts of materials management; and managing materials for a circular economy. EPA states that during the next few months, it will work collaboratively with stakeholders to develop a plan to implement the 2021 Strategy. EPA will collaborate with communities, local, state, federal, and Tribal partners, and with public and private stakeholders to achieve the Strategy’s ambitious goals.
White House EJ Advisory Council Will Meet November 17 And 18: The White House EJ Advisory Council will meet November 17-18, 2021. The meeting discussion will focus on several topics, including, but not limited to, the discussion and deliberation of draft recommendations to the Chair of the CEQ and the White House Interagency Council on EJ from the Justice40 Work Group, Climate and Economic Justice Screening Tool Work Group, and the Scorecard Work Group. The meeting is open to the public. Pre-registration is required.
EPA Posts Recording Of Webinar On Green Chemistry Challenge Awards For 2022: EPA has posted a recording of the September 22, 2021, webinar that it hosted to educate stakeholders on the Green Chemistry Challenge Awards and the nomination process. The webinar reviewed the history of the awards, the categories within the awards, eligibility requirements, and what is needed to submit a nomination. As reported in our August 27, 2021, blog item, EPA is currently accepting nominations for the 2022 Green Chemistry Challenge Awards from companies or institutions that have developed a new green chemistry process or product that helps protect human health and the environment. Nominations are due December 10, 2021.
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