Recent Federal Developments: June 2022
EPA Amends Several TSCA Section 4 Test Orders For Chemicals Undergoing Risk Evaluation: On March 24, 2022, EPA announced that it issued a second round of test orders under Section 4 of TSCA to obtain additional data on eight of the next 20 chemicals undergoing risk evaluation. In April 2022, EPA issued corrections to the following test orders: 1,1,2-trichloroethane; 1,2-dichloroethane; 1,2-dichloropropane; 4,4'-(1-methylethylidene)bis[
EPA Resolves Case Involving Export Of Carbon Nanomaterial In Violation Of TSCA Section 12(b) And Notice Of Export Requirements: EPA filed a complaint with the Environmental Appeals Board on March 15, 2022, alleging that Vorbeck Materials violated TSCA Section 12(b) and the Notice of Export rule requirements at 40 C.F.R. Part 707, Subpart D. According to EPA, Vorbeck exported a carbon nanomaterial substance that is subject to a TSCA Section 5(e) consent order on one occasion to one country without prior notification to EPA as required by TSCA Section 12(b) and 40 C.F.R. Section 707.60, and as specified in 40 C.F.R. Sections 707.65 and 707.67. EPA proposed a penalty of $8,277 for the alleged violations. According to the April 19, 2022, final order of the Environmental Appeals Board, EPA received full payment of the penalty ($8,277), and the case is resolved. More information is available in our June 1, 2022, blog item.
EPA Proposes To Update CBI Requirements Under TSCA: On May 12, 2022, EPA proposed new and amended requirements concerning the assertion and treatment of confidential business information (CBI) claims for information reported to or otherwise obtained by EPA under TSCA. 87 Fed. Reg. 29078. The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments to TSCA in 2016 included many new provisions concerning the assertion, EPA review, and treatment of confidentiality claims. EPA proposes procedures for submitting such claims in TSCA submissions and addresses issues such as substantiation requirements, exemptions, electronic reporting enhancements (including expanding electronic reporting requirements), maintenance or withdrawal of confidentiality claims, and provisions in current rules that are inconsistent with amended TSCA. The proposed rule also addresses EPA procedures for reviewing and communicating with TSCA submitters about confidentiality claims. Comments are due on or before July 11, 2022.
Our May 17, 2022, memorandum summarizes and comments on the provisions concerning the purpose and applicability of the proposed new Part 703 and the requirements for asserting a confidentiality claim. Our May 18, 2022, memorandum continues to address EPA’s review of confidentiality claims and related or corresponding revisions to other TSCA rules.
EPA Publishes Notice Concerning Court-Ordered Stay Of Effectiveness For Pesticide Application Exclusion Zone Provision Of The Agricultural Worker Protection Standard: As reported in our November 2, 2020, blog item, on October 30, 2020, EPA issued a final rule on the Agricultural Worker Protection Standard (WPS) regulation that revises the requirements on the pesticide application exclusion zone (AEZ), defined as an “area surrounding the point(s) of pesticide discharge from the application equipment that must generally be free of all persons during pesticide applications.” The final AEZ requirements were scheduled to go into effect on December 29, 2020, but on December 28, 2020, the U.S. District Court for the Southern District of New York issued an order in the case of State of New York et al. v. EPA that resulted in a stay of the requirements. Subsequent orders have extended this stay of the effectiveness.
EPA published a May 16, 2022, Federal Register notice stating that as of February 15, 2022, the effectiveness of the WPS final rule is stayed by court order until August 22, 2022. 87 Fed. Reg. 29673. According to the notice, EPA intends to publish another document in the Federal Register to address the status of the 2020 final rule if the stay of effectiveness expires or is lifted, but EPA “does not intend to publish additional Federal Register documents to announce any additional court orders entered to further stay the effectiveness of the 2020 final rule.”
EPA Releases Meeting Minutes And Final Report For March SACC Meeting On Draft TSCA Screening Level Approach For Fenceline Communities: On May 19, 2022, EPA announced the availability of the meeting minutes and final report for the March 15-17, 2022, Science Advisory Committee on Chemicals (SACC) virtual meeting regarding EPA’s proposed Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0 under TSCA. According to the meeting minutes and final report, SACC “agreed that the methodological document was well organized and generally well written.” SACC states that it “had difficulty reproducing results that were relevant to understanding and reviewing the document and indicated multiple limitations and uncertainties,” however. To make the tool applicable for any unique community, the meeting minutes and final report state that additional exposure scenarios and relevant data must be applied. SACC offered specific commentary and suggestions, along with a collection of references. A meeting transcript is available. More information is available in our May 19, 2022, blog item.
Vinyl Institute Seeks Review Of EPA’s TSCA Section 4 Test Order For 1,1,2-Trichloroethane: On May 23, 2022, the Vinyl Institute, Inc. (VI) filed suit in the U.S. Court of Appeals for the District of Columbia against EPA, seeking review of EPA’s March 2022 test order for 1,1,2-trichloroethane issued under TSCA Section 4(a)(2). The VI seeks judicial review of the test order under federal law, including but not limited to the Administrative Procedure Act (APA), TSCA, and EPA’s regulations promulgated thereunder. The VI seeks a determination that, inter alia, the test order violates these authorities; is arbitrary, capricious, an abuse of discretion, and otherwise not in accordance with the law; is in excess of statutory jurisdiction, authority, or limitations, or short of statutory right; is without observance of procedure required by law; is unsupported by substantial evidence; and is otherwise contrary to law. The VI asks that the court hold unlawful, vacate, enjoin, set aside, and remand the test order.
EPA Extends Comment Period For Proposed Rule To Ban Ongoing Uses Of Asbestos: On May 25, 2022, EPA extended the public comment period for the April 12, 2022, proposed rule that would prohibit ongoing uses of chrysotile asbestos to give stakeholders more time to review the proposed regulation and prepare comments. 87 Fed. Reg. 31814. EPA is extending the comment period an additional 30 days, from June 13, 2022, to July 13, 2022. As reported in our April 7, 2022, memorandum, the proposed rule would ban chrysotile asbestos, the only known form of asbestos that is currently imported into the United States and is found in products like asbestos diaphragms used by the chlor-alkali industry, sheet gaskets, brake blocks, aftermarket automotive brakes/linings, other vehicle friction products, and other gaskets also imported into the United States. EPA also proposed targeted disposal and recordkeeping requirements.
EPA Publishes Receipt And Status Information For Certain New Chemicals For April 2022: On May 25, 2022, EPA published the receipt and status reports for the period from April 1, 2022, to April 30, 2022. 87 Fed. Reg. 31882. EPA states that it 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 (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 June 24, 2022.
EPA Activates Emergency Viral Pathogen Guidance For Monkeypox Virus: EPA announced on May 26, 2022, that on Monday, May 23, 2022, it has activated its Emerging Viral Pathogen (EVP) Guidance for Antimicrobial Pesticides (Guidance) in response to monkeypox, which had been considered to be a rare disease caused by infection with the monkeypox virus. More information on monkeypox and the Guidance is available in our June 1, 2022, blog item.
EPA Seeks Nominations For Technical Experts To Review New Chemicals Collaborative Research Program: On May 27, 2022, EPA requested nominations for technical experts to serve as special government employees (SGE) to participate in the review of the New Chemicals Collaborative Research Program with the Board of Scientific Counselors (BOSC), a federal advisory committee to EPA’s Office of Research and Development (ORD). 87 Fed. Reg. 32161. BOSC will be evaluating ORD’s draft Strategic Research Action Plans Fiscal Years 2023-2026 in fall 2022. According to EPA, the fall 2022 meeting will provide a more in-depth evaluation of the TSCA New Chemicals Collaborative Research Program and associated research plan. EPA states that it will provide an additional draft document that summarizes technical details of the research plan. Nominations are due June 30, 2022. More information is available in our May 27, 2022, blog item.
EPA Publishes Draft FY 2023-2024 NPGs For Comment, Including NPG For OCSPP: EPA has published the draft fiscal year (FY) 2023-2024 National Program Guidances (NPG) for public comment. The NPGs set forth the strategies and actions EPA and its state and Tribal partners intend to undertake to protect human health and the environment. The draft FY 2023-2024 NPGs include an NPG for the Office of Chemical Safety and Pollution Prevention (OCSPP). OCSPP’s program priorities include:
Pesticide Cooperative Agreements with States and Tribes;
Pollinator Protection Efforts;
Revised Pesticide Worker Protection Standard Rule;
Revised Certification of Pesticide Applicators Rule;
Region-Specific Pesticide Priorities on Those Areas of Greatest Need Nationally;
Toxics Release Inventory (TRI);
Lead Risk Reduction; and
Pollution Prevention (P2).
Comments on the draft NPGs are due July 14, 2022.
EPA Announces Winners Of The 2022 Green Chemistry Challenge Awards: On June 6, 2022, EPA announced the winners of the 2022 Green Chemistry Challenge Awards. EPA states that green chemistry “is the design of chemical products and processes that reduce or eliminate the generation and use of hazardous substances.” According to EPA, the winners “have developed new and innovative green chemistry technologies that provide solutions to significant environmental challenges and spur innovation and economic development.” In support of the Biden Administration’s commitment to tackle the climate crisis, EPA added a new award category recognizing technology that reduces or eliminates greenhouse gas (GHG) emissions. More information is available in our June 6, 2022, blog item.
EPA Issues First In Series Of TSCA Test Orders For PFAS: EPA announced on June 6, 2022, that it issued the first in a series of TSCA test orders to require companies to conduct and submit testing on per- and polyfluoroalkyl substances (PFAS). EPA issued the order as part of its PFAS Strategic Roadmap. When EPA announced the Strategic Roadmap to confront PFAS contamination nationwide, it also released the National PFAS Testing Strategy to help identify PFAS data needs and require testing to fill those gaps. More information on EPA’s PFAS Strategic Roadmap and National PFAS Testing Strategy is available in our October 19, 2021, memorandum. For more information regarding this test order, please see our June 8, 2022, memorandum.
EPA Proposes Revised VOC Emission Limits For Automobile And Light Duty Truck Surface Coating Operations: On May 18, 2022, EPA published a proposed rule that presents the preliminary results of its review of the New Source Performance Standards (NSPS) for Automobile and Light Duty Truck Surface Coating Operations as required by the Clean Air Act (CAA). 87 Fed. Reg. 30141. EPA is proposing, in a new NSPS subpart, revised volatile organic compound (VOC) emission limits for prime coat, guide coat, and topcoat operations for affected facilities that commence construction, modification, or reconstruction after May 18, 2022. In addition, EPA proposes amendments under the new NSPS subpart, amendments to NSPS subpart MM, and to add electronic reporting requirements. Comments are due July 18, 2022. EPA states that under the Paperwork Reduction Act (PRA), comments on the information collection provisions “are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before June 17, 2022.”
EPA Adds Five PFAS To List Of Regional Screening And Removal Management Levels To Protect Human Health And The Environment: On May 18, 2022, EPA announced that it added five PFAS to a list of risk-based values that help EPA determine if response or remediation activities are needed. EPA notes that screening and removal management levels are not cleanup standards. They are risk-based values that help EPA determine if further investigation or actions are needed to protect public health, such as, sampling, assessing risks, and taking further action, which could include providing alternative drinking water. The five PFAS include: hexafluoropropylene oxide dimer acid and its ammonium salt (HFPO-DA, also referred to as GenX chemicals); perfluorooctanesulfonic acid (PFOS); perfluorooctanoic acid (PFOA); perfluorononanoic acid (PFNA); and perfluorohexanesulfonic acid (PFHxS).
EPA Withdraws Proposed SNAP Program Listings For Three Foam Blowing Agents: On October 6, 2021, EPA issued a supplemental proposed rulemaking under the Significant New Alternatives Policy (SNAP) program to list certain substitutes to ozone-depleting substances in the foam blowing sector, extruded polystyrene: boardstock and billet end-use, as acceptable, subject to narrowed use limits, from the effective date of a subsequent final rule until January 1, 2023. This followed EPA's June 12, 2020, initial proposal that proposed to list three foam blowing agents, which are hydrofluorocarbon blends, as acceptable. Taking into consideration information available to EPA since issuance of that initial proposal, EPA proposed narrowed use limits and time-limited use of the substitutes in the supplemental proposal. On May 20, 2022, based on further information, EPA withdrew the proposed listings for the three foam blowing agents described in the initial and supplemental proposals. 87 Fed. Reg. 30852. EPA summarizes the proposed listings and provides an explanation for its decision not to issue a final rule.
EPA Publishes Proposed Consent Decree In Case Concerning Renewable Fuel Program: On May 23, 2022, EPA gave notice of a proposed consent decree in Growth Energy v. Regan, No. 1:22-cv-01191 (D. DC). 87 Fed. Reg. 31233. On April 29, 2022, Plaintiff Growth Energy filed a complaint in the U.S. District Court for the District of Columbia alleging that EPA failed to perform a non-discretionary duty in accordance with the CAA to establish volumes under the renewable fuel program for 2023. The proposed consent decree would establish deadlines for EPA to establish the 2023 renewable fuel program volumes: signature of a proposed rule by September 16, 2022, and signature of a final rule by April 28, 2023. Written comments on the proposed consent decree are due June 22, 2022.
EPA Releases Policy Assessment For Reconsideration Of PM NAAQS: On May 26, 2022, EPA announced that on or about May 23, 2022, it will make available the Policy Assessment for the Reconsideration of the National Ambient Air Quality Standards for Particulate Matter. 87 Fed. Reg. 31965. EPA states that it prepared this document as a part of its current reconsideration of the 2020 final decision on the National Ambient Air Quality Standards (NAAQS) for particulate matter (PM). The Policy Assessment serves to “bridge the gap” between the currently available scientific and technical information and the judgments required of the Administrator in determining whether to retain or revise the existing PM NAAQS.
Proposed Determination Would Prohibit And Restrict Use Of Certain Waters In Bristol Bay Watershed: Pursuant to Section 404(c) of the Clean Water Act (CWA), EPA Region 10 requested public comment on May 26, 2022, on its 2022 proposed determination to prohibit and restrict the use of certain waters in the South Fork Koktuli River (SFK), North Fork Koktuli River (NFK), and Upper Talarik Creek (UTC) watersheds as disposal sites for the discharge of dredged or fill material associated with mining the Pebble deposit, a copper-, gold-, and molybdenum-bearing ore body located in Southwest, Alaska. 87 Fed. Reg. 32021. EPA Region 10 also announced public hearings on June 16 and June 17, 2022, on the proposed determination. Comments on the proposed determination are due on or before July 5, 2022.
EPA Extends Comment Period On Draft Recommended Aquatic Life Ambient Water Quality Criteria For PFOA And PFOS: On May 31, 2022, EPA extended the comment period for the draft recommended aquatic life ambient water quality criteria for PFOA and PFOS. 87 Fed. Reg. 32410. According to EPA, a number of groups have requested additional time to submit comments. In response, EPA is extending the public comment period for an additional 30 days through July 2, 2022.
EPA’s Annual Air Report Highlights Trends Through 2021: On June 1, 2022, EPA released the annual interactive report tracking America’s progress in controlling air pollution. EPA states that the report “offers readers an opportunity to learn about the health and environmental impacts of air pollution; track trends in air quality and emissions data, explore efforts to improve visibility in treasured national parks; and explore community-level health impacts of air toxics emissions reported for 2017.” The 2021 interactive report includes a new tool to explore the latest (2017) air toxics emissions data and risks. The summary tool provides access to community-level information regarding potential cancer risk and noncancer hazards from air toxics emissions.
EPA Proposes Amendments To Miscellaneous Coating Manufacturing NESHAP: On June 7, 2022, EPA proposed amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Miscellaneous Coating Manufacturing facilities, as required by the CAA. 87 Fed. Reg. 34614. EPA states that to complete the required technology review that was originally promulgated on August 14, 2020, it is proposing inorganic hazardous air pollutant (HAP) standards for process vessels. Comments are due August 8, 2022. EPA notes that under the PRA, comments on the information collection provisions are best assured of consideration if OMB receives a copy on or before July 7, 2022.
EPA Requests Comment On Proposed Consent Decrees In CAA Citizen Suits: On June 7, 2022, EPA requested comment on two proposed consent decrees: one would resolve all claims in Concerned Citizens of St. John, et al. v Regan, No. 21-cv-03063-TNM (D.D.C.), as well as the same claims brought in Environmental Integrity Project, et al. v. Regan, No. 20-cv-03119-TNM (D.D.C.), and the second proposed consent decree would resolve all other claims in the Environmental Integrity Project (EIP) matter. 87 Fed. Reg. 34684. The two cases have been consolidated. EPA states that it is providing notice of the proposed consent decrees that would resolve all claims in both cases by establishing deadlines for EPA to take proposed and final actions on, in the first consent decree, the NESHAP for the Group I Polymers & Resins source category, and in the second, certain NSPS and NESHAP specified in that decree. Comments on the proposed consent decrees are due July 7, 2022.
EPA Seeks Information On End-of-Life Management Of Batteries And Current Labeling Standards And Requirements Regarding Their End-of-Life: EPA’s Office of Resource Conservation and Recovery (ORCR) published a request for information (RFI) on June 9, 2022, seeking information on the end-of-life management of batteries, including their generation, collection, recycling, and reuse, as well as the current labeling standards and requirements for batteries regarding their end-of-life. 87 Fed. Reg. 35202. According to the RFI, EPA is developing best practices with respect to the collection of batteries to be recycled, as well as establishing a program intended to promote battery recycling through the development of voluntary labeling guidelines for batteries and communication materials for battery producers and consumers as directed by the Infrastructure Investment and Jobs Act of 2021. Comments are due July 11, 2022. According to the RFI, EPA will hold feedback sessions providing an opportunity for stakeholders to provide oral comments. EPA has posted the dates and times for the feedback sessions on its website -- June 14, 2022, 11:00 a.m. - 12:30 p.m. (EDT), and June 15, 2022, 1:30 - 3:00 p.m. (EDT). EPA states that stakeholders can stay informed about the feedback sessions by subscribing online. More information is available in our June 10, 2022, memorandum.
EPA Proposes Amendments To NESHAP For Gasoline Distribution Facilities And The Standards Of Performance For Bulk Gasoline Terminals: On June 10, 2022, EPA proposed amendments to the NESHAP for Gasoline Distribution facilities and the Standards of Performance for Bulk Gasoline Terminals. 87 Fed. Reg. 35608. EPA proposes to revise the NESHAP requirements for storage tanks, loading operations, and equipment leaks to reflect cost-effective developments in practices, process, or controls. EPA also proposes NSPS to reflect best system of emissions reduction for loading operations and equipment leaks. In addition, EPA proposes revisions related to emissions during periods of startup, shutdown, and malfunction; to add requirements for electronic reporting of performance test results, performance evaluation reports, and compliance reports; to revise monitoring and operating requirements for control devices; and to make other minor technical improvements. Comments are due August 9, 2022. Under the PRA, comments on the information collection provisions are best assured of consideration if OMB receives a copy on or before August 9, 2022.
EPA Requests Nominations For SAB Panel On BenMAP And Benefits Methods: On June 13, 2022, the Science Advisory Board (SAB) Staff Office announced that it is expanding its request for nominations for scientific experts to form a panel to review EPA’s new cloud-based Environmental Benefits and Mapping (BenMAP) tool, an open-source computer program that calculates estimated air pollution-related deaths and illnesses and their associated economic values. 87 Fed. Reg. 35771. In that notice, the SAB Staff Office indicated its intention to announce a separate panel that would address the approach EPA takes for selecting and applying evidence in its benefits assessments for PM with diameters that are generally 2.5 micrometers and smaller (PM2.5) and ozone. Because the two panels would require substantially similar expertise, the SAB Staff Office has now determined that it is appropriate to combine them into a single panel with a more comprehensive charge. The SAB Staff Office is soliciting additional candidates to complement those nominated for the review of BenMAP. Nominations are due June 27, 2022.
EPA Announces New And Updated Drinking Water Health Advisories For PFAS: EPA released on June 15, 2022, four drinking water health advisories for PFAS in the latest action under President Biden’s action plan to deliver clean water and EPA Administrator Regan’s PFAS Strategic Roadmap. EPA also announced that it is inviting states and territories to apply for $1 billion -- the first of $5 billion in Bipartisan Infrastructure Law grant funding -- to address PFAS and other emerging contaminants in drinking water, specifically in small or disadvantaged communities. The advisories indicate the level of drinking water contamination below which adverse health effects are not expected to occur. EPA is issuing interim, updated drinking water health advisories for PFOA and PFOS that replace those EPA issued in 2016. According to EPA, the updated advisory levels, which are based on new science and consider lifetime exposure, indicate that some negative health effects may occur with concentrations of PFOA or PFOS in water that are near zero and below EPA’s ability to detect at this time. Tribes, territories, and drinking water utilities that detect PFOA and PFOS take steps to reduce exposure. For the first time, EPA is issuing final health advisories for perfluorobutane sulfonic acid and its potassium salt (PFBS) and for hexafluoropropylene oxide (HFPO) dimer acid and its ammonium salt (“GenX” chemicals). According to EPA, the GenX chemicals and PFBS health advisory levels are well above the level of detection, based on risk analyses in recent scientific studies. EPA notes that it intends to propose National Primary Drinking Water Regulations for PFOA and PFOS in fall 2022.
Reinstated Superfund Excise Tax Imposed On Certain Chemical Substances: On November 15, 2021, President Biden signed into law the Infrastructure Investment and Jobs Act (IIJA), Public Law 117-58, 135 Stat. 429. Section 80201 of the IIJA reinstates the Superfund excise tax on certain chemical substances under Sections 4661 and 4671 of the Internal Revenue Code (Tax Code), effective July 1, 2022. Section 80201(c)(1) of the IIJA modified the method for determining whether a substance is a taxable substance by lowering the required percentage of taxable chemicals used to produce the substance from 50 percent to 20 percent of the weight (or the value) of the materials used to produce such substance. Since its reinstatement, the excise tax has raised many questions and caused significant industry consternation. Our May 19, 2022, memorandum explains why.
PHMSA Extends Comment Period On Hazardous Materials FAQs And Will Hold Webinar On June 27, 2022: The Pipeline and Hazardous Materials Safety Administration (PHMSA) announced on June 13, 2022, that it is extending the comment period on its initiative to convert historical letters of interpretation applicable to the Hazardous Materials Regulations (HMR) that have been issued to specific stakeholders into broadly applicable frequently asked questions (FAQ) on its website. 87 Fed. Reg. 35847. PHMSA requested comment on the initiative and input on the prioritization of future sets of FAQs. PHMSA extended the comment period to July 22, 2022. In addition, PHMSA plans to host a webinar to discuss the process and intent of this initiative with stakeholders on June 27, 2022.
FDA Issues Final Rule For Phthalate Plasticizers: The U.S. Food and Drug Administration (FDA) issued a final rule on May 20, 2022, rescinding the authorization to use 25 plasticizers in various food contact applications because the uses have been abandoned. 87 Fed. Reg. 31080. The rule responds to a food additive petition submitted by the Flexible Vinyl Alliance in 2018. The rule resulted in the removal of listings of phthalate plasticizers from 21 C.F.R. Sections 175.105, 175.300, 175.320, 176.170, 176.180, 176.300, 177.1010, 177.1200, 177.1460, 177.1590, 177.2420, 177.2600, 178.3740, and 178.3910. The rule was immediately effective.
FDA Denies NRDC Petition For Ortho-Phthalates: On May 20, 2022, FDA denied a food additive petition submitted by the Natural Resources Defense Council (NRDC) and others, requesting that FDA amend or revoke the food contact regulations to no longer permit use of 28 ortho-phthalates. 87 Fed. Reg. 31066. After reviewing the petition and other data and information relevant to the petitioners’ request, FDA concluded that “the petition provides insufficient information to support a finding that there is no longer a reasonable certainty of no harm for the proposed class of ortho-phthalates.”
FDA Issues Information Request For Ortho-Phthalates: On May 20, 2022, FDA opened a docket to obtain data and information on the use of ortho-phthalates for food contact applications. 87 Fed. Reg. 31090. FDA is seeking information on the current food contact uses, use levels, dietary exposure, and safety data on ortho-phthalates currently used in food contact applications, but is not requesting information for uses that have been abandoned. Electronic comments must be submitted on or before July 19, 2022.
FDA Hosts Webinar On New Era Of Smarter Food Safety: FDA held its third in a series of webinars on May 18, 2022, focusing on food safety. This webinar, titled “Building a Coalition of Food Safety Culture Champions Across Your Organization,” is the third in a series that started in 2021. The series explores one of the core elements of FDA’s New Era of Smarter Food Safety that seeks to “…create a safer and more digital traceable food system…” to further reduce foodborne illness. Recordings are available for all three webinars here.
HHS Issues SUNSET Final Rule: On May 27, 2022, the U.S. Department of Health and Human Services (HHS) issued its final rule to withdraw the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET final rule) published in January 2021. 87 Fed. Reg. 32246. HHS “…undertook to reexamine the SUNSET final rule in light of the allegations in the lawsuit, the many substantive comments submitted on the SUNSET proposed rule, and the different policy views held by the Biden-Harris Administration as compared to the previous Administration which issued the SUNSET final rule.” The SUNSET final rule issued on January 19, 2021, 86 Fed. Reg. 5694, was scheduled to take place March 22, 2021, and “…provides, among other things, that all regulations, subject to certain exceptions, issued by the Secretary of the Department of Health and Human Services (Secretary) or his delegates or sub-delegates shall expire at the end of (1) five calendar years after the year that the SUNSET final rule first becomes effective, (2) ten calendar years after the year of the regulation’s promulgation, or (3) ten calendar years after the last year in which the Department “Assessed” and, if required, “Reviewed” the regulation, whichever is latest.” Legal challenges resulted in the withdrawal of the rule.
France Asks Providers To Give Updated R-Nano Declaration Numbers To Customers Upon Request: The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) has posted “important information” for the 2022 reporting period under R-Nano, France’s national reporting scheme for substances in nanoparticle form. ANSES states that it is asking providers to give an updated declaration number to their customers upon request, “even if they have no declaration to perform.” ANSES has extended the declaration period to May 31, 2022. More information is available in our May 18, 2022, blog item.
Improvements To ECHA’s Chemicals Database Include Nanomaterial Form Characterization Information: The European Chemicals Agency (ECHA) has made recent improvements to its chemicals database. For nanomaterials on the European Union (EU) market, the details page of the database now includes information on the nanomaterial form characterization. More information is available in our May 20, 2022, blog item.
ISO Publishes Standard On Characterization Of CNT And CNF Aerosols For Inhalation Toxicity Tests: The International Organization for Standardization (ISO) recently published ISO/TR 23463:2022, “Nanotechnologies -- Characterization of carbon nanotube and carbon nanofibre aerosols to be used in inhalation toxicity tests.” The standard reviews characterization of carbon nanotube (CNT) and carbon nanofiber (CNF) aerosols for inhalation exposure studies. More information is available in our May 26, 2022, blog item.
EUON Publishes Nanopinion On Urinary MicroRNA-based Early Cancer Detection Using Nanowire-based Devices: On May 31, 2022, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Urinary MicroRNA-based Early Cancer Detection Using Nanowire-based Devices” by Dr. Yasui Takao on using nanowire devices to extract microRNAs from urine to distinguish cancer patients from healthy individuals and improve the early detection of cancer.
EC Revises Definition Of Nanomaterials: On June 10, 2022, the European Commission (EC) announced that it is clarifying the definition of nanomaterials in a new Recommendation that supports a coherent EU regulatory framework for nanomaterials, helping to align legislation across all sectors. The Recommendation states:
‘Nanomaterial’ means a natural, incidental or manufactured material consisting of solid particles that are present, either on their own or as identifiable constituent particles in aggregates or agglomerates, and where 50% or more of these particles in the number-based size distribution fulfil at least one of the following conditions:
one or more external dimensions of the particle are in the size range 1 nm to 100 nm;
the particle has an elongated shape, such as a rod, fibre or tube, where two external dimensions are smaller than 1 nm and the other dimension is larger than 100 nm;
the particle has a plate-like shape, where one external dimension is smaller than 1 nm and the other dimensions are larger than 100 nm.
In the determination of the particle number-based size distribution, particles with at least two orthogonal external dimensions larger than 100 µm need not be considered.
However, a material with a specific surface area by volume of < 6 m2/cm3 shall not be considered a nanomaterial.
More information is available in our June 10, 2022, blog item.
EUON Announces Update To NanoData: EUON announced on June 10, 2022, that NanoData has been updated with “a new look and feel to improve the user experience.” NanoData is the knowledge base on nanosciences and -technology hosted by EUON. It contains data on different products, research projects, publications, patents, and organizations.
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 And Richard E. Engler, Ph.D., Contribute To The Global Council For Science And The Environment’s “Compilation Memorandum regarding the GCSE Plastics Reports”: In February 2022, France and the United States announced their commitment to protect our shared environment for future generations against the harm resulting plastic pollution. Both nations stated their united recognition of the transboundary impacts of plastic pollution and the importance of mitigating plastic waste at its source. On March 2, 2022, as reported by the 5th UN Environment Assembly (UNAE-5.2) in Nairobi, both France and the United States, along with 173 other nations, adopted a Resolution to End Plastic Pollution with an international legally binding agreement by 2024, with discussions beginning in 2022. Significantly, the Resolution to End Plastic Pollution defines “plastic waste” to include “microplastic.” Building upon the historic collaboration between France and the United States regarding plastic waste and learning from the contrasts in their governmental structures and approaches to environmental regulation, this French and United States Comparative Law Analysis and Recommendations Regarding Plastic Waste is offered for use by policy makers in the upcoming negotiations regarding the global plastic waste treaty.
Congressional Committees Hold Additional Hearings On EPA’s FY 2023 Budget Request: The House Energy and Commerce Subcommittee on Environment and Climate Change held a hearing on May 17, 2022, on the FY 2023 budget for EPA, and the Senate Appropriations Subcommittee on Interior, Environment, and Related Agencies held a separate hearing on May 18, 2022. EPA Administrator Michael S. Regan was the only witness at each hearing. The hearings included questions about EPA’s implementation of the Lautenberg Act amendments to TSCA, the new chemicals program, and EPA’s review of pesticides and compliance with the Endangered Species Act (ESA). More information about the hearing is available in our May 20, 2022, memorandum.
Bicameral Legislation Would Ban Asbestos: On May 18, 2022, Senator Jeff Merkley (D-OR) and Representative Suzanne Bonamici (D-OR) introduced the Alan Reinstein Ban Asbestos Now Act of 2022 (H.R. 7810, S. 4244) to prohibit the manufacture, processing, use, and distribution in commerce of commercial asbestos. According to Merkley’s May 18, 2022, press release, the bill would “ban the importation and use of all six of the recognized asbestos fibers, expanding on the EPA’s recent proposed rulemaking which will only ban one.”
Legislation Would Prevent Discharge Of Plastic Pellets Into Water Systems, Rivers, And Oceans: On May 20, 2022, Representative Alan Lowenthal (D-CA) introduced legislation (H.R. 7861) to prevent the discharge of plastic pellets into the environment during the manufacture or transport of the pellets or during the manufacture of plastic products from the pellets. According to Lowenthal’s May 19, 2022, press release, “[t]here are currently no federal rules that address plastic pellets specifically and most states have no meaningful regulations to prohibit the discharge of these pellets, with statehouses relying in most cases on the plastics industry to set standards for itself.” The bill would require EPA to create regulations within 60 days that prohibit the discharge of plastic pellets into waterways, storm drains, or sewers from facilities that “…make, use, package, or transport plastic pellets or other pre-production plastic materials.”
Legislation Would Strengthen Regulation Of GRAS Substances And Create Office Of Food Chemical Safety Reassessment Within FDA: On May 27, 2022, Senator Edward J. Markey (D-Mass) introduced the Ensuring Safe and Toxic-Free Foods Act (S. 4316), comprehensive legislation intended to ensures that the HHS “fulfills its responsibility to promote the health and well-being of American families” by directing FDA to strengthen the rule concerning substances “generally recognized as safe,” which exempts companies from seeking pre-market approval for food chemicals. According to Markey’s May 27, 2022, press release, the legislation would also direct the Secretary of HHS to create an Office of Food Chemical Safety Reassessment within FDA’s Center for Food Safety and Applied Nutrition, “which would be charged with reassessing whether existing substances such as bisphenols and PFAS are safe for American families to consume.”
PFAS Reference Standards Act Introduced In The House: On May 27, 2022, Representative John Sarbanes (D-MD) introduced the PFAS Reference Standards Act (H.R. 7897). According to Sarbanes’s May 27, 2022, press release, the bill would “take a critical first step to protecting communities against dangerous health risks,” enabling EPA to identify and track PFAS more accurately. The press release states that the bill would build on the Biden Administration’s PFAS Roadmap. The press release notes that while the Roadmap includes instituting a national testing strategy to monitor PFAS levels, “it does not provide a method to reliably identify the PFAS for which EPA is testing.”
Bipartisan Senate Bill Would Address Water Pollution From Acid Mine Drainage: On June 7, 2022, the Senate Committee on Energy and Natural Resources announced that Senators Joe Manchin (D-WV), Chair of the Committee, and Shelley Moore Capito (R-WV), Ranking Member of the Committee, co-sponsored the Safeguarding Treatment for the Restoration of Ecosystems from Abandoned Mines (STREAM) Act introduced by Senators Bob Casey (D-PA) and Mike Braun (R-IN). The bipartisan legislation would allow states to set aside a portion of the abandoned mine land funding from the bipartisan Infrastructure Investment and Jobs Act to specifically treat acid mine drainage, reducing long-term water pollution, and investing in the economic health of local communities.
House Passes Food And Drug Amendments Of 2022: On June 8, 2022, the House passed the Food and Drug Amendments of 2022 (H.R. 7667), which reauthorizes the FDA user fee programs for prescription drugs, generic drugs, biosimilars, and medical devices, by a vote of 392-28. According to the June 8, 2022, House Committee on Energy and Commerce press release, the bipartisan bill includes provisions that would:
Reform the accelerated approval program by allowing FDA to require that sponsors begin post-approval studies before a drug goes on the market, providing greater transparency in drug labeling, and streamlining the process for FDA to remove products from the market when the sponsors have failed to act with due diligence to conduct studies or where studies have failed to show a benefit to patients;
Improve clinical trials by requiring drug and medical device manufacturers to develop a clinical trial diversity action plan early in the development process that reflects the diversity of the patient population expected to use the product and submit the plan to FDA;
Bring down the cost of prescription drugs by making it easier for more affordable generic drugs to come to market sooner; and
Address the infant formula crisis and help prevent future problems related to food safety and supply by extending flexibilities to hire technical staff with competitive salaries throughout FDA, including to those overseeing food safety.
CDC Publishes Guidelines For Examining Unusual Patterns Of Cancer And Environmental Concerns: On May 25, 2022, the Centers for Disease Control and Prevention (CDC) announced the opening of a docket to obtain comment on the Draft Guidelines for Examining Unusual Patterns of Cancer and Environmental Concerns (2022 Draft Guidelines). 87 Fed. Reg. 31888. The 2022 Draft Guidelines provide updates to the 2013 publication, Investigating Suspected Cancer Clusters and Responding to Community Concerns: Guidelines from the CDC and the Council of State and Territorial Epidemiologists (CSTE) (2013 Guidelines). According to CDC, the updates provide state, Tribal, local, and territorial health departments guidance for a revised and expanded approach to evaluating concerns about unusual patterns of cancer in communities, including those associated with local environmental concerns. CDC notes that the 2022 Draft Guidelines provide recommendations only; compliance with these recommendations is voluntary. Written comments are due July 25, 2022.
Senate Confirms Dr. Christopher Frey As ORD Assistant Administrator: On May 25, 2022, the Senate voted 51-43 to confirm Dr. Christopher Frey as Assistant Administrator of EPA’s ORD. Frey was previously the Deputy Assistant Administrator for Science Policy in ORD as an appointee of the Biden Administration. According to the White House announcement on Frey’s nomination, at EPA, Frey “is a champion of scientific integrity and the role of science to inform decision-making,” leading scientific and technical research on Administration priorities, including climate change, environmental justice, PFAS, and lead, as well as promoting the advancement of innovative scientific methods and approaches.
DPR Announces Public Workshops On Development Of Statewide Pesticide Application Notification System: On May 25, 2022, the California Department of Pesticide Regulation (DPR) announced that it will hold three public workshops to collect feedback on the next phase of design and development for DPR’s pesticide application notification system. For more information on the workshops, please see our June 6, 2022, blog item.
HHS Establishes Office Of Environmental Justice: On June 1, 2022, the Office of the Assistant Secretary for Health (OASH) announced that it has modified its structure to establish the Office of Environmental Justice (OEJ) in its Office of Climate Change and Health Equity. 87 Fed. Reg. 33174. The OEJ will focus on leading initiatives that integrate environmental justice in the HHS mission to improve health in disadvantaged communities and vulnerable populations across the nation; supporting senior leadership at OASH and HHS on environmental justice and health issues; developing and implementing an HHS-wide strategy on environmental justice and health; coordinating annual HHS environmental justice reports; providing expertise and coordination to the White House, Secretary of HHS, and federal agencies related to environmental justice deliverables and activities, including executive order implementation; providing HHS Office of Civil Rights with environmental justice expertise to support compliance under Title VI of the Civil Rights Act of 1964; and promoting training opportunities to build an environmental justice workforce.