Monthly Update for March 2022


WEBINAR -- “UK REACH, What’s Happened And What’s Next?,” March 23, 2022, 11:00 a.m. - 12:00 p.m. (EDT)/15:00 - 16:00 (GMT): Companies worldwide must be aware of the significant implications for chemical regulatory compliance under the United Kingdom (UK) REACH regulation as the UK has completed its first year of complete separation from the European Union (EU). Companies should act quickly to understand their rights and obligations under UK REACH to maintain continuity of their supply chains and market access. Join Steven P. Brennan, Ph.D., Senior Manager, REACH, and Jane S. Vergnes, Ph.D., DABT®, Vice President, Scientific Affairs and Director of Toxicology, for “UK REACH, What’s Happened and What’s Next?,” a webinar exploring these important issues. Presented by Bergeson & Campbell P.C.’s (B&C®) consulting affiliate The Acta Group (Acta®).

WEBINAR -- “FIFRA Hot Topics,” April 20, 2022, 12:00 p.m. - 1:00 p.m. (EDT): Register now for B&C’s webinar “FIFRA Hot Topics,” with presenters Edward Messina, Director, U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP), and James V. Aidala, Senior Government Affairs Consultant, B&C. Moderated by Lisa M. Campbell, Partner, B&C.

TSCA/FIFRA/TRI

The “PIPing” Point — A Conversation With Kelly Scanlon, DrPH, Director Of EHS At IPC: Lynn L. Bergeson and Kelly Scanlon, DrPH, CIH, Director of Environmental Policy & Research, Global Government Relations, at IPC sit down for this episode of All Things Chemical® to discuss IPC’s work on environment, health, and safety (EHS) policy, enhanced regulation of articles under the Toxic Substances Control Act (TSCA), and other challenges the electronics industry faces.

Toxics And Human Rights — A Conversation With Baskut Tuncak, Director Of TURI: On this episode of All Things Chemical, Lynn L. Bergeson and Baskut Tuncak discuss Baskut’s goals as Director of the Toxics Use Reduction Institute (TURI) at the University of Massachusetts, Lowell, one of three agencies implementing the Massachusetts Toxics Use Reduction Act, and his prior role of United Nations (UN) Special Rapporteur on toxics and human rights. Listen now.

Lynn L. Bergeson Authors “PFAS: Making Sound Investment Decisions,” Financier Worldwide: The ubiquity of per- and polyfluoroalkyl substances (PFAS) and the manufacturing sector’s decades-long reliance on them to impart functionalities in a dizzying array of products put the investor between the proverbial rock and a hard place. PFAS’ varied chemical properties make the broad categorization of “PFAS” into a monolithic category of “forever chemicals” chemically and scientifically questionable. For better or worse, however, that is exactly what is happening today, and distinguishing between commercially promising and commercially risky PFAS chemicals is challenging. Yet, the ability to make this distinction could be the difference between a great investment and a commercially disastrous one. This article explores this difficult assessment, provides essential information on PFAS, and offers some suggestions to avoid making bad investment decisions.

Lynn L. Bergeson Authors “Per- And Polyfluoroalkyl Substances (PFAS): One Size Does Not Fit All,” Chemical Processing: PFAS are getting a lot of attention in the United States and globally. Their varied chemical properties make the categorization of “PFAS” into a single category chemically and scientifically questionable. Increasingly, the ability to make distinctions among this large chemical category is challenging, yet failure to do so could be unwise. This article provides information on PFAS and offers a few suggestions to keep in mind when making business decisions.

EPA Updates Resources On Mercury Inventory Reporting Rule: On February 22, 2022, EPA announced the release of the updated Mercury Electronic Reporting (MER) application and compliance guide for calendar year 2021 data reporting. The mercury rule applies to any person who manufactures (including imports) mercury or mercury-added products (including pre-assembled products that contain mercury-added components) or otherwise intentionally uses mercury in a manufacturing process (including processes traditionally not subject to TSCA, such as for the manufacture of pharmaceuticals and pesticides). EPA states that it updated the mercury inventory reporting rule compliance guide to reflect the new requirement to report pre-assembled products that contain mercury-added components, such as a watch with a mercury-added battery. The deadline to report 2021 data is July 1, 2022. More information is available in our February 23, 2022, blog item.

EPA Holds Webinar On TSCA Requirements And PMN Process For Biofuels: On February 23, 2022, EPA held a webinar on requirements under TSCA and the premanufacture notice (PMN) process for biofuels. As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. According to EPA, it has received more than 30 biofuel PMNs “that collectively describe plans for close to 800 million gallons per year of production of advanced biofuels, that could contribute to annual volume mandates under the [Renewable Fuel Standard (RFS)] program and help support the goals of energy security through increasing domestic production” within the United States. Future webinars will cover the TSCA Inventory, nomenclature, and Bona Fide process; new chemicals risk assessments, including applications of the tools, models, and databases; and new chemicals risk management actions, including TSCA Section 5 orders and significant new use rules (SNUR). For more information on this webinar, see our March 1, 2022, memorandum.

EPA Provides Final Opportunity To Submit A Request Under The 1980 Guidelines To Correct The Chemical Identity Of A Substance On The TSCA Inventory: On February 25, 2022, EPA announced that it is revoking the 1980 guidelines and associated procedures for correcting the specific chemical identities of incorrectly described chemical substances submitted to EPA in 1978 using the original reporting form for inclusion on the TSCA Inventory. 87 Fed. Reg. 10781. EPA states that it is providing a final opportunity to use the 1980 guidelines and form to request corrections of Inventory listings to address errors with the chemical identities submitted in the original reporting forms. The regulated community will have until April 26, 2022, to submit any final Inventory corrections. EPA also announced the discontinuation of the related form and associated approval of the collection activities under the Paperwork Reduction Act (PRA). The revocation will be effective May 31, 2022. All final Inventory corrections must be received on or before April 26, 2022. If, after April 26, 2022, a person discovers for any reason an error in the specific chemical identity of a chemical substance submitted on an original Inventory reporting form, a PMN or exemption notice may need to be filed if the chemical substance is not already listed on the TSCA Inventory. More information is available in our February 28, 2022, blog item.

EPA Releases Response Denying Objections To Its Final Rule Revoking All Tolerances For Chlorpyrifos: On February 25, 2022, EPA announced it has issued a response denying the objections filed against its final rule revoking all chlorpyrifos tolerances. EPA issued the August 18, 2021, final rule in response to the Ninth Circuit Court’s Order directing EPA to issue a final rule in response to Pesticide Action Network North America and Natural Resources Defense Council’s 2007 petition, which requested EPA to revoke all chlorpyrifos tolerances. More information is available in our March 8, 2022, blog.

EPA Proposes TSCA New Chemicals Collaborative Research Program, Will Hold Public Meeting In April: EPA will hold a virtual public meeting April 20-21, 2022, to seek individual input on the proposed TSCA New Chemicals Collaborative Research Program. 87 Fed. Reg. 10784. In addition, EPA announced the availability of and is soliciting public comment on the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” EPA states that the Office of Chemical Safety and Pollution Prevention (OCSPP) is proposing to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. According to EPA, the effort will be performed in partnership with its Office of Research and Development (ORD) and other federal entities to leverage their expertise and resources. EPA will hold a virtual public meeting April 20-21, 2022, to seek individual input. Written comments on the draft document are due April 26, 2022. For more information, please read the full memorandum.

EPA Publishes Receipt And Status Information For Certain New Chemicals For January 2022: On February 28, 2022, EPA published the receipt and status reports for the period from January 1, 2022, to January 31, 2022. 87 Fed. Reg. 11069. EPA states that it is providing notice of receipt of a 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 March 30, 2022.

EPA Announces That TRI Data For 2020 Show Decline In Releases Of Certain Chemicals: On March 3, 2022, EPA announced the release of its 2020 Toxics Release Inventory (TRI) National Analysis, which shows that environmental releases of TRI chemicals by facilities covered by the program declined by ten percent between 2019 and 2020. The 2020 TRI National Analysis summarizes TRI chemical waste management activities, including releases that occurred during calendar year 2020. More than 21,000 facilities report annually on over 800 chemicals they release into the environment or otherwise manage as waste. EPA, states, and tribes receive TRI data from facilities in industry sectors such as manufacturing, mining, electric utilities, and commercial hazardous waste management. EPA notes that the 2020 Analysis includes enhancements to make data more useful and accessible to communities, including communities with environmental justice concerns. The 2020 Analysis is also the first to feature reporting on the 172 PFAS added to TRI by the 2020 National Defense Authorization Act (NDAA). According to EPA, facilities reported managing 800,000 pounds of these chemicals in 2020, but of that, only around 9,000 pounds were reported as releases. Most of the production-related PFAS waste was reported by hazardous waste management facilities or chemical manufacturers, and most releases of PFAS were reported by the chemical manufacturing sector. EPA states that it continues to work to understand better the seemingly limited scope of PFAS reporting. EPA used existing data to generate lists of potential producers and recipients of PFAS waste, and has contacted facilities with potential reporting errors, as well as those that were expected to report but did not.

EPA Updates TSCA Inventory: On March 4, 2022, EPA announced the availability of the latest TSCA Inventory. EPA states that the biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. EPA plans the next regular update of the Inventory for summer 2022. According to EPA, the Inventory contains 86,631 chemicals, of which 42,039 are active in U.S commerce. Other updates include new chemical substance additions, commercial activity data and regulatory flags, such as polymer exemptions, TSCA Section 4 test orders, and TSCA Section 5 SNURs. EPA notes that on October 15, 2021, it announced a list of 377 specific chemical identities that were expected to lose their confidential status and move to the public portion of the Inventory. According to EPA, these 377 are listed in this public Inventory posting by their specific chemical identities.

EPA Publishes Final Scope Of D4 Risk Evaluation, Seeks Comment On Draft Revision To PV29 Risk Determination: On March 7, 2022, EPA announced the availability of the final scope of the risk evaluation to be conducted for octamethylcyclotetra-siloxane (D4), a chemical substance for which EPA received a manufacturer request for risk evaluation under TSCA. 87 Fed. Reg. 12696. The scope document includes the conditions of use (COU), hazards, exposures, and the potentially exposed or susceptible subpopulations (PESS) that EPA plans to consider in conducting the risk evaluation for this chemical substance. EPA also published a separate notice announcing the availability of and requesting public comment on a draft revision to the risk determination for the Colour Index Pigment Violet 29 (PV29) risk evaluation. 87 Fed. Reg. 12690. EPA states that the draft revision finds that PV29, as a whole chemical substance, presents an unreasonable risk of injury to health when evaluated under its COUs. The draft revision would supersede the COU-specific no unreasonable risk determinations in the January 2021 PV29 risk evaluation, would withdraw the associated order, and would make a revised determination of unreasonable risk for PV29 as a whole chemical substance. EPA notes that in addition, the draft revised risk determination does not reflect an assumption that workers always appropriately wear personal protective equipment (PPE). Comments on the draft revision to the PV29 risk determination are due April 21, 2022. More information is available in our March 8, 2022, memorandum.

EPA Will Extend Compliance Dates For Articles Containing PIP (3:1): On March 8, 2022, EPA amended the regulations applicable to phenol, isopropylated phosphate (3:1) (PIP (3:1)) promulgated under TSCA. 87 Fed. Reg. 12875. EPA states that it is extending the compliance date applicable to the prohibition on 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 compliance date for the associated recordkeeping requirements for manufacturers, processors, and distributors of PIP (3:1)-containing articles. The final rule was effective on March 8, 2022. More information is available in our March 7, 2022, memorandum.

EPA Proposes To Consolidate TSCA Section 8 ICRs: EPA announced on March 8, 2022, that it is planning to consolidate several Information Collection Requests (ICR) covering reporting and recordkeeping activities under TSCA Section 8. 87 Fed. Reg. 12954. Before submitting the consolidated ICR to the Office of Management and Budget (OMB) for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection. The consolidated ICR is entitled “Reporting and Recordkeeping Under Section 8 of the Toxic Substances Control Act (TSCA)” and is identified under EPA ICR No. 2703.01 and OMB Control No. 2070-[NEW]. According to EPA, it intends to streamline the presentation of the paperwork burden estimates for these various activities and eliminate any duplication, which in turn is expected to reduce the administrative burden for both the public reviewers and EPA. EPA’s Supporting Statement summarizes the currently approved ICRs that would be consolidated in the new ICR:

  • TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR);
     
  • Chemical-Specific Rules, TSCA Section 8(a);
     
  • Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment; and
     
  • Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies.
     

Comments are due May 9, 2022.

Registration Opens For April SACC Meeting On Draft TSCA Systematic Review Protocol: EPA announced on March 10, 2022, that registration is now open for the April 19-21, 2022, virtual meeting of the Science Advisory Committee on Chemicals (SACC). During the meeting, SACC will peer review the draft TSCA Systematic Review Protocol. SACC’s virtual meeting is open to the public, and registration is required. EPA states that the draft Protocol, released in December 2021 for public comment, incorporates changes to address the recommendations from the National Academies of Sciences, Engineering, and Medicine (NASEM), as well as comments received from SACC and the public. According to EPA, the SACC review “will provide a transparent process to ensure that the protocol follows sound science and incorporates independent scientific advice and recommendations.” Stakeholders wishing to provide oral comments during the virtual meeting must register by 12:00 p.m. (EDT) on April 4, 2022. Stakeholders may register as listen-only attendees at any time until the end of the meeting on April 21, 2022. More information on the draft Protocol is available in our December 21, 2021, memorandum.

FIFRA Stakeholders: Update To How To Respond To An Enforcement Action Or Inquiry: Contrary to popular opinion, EPA’s enforcement activity under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) has been trending upward over the last couple of years. As noted in our earlier advisory memorandum on enforcement activity under TSCA, although most parties subject to TSCA inspections receive a “boilerplate” letter, FIFRA enforcement actions tend to be more heterogeneous. Potential FIFRA enforcement communications include a notice or letter announcing that EPA has commenced an investigation or will conduct an inspection, a Notice of Warning (NOW), a refused Notice of Arrival (NOA) or a Notice of Detention (NOD), or a Stop Sale, Use, or Removal Order (SSURO). EPA also sends Information Request Letters (IRL), although less frequently than it does in TSCA contexts. This memorandum provides guidance to FIFRA stakeholders on how to respond to a typical EPA FIFRA inspection letter. See our February 28, 2022, memorandum for more information.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA Reviews Standards Of Performance For Lead Acid Battery Manufacturing Plants And NESHAP For Lead Acid Battery Manufacturing Area Sources Technology Review: On February 23, 2022, EPA published the results of its review of the New Source Performance Standards (NSPS) for Lead Acid Battery Manufacturing Plants and the technology review (TR) for the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Lead Acid Battery Manufacturing Area Sources. 87 Fed. Reg. 10134. EPA proposes revised lead emission limits for grid casting, paste mixing, and lead reclamation operations for both the area source NESHAP (for new and existing sources) and under a new NSPS subpart (for lead acid battery facilities that begin construction, reconstruction, or modification after February 23, 2022). In addition, EPA proposes the following amendments for both the area source NESHAP (for new and existing sources) and under a new NSPS subpart (for lead acid battery facilities that begin construction, reconstruction, or modification after February 23, 2022): performance testing once every five years to demonstrate compliance; work practices to minimize emissions of fugitive lead dust; increased inspection frequency of fabric filters; bag leak detection systems for facilities above a certain size; clarification of activities that are considered to be lead reclamation activities; electronic reporting of performance test results and semiannual compliance reports; and the removal of exemptions for periods of start-up, shut down, and malfunctions. EPA also proposes a revision to the applicability provisions in the area source NESHAP such that facilities that make lead-bearing battery parts or process input material, including but not limited to grid casting facilities and lead oxide manufacturing facilities, will be subject to the area source NESHAP. Comments are due April 25, 2022. EPA notes that under the PRA, “comments on the information collection provisions are best assured of consideration if OMB receives a copy of your comments on or before March 25, 2022.”

EPA Extends Comment Period On New Emission Standards For Primary Copper Smelters: On February 24, 2022, EPA announced that it is extending the comment period on its January 11, 2022, proposed rule entitled “National Emission Standards for Hazardous Air Pollutants: Primary Copper Smelting Residual Risk and Technology Review and Primary Copper Smelting Area Source Technology Review.” 87 Fed. Reg. 10325. EPA is extending the comment period by 60 days to allow additional time for Tribal Nations and stakeholders to review and comment on the proposal. Comments are due April 26, 2022.

EPA And Army Select Ten Roundtables To Highlight Regional Implications Of WOTUS: On February 24, 2022, EPA and the U.S. Department of the Army announced the selection of ten geographically varied roundtables with participants representing diverse perspectives, including agriculture, conservation groups, developers, drinking water and wastewater managers, environmental organizations, communities with environmental justice concerns, industry, Tribal nations, and state and local governments. The agencies will work with each selected roundtable to facilitate discussion on implementation of “waters of the United States” (WOTUS), while highlighting regional differences. EPA states that the regional roundtables will provide opportunities to discuss geographic similarities and differences, particular water resources that are characteristic of or unique to each region, and site-specific feedback about the ongoing implementation of WOTUS by the agencies. The agencies anticipate hosting these regional roundtables virtually during spring and summer 2022.

GAO Recommends EPA Ensure RMP Facilities Consider Risks From Climate Change: On February 28, 2022, the U.S. Government Accountability Office (GAO) published a report entitled Chemical Accident Prevention: EPA Should Ensure Regulated Facilities Consider Risks from Climate Change. EPA’s Risk Management Plan (RMP) rule requires certain facilities that make, use, handle, or store hazardous substances to develop and implement a risk management program to detect and prevent or minimize the consequences of an accidental release. GAO examined (1) what available federal data indicate about RMP facilities in areas with natural hazards that may be exacerbated by climate change; and (2) challenges RMP facilities face in managing risks from natural hazards and climate change, and opportunities for EPA to address these challenges. GAO made six recommendations, including that EPA issue regulations, guidance, or both to clarify requirements and provide direction to facilities on incorporating natural hazards and climate change into risk management programs. EPA agreed with GAO’s recommendations.

EPA Proposes Not To Revise NESHAP For Wood Preserving Area Sources: On March 7, 2022, EPA proposed the results of the technology review for the NESHAP for Wood Preserving Area Sources. 87 Fed. Reg. 12633. EPA states that it is proposing no changes to the NESHAP as a result of the technology review. EPA is proposing minor editorial and formatting changes to the table of applicable general provisions. Unrelated to the review for the Wood Preserving Area Sources NESHAP, EPA is also proposing technical corrections to the Surface Coating of Wood Building Products NESHAP. Comments are due April 21, 2022. According to EPA, under the PRA, comments on the information collection provisions are best assured of consideration if OMB receives a copy of the comments on or before April 6, 2022.

EPA Will Propose Stronger Standards For Heavy-Duty Vehicles And Engines: On March 7, 2022, EPA announced that it will propose new, stronger standards to promote clean air and reduce pollution from heavy-duty vehicles and engines starting in model year (MY) 2027. According to EPA, the proposed standards would reduce emissions of smog- and soot-forming nitrogen oxides (NOx) from heavy-duty gasoline and diesel engines and set updated GHG standards for certain commercial vehicle categories. EPA states that the proposed revisions to existing GHG standards for MY 2027 and beyond would set updated GHG emissions standards for subsectors where electrification is advancing at a more rapid pace. These sectors include school buses, transit buses, commercial delivery trucks, and short-haul tractors. EPA notes that the proposal is the first step in its “Clean Trucks Plan” -- a series of clean air and climate regulations that EPA will develop over the next three years to reduce pollution from trucks and buses and to advance the transition to a zero-emissions transportation future. In a separate action, EPA will set new GHG emissions standards for heavy-duty vehicles as soon as MY 2030. EPA intends this action to address more comprehensively the long-term trend towards zero emissions vehicles across the heavy-duty sector.

EPA Issues Memorandum Outlining Strategy To Equitably Deliver Clean Water Through Bipartisan Infrastructure Law: EPA announced on March 8, 2022, that it issued a memorandum to guide collaborative implementation with state, local, and Tribal partners of $43 billion in water infrastructure funding through the Bipartisan Infrastructure Law. According to EPA, the memorandum “is a key implementation step that outlines requirements and recommendations for the Drinking Water and Clean Water State Revolving Funds (SRFs) to ensure the country is working together to deliver clean and safe water and replace lead pipes for all Americans, especially disadvantaged communities.”

EPA Publishes State-Level GHG Emissions Data And Resources To Promote State Action On Climate: On March 8, 2022, EPA announced the release of new and updated resources “to support states as they work to address the climate crisis and reduce climate pollution.” These resources include new state-level data on GHGs and sinks, updates to EPA’s existing State Inventory Tool to help states compile their own emission and sink estimates, and information on state-level opportunities to reduce emissions of highly-potent GHGs.

EPA Issues Final Amendments To NESHAP For Stationary Combustion Turbines: On March 9, 2022, EPA issued final amendments to the NESHAP for Stationary Combustion Turbines. 87 Fed. Reg. 13183. The final rule removes the stay of the effectiveness of the standards for new lean premix and diffusion flame gas-fired turbines that was promulgated in 2004. The final rule was effective on March 9, 2022.

EPA Releases Volumes 1 And 2 Of Integrated Review Plan For Lead NAAQS: EPA announced on March 10, 2022, Volumes 1 and 2 of the Integrated Review Plan for the Lead National Ambient Air Quality Standards (IRP). 87 Fed. Reg. 13732. The national ambient air quality standards (NAAQS) for lead are set to protect the public health and the public welfare from lead in ambient air. Volume 1 of the IRP contains contextual background material and the anticipated schedule for the current review of the air quality criteria and NAAQS for lead. Volume 2 identifies policy-relevant issues in the review and describes key considerations in EPA's development of the Integrated Science Assessment (ISA). The ISA provides the scientific basis for the EPA's decisions, in conjunction with additional technical and policy assessments, for the review of the NAAQS, as described in Section 108(a) of the Clean Air Act (CAA). Comments are due April 4, 2022.

EPA Will Propose Regulations To Require Certain Facilities To Plan For Hazardous Substance Discharges In Adverse Weather Conditions: EPA announced on March 11, 2022, that it will propose new requirements for certain facilities to plan for worst-case discharges of Clean Water Act (CWA) hazardous substances. EPA states that a worst-case discharge “is the largest foreseeable discharge in adverse weather conditions, including those due to climate change.” According to EPA, the proposed rule would apply to facilities that could reasonably be expected to cause substantial harm to the environment, based on their location. These include industrial facilities with a maximum capacity on site of any CWA hazardous substances that meets or exceeds established threshold quantities, located within a 0.5-mile radius of navigable water or a conveyance to navigable water, and that meet one or more substantial harm criteria. Facilities that would be subject to the proposed rule would be required to prepare response plans for worst-case discharges, or threat of such discharges, and submit them to EPA. Publication of the proposed rule in the Federal Register will begin a 60-day comment period.

EPA Will Propose “Good Neighbor” Plan Intended To Reduce Ground Level Ozone For Much Of The United States: EPA announced on March 11, 2022, that it will propose a federal plan that would cut pollution from power plants and industrial sources that significantly contribute to unhealthy levels of ground-level ozone for millions of Americans who live downwind. According to EPA, relying on a longstanding regulatory framework and commonly used, affordable pollution controls, this action would help states fully resolve their CAA “good neighbor” obligations for the 2015 ozone NAAQS, enhancing public health and environmental protections regionally and for local communities. EPA states that its proposal builds upon a combination of proven approaches to limit ozone season emissions of NOx. Beginning in 2023, EPA is proposing to include electric generating units in 25 states in the Cross-State Air Pollution Rule (CSAPR) NOX Ozone Season Group 3 Trading Program, which would be revised and strengthened for the 2015 ozone NAAQS. Beginning in 2026, EPA is proposing emissions standards for certain industrial sources in 23 states that have a significant impact on downwind air quality. Publication of the proposed rule in the Federal Register will begin a 60-day comment period.

EPA Reinstates California’s Authority To Enforce GHG Emission Standards For Cars And Light Trucks: On March 14, 2022, EPA reinstated California’s authority under the CAA to implement its own GHG emission standards and zero emission vehicle (ZEV) sales mandate. 87 Fed. Reg. 14332. According to EPA, this action concludes its reconsideration of 2019’s Safer Affordable Fuel-Efficient Vehicles Rule Part One: One National Program Rule (SAFE-1) by finding that the actions taken under the previous administration as a part of SAFE-1 were decided in error and are now entirely rescinded. With this action, EPA is also withdrawing the SAFE-1 interpretation of the CAA that would prohibit other states from adopting the California GHG emission standards. As a result, other states may choose to adopt and enforce California’s GHG emission standards in lieu of the federal standards, consistent with CAA Section 177. Petitions for review must be filed by May 13, 2022.

FDA

FDA Update For PFAS: On February 24, 2022, the U.S. Food and Drug Administration (FDA) issued a Constituent Update covering testing for PFAS in food and details for the planned phase-out of certain short-chain PFAS. FDA reported that 89 of 92 food samples tested contained no detectable levels of PFAS and that there were three seafood samples (i.e., tilapia, cod, and shrimp) that contained levels of PFAS. The update includes the following clarification:

Based on the best available current science, the FDA has no scientific evidence that the levels of PFAS found in the TDS samples tested to date indicate a need to avoid any particular food.

FDA, separately in the update, confirmed the receipt of updates from manufacturers of food contact substances containing short-chain PFAS with 6:2 fluorotelomer alcohol (6:2 FTOH), which is being phased out over a three-year period that started in 2021.

FDA Guidance For Voluntary Recalls: On March 4, 2022, FDA announced the availability of a final guidance document for industry titled “Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C,” which finalizes guidance initially issued on April 24, 2019. 87 Fed. Reg. 12401. The guidance is available at 21 C.F.R. Part 7, Subpart C.

New Era Of Smarter Food Safety Podcast: On March 7, 2022, FDA announced it will air the third “TechTalk” podcast on March 21, 2022. This episode, entitled TechTalk Podcast Episode 3: Artificial Intelligence in the New Era of Smarter Food Safety, is part of the FDA quarterly update series meant to address advancements in technology with the aim of improving food safety. This podcast will focus on artificial intelligence as a mechanism for expanding predictive analytics. FDA’s New Era of Smarter Food initiative was launched in 2019 and consists of four core elements as stated in the 2020 blueprint. The second core element, Smarter Tools and Approaches for Prevention and Outbreak Response, is the focus of the series of podcasts. Registration is not required, but questions were required to be e-mailed by March 14, 2022.

FDA Announces Final Guidance For Five Of Seven FSMA Foundational Rules: On March 11, 2022, FDA announced the availability of final guidance for industry. The guidance, entitled “Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions,” addresses FDA policy in five of the seven foundational rules established under the Food Safety Modernization Act (FSMA). The guidance is intended to clarify the requirements related to supply-chain programs and indicates FDA does not intend to “enforce certain regulatory requirements for certain entities and/or activities covered by these five rules.”

NANOTECHNOLOGY

NanoHarmony Survey Identifies Challenges In OECD Test Guidelines Development, Webinar Held March 1: To identify difficulties arising during the development process for Organization for Economic Cooperation and Development (OECD) test guidelines (TG) and guidance documents (GD), NanoHarmony asked stakeholders to share their experiences in a short survey. According to NanoHarmony’s February 16, 2022, news item, NanoHarmony received 73 responses from different stakeholder groups. During the first half of 2022, NanoHarmony is hosting a webinar series covering the different phases that an OECD TG progresses through during its journey from a science-based initial idea through to use by industry to fulfill regulatory obligations. A recording of the March 1, 2022, webinar on the use of TGs in industry is now available. A short survey is available to collect stakeholder viewpoints on the use of TGs and is a follow-up to the webinar.

EUON Publishes Nanopinion On How To Assess The Risks Of Nanoplastics: On February 24, 2022, the EU Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Are nanoplastics hazardous? The way forward to overcome the uncertainties of risk assessment” by Dr. Anita Jemec Kokalj and Dr. Dana Kühnel about defining the criteria to evaluate which properties of nanoplastics should be reported in future studies to decrease uncertainties in their risk assessment.

NNI Holds NanoEHS Webinar On “What We Know About NanoEHS: Building International Bridges”: On March 1, 2022, the National Nanotechnology Initiative (NNI) held a webinar “What We Know about NanoEHS: Building International Bridges.” NNI states that it has supported the emergence of an international community of collaborative researchers on the environmental, health, and safety aspects of nanomaterials (nanoEHS). According to NNI, “[b‌]y advancing tools, methods, and standards for robust health and safety evaluation, these cooperative efforts have furthered the safe and responsible development of nanotechnology around the world.”

EUON Launches Two Calls For Tenders To Conduct Studies On Nanomaterials: EUON has launched two calls for tenders to conduct studies on nanomaterials. The first call for tender is on valid in silico modeling tools and read-across approaches, including creating case studies on read-across for specific types of nanomaterials. The second call for tender is for a study on nano-specific alternative methods in human risk/safety assessment under different EU regulations, considering the animal testing bans already in place for cosmetics and cosmetic ingredients. Expressions of interest are due March 24, 2022.

BIOBASED/RENEWABLE PRODUCTS

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.

How Can Battery Production Be Greener? -- A Conversation With Mathy Stanislaus: During this episode of All Things Chemical®, Lynn L. Bergeson and Mathy Stanislaus cover a broad range of issues, including the mission of the Global Battery Alliance (GBA), Mathy’s new role as Vice Provost and Executive Director of Drexel University’s Environmental Collaboratory, GBA’s fascinating and potentially transformational Battery Passport project, and other interesting topics. Listen now.

LEGISLATIVE

Legislation Would Address Air Quality In Underserved Communities: On February 18, 2022, Representatives Kathy Castor (D-FL), Lisa Blunt Rochester (D-DE), and Ritchie Torres (D-NY) introduced the Environmental Justice Air Quality Monitoring Act, which would help address pollution in environmental justice communities by expanding access to local air quality data. According to the February 18, 2022, press release from the House Select Committee on the Climate Crisis, the bill would establish a five-year pilot program for hyperlocal air quality monitoring projects in communities of color, low-income communities, and other underserved neighborhoods. Under a $100 million annual budget, the program would enable state, local, and Tribal air agencies to partner with local nonprofit organizations or air quality data providers to identify block-level hotspots for multiple pollutants, empowering them to use these data to build online mapping tools, inform local communities and air pollution managers about where poor air quality exists, and recommend a course of action to reduce pollution in identified hotspots.

Bipartisan, Bicameral Leaders Urge DOJ To Issue FOIA Guidance That Prioritizes Transparency: On February 23, 2022, the House Committee on Oversight and Reform announced that Representative Carolyn B. Maloney (D-NY), Chair of the House Committee on Oversight and Reform, Representative James Comer (R-KY), Ranking Member of the Committee on Oversight and Reform, Senator Dick Durbin (D-IL), Chair of the Senate Committee on the Judiciary, Senator Chuck E. Grassley (R-IA), Ranking Member of the Senate Committee on Judiciary, Senator Patrick Leahy (D-VT), and Senator John Cornyn (R-TX) sent a letter to Attorney General Merrick Garland of the Department of Justice (DOJ) urging him to issue a memorandum to all agencies encouraging the implementation of the Freedom of Information Act (FOIA) in a manner that emphasizes openness and transparency. The letter urges DOJ to implement GAO’s recommendation that the Office of Information Policy (OIP) identify ways that reporting requirements can inform current and emerging FOIA challenges and risks, including those related unusual-circumstances designations and litigation.

Congress Passes FY 2022 Omnibus Appropriations Bill: On March 9, 2022, the House passed the Fiscal Year (FY) 2022 Omnibus Appropriations Bill (H.R. 2471), and the Senate passed the bill on March 10, 2022. The $1.5 trillion bill includes $9.56 billion for EPA, $323 million above the 2021 enacted level. Of this amount, the bill includes:

  • $3.566 billion for EPA’s core science and environmental program work, an increase of $224 million above the 2021 enacted level. Within these amounts, the bill includes:
     
    • $587 million for Geographic Programs that help with restoration of nationally significant bodies of water like the Great Lakes, Chesapeake Bay, and Long Island Sound. This is an increase of $45 million above the 2021 enacted level; and
       
    • $539 million for environmental compliance monitoring and enforcement activities and grants, a $13 million increase above the 2021 enacted level;
       
  • $4.352 billion for State and Tribal Assistance Grants, a $38 million increase above the 2021 enacted level. Within this amount, the bill includes:
     
    • $2.77 billion for Clean Water and Drinking Water State Revolving Funds, equal to the 2021 enacted level;
       
    • $43 million for Combined Sewer Overflow grants, a $3 million increase above the enacted level;
       
    • $92 million for Brownfields cleanups, a $1 million increase above the 2021 enacted level; and
       
    • $92 million for Diesel Emissions Reductions grants, a $2 million increase above the enacted level;
       
  • $1.233 billion for Superfund, a $27 million increase above the 2021 enacted level; and
     
  • $100 million for environmental justice activities, an $83 million increase above the 2021 enacted level.
     

President Biden signed the bill on March 15, 2022.

House Committee Will Hold Hearing On Bioenergy Research And Development For The Fuels And Chemicals Of Tomorrow: On March 16, 2022, the House Committee on Science, Space, and Technology will hold a hearing on “Bioenergy Research and Development for the Fuels and Chemicals of Tomorrow.” According to the hearing charter, the purpose of the hearing is to examine the status of bioenergy research, development, and demonstration (RD&D) activities carried out by the U.S. Department of Energy (DOE). The hearing will also consider advancements in bioenergy research and the potential role of this resource in a cleaner energy transition. Lastly, the hearing will help inform future legislation to support and guide the U.S.’s bioenergy RD&D enterprise. The Committee will hear from the following witnesses:

  • Dr. Jonathan Male, Chief Scientist, Energy Processes and Materials, Pacific Northwest National Laboratory (PNNL);
     
  • Dr. Andrew Leakey, Director, Center for Advanced Bioenergy and Bioproducts Innovation, University of Illinois Urbana-Champaign;
     
  • Dr. Laurel Harmon, Vice President, Government Affairs, LanzaTech; and
     
  • Dr. Eric Hegg, Professor, Biochemistry and Molecular Biology, Michigan State University.
     
MISCELLANEOUS

ATSDR Announces Availability Of Six Draft Toxicological Profiles: On February 22, 2022, the Agency for Toxic Substances and Disease Registry (ATSDR) announced the opening of a docket to obtain comments on drafts of six updated toxicological profiles: beryllium, chloromethane, 1,2-dichloroethane, methyl tert-butyl ether (MTBE), n-nitrosodimethylamine, and chlorodibenzofurans. 87 Fed. Reg. 9618. ATSDR seeks public comments and additional information or reports on studies about the health effects of the six substances for review and potential inclusion in the profiles. ATSDR states that it considers key studies for these substances during the profile development process. The notice solicits any relevant, additional studies. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion in the profile. Comments are due May 23, 2022.

USGS Releases 2022 List Of Critical Minerals: On February 22, 2022, the U.S. Geological Survey (USGS) announced the release of the 2022 list of critical minerals, which “was determined using the most up-to-date scientific methods to evaluate mineral criticality.” USGS states that the new list contains 15 more commodities compared to the first list of critical minerals created in 2018. According to USGS, much of the increase in the new list is the result of splitting the rare earth elements and platinum group elements into individual entries rather than including them as “mineral groups.” In addition, the 2022 list of critical minerals adds nickel and zinc to the list while removing helium, potash, rhenium, and strontium.

OEHHA Adds PFOA To Proposition 65: On February 25, 2022, the California Office of Environmental Health Hazard Assessment (OEHHA) announced that it added perfluorooctanoic acid (PFOA) to the list of chemicals known to the state of California to cause cancer. The listing is based on its formal identification by the National Toxicology Program (NTP), an authoritative body for purposes of Proposition 65, that the chemical causes cancer.

EPA Announces New Science Supporting EPA Decisions Process: On February 28, 2022, EPA announced the implementation of a new process by which the Science Advisory Board (SAB) will assess the science that informs decisions regarding EPA proposed rules. EPA states that the new process “will restore opportunities for peer review and strengthen the independence of” SAB. According to EPA, the new Science Supporting EPA Decisions process strengthens peer review at EPA by:

  • Restoring SAB’s role by having structured opportunities to conduct peer review of critical scientific and technical actions developed by EPA;
     
  • Strengthening the independence of SAB’s role by scoping and identifying the peer review need for EPA decisions;
     
  • Ensuring EPA considers and develops peer reviewed science early in its rulemaking development process; and
     
  • Restoring public faith in EPA by ensuring the use of peer reviewed science to inform decision making.
     

The process is effective immediately.

OSTP Publishes RFI To Support Development Of A Federal Scientific Integrity Policy Framework: On March 3, 2022, the White House Office of Science and Technology Policy (OSTP) published a request for information (RFI) to support the development of a federal scientific integrity policy framework. 87 Fed. Reg. 12165. According to OSTP, the framework will include assessment criteria that OSTP and agencies can use to inform, review, and improve the content and implementation of agency scientific integrity policies. To support this framework, OSTP seeks information on: (1) how scientific integrity policies can address important and emergent issues, including diversity, equity, inclusion, and accessibility; new technologies; emerging modes of science; and coordination with related policy domains; (2) the criteria to evaluate scientific integrity policy content, implementation, outcomes, and impacts in the Executive Branch; (3) how to ensure that scientific integrity evaluation findings lead to effective iterative improvement of federal scientific integrity policy and practices; and (4) how to ensure the long-term viability and implementation of federal scientific integrity policies, practices, and culture through future administrations. Comments are due April 4, 2022.

PHMSA Provides Notice Of Public Meeting For International Standards On The Transport Of Dangerous Goods: On March 3, 2022, the Pipeline and Hazardous Materials Safety Administration’s (PHMSA) Office of Hazardous Materials Safety announced that it will host three public meetings during 2022 in advance of certain international meetings. 87 Fed. Reg. 12214. The first meeting will be held in preparation of the 60th session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCOE TDG) scheduled for June 27 to July 6, 2022, in Geneva, Switzerland. The second meeting will be held in preparation of the International Civil Aviation Organization’s (ICAO) Dangerous Goods Panel (DGP) Working Group 22 tentatively scheduled for November 21-25, 2022, in Montreal, Canada. The third meeting will be held in preparation of the 61st session of the UNSCOE TDG scheduled for November 28 to December 6, 2022, in Geneva, Switzerland. For each of these meetings, PHMSA will solicit public input on current proposals.

President Biden Nominates Joseph Goffman To Be Assistant Administrator For OAR: On March 8, 2022, President Joseph Biden announced the nomination of Joseph Goffman to be Assistant Administrator for the Office of Air and Radiation (OAR). According to the announcement, Goffman has served as the OAR Principal Deputy Assistant Administrator since January 2021. Prior to that, he was Executive Director of the Environmental and Energy Law Program at Harvard Law School. In 2017, he served as Democratic Chief Counsel to the U.S. Senate Committee on Environment and Public Works. From 2009 to 2017, Goffman was Associate Assistant Administrator for Climate and Senior Counsel to the Assistant Administrator for OAR. His career has also included senior legal, policy, and management positions at the Environmental Defense Fund.

CDTSC Announces That Treatments Containing PFAS For Use On Converted Textiles Or Leathers Will Become A Priority Product On April 1, 2022: The California Department of Toxic Substances Control (CDTSC) announced on March 8, 2022, that it adopted a final regulation effective April 1, 2022, to list as a new Priority Product treatments containing PFAS for use on converted textiles or leathers such as carpets, upholstery, clothing, and shoes. Domestic and foreign manufacturers of treatments for converted textiles or leathers that contain any member of the class of PFAS selling their products in California must submit a Priority Product Notification (PPN) for those products by May 31, 2022. The PPN must name all of the manufacturer’s products that contain PFAS and are sold in California.

SEC Will Discuss Standardizing Climate-Related Disclosures For Investors: The Securities and Exchange Commission (SEC) announced on March 14, 2022, that it will hold an open meeting on March 21, 2022. 87 Fed. Reg. 14304. According to the Federal Register notice, the SEC will consider whether to propose amendments “that would enhance and standardize registrants’ climate-related disclosures for investors.”

U.S. Commercial Service Announces PFAS Mini Boot Camp For Exporters: The U.S. Commercial Service, part of the U.S. Department of Commerce’s International Trade Administration, is holding a webinar series designed to inform exporters and manufacturers about potential PFAS risks affecting their business. The first webinar, Part I: “PFAS Basics: What you need to know,” was held March 9, 2022. Registration is open for Part II: “PFAS Technologies: Where are we & where are we going,” which will be held April 6, 2022. The session will cover the current and future state of the many technologies needed to handle the increasing attention on PFAS.

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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