Monthly Update for October 2022


WEBINAR -- Registration Is Open For “Food Safety Issues In The United States”: Register now to join Thomas J. Dunn, Karin F. Baron, and Lynn L. Bergeson for the Bergeson & Campbell, P.C. (B&C®) sponsored webinar, “Food Safety Issues in the United States.” This webinar will focus on the Food Safety Modernization Act (FSMA) and discuss the incremental progress the law has achieved in assuring food safety. In addition, the webinar will include a look at the New Era of Smarter Food Safety, a 2020 initiative meant to enhance FSMA, and improve food safety outcomes by leveraging technology.

WEBINAR -- Recording Available For “Environmental, Social, And Governance Issues: A Business Imperative”: B&C’s October 11, 2022, webinar “Environmental, Social, and Governance Issues: A Business Imperative” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/4666338769766648838. During this one-hour webinar, experts from FTI Consulting, Christine DiBartolo, Senior Managing Director, Head of Americas Corporate Reputation, and Ken Ditzel, Senior Managing Director, explore the hows and whys of environmental, social, and governance (ESG) issues, clearing up what can be a confusing “alphabet soup” for newcomers and providing practical tips for embarking upon an ESG journey for entities beginning the process. In conversation with Lynn L. Bergeson, panelists discussed how to conduct an ESG assessment, what makes an ESG program successful, and risks and opportunities that must be considered when undertaking this significant task.

SEMINAR -- IBA Annual Conference, October 30-November 4, 2022, Miami, FL: The International Bar Association (IBA) Annual Conference is open to both members and non-members of the IBA, with lawyers from over 130 jurisdictions and all parts of the legal profession attending. The conference will cover law firm management and international relationships; ethics; the future of the legal profession; and the rule of law and human rights. The IBA’s Agricultural Law Section, co-chaired by Lynn L. Bergeson, will present the Sustainability Focus session titled “Sustainable Investment In Agriculture – The Role Lawyers Play.”

PODCAST -- Misunderstood: The Excise Tax No One Likes Or Understands — A Conversation With Douglas Charnas And Richard E. Engler, Ph.D.: Lynn L. Bergeson, Richard E. Engler, Ph.D., and Doug Charnas, a nationally-recognized corporate and tax attorney and partner at McGlinchey, discuss the recently reinstated Superfund tax, which entities the tax applies to, what exactly is a taxable chemical and how to distinguish between taxable chemicals and taxable substances, and why just about everyone is really grumpy about this newly reinstated tax. Listen now.

ARTICLE -- Lynn L. Bergeson Authors “Due Diligence In Mergers And Acquisitions Involving Chemical Products,” For Financier Worldwide: The scope of what diligence is due in any corporate transaction has evolved greatly over the past decade, particularly with respect to transactions involving chemical products. Once upon a time, transactional due diligence involving chemical products, whether “neat” (pure) chemicals, formulations, or end-use products, typically consisted of a phase I or phase II environmental site assessment (ESA) focusing on identifying contamination derivative of chemical releases into environmental media as effluent, emissions, fugitive releases, or waste, as well as quantifying the potential for such releases to pose litigation risks or regulatory enforcement, or require costly remediation. Increasingly, parties to corporate transactions now continue to focus on these liabilities and on the compositional elements of chemical products themselves as potential sources of liability and commercial disruption. This article explains why the transition to chemical product due diligence has been slow and offers a few tips to help assess what diligence is due in corporate transactions involving chemical products.

TSCA/FIFRA/TRI

PODCAST -- TSCA New Approach Methodologies — A Conversation With James W. Cox: Lynn L. Bergeson and James W. Cox, M.S. discuss New Approach Methodologies (NAM), their significance in chemical risk assessment under the Toxic Substances Control Act (TSCA), how NAMs will enable diminished reliance on animal testing, and some of the challenges facing chemical stakeholders in moving away from animal testing. Listen now.

ARTICLE -- Lynn L. Bergeson Authors “Toxics Regulation: A Brave New World Catching Many Off Guard,” For PLI Current: Given the passage of time since TSCA was enacted in 1976, the public’s growing awareness of the potential for exposure from chemicals in “articles,” or finished goods, during use, and greater focus on the implications of end-of-life product disposal, the U.S. Environmental Protection Agency’s (EPA) regulation of articles under TSCA has shifted significantly. Historically, EPA elected not to regulate articles for the most part. EPA’s more recent announcement of its intent to regulate chemicals in articles to a much greater extent has caught many off guard and reflects a significant shift in U.S. chemical regulation policy. Read more.

EPA Publishes Supplemental NPRM Proposing Updates To Formaldehyde Emission Standards For Composite Wood Products: On March 29, 2022, EPA proposed to update the incorporation by reference of several voluntary consensus standards in its formaldehyde standards for composite wood products regulations under TSCA. 87 Fed. Reg. 57432. EPA published a supplemental notice of proposed rulemaking (NPRM) on September 20, 2022, proposing to update the incorporation by reference of two additional voluntary consensus standards that were updated by the issuing standards organization after the public comment period for the March 29, 2022, proposed rule ended. Comments on the supplemental NPRM are due October 20, 2022. More information is available in EPA’s September 20, 2022, press release.

EPA Denies TSCA Section 21 Petition To Phase Out GHG Pollution: On September 21, 2022, EPA announced that it denied a petition filed under TSCA Section 21 requesting EPA to “phase out the anthropogenic manufacture, processing, distribution, use, and disposal of greenhouse gas (GHG) emissions, fossil fuels, and fossil fuel emissions.” 87 Fed. Reg. 57665. According to EPA’s September 14, 2022, letter denying the petition, of the various actions described in the petition, EPA determined that only the request to initiate a proceeding for the issuance of a rule under TSCA Section 6(a) is within the ambit of a TSCA Section 21 petition. EPA states that based on its review, and after careful consideration of the specific requests, it is denying the request to initiate a proceeding for the issuance of a rule under TSCA Section 6(a) because, “although EPA shares the petitioners’ concerns regarding the threat posed by climate change, the Agency found that the petition was insufficiently specific and failed to establish that it is necessary to issue a rule under TSCA section 6, in light of ongoing and expected federal government actions, the relative efficiency of TSCA rulemaking, and lack of TSCA section 6(a) authority to regulate historical GHG emissions.”

EPA Publishes Receipt And Status Information For Certain New Chemicals For August 2022: On September 22, 2022, EPA published the receipt and status reports for the period from August 1, 2022, to August 31, 2022. 87 Fed. Reg. 57891. 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 October 24, 2022.

EPA Issues Final SNURs For Certain Chemical Substances: On September 29, 2022, EPA issued final significant new use rules (SNUR) under TSCA for chemical substances that were the subject of PMNs. 87 Fed. Reg. 58999. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification will initiate EPA’s evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required by that determination. The SNURs will be effective on November 28, 2022.

EPA Announces Initiative To Bring To Market New Chemicals Used In Electric Vehicle, Semiconductor, And Clean Energy Sectors: EPA announced on October 5, 2022, a new effort under TSCA to implement a streamlined and more efficient process under the New Chemicals Program to assess risk and apply mitigation measures, as appropriate, for new chemicals with applications in batteries, electric vehicles, semiconductors, and renewable energy generation. The new process is for mixed metal oxides (MMO), including new and modified cathode active materials (CAM). EPA states that MMOs are innovative chemistries and have numerous electrical applications in batteries, as well as use as catalysts, adsorbents, and in ceramics. According to EPA, MMOs, including CAMs, are notably a key component in lithium-ion batteries used in electric vehicles, “a growing and important industry.” New MMOs can also be used for semi-conductors, and renewable energy generation and storage, such as solar cells and wind power turbines. They typically consist of lithium, nickel, cobalt, and other metals, and they are the key material used in the production of the cathode in battery cells, which are subsequently assembled into a battery. For more information and our commentary, please read our October 11, 2022, memorandum.

ORD’s BOSC Will Review New Chemicals Collaborative Research Program: EPA announced on October 11, 2022, that the Office of Research and Development’s (ORD) Board of Scientific Counselors (BOSC) will review the TSCA New Chemicals Collaborative Research Program. 87 Fed. Reg. 61313. The meeting will be held October 24-25, 2022, via videoconference. Attendees must register by October 23, 2022. Comments must be received by October 23, 2022, to be considered by BOSC. EPA states that requests for the draft agenda or to make a presentation at the meeting will be accepted until October 23, 2022. The meeting agenda and materials will be posted on BOSC’s website. According to the Federal Register notice, proposed agenda items for the meeting include, but are not limited to, review of the New Chemicals Collaborative Research Program. More information is available in our October 12, 2022, blog item.

EPA Holds Training Webinar On Web-ICE Toxicity Extrapolation Tool: On October 13, 2022, EPA held a webinar on its web-based Interspecies Correlation Estimation (Web-ICE) tool. EPA developed the Web-ICE tool to allow toxicity extrapolation from standard test organisms to diverse taxa, including endangered species. The publicly accessible application allows risk assessors and environmental managers from all sectors to estimate chemical toxicity to a diversity of fresh and saltwater invertebrates and fish, birds and mammals, and aquatic plants (algae) that may have limited toxicity data. The training webinar provided an overview of Web-ICE, including a brief overview of ICE models, demonstration of its application with example case studies, and a tutorial on using the Internet application.

EPA Will Hold October 18 Webinar On New Chemical Review Process Under TSCA: EPA’s New Chemicals Program will host a webinar on October 18, 2022, on EPA’s process for assessing the potential risks of new chemicals under TSCA Section 5 and the types of data EPA considers in this assessment. The webinar will cover examples of quantitative and qualitative data unlikely to be accepted for engineering assessment, considerations EPA makes when evaluating data, and clarifications of common misconceptions in EPA’s new chemical assessments. More information is available in our October 13, 2022, blog item.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

PHMSA Publishes ANPRM Seeking Comment On Adjusting Registration And Fee Assessment Program: On September 22, 2022, the Pipeline and Hazardous Materials Safety Administration (PHMSA) published an advance notice of proposed rulemaking (ANPRM) to solicit feedback on potential adjustments to the statutorily mandated hazardous materials registration and fee assessment program. 87 Fed. Reg. 57859. According to the ANPRM, actions such as the potential adjustment of fees or the addition of other entities among those required to register may be necessary to fund PHMSA’s national emergency preparedness grant programs at the newly authorized level in accordance with the Infrastructure Investment and Jobs Act of 2021. To engage fully with stakeholders, the ANPRM solicits comments and input on questions related to the scope of the registration and fee assessment program. Any comments, data, and information received will be used to evaluate and draft proposed amendments. Comments are due December 21, 2022. PHMSA states that it will consider late-filed comments “to the extent possible,” however.

EPA Issues Final EJ Action Plan For Land Protection And Cleanup Programs: On September 30, 2022, EPA’s Office of Land and Emergency Management (OLEM) announced the final “EJ Action Plan: Building Up Environmental Justice in EPA’s Land Protection and Cleanup Programs.” The plan highlights projects, tools, and practices to be applied to the Superfund, Brownfields, Emergency Response, Solid Waste Management, Resource Conservation and Recovery Act (RCRA) Corrective Action, and Underground Storage Tank (UST) programs. According to EPA, the $3.5 billion in Bipartisan Infrastructure Law investments will significantly enhance implementation of the plan, including the first wave of $1 billion to initiate cleanup and clear the backlog of 49 previously unfunded Superfund sites and accelerate cleanup at dozens of other sites across the country. The plan includes four main goals:

  • Strengthening compliance with cornerstone environmental statutes;
     
  • Incorporating environmental justice (EJ) considerations during the regulatory development process;
     
  • Improving community engagement in rulemakings, permitting decisions, and policies; and
     
  • Implementing President Biden’s Justice40 Initiative.
     

EPA Publishes RFI On Better Indoor Air Quality Management To Help Reduce COVID-19 And Other Disease Transmission In Buildings: On October 5, 2022, EPA published a request for information (RFI) that seeks to promote and advance “the widespread adoption of actions that lead to improvements in indoor air quality (IAQ) in the nation’s building stock to help mitigate disease transmission (e.g., COVID-19).” 87 Fed. Reg. 60396. EPA requests information and recommendations from a broad array of individuals and organizations with knowledge and expertise relating to the built environment and health, IAQ, epidemiology, disease transmission, social sciences, and other disciplines. EPA states that it will analyze information received from the RFI to consider and support the potential development, improvement, and implementation of technical assistance efforts and other strategies “to support IAQ related improvements in the nation's building stock, with a particular emphasis on schools and commercial buildings.” Comments are due December 5, 2022.

EPA Amends NESHAP At Major Sources From New And Existing ICI Boilers And Process Heaters: On October 6, 2022, EPA amended the national emission standards for hazardous air pollutants (NESHAP) at major sources from new and existing industrial, commercial, and institutional (ICI) boilers and process heaters. 87 Fed. Reg. 60816. Certain aspects of the NESHAP were challenged and subsequently remanded to EPA by the U.S. Court of Appeals for the District of Columbia Circuit. The final rule amends several numeric emission limits for new and existing boilers and process heaters consistent with the court’s opinion and sets compliance dates for these new emission limits. The final rule also provides further explanation of one aspect of EPA’s use of carbon monoxide (CO) as a surrogate for organic hazardous air pollutants (HAP) and its use of a CO threshold to represent the application of the maximum achievable control technology (MACT) for organic HAP. The final rule is effective on December 5, 2022.

EPA Issues Calendar Year 2023 Allowances For Production And Consumption Of HFCs: On October 11, 2022, EPA announced that it issued calendar year 2023 allowances for the production and consumption of hydrofluorocarbons (HFC) in accordance with its regulations as established in the 2021 final rule entitled “Phasedown of Hydrofluorocarbons: Establishing the Allowance Allocation and Trading Program under the American Innovation and Manufacturing Act.” 87 Fed. Reg. 61314. The American Innovation and Manufacturing (AIM) Act directs EPA by October 1 of each calendar year to determine the quantity of production and consumption allowances for the following calendar year. EPA also provided notice to certain companies on September 30, 2022, that it intends to retire an identified set of those companies’ allowances in accordance with the administrative consequences provisions established in the final rule.

PHMSA Publishes Notice Concerning Safety Device Classification Policy: On October 13, 2022, PHMSA published a notice setting forth and requesting comment regarding its policy on classification of articles containing hazardous materials used in vehicles, vessels, or aircraft to enhance safety to persons. 87 Fed. Reg. 62177. According to the notice, PHMSA will approve as Class 9 (UN3268) safety devices articles that are complete, assembled components used in transportation by vehicle, vessel, or aircraft and that perform a stand-alone mechanical action enhancing safety to persons. PHMSA states that because subcomponents of safety devices do not meet the threshold and because they pose a potential risk when transported, they must continue to be transported under existing regulatory authorities. The notice also provides guidance on the types of data and documentation an applicant can provide to support an application to the Associate Administrator for Hazardous Materials Safety for classification of an article as a Class 9 (UN3268) safety device. Comments are due November 14, 2022.

EPA Proposes To Reconsider Fugitive Emissions Rule: EPA published a proposed rule on October 14, 2022, that would repeal regulatory amendments promulgated through a final rule adopted in 2008 that addressed the consideration of “fugitive” emissions of air pollutants from stationary sources when determining the applicability of certain permitting requirements under the Clean Air Act (CAA). 87 Fed. Reg. 62322. EPA states that those amendments have been stayed as a result of the reconsideration process. To bring closure to the reconsideration proceeding, EPA proposes to repeal fully the 2008 rule by removing the stayed provisions of the regulatory amendments adopted in 2008. EPA also proposes to remove a related exemption for modifications that would be considered major solely due to the inclusion of fugitive emissions. According to EPA, as a result of the proposed changes, all existing major stationary sources would be required to include fugitive emissions in determining whether a physical or operational change constitutes a “major modification,” requiring a permit under the Prevention of Significant Deterioration (PSD) or Nonattainment New Source Review (NNSR) programs. Comments are due December 13, 2022.

NASEM Report Finds Current EPA Framework Effective For Evaluating Scientific Evidence Used In Setting NAAQS: On October 14, 2022, the National Academies of Sciences, Engineering, and Medicine (NASEM) released a new report that states that EPA’s current framework for evaluating the scientific evidence used for setting National Ambient Air Quality Standards (NAAQS) “is effective, reliable, and scientifically defensible provided that key scientific questions are identified and a range of appropriate expertise is engaged.” According to NASEM, more transparency in how evidence is integrated could improve confidence in EPA’s determinations, including its guidance on how to examine evidence for key sensitive groups, such as older or immunocompromised people, or endangered species or habitats.

EPA Proposes Endangerment Finding For Lead Emissions From Aircraft Engines That Operate On Leaded Fuel: On October 17, 2022, EPA proposed to find that emissions of lead from covered aircraft engines cause or contribute to lead air pollution that may reasonably be anticipated to endanger public health and welfare. 87 Fed. Reg. 62753. According to EPA, covered aircraft would, for example, include smaller piston-engine aircraft, such as the Cessna 172 (single-engine aircraft) and the Beechcraft Baron G58 (twin-engine aircraft), as well as the largest piston-engine aircraft -- the Curtiss C-46 and the Douglas DC-6. EPA states that other examples of covered aircraft would include rotorcraft, such as the Robinson R44 helicopter, light-sport aircraft, and ultralight vehicles equipped with piston engines. For purposes of this action, EPA is proposing to define the “air pollution” referred to in Section 231(a)(2)(A) of the CAA as lead, which it also refers to as the lead air pollution in the notice. EPA plans to hold a virtual public hearing on November 1, 2022. Registration is required. Comments on the proposed action are due January 17, 2023.

EPA Publishes NODA Regarding The United States' HFC Reclamation Market: On October 17, 2022, EPA published a Notice of Data Availability (NODA) to alert stakeholders of information from EPA regarding the United States’ HFC reclamation market and to solicit stakeholder input. 87 Fed. Reg. 62843. EPA states that it is making available a draft report, Analysis of the U.S. Hydrofluorocarbon Reclamation Market: Stakeholders, Drivers, and Practices, that analyzes the United States’ HFC reclamation market and describes the reclamation process, factors affecting costs of reclamation, incentives, and barriers to refrigerant reclamation. EPA is providing this information in preparation for an upcoming regulatory action that EPA intends to propose under AIM Act Subsection (h). The notice identifies possible data gaps and requests comment on areas where additional information could improve EPA’s information on the United States HFC reclamation market and practices. EPA also provided notice of a stakeholder meeting to enable stakeholders to provide input as EPA prepares to engage in rulemaking. EPA will post more information regarding the meeting on its website. To ensure that comments can be accounted for in an upcoming proposed rule that EPA is considering, comments are due November 7, 2022.

EPA To Hold Open Houses And Community Meetings About Health Risks From Ethylene Oxide Emissions: EPA will host public forums in Memphis, Tennessee, Ardmore, Oklahoma, and Sandy, Utah, to share information about ethylene oxide emissions and risk information impacting residents. EPA is reaching out to communities facing the highest risks from commercial sterilizer facilities that use ethylene oxide. EPA will soon propose a new rule to limit ethylene oxide emissions from commercial sterilizers and will seek public input on the rule. In the meantime, it is working with sterilizers on ways they can voluntarily control emissions to reduce risk. Meetings will be held October 18, 2022, in Memphis, Tennessee; October 18, 2022, in Ardmore, Oklahoma, and October 20, 2022, in Sandy, Utah.

FDA

PODCAST -- The New Era Of Smarter Food Safety — A Conversation With Karin Baron: Lynn L. Bergeson and Karin F. Baron, MSPH discuss the U.S. Food and Drug Administration’s (FDA) initiative called the New Era of Smarter Food Safety, intended to diminish the number of foodborne illnesses. This conversation covers the use of emerging technologies to achieve FDA’s goal, and how FDA is trying to change the culture of food safety in the United States. Listen now.

FDA Approves Color Additive Petition For Calcium Carbonate: On September 27, 2022, FDA issued a final rule announcing that the color additive regulations at 21 C.F.R. Section 73.70 will be amended to provide for the safe use of calcium carbonate in dietary supplement tablets and capsules. 87 Fed. Reg. 58445. FDA took the action in response to a color additive petition (CAP) submitted by Colorcon, Inc. The final rule will be effective on October 28, 2022.

FDA Reopens Comment Period For Ortho-Phthalates: On September 27, 2022, FDA reopened the comment period for the notice titled “Ortho-phthalates for Food Contact Use; Request for Information.” 87 Fed. Reg. 58502. Comments will be accepted until December 27, 2022.

FDA Announces Broad Agency Announcement Day: On September 28, 2022, FDA announced that the 2022 FDA Broad Agency Announcement Day will take place on December 6, 2022, between 10:00 a.m. and 5:00 p.m. (EST). Additional information is available at the link here.

FDA Makes Available TechTalk On Data Exchange: An FDA New Era of Smarter Food Safety TechTalk Podcast titled Data Exchange in the New Era of Smarter Food Safety, which explores a platform created by FDA’s Office of Regulatory Affairs (ORA) to share securely information between the agency and its regulatory partners at the state and local levels, aired on October 12, 2022. Podcast recordings are available at the link here.

FDA Provides Reminder Of Food Facility Registration And Renewal Period: On September 30, 2022, FDA published a reminder that owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing/processing, packing, or holding food for consumption by humans or animals in the United States are required to register the facility with FDA. The registration and renewal period is open between October 1 and December 31, 2022.

FDA Will Host Webinar Discussing Proposed Changes To The Definition Of “Healthy”: FDA will host a webinar on Friday, October 21, 2022, at 1:00 p.m. (EDT) to provide an overview of the recently released proposed rule to update the definition of the nutrient content claim “healthy.” Additional information on the webinar is available here. Comments on the proposed rule are due December 28, 2022.

NANOTECHNOLOGY

EU Programs Conducting Survey On Risk Governance For Nanotechnology: Gov4Nano, NANORIGO, and RiskGONE, three projects funded by the European Union (EU), are working together “to develop and establish a robust public policy framework for the use of nanomaterials based on scientific evidence supporting a clear understanding of risks, their assessment and management within wider societal considerations.” The projects recently conducted a survey to understand better how the needs of different stakeholders can be addressed through the outputs of the projects. Responses were due September 30, 2022. More information is available in our September 21, 2022, blog item.

EPA Issues Final SNUR For MWCNTs (Generic): On September 29, 2022, EPA issued a final SNUR for multi-walled carbon nanotubes (MWCNT) (generic). 87 Fed. Reg. 58999. The SNUR requires persons who intend to manufacture (defined by statute to include import) or process the chemical substance identified generically as MWCNTs (PMN P-20-72) for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required by that determination. Under the final SNURs, the significant new uses are protection in the workplace; hazard communication; industrial, commercial, and consumer activities; disposal; and release to water. The SNUR will be effective on November 28, 2022. More information is available in our September 30, 2022, blog item.

OECD Accepting Comment On Draft Study Report On Applicability Of The Key Event Based TG 442D For In Vitro Skin Sensitisation Testing Of Nanomaterials: The Organization for Economic Cooperation and Development (OECD) has published for comment a draft study report entitled “Applicability of the key event based TG 442D for in vitro skin sensitisation testing of nanomaterials.” Switzerland conducted experimental work with selected nanomaterials using OECD Test Guideline (TG) 442D (KeratinoSensTM) and made a basic in vitro to in vivo correlation to outline the potential relevance of the results for prediction of skin sensitisation of nanomaterials. Comments are due November 7, 2022. Instructions for commenting are available on the OECD website. More information is available in our September 30, 2022, blog item.

JBCE Proposes Harmonization Of The Classification Of MWCNTs: According to a September 29, 2022, press release, the Japan Business Council in Europe (JBCE) has proposed a harmonization of the classification of MWCNTs “based on the latest knowledge on the effects of carbon nanotubes (CNTs) in organisms.” More information is available in our October 13, 2022, blog item.

NIOSH Blog Post Summarizes Work In The Area Of Engineered Nanomaterials: On October 6, 2022, the National Institute for Occupational Safety and Health (NIOSH) posted a blog item entitled “NIOSH News for National Nanotechnology Day!”. In honor of National Nanotechnology Day, October 9, the item summarizes NIOSH’s work in the area of engineered nanomaterials, including the NIOSH Nanomaterial Exposure Assessment Technique (NEAT 2.0), which can be used to identify the potential for exposure to engineered nanomaterials in the workplace. More information is available in our October 7, 2022, blog item.

White House OSTP And NNCO Mark National Nanotechnology Day 2022: On October 7, 2022, the White House Office of Science and Technology Policy (OSTP) and the National Nanotechnology Coordination Office (NNCO) made key announcements intended to advance the Biden Administration’s efforts “to leverage the promise of science and technology to benefit all Americans.” The announcements include the inaugural National Nanotechnology Challenge, Nano4EARTH. Nano4EARTH will leverage recent investments in understanding and controlling matter at the nanoscale to develop technologies and industries that address climate change. OSTP and NNCO announced Dr. Branden Brough as the new Director of NNCO and Dr. Quinn Spadola as its Deputy Director. More information is available in our October 16, 2022, blog item.

Conference On Future-Proof Approaches For Risk Governance Will Be Held In January 2023: NANORIGO, RiskGONE, and Gov4Nano, in collaboration with OECD’s Working Party on Manufactured Nanomaterials (WPMN), will hold a conference in January 2023 on “Future-proof Approaches for Risk Governance.” According to NANORIGO’s September 14, 2022, press announcement, the conference is intended to help shape international approaches to addressing future challenges in risk governance of nano- and advanced materials. This includes safe and sustainable by design (SSbD) and harmonization and standardization. More information is available in our October 6, 2022, blog item.

BIOBASED/RENEWABLE PRODUCTS/SUSTAINABILITY

B&C® Biobased And Sustainable Chemicals Blog: For access to a summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to https://biobasedblog.lawbc.com.

LEGISLATIVE

Bipartisan Senate Bill Would Improve Coordination Between Federal And Local Governments To Protect Communities From PFAS: On September 13, 2022, Senator Gary Peters (D-MI), Chair of the Homeland Security and Governmental Affairs Committee, introduced bipartisan legislation to improve coordination between federal and local governments to protect Michiganders from exposure to per- and polyfluoroalkyl substances (PFAS). According to Peters’s September 13, 2022, press release, the PFAS Intergovernmental Coordination Act (S. 4829) would create a working group within the Office of Management and Budget (OMB) to improve intergovernmental coordination to address PFAS contamination. The working group would include representatives from federal agencies; state, local, and Tribal governments; and academic research institutions. It would meet quarterly for two years and would be tasked with providing a report to the Senate Homeland Security and Governmental Affairs Committee and the House Committee on Oversight and Reform that outlines their recommendations and methodologies to improve responses to current PFAS contamination efforts and mitigate future contamination efforts.

Senate Bill Would Prohibit EPA Monitoring Of Livestock Emissions: On September 14, 2022, Senators John Thune (R-SD), a member of the Senate Committee on Agriculture, Nutrition, and Forestry, and Joni Ernst (R-IA), a member of the Senate Committee on Agriculture, Nutrition, and Forestry and Senate Committee on Environment and Public Works, introduced a bill (S. 4850) that would prohibit EPA from monitoring methane emissions from livestock. Thune’s September 14, 2022, press release states that the bill would amend the CAA to prohibit EPA from issuing permits for any carbon dioxide, nitrogen oxide, water vapor, or methane emissions resulting from biological processes associated with livestock production.

Senate Ratifies Kigali Amendment To Reduce HFCs: On September 21, 2022, the Senate voted 69 to 27 to ratify the Kigali Amendment to the Montreal Protocol. The Kigali Amendment is an international agreement to reduce gradually the consumption and production of HFCs, GHGs commonly used in refrigeration and air conditioning. It is a legally binding agreement that has been ratified or accepted by 138 countries, now including the United States. The phase-out of HFCs is expected to avoid a half a degree Celsius of global warming between now and 2100.

Members Of The House Science Committee Introduce Methane Emissions Research Bills: On September 28, 2022, three House Science Committee members introduced legislation to address methane emissions and strengthen emissions research:

  • Chair Eddie Bernice Johnson (D-TX) introduced the Methane Emissions Research Act (H.R. 8991), which would create a pilot study at EPA to quantify methane emissions from oil and gas infrastructure in the United States.
     
  • Representative Don Beyer (D-VA) introduced a bill (H.R. 8992) to address methane “super-emitters” in oil and gas operations. Beyer’s September 28, 2022, press release states that the bill “addresses a finding of the Committee on Science, Space, and Technology’s investigation into oil and gas sector methane leaks and June 8, 2022 hearing on the same topic, which determined that oil and gas companies are failing to address super-emitting leaks.”
     
  • Representatives Sean Casten (D-IL) and Peter Meijer (R-MI) introduced the Methane Emissions Mitigation Research and Development Act (H.R. 8993) to reduce methane emissions. According to Casten’s September 28, 2022, press release, the bill directs the Department of Energy (DOE) to coordinate a technical assistance program to work with state and local governments, as well as private industry, to reduce methane emissions and protect public safety.
     

Congress Passes Bill Funding Federal Government Through December 16, 2022: On September 29, 2022, the Senate passed an amended bill (H.R. 6833) to appropriate funding at the levels and under the conditions provided in fiscal year 2022 appropriations acts for continuing projects and activities, with exceptions including for technical budgetary issues and certain extensions and authorities. The House agreed to the amended bill on September 30, 2022. Spending under the continuing resolution will be charged to the full-year appropriations bills when such bills are enacted. The appropriations and authorities provided by the continuing resolution will continue through the earlier of December 16, 2022, or the enactment of the applicable appropriations act.

Bipartisan Bill Would Amend FIFRA To Provide Nine Months For Farmers To Adapt To Any New Restrictions On Pesticides: On September 29, 2022, Representatives Jim Baird (R-IN) and Cindy Axne (D-IA) introduced the Farmers Deserve Notification Act (H.R. 9035). According to Baird’s September 29, 2022, press release, the bill would prevent EPA from canceling, suspending, or enacting new restrictions on pesticides without first providing a 270-day advance notice in the Federal Register. If new data or science demand restrictions go into effect sooner, the 270-day requirement could be waived by a majority vote of the “independent FIFRA Scientific Advisory Panel.”

MISCELLANEOUS

DOL Expands Criteria For Placement In OSHA’s Severe Violator Enforcement Program: On September 15, 2022, the U.S. Department of Labor (DOL) announced that to strengthen enforcement and improve compliance with workplace safety standards and reduce worker injuries and illnesses, it is expanding the criteria for placement in the Occupational Safety and Health Administration’s (OSHA) Severe Violator Enforcement Program. According to DOL, the new criteria include violations of all hazards and OSHA standards and will continue to focus on repeat offenders in all industries. The updated criteria include:

  • Program placement for employers with citations for at least two willful or repeated violations or who receive failure-to-abate notices based on the presence of high-gravity serious violations;
     
  • Follow-up or referral inspections made one year, but not longer than two years, after the final order;
     
  • Potential removal from the Severe Violator Enforcement Program three years after the date of receiving verification that the employer has abated all program-related hazards. In the past, removal could occur three years after the final order date; and
     
  • Employers’ ability to reduce time spent in the program to two years, if they consent to an enhanced settlement agreement that includes use of a safety and health management system with seven basic elements in OSHA’s Recommended Practices for Safety and Health Programs.
     

ACGIH® Announces New Compressed Schedule To TLV Development: On September 16, 2022, the American Conference of Governmental Industrial Hygienists (ACGIH®) announced that it is updating its development process to meet better the needs of occupational and environmental health professionals. In 2023, it will be offering stakeholders the opportunity to provide comments twice per year for draft documentation on the Notice of Intended Changes (NIC) and Notice of Intent to Establish (NIE) lists. The comment periods will run from January 1 to March 31 and July 1 to September 30, with ratification occurring in May and November, and all changes will be posted online using Data Hub. Threshold Limit Values (TLV®) books will continue to be published at the beginning of every year. ACGIH® states that the under study list will no longer be tiered to allow chemical substances and physical agents to be added throughout the year and worked on immediately. All updates to the under study list will be reflected in ACGIH® communications and on the ACGIH® website.

EPA Launches Office Of EJ And External Civil Rights: On September 24, 2022, EPA announced that it is establishing the Office of EJ and External Civil Rights, a new national office charged with advancing EJ and civil rights. According to EPA, the new office will dedicate more than 200 EPA staff in EPA headquarters and across ten regions towards solving environmental challenges in communities that have been underserved. These staff will engage with communities with EJ concerns to understand their needs, as well as Tribal, state, and local partners; manage and disburse historic levels of grants and technical assistance; work with other EPA offices to incorporate EJ into EPA’s programs, policies, and processes, as allowed by law; and ensure EPA funding recipients comply with applicable civil rights laws. The office will be led by a Senate-confirmed Assistant Administrator, to be announced at a later date.

CDC Adds New And Updated Data Tables To National Report On Human Exposure To Environmental Chemicals: On September 26, 2022, the Centers for Disease Control and Prevention (CDC) announced that it added four tables for two chemicals reported for the first time and updated 94 data tables for 45 chemicals measured in urine specimens. The chemicals reported for the first time are two flame retardants, urinary 2-((isopropyl)phenyl)phenyl phosphate and urinary 4-((tert-butyl)phenyl)phenyl phosphate. The chemicals with updated data include phthalates and plasticizer metabolites; flame retardants; organophosphate insecticides: dialkyl phosphate metabolites; and tobacco alkaloids and metabolites.

SBA Adopts NAICS 2022 For Size Standards: On September 29, 2022, the U.S. Small Business Administration (SBA) issued a final rule amending its small business size regulations to incorporate the OMB’s North American Industry Classification System (NAICS) revision for 2022, identified as NAICS 2022, into its table of small business size standards. 87 Fed. Reg. 59240. The NAICS 2022 revision created 111 new industries by reclassifying, combining, or splitting 156 NAICS 2017 industries or their parts. SBA sates that its size standards for these 111 new industries under NAICS 2022 have resulted in an increase to the size standards for 22 industries and 29 parts of two industries under NAICS 2017, a decrease to size standards for seven industries and 53 parts of two industries, a change in the size standard measure from average annual receipts to number of employees for one industry, a change in the size standard measure from number of employees to average annual receipts for a part of one industry, and no change in size standards for 117 industries and 19 parts of seven industries. The rule is effective October 1, 2022.

New Online Tools Provide Communities With Information On Environmental Enforcement And Compliance: EPA announced on October 3, 2022, two new online tools available to the public that provide additional information on environmental enforcement and compliance in their communities:

  • EJ Metrics Integrated with ECHO: Members of the public can use EPA’s Enforcement and Compliance History Online (ECHO) website to search for facilities in their communities to assess their compliance with environmental regulations; and
     
  • Benzene Fenceline Monitoring Dashboard: Beginning in 2015, petroleum refineries were required to install air monitors around the perimeter of their facilities. Petroleum refineries must monitor benzene concentrations and report the results to EPA on a quarterly basis. Those results are now accessible to the public on EPA’s Benzene Fenceline Monitoring Dashboard.
     

More information is available in our October 5, 2022, blog item.

ITA Seeks Comment On Draft Harmonized System Code List Of Critical Supply Chains: On October 4, 2022, the U.S. Department of Commerce’s International Trade Administration (ITA) published a request for comment (RFC) on a draft list of critical goods and materials within four of the supply chains assessed under the February 24, 2021, “Executive Order on America’s Supply Chains”: public health and biological preparedness; information and communications technology (ICT); energy; and critical minerals. 87 Fed. Reg. 60118. The draft list, defined by eight- and ten-digit tariff lines of the Harmonized Tariff Schedule of the United States (HTSUS), is available online. According to ITA, the list of critical goods and materials will serve as a tool to facilitate ongoing targeted analysis of trade data and the evaluation of policies to strengthen these supply chains. The RFC is a part of the government’s ongoing work to identify risks, address vulnerabilities, and develop a strategy to promote American supply chains resiliency in accordance with the Order. Comments are due November 3, 2022.

EPA Updates EJ Mapping Tool EJScreen: EPA announced on October 11, 2022, that it has updated and added new capabilities to EJScreen, its public EJ screening and mapping tool. EJScreen combines environmental and socioeconomic information to identify areas overburdened by pollution. EPA states that EJScreen 2.1 includes the addition of new data on U.S. territories, threshold maps that provide a cumulative outlook, and supplemental indexes providing additional socioeconomic information.

PFAS Reporting Will Take Effect In Maine On January 1, 2023, Unless An Extension Is Obtained: Maine enacted “An Act To Stop Perfluoroalkyl and Polyfluoroalkyl Substances Pollution” in July 2021. Under the bill, manufacturers of products with intentionally added PFAS must report the presence of the intentionally added PFAS in those products to the Maine Department of Environmental Protection (MDEP) beginning January 1, 2023. According to the MDEP website, MDEP is in the process of developing a rule to clarify the January 1, 2023, reporting requirements. Stakeholders can subscribe to receive notification of MDEP rulemaking and opportunity to comment notices on its website. Pending clarification of the reporting requirements, reporting entities may need to request an extension of time to notify MDEP of any products for sale in the state of Maine that contain intentionally added PFAS. More information is available in our September 30, 2022, blog item.

This Update is provided as a complimentary service to our clients and is for informational purposes. This Update may be copied or quoted, provided proper attribution is given. The contents are not intended and cannot be considered as legal advice.

 
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