Federal Development Update for February 2021


Biden-Harris Administration Freezes Rules Pending Review: On January 20, 2021, Ronald A. Klain, Assistant to the President and Chief of Staff, issued a memorandum regarding “Regulatory Freeze Pending Review.” 86 Fed. Reg. 7424. For rules that have not yet taken effect, the memorandum directs the heads of executive departments and agencies to consider postponing the rules’ effective dates for 60 days from the date of the memorandum for the purpose of reviewing any questions of fact, law, and policy the rules may raise. For postponed rules, during the 60-day period, the memorandum asks agencies to consider opening a 30-day comment period to allow interested parties to provide comments about issues of fact, law, and policy raised by those rules, and consider pending petitions for reconsideration involving such rules. Where necessary to continue to review these questions of fact, law, and policy, agencies should consider further delaying, or publishing for notice and comment proposed rules further delaying, such rules beyond the 60-day period. Following the 60-day delay in effective date, for those rules that raise no substantial questions of fact, law, or policy, no further action needs to be taken. For those rules that raise substantial questions of fact, law, or policy, agencies should notify the Director of the Office of Management and Budget (OMB) and take further appropriate action in consultation with the OMB Director.

Lynn L. Bergeson And Alexandra Dapolito Dunn To Present “Chemicals Regulation: Latest Developments” At Environmental Law 2021: The American Law Institute Continuing Legal Education (ALI CLE) and the Environmental Law Institute’s (ELI) Environmental Law 2021 webcast, February 24-26, 2021, educates lawyers on key current environmental law issues, including the latest developments in air, water, endangered species, climate change, chemicals, and renewable energy. Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), and Alexandra Dapolito Dunn, former Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP), U.S. Environmental Protection Agency (EPA), will present “Chemicals Regulation: Latest Developments” on February 25, 2021. B&C has access to a limited number of discounted registrations that we would be pleased to share with clients and friends; contact hlewis@lawbc.com for more details.

Chemical Watch’s “Key Regulatory Updates: Europe, Asia and the Americas 2021” Includes Presentations By Lynn L. Bergeson And Lisa R. Burchi: Chemical Watch presents Key Regulatory Updates: Europe, Asia and The Americas 2021 on March 23-25, 2021, taking a close look at the latest updates in chemicals control legislation across Europe, Asia, and the Americas. Lynn L. Bergeson will present “The Challenges of Enforcing TSCA” and Lisa R. Burchi, Of Counsel, B&C, will present “FIFRA Hot Topics for Team Biden.”

Available On-Demand: “What To Expect When You’re Electing (a New President)” Webinar, Presented January 28: B&C is pleased to offer an on-demand version of “What To Expect When You’re Electing (a New President),” a webinar focusing on the Biden Administration’s EPA, what policies and initiatives can be expected in the next four years, and how any likely regulatory directions may affect our clients.

TSCA/FIFRA/TRI

“Environmental Justice: Operationalizing TSCA to Fulfill Its Destiny,” By Lynn L. Bergeson For The American College Of Environmental Lawyers (ACOEL) Blog: The Biden Administration has embraced environmental justice with unprecedented gusto. In its July 2020 Plan to Secure Environmental Justice and Equitable Economic Opportunity, the Biden Administration sets out in broad terms how it intends to use an “All-of-Government” approach to “rooting out systemic racism in our laws, policies, institutions, and hearts.” Read the full article online.

EPA Issues Final Compliance Guide Addressing Surface Coatings Under PFAS SNUR: On January 19, 2021, EPA announced the availability of a final compliance guide that outlines which imported articles are covered by EPA’s July 2020 final significant new use rule (SNUR) that prohibits companies from manufacturing, importing, processing, or using certain long-chain per- and polyfluoroalkyl substances (PFAS) without prior EPA review and approval. The final guide is “the official compliance guide for imported articles that may contain long-chain perfluoroalkyl carboxylate chemical substances as part of a surface coating.” Specifically, the guide provides additional clarity on what is meant by a “surface coating,” identifies which entities are regulated, describes the activities that are required or prohibited, and summarizes the notification requirements of the final SNUR. EPA states that there “are no significant changes between the final guidance document and the draft document, which was released for public comment in December.” More information on the draft compliance guide is available in our December 14, 2020, memorandum, “EPA Publishes Draft Compliance Guide Addressing Surface Coatings under PFAS SNUR.” Comments on the draft guide were due January 15, 2021.

EPA Announces Request For Public Input On The Current Pesticide Exemption Provision Process: On January 19, 2021, EPA announced it will issue an Advance Notice of Proposed Rulemaking (ANPRM) to solicit information on the current pesticide exemption provision process. EPA announced that it is considering whether regulatory and policy changes are needed to improve the exemption provisions for pesticides that may be considered minimum risk under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA states that changes to the current process could make the implementation and evaluation of the exemption provisions more efficient. Comments on the ANPRM would be due on or before 90 days after publication of the ANPRM in the Federal Register in docket ID number EPA-HQ-OPP-2020-0537. More information is available in our February 2, 2021, blog.

EPA Announces Availability Of Final Risk Evaluation For PV29: On January 21, 2021, EPA announced the availability of the final risk evaluation for Pigment Violet 29 (PV29). 86 Fed. Reg. 6322. EPA states that the final risk evaluation determined that there are unreasonable risks to workers and occupational non-users (ONU) from ten out of 14 conditions of use. EPA found no unreasonable risks to the environment, consumers, or the general public. The next step in the process required by the Toxic Substances Control Act (TSCA) is developing a plan to address the unreasonable risks identified in the final risk evaluation. Potential actions EPA could take to address these risks include regulating how PV29 is used, and limiting or prohibiting the manufacture, processing, distribution in the marketplace, use, or disposal of PV29, as applicable. More information is available in our January 25, 2021, memorandum.

EPA Denies TSCA Section 21 Petition Seeking Section 4 Test Rule For 54 PFAS: On January 22, 2021, EPA published the reasons for its denial of a petition requesting it to require health and environmental effects testing on 54 PFAS. 86 Fed. Reg. 6602. The petition sought issuance of a rule or order under TSCA Section 4 compelling The Chemours Company to fund and carry out this testing under the direction of a panel of independent scientists. EPA states that it finds the petitioners have not provided the facts necessary for it to determine for each of the 54 PFAS that “existing information and experience are insufficient and testing of such substance or mixture with respect to such effects is necessary to develop such information.” After “careful consideration,” EPA denied the TSCA petition for the following reasons: insufficient information and experience; testing of such substance or mixture with respect to such effects is necessary to develop such information; class-based approach to testing; practicability of National Academy of Sciences oversight; selection of PFAS for health and environmental effects testing; scientific standards; and vertebrate testing. More information is available in our January 26, 2021, blog item.

EPA Announces Latest Update To The TSCA Inventory: On February 3, 2021, EPA announced the latest update to the TSCA Inventory, “a list of all existing chemical substances manufactured, processed, or imported” in the United States. EPA states that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. EPA plans to release the next regular update of the Inventory in summer 2021. According to EPA, the Inventory contains 86,557 chemicals of which 41,864 are active in U.S commerce. EPA notes that other updates to the TSCA Inventory 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.

Biden-Harris EPA Provides Updates On Chemical Safety Actions: On February 5, 2021, EPA announced that it is reviewing actions issued under the previous Administration and will take any needed steps to ensure that they protect human health and the environment. The announcement included an update on the following chemical safety actions that have immediate or near-term effective dates or other steps associated with them: the final rules for five persistent, bioaccumulative, and toxic (PBT) chemicals -- 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP) (86 Fed. Reg. 866); decabromodiphenyl ether (decaBDE) (86 Fed. Reg. 880); hexachlorobutadiene (HCBD) (86 Fed. Reg. 922); pentachlorothiophenol (PCTP) (86 Fed. Reg. 911); and phenol, isopropylated phosphate (3:1) (PIP (3:1)) (86 Fed. Reg. 894); the January 2021 final rule establishing lower clearance levels for the amount of lead that can remain in dust on floors and window sills after lead removal activities (abatement) (86 Fed. Reg. 983); and TSCA risk evaluations and risk management for the first ten chemicals. More information is available in our February 8, 2021, blog item.

EPA Updates List Of Alternative Test Methods To Animal Testing: On February 5, 2021, EPA announced that it updated its list of alternative test methods or strategies (New Approach Methodologies (NAM)) that do not require new vertebrate animal testing. EPA states that this action helps meet the TSCA requirements to reduce and replace, to the extent practicable and scientifically justified, the use of vertebrate animals in the testing of chemical substances or mixtures. EPA added one new test guideline that relates to human health effects; incorporated two additional EPA guidance documents that reduce the use of animal testing; and added version 9.0 of the organic chemicals’ module of OncoLogicTM, “a more user-friendly version of the most widely used piece of this system that evaluates a chemical’s potential to cause cancer.”

EPA Updates TSCA CBI Review Statistics: On February 8, 2021, EPA published a periodic update of the TSCA confidential business information (CBI) review statistics. TSCA Section 14(g)(1) requires that EPA, within 90 days of receipt of a CBI claim: review and make determinations on CBI claims for chemical identity after the chemical substance has been offered for commercial distribution; and review and make determinations on a representative subset of at least 25 percent of other CBI claims that are not exempt from substantiation and review. The updated data summarize the number of CBI cases under review and results of completed reviews through December 28, 2020. In addition, a spreadsheet is available showing the details of completed TSCA CBI determinations through December 28, 2020.

EPA Publishes Statements Of Findings For Certain New Chemicals Or Significant New Uses: On February 8, 2021, EPA published statements of Administrator findings under TSCA Section 5(a)(3)(C) for August 2019 (86 Fed. Reg. 8628) and for September through December 2019 (86 Fed. Reg. 8622). TSCA Section 5(g) requires EPA to publish in the Federal Register a statement of its findings after its review of TSCA Section 5(a) notices when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. Such statements apply to premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN) submitted to EPA under TSCA Section 5.

EPA Publishes Receipt And Status Information For Certain New Chemicals: On February 9, 2021, EPA published the receipt and status reports for TSCA Section 5 submissions for November 2020. 86 Fed. Reg. 8786. On February 10, 2021, EPA published the receipt and status reports for December 2020. 86 Fed. Reg. 8898. EPA provides notice of receipt of PMNs, SNUNs, and MCANs (including amended notices and test information); an exemption application under 40 C.F.R. Part 725 (Biotech exemption); test marketing exemptions (TME), both pending and/or concluded; notices of commencement (NOC) to manufacture a new chemical substance; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. EPA also provides information on its website about cases reviewed under the amended TSCA, including the Section 5 PMN/SNUN/MCAN and exemption notices received, the date of receipt, the final EPA determination on the notice, and the effective date of EPA’s determination for PMN/SNUN/MCAN notices.

Biden-Harris EPA Withdraws PFBS Toxicity Assessment “Compromised By Political Interference”: On February 9, 2021, EPA announced that “EPA career scientists have reviewed content shared in a January 19, 2021 press release, which can be found here, and made an initial determination that the conclusions in the PFBS (Perfluorobutanesulfonic acid, a PFAS compound) Toxicity Assessment posted in that release were compromised by political interference as well as infringement of authorship and the scientific independence of the authors’ conclusions.” The press release states that this “constitutes a violation of the agency’s Scientific Integrity Policy and the documents have been removed from the EPA website while the agency completes its review.”

EPA Will Hold Webinar On Proposed Revisions To The TSCA Fees Rule On February 18, 2021: EPA will hold a webinar on February 18, 2021, “to educate stakeholders on proposed revisions to the Toxic Substances Control Act (TSCA) Fees Rule announced in December 2020.” The webinar will also provide stakeholders an opportunity to provide comment to EPA on the proposed changes. Stakeholders who would like to provide oral comments during the webinar must register by 5:00 p.m. (EST) on February 16, 2021. Stakeholders may register as listen-only attendees at any time up to the end of the meeting. EPA will provide details on how to access the webinar and slides after participants register via Eventbrite.com. EPA states that it will provide a transcript and recording on the TSCA Administration Fees website following the webinar. Comments on the proposed revisions to the rule are due February 25, 2021. More information on the proposed rule is available in our December 30, 2020, memorandum, “EPA Intends Proposed Rule to Increase Flexibility and Reduce Burdens under TSCA Fees Program.”

Registration Opens For Webinars On PV29 And NMP: On February 9, 2021, EPA announced that it will host two webinars intended to educate stakeholders on the risk management process under TSCA and the findings in the final risk evaluations for PV29 and n-methylpyrrolidone (NMP). The webinars will also allow the public to provide input on considerations EPA should take into account for managing any unreasonable risks found with these chemicals. The PV29 webinar will be held on February 23, 2021, and the NMP webinar will be held on February 24, 2021. To provide oral comments during the PV29 webinar, registration is due by February 18, 2021. To provide oral comments during the NMP webinar, registration is due by February 19, 2021. More information is available in our February 12, 2021, blog item.

EPA Seeks Participants For Small Business Review Panel On Risk Management Rulemaking For Asbestos, Part 1: Chrysotile Asbestos: EPA announced on February 11, 2021, that it is inviting small businesses, governments, and not-for-profits to participate as Small Entity Representatives (SER) to provide advice and recommendations to a Small Business Advocacy Review (SBAR) Panel for asbestos, part 1: chrysotile asbestos. The Panel will focus on EPA’s development of a proposed rule to address unreasonable risks identified in EPA’s TSCA risk evaluation for asbestos, part 1: chrysotile asbestos. EPA is now moving to the risk management step in the TSCA process by working to draft regulations to protect public health from the unreasonable risks identified in the final risk evaluation. EPA states that it is seeking self-nominations directly from the small entities that may be subject to the rule’s requirements. EPA notes that other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs. Self-nominations may be submitted online and must be received by February 25, 2021.

Deadline For Filing Annual Pesticide Production Reports -- March 1, 2021: The March 1, 2021, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2020 reporting year is fast approaching. Pursuant to FIFRA Section 7(c)(1) (7 U.S.C. § 136e(c)(1)), “Any producer operating an establishment registered [under Section 7] shall inform the Administrator within 30 days after it is registered of the types and amounts of pesticides and, if applicable, active ingredients used in producing pesticides” and this information “shall be kept current and submitted to the Administrator annually as required.” Reports must be submitted on or before March 1 annually for the prior year’s production. The report, filed through the submittal of EPA Form 3540-16: Pesticide Report for Pesticide-Producing and Device-Producing Establishments, must include the name and address of the producing establishment; and pesticide production information, such as product registration number, product name, and amounts produced and distributed. The annual report is always required, even when no products are produced or distributed. For more information on filing the annual report, see our January 27, 2021, blog.

COVID-19

EPA Announces Approval Of Airborne Antiviral Treatment Product For Use Against COVID-19: On January 15, 2021, EPA announced the issuance of a FIFRA Section 18 emergency exemption to the states of Georgia and Tennessee permitting the use of an air treatment product, Grignard Pure, in health care facilities, intrastate transportation, food processing facilities, and indoor spaces within buildings -- including government facilities -- where people are conducting activity deemed essential by the state. According to the EPA Authorizations for Georgia and Tennessee (EPA Authorizations), Grignard Pure forms a mist with activity against airborne SARS-CoV-2, the virus that causes COVID-19. It contains the active ingredient triethylene glycol (TEG), an ingredient commonly used in fog machines for concerts and theater productions. For more information on the emergency exemption, see our January 29, 2021, blog.

EPA Announces Approval Of Extensions To August 24, 2020, First-Ever Long-Lasting Antiviral Product For Use Against COVID-19: On January 19, 2021, EPA announced the issuance of a FIFRA Section 18 emergency exemption to the states of Oklahoma and Arkansas, permitting American Airlines to use SurfaceWise2, believed to inactivate coronaviruses like the SARS-CoV-2 virus on surfaces, in specific airport facilities and planes. EPA also has revised the terms of use for SurfaceWise2 for all current emergency exemptions. EPA’s initial emergency exemption for the state of Texas issued on August 24, 2020, specified that the product remained effective for seven days. According to its updated labels for all three states, EPA has now approved claims that SurfaceWise2 provides residual surface control of the coronavirus SARS-CoV-2 on surfaces that are undisturbed for up to 30 days. The approved Section 18 emergency requests are effective for one year. This public health exemption will expire August 24, 2021. As new data emerge, EPA may alter the terms of the product’s emergency uses, as it did with the modifications discussed in our February 3, 2021, blog.

OSHA Issues Stronger Workplace Guidance On Coronavirus: On January 29, 2021, the Occupational Safety and Health Administration (OSHA) announced that it issued stronger worker safety guidance to help employers and workers implement a coronavirus prevention program and better identify risks that could lead to exposure and contraction. “Protecting Workers: Guidance on Mitigating and Preventing the Spread of COVID-19 in the Workplace” provides updated guidance and recommendations, and outlines existing safety and health standards. According to OSHA, the guidance recommends several essential elements in a prevention program: conduct a hazard assessment; identify control measures to limit the spread of the virus; adopt policies for employee absences that do not punish workers as a way to encourage potentially infected workers to remain home; ensure that coronavirus policies and procedures are communicated to both English and non-English speaking workers; and implement protections from retaliation for workers who raise coronavirus-related concerns.

EPA Announces The Issuance Of A Revised Advisory On Disinfectants Making False And Misleading Claims Against COVID-19: In January 2021, EPA’s Office of Enforcement and Compliance Assurance (OECA) announced that it issued a revised compliance advisory (Advisory) on products claiming to kill SARS-CoV-2, the novel coronavirus that causes COVID-19. EPA first issued this guidance on June 1, 2020, and it is discussed in our blog here. The Advisory has been revised significantly, reflecting new developments and experience since the Advisory was first issued. For more information on the changes to the Advisory since it was first issued, see our February 2, 2021, blog item.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA Will Issue ANPRM Addressing PFOA And PFOS In The Environment: On January 14, 2021, EPA announced that it will publish an ANPRM seeking comment on whether EPA should consider using authorities other than those it has already used and, if so, what other authorities it might seek to exercise through rulemaking, to address environmental contamination by perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers. EPA is seeking comments and data to assist in the consideration of potential development of future regulations pertaining to PFOA and PFOS under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and Resource Conservation and Recovery Act (RCRA). Comments will be due 60 days after the ANPRM is published in the Federal Register. EPA posted a pre-publication version of the ANPRM.

Final Rule Intended To Reduce Regulatory Burden And Emissions From Large Storage Tanks By Allowing Alternative Inspection Method: On January 19, 2021, EPA published a final rule offering regulatory flexibility to more than 3,500 petroleum, chemical, and coal products manufacturing facilities and petroleum bulk stations and terminals by allowing an alternate, less cumbersome mode of inspection of liquid storage tanks to show compliance with Clean Air Act (CAA) regulations. 86 Fed. Reg. 5013. The amendments to the Standards of Performance for Volatile Organic Liquid Storage Vessels (Including Petroleum Liquid Storage Vessels) for Which Construction, Reconstruction, or Modification Commenced After July 23, 1984, will allow owners/operators of Volatile Organic Liquid Storage Vessels to conduct less cumbersome “in-service” inspections of the tanks, without emptying and degassing the storage tank. The final rule was effective January 19, 2021.

EPA Publishes Proposed Rule Regarding E15 Fuel Dispenser Labeling And Compatibility With USTs: EPA currently requires fuel dispenser labels for gasoline-ethanol blends of greater than ten volume percent (vol%) ethanol and up to 15 vol% ethanol (E15). 86 Fed. Reg. 5094. EPA states that the label was designed to alert consumers to the appropriate and lawful use of the fuel. EPA is co-proposing either to modify the E15 label or remove the label requirement entirely and seeks comment on whether state and local governments may be preempted from requiring different labels on fuel dispensers. To facilitate the proper storage of E15 in underground storage tank (UST) systems, EPA is proposing to modify the UST regulations to grant certain allowances for compatibility demonstration for storage of ethanol blends. EPA is also proposing compatibility requirements for future UST installations or component replacements that would ensure compatibility with higher blends of ethanol. Comments are due April 19, 2021.

EPA Announces Final Regulatory Determinations For CCL 4: On January 19, 2021, EPA announced final regulatory determinations for contaminants on the fourth Contaminant Candidate List (CCL 4). EPA is making final determinations to regulate two contaminants, PFOS and PFOA, in drinking water and not to regulate six contaminants (1,1-dichloroethane, acetochlor, methyl bromide (bromomethane), metolachlor, nitrobenzene, and RDX). EPA has posted a pre-publication version of the Federal Register notice.

EPA Issues Memorandum Providing Guidance In County Of Maui v. Hawaii Wildlife Fund: On January 21, 2021, EPA announced the availability of a memorandum to provide guidance to the regulated community and permitting authorities on applying the recent decision of the U.S. Supreme Court in County of Maui v. Hawaii Wildlife Fund in the Clean Water Act (CWA) Section 402 National Pollutant Discharge Elimination System (NPDES) permit program for point source discharges that travel through groundwater before reaching a water of the United States. 86 Fed. Reg. 6321. Consistent with EPA Guidance; Administrative Procedures for Issuance and Public Petitions, published in the Federal Register on October 19, 2020, EPA solicited public comments on the draft guidance. EPA states that it has developed a responsiveness summary to address major concerns and comments, and it is available in the docket for this action. EPA notes that the guidance does not have the force and effect of law and it does not bind the public in any way. According to the notice, by issuing this guidance, EPA “intends only to provide clarity to the public regarding existing requirements under the law or Agency policies.” More information on the Court’s decision is available in our April 27, 2020, blog item.

EPA Publishes Inventory Of U.S. Greenhouse Gas Emissions And Sinks: 1990-2019: On February 12, 2021, EPA announced the availability of the Draft Inventory of U.S. Greenhouse Gas Emissions and Sinks: 1990-2019 for public review. 86 Fed. Reg. 9339. EPA requests recommendations for improving the overall quality of the inventory report to be issued in final in April 2021, as well as subsequent inventory reports. Comments are due March 15, 2021.

FDA

FDA’s 2020 Inspection Citation Dataset: On February 8, 2021, the U.S. Food and Drug Administration (FDA) released an updated Inspection Citation Dataset that includes citations as current as of February 3, 2021. The updated dataset discloses findings from FDA’s inspections in an effort to “protect the public health, provide the public with a rationale for the Agency’s enforcement actions, and to help inform public and industry decision-making allowing them to make more informed marketplace choices and help to encourage compliance.” Additional details regarding FDA’s inspection observations are available in FDA’s annual Inspectional Observation Data Sets.

NANOTECHNOLOGY

Health, Environment, And Justice Organizations Seek Clarification From ECHA On Nano And Biocidal-Treated Products: On January 20, 2021, Health Care Without Harm (HCWH) Europe and 12 other health, environment, and justice organizations sent a letter to Bjorn Hansen, Executive Director of the European Chemicals Agency (ECHA) “seeking clarifications on both the applicable legal framework and risk management measures in place, for nano/biocidal-treated articles in the context of the current COVID-19 pandemic.” More information is available in our January 26, 2021, blog item.

FDA’s NCTR Highlights Its Nanotechnology-Related Activities In 2020: The January 27, 2021, issue of FDA’s NCTR Research Highlights includes an item highlighting the National Center for Toxicological Research’s (NCTR) nanotechnology-related activities in 2020. The activities include: nanotechnology standards; Nanotechnology Task Force (NTF) Report; FDA Grand Rounds; and Nano Day. More information is available in our January 29, 2021, blog item.

EC DG Invites Offers For Study On Providing Market Data About Nanotechnology To Enhance Transparency: In December 2020, the European Commission (EC) Directorate-General (DG) for Research and Innovation opened a call for tenders for “Providing market data about nanotechnology to enhance transparency.” The description states that the study on nanotechnology/nanomaterials is aimed to provide a new set of data from the period of 2017 to 2020 into the NanoData database, available on the European Union (EU) Observatory for Nanomaterials (EUON) website. Tenders are due February 22, 2021.

OSHA’s Proposed Updates To Hazard Communication Standard Will Include Particle Characteristics: OSHA published a notice of proposed rulemaking (NPRM) on February 16, 2021, that would modify the Hazard Communication Standard (HCS) to conform to the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Revision 7 “to address issues that arose during the implementation of the 2012 update to the HCS, and provide better alignment with other U.S. agencies and international trading partners, without lowering overall protections of the standard.” 86 Fed. Reg. 9576. The NPRM notes that “the change in section 9 (physical characteristics to include particle characteristics) will identify exposure issues that are not addressed by the current format.” According to the NPRM, “[t]his should, among other things, improve the hazard information required for nanomaterials.” More information is available in our February 11, 2021, blog item. Comments are due April 19, 2021.

OECD Will Hold Webinar On Assessing The Dispersion Stability And Dissolution Of Nanomaterials In The Environment: On February 25, 2021, the Organization for Economic Cooperation and Development (OECD) will hold a webinar on “Assessing the dispersion stability and dissolution (rate) of nanomaterials in the environment” to discuss the scope, content, and use of Test Guideline No. 318: Dispersion Stability of Nanomaterials in Simulated Environmental Media and its accompanying guidance document. More information is available in our February 2, 2021, blog item.

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.

LEGISLATIVE

Sustainable Chemistry Research And Development Act Passed As Part Of National Defense Authorization Act: On December 28, 2020, the House overrode President Trump’s veto and passed the National Defense Authorization Act for Fiscal Year 2021 (H.R. 6395) by a vote of 322 to 87, and the Senate passed the bill on January 1, 2021, by a vote of 81 to 13. Subtitle E of Title II of the Act (Subtitle E) includes the text of the bipartisan Sustainable Chemistry Research and Development Act of 2019. Subtitle E will establish an interagency working group led by the Office of Science and Technology Policy (OSTP) to coordinate federal programs and activities in support of sustainable chemistry (also called green chemistry). No later than 180 days after enactment, an interagency working group will be convened to oversee the coordination of federal programs and activities in support of sustainable chemistry. To be terminated ten years after the date of the enactment, the working group would be co-chaired by the Director of OSTP and a representative from EPA, the National Institute of Standards and Technology (NIST), the National Science Foundation (NSF), or the U.S. Department of Energy (DOE), as selected by the Director of OSTP. For more information, read our January 19, 2021, memorandum.

House Bill Would Modify Procedures Related To Specified Chemical Assessments: On January 4, 2021, Representative Andy Biggs (R-AZ) introduced the Improving Science in Chemical Assessments Act (H.R. 62). According to Biggs’ January 3, 2021, press release, the bill “ensures that potentially toxic substances are accurately identified and reported to the public” and eliminates EPA’s “unauthorized and duplicative Integrated Risk Information System (IRIS), which has a track record of carrying out flawed chemical assessments using improper science.” Under the bill, chemical assessments would be conducted by the “relevant program office,” including the Office of Water, the Office of Air and Radiation, the Office of Land and Emergency Management, and OCSPP, “so long as the relevant program office determines there is a need for such an assessment.” Assessment would be conducted using “scientific information, technical procedures, measures, methods, protocols, methodologies, or models in a manner consistent with the best available science.”

Carper To Chair Senate Environment And Public Works Committee: On February 4, 2021, Senator Tom Carper (D-DE) became Chair of the Senate Committee on Environment and Public Works. Senator Shelley Moore Capito (R-WV) is Ranking Member. On February 9, 2021, Committee members approved Carper’s proposed rule changes, including renaming two of the standing Subcommittees. The Subcommittee formerly known as Clean Air and Nuclear Safety has been changed to Clean Air, Climate, and Nuclear Safety. The Subcommittee formerly known as Superfund, Waste Management and Regulatory Oversight has been changed to Chemical Safety, Waste Management, Environmental Justice, and Regulatory Oversight. In its February 9, 2021, press release, the Committee notes that “[t]his is the first time that environmental justice has been enumerated in the title of a Senate standing subcommittee.”

Manchin Will Chair Senate Energy And Natural Resources Committee: On February 4, 2021, the Senate Energy and Natural Resources Committee announced that Senator Joe Manchin (D-WV) will serve as Chair of the Committee. According to the press release, Manchin noted that “there is no shortage of work to do to advance a cleaner energy future while ensuring no worker is left behind and our energy independence remains uncompromised.” John Barrasso (R-WY) is the Ranking Member.

Senators Reintroduce Bipartisan Bill To Protect Firefighters From PFAS: On February 4, 2021, the Senate Committee on Environment and Public Works announced that Senators Tom Carper (D-DE), Chair of the Senate Environment and Public Works Committee, and Gary Peters (D-MI), Chair of the Homeland Security and Governmental Affairs Committee, reintroduced a bipartisan bill intended to help protect the health and safety of firefighters, emergency responders, and the communities they serve. The Protecting Firefighters from Adverse Substances (PFAS) Act, which passed the Senate last Congress, directs federal agencies to develop best practices, training, and educational programs to reduce, limit, and prevent exposure to PFAS.

Senate Environment And Public Works Committee Sends Nomination Of Michael Regan For EPA Administrator To Senate Floor: On February 9, 2021, the Senate Environment and Public Works Committee convened a business meeting to consider the nomination of Michael S. Regan to be EPA Administrator. A bipartisan majority of Committee members voted to move forward on his confirmation by a recorded vote of 14 to 6. His nomination now heads to the Senate floor for a full vote.

House Committee Will Hold Hearing On “A Smarter Investment: Pathways To A Clean Energy Future”: On February 18, 2021, the House Committee on Energy and Commerce will hold a hearing on “A Smarter Investment: Pathways to a Clean Energy Future.” The hearing will be held via Cisco WebEx.

MISCELLANEOUS

OEHHA Proposes Significant Changes To “Short-Form” Warnings: On January 8, 2021, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed significant revisions to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations for “short-form” warnings. When OEHHA’s revisions to the warning requirements were issued in 2016 (and in full effect as of August 30, 2018), OEHHA included a short-form warning option as an acceptable alternative to the revised requirements for consumer product exposure warnings. Many use this option. Its advantages include shorter language that can fit on a product’s label or packaging and the ability to provide a compliant warning without identifying at least one chemical listed under Prop 65 that triggers the warning, which is otherwise now a requirement for consumer product exposure warnings under OEHHA’s revised regulations. Over time, OEHHA has expressed concerns regarding the reliance on short-form warnings when label/packaging space is not an issue, despite the fact that such use is compliant with OEHHA’s regulations and guidance. OEHHA’s proposal to amend its regulations will significantly constrict the circumstances when a short-form warning is permissible, as well as elongate the warning by now requiring the inclusion of a Prop 65 listed substance. Comments on this proposal can be submitted to OEHHA no later than March 8, 2021. OEHHA also will schedule a public hearing if a request for such a hearing is received no later than February 22, 2021. For more information, see our January 21, 2021, memorandum.

SEC Adopts Final Rule Regarding Disclosure Of Payments By Resource Extraction Issuers: On January 15, 2021, the Securities and Exchange Commission (SEC) issued a final rule under the Securities Exchange Act of 1934 (Exchange Act) and an amendment to Form SD to implement Section 13(q) of the Exchange Act. 86 Fed. Reg. 4662. Section 13(q), which was added to the Exchange Act in 2010 by Section 1504 of the Dodd-Frank Wall Street Reform and Consumer Protection Act, directs the SEC to issue rules requiring resource extraction issuers to include in an annual report information relating to payments made to a foreign government or the federal government for the purpose of the commercial development of oil, natural gas, or minerals. Section 13(q) requires these issuers to provide information about the type and total amount of payments made for each of their projects related to the commercial development of oil, natural gas, or minerals, and the type and total amount of payments made to each government. In addition, Section 13(q) requires a resource extraction issuer to provide information about those payments in an interactive data format. The final rule and form amendment will be effective March 16, 2021.

Biden Signs EO On Protecting Public Health And The Environment And Restoring Science To Tackle The Climate Crisis: On January 20, 2021, President Biden signed an Executive Order (EO) on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis. 86 Fed. Reg. 7037. According to the EO, it is the policy of the Biden Administration “to listen to the science; to improve public health and protect our environment; to ensure access to clean air and water; to limit exposure to dangerous chemicals and pesticides; to hold polluters accountable, including those who disproportionately harm communities of color and low-income communities; to reduce greenhouse gas emissions; to bolster resilience to the impacts of climate change; to restore and expand our national treasures and monuments; and to prioritize both environmental justice and the creation of the well-paying union jobs necessary to deliver on these goals.” The EO directs all executive departments and agencies to review immediately and, as appropriate and consistent with applicable law, take action to address the promulgation of federal regulations and other actions during the Trump Administration that conflict with the Biden Administration’s national objectives, and to commence work immediately to confront the climate crisis. The EO calls for the heads of all agencies to review immediately “all existing regulations, orders, guidance documents, policies, and any other similar agency actions (agency actions) promulgated, issued, or adopted between January 20, 2017, and January 20, 2021, that are or may be inconsistent with, or present obstacles to,” the Biden Administration’s policy. For any identified actions, the EO directs the heads of agencies to “consider suspending, revising, or rescinding the agency actions.” In addition, for certain specified agency actions, the EO states that the head of the relevant agency “shall consider publishing for notice and comment a proposed rule suspending, revising, or rescinding the agency action within the time frame specified.”

Memorandum Directs OMB To Produce Recommendations For Improving And Modernizing Regulatory Review: On January 20, 2021, President Biden signed a memorandum that directs the Director of OMB, in consultation with representatives of executive departments and agencies, as appropriate and as soon as practicable, to begin a process to produce a set of recommendations for improving and modernizing regulatory review. 86 Fed. Reg. 7223. The memorandum states that the recommendations should provide concrete suggestions on how the regulatory review process can promote public health and safety, economic growth, social welfare, racial justice, environmental stewardship, human dignity, equity, and the interests of future generations. The recommendations should also include proposals that would ensure that regulatory review serves as a tool to promote regulations affirmatively that advance these values. According to the memorandum, the recommendations should be informed by public engagement with relevant stakeholders.

Dan Utech Is EPA’s Incoming Chief Of Staff: On January 21, 2021, Dan Utech, Incoming Chief of Staff for EPA, announced to EPA that until Michael Regan, Secretary of the North Carolina Department of Environmental Quality, is confirmed as EPA Administrator, Jane Nishida will serve as Acting Administrator. In his announcement, Utech notes that on January 20, 2021, President Biden signed an EO on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis (see above for more information on this EO). According to Utech, EPA will be guided by science as it moves to achieve these goals and address other threats to public health and the environment. Utech states that Biden also signed an EO on Advancing Racial Equity and Support for Underserved Communities through the Federal Government. In addition to providing a framework for advancing equity, it revokes EO 13950, “Combating Race and Sex Stereotyping.” More information, including an updated list of current and acting leaders and a list of incoming appointees, is available in our January 22, 2021, blog item and in EPA’s January 21, January 27, and February 2, 2021, press releases.

President Signs EO On Tackling The Climate Crisis At Home And Abroad: On January 27, 2021, President Biden signed an EO on tackling the climate crisis at home and abroad. 86 Fed. Reg. 7619. The EO directs the Biden-Harris Administration to center the climate crisis in U.S. foreign policy and national security considerations; take a whole-of-government approach to the climate crisis; leverage the federal government’s footprint and buying power to lead by example; rebuild our infrastructure for a sustainable economy; advance conservation, agriculture, and reforestation; revitalize energy communities; and secure environmental justice and spur economic opportunity.

President Signs Memorandum On Restoring Trust In Government Through Scientific Integrity And Evidence-Based Policymaking: On January 27, 2021, President Biden signed the Memorandum on Restoring Trust in Government through Scientific Integrity and Evidence-Based Policymaking, which directs agencies to make evidence-based decisions guided by the best available science and data. 86 Fed. Reg. 8845. The memorandum states that scientific and technological information, data, and evidence are central to the development and iterative improvement of sound policies, and to the delivery of effective and equitable programs. According to the memorandum, improper political interference in the scientific process, with the work of scientists, and in the communication of scientific facts undermines the welfare of the nation, contributes to systemic inequities and injustices, and violates the public trust. The memorandum charges the Director of OSTP with the responsibility for ensuring scientific integrity across federal agencies. The OSTP Director is directed to review the effectiveness of agency scientific-integrity policies and assess agency scientific-integrity policies and practices going forward.

President Signs EO On President’s Council Of Advisors On Science And Technology: On January 27, 2021, President Biden signed an EO that re-establishes the President’s Council of Advisors on Science and Technology (PCAST). 86 Fed. Reg. 7615. In alignment with the January 27, 2021, scientific-integrity memorandum’s charge to reestablish scientific and technological advisory committees, the EO re-establishes PCAST. PCAST, co-chaired by the President’s Science Advisor, will advise the President on policy that affects science, technology, and innovation. PCAST will also advise the President on scientific and technical information that is needed to inform public policy relating to the economy, worker empowerment, education, energy, environment, public health, national and homeland security, racial equity, and other topics.

Court Grants EPA’s Motion To Vacate And Remand Final Rule On “Strengthening Transparency In Pivotal Science Underlying Significant Regulatory Actions And Influential Scientific Information”: On February 1, 2021, the U.S. District Court for the District of Montana granted EPA’s January 31, 2021, unopposed motion to vacate and remand its January 6, 2021, final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information” (86 Fed. Reg. 469). EDF v. EPA, No. 4:21-cv-03-BMM. On January 11, 2021, the Environmental Defense Fund (EDF), Montana Environmental Information Center (MEIC), and Citizens for Clean Energy (CCE) filed suit against EPA, claiming that the January 6, 2021, final rule was unlawful and that EPA’s decision to make the final rule effective on publication was unlawful. On January 27, 2021, the court granted summary judgment to the plaintiffs, finding that EPA did not provide good cause to exempt the final rule from the Administrative Procedure Act’s (APA) 30-day notice requirement. The court stated that “EPA’s decision to make the Final Rule immediately effective on publication was ‘arbitrary, capricious’ and ‘otherwise not in accordance with law.’” In its January 31, 2021, motion, EPA states based on the court’s conclusion that the final rule constitutes a substantive rule and that EPA “lacked authorization to promulgate the rule pursuant to its housekeeping authority.” EPA notes that because the final rule was in effect for less than a month, and it had not applied the rule in any circumstance while the rule was in effect, “there would be no disruptive consequences in remanding and vacating the rule.” More information is available in our February 1, 2021, blog item.

EPA Requests Nominations To National Environmental Justice Advisory Council: On February 2, 2021, EPA invited nominations from a diverse range of qualified candidates to be considered for appointment to its National Environmental Justice Advisory Council (NEJAC). 86 Fed. Reg. 7866. EPA states that NEJAC was chartered to provide advice regarding “broad, cross-cutting issues related to environmental justice.” EPA seeks to fill approximately seven new vacancies for terms through September 2022. To maintain the representation outlined by the charter, nominees will be selected to represent: academia (one vacancy); community-based organizations (two vacancies); non-governmental organizations (NGO) (one vacancy); state and local governments (two vacancies); and tribal governments and indigenous organizations (one vacancy). EPA states that it is interested in adding members located in EPA Regions 1, 2, 7, 8, 9, and 10. According to the notice, vacancies are anticipated to be filled by September 2021. EPA notes that it will use sources in addition to this Federal Register notice in the solicitation of nominees. Nominations are due March 24, 2021.

DOJ Memorandum To ENRD Section Chiefs And Deputy Section Chiefs Withdraws Memoranda And Policy Documents: On February 4, 2021, the U.S. Department of Justice (DOJ) issued a memorandum to Environment and Natural Resources Division (ENRD) Section Chiefs and Deputy Section Chiefs noting that the January 20, 2021, EO on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis, directs agencies to “immediately review and, as appropriate and consistent with applicable law, take action to address” certain regulations or other agency actions “that conflict with these important national objectives, and to commence immediately work to confront the climate crisis.” Accordingly, the following documents are hereby withdrawn, effective immediately:

  • “Enforcement Principles and Priorities,” January 14, 2021;
     
  • “Additional Recommendations on Enforcement Discretion,” January 14, 2021;
     
  • “Guidance Regarding Newly Promulgated Rule Restricting Third-Party Payments, 28 C.F.R. § 50.28,” January 13, 2021;
     
  • “Equitable Mitigation in Civil Environmental Enforcement Cases,” January 12, 2021;
     
  • “Civil Enforcement Discretion in Certain Clean Water Act Matters Involving Prior State Proceedings,” July 27, 2020;
     
  • “Supplemental Environmental Projects (“SEPs”) in Civil Settlements with Private Defendants,” March 12, 2020;
     
  • “Using Supplemental Environmental Projects (“SEPs”) in Settlements with State and Local Governments,” August 21, 2019;
     
  • “Enforcement Principles and Priorities,” March 12, 2018; and
     
  • “Settlement Payments to Third Parties in ENRD Cases,” January 9, 2018.
     

EPA Renews Emphasis On Self-Disclosed Violation Policies: On February 5, 2021, EPA posted updated frequently asked questions (FAQ) about its Audit Policy Program. According to EPA, it developed the updated FAQs as part of its renewed emphasis on its self-disclosed violations policies. EPA notes that the updated FAQs supersede the 1997 Audit Policy Interpretive Guidance, The Audit Policy: Frequently Asked Questions 2007, and the 2015 eDisclosure FAQs. EPA states that as part of its renewed emphasis on the self-disclosed violation policies, it also:

  • Made user-friendly enhancements to the eDisclosure system;
     
  • Clarified several features of its self-disclosure policies “in response to some common misconceptions in the regulated community”;
     
  • Developed a New Owner Clean Air Act Audit Program tailored to the oil and natural gas sector; and
     
  • Expanded its outreach and education efforts to the regulated community and other stakeholders concerning its New Owner Audit Policy.
     

EPA Publishes NDA Relevant To U.S. Hydrofluorocarbon Baselines And Mandatory Allocations: On February 11, 2021, EPA published a notice of data availability (NDA) to alert stakeholders of information from EPA regarding hydrofluorocarbon consumption and production in the United States for the years 2011, 2012, and 2013 and solicit stakeholder input. 86 Fed. Reg. 9059. EPA states that it is providing this information in preparation for upcoming regulatory actions under the American Innovation and Manufacturing Act of 2020, included in the Consolidated Appropriations Act, 2021. Among other provisions, the Act directs EPA to develop production and consumption baselines and to phase down hydrofluorocarbon production and consumption relative to those baselines. EPA identifies possible data gaps and requests comment on areas where additional information could improve EPA’s data on hydrofluorocarbon consumption and production in the United States for those three years. Comments are due February 25, 2021.

National Climate Task Force Holds First Meeting: On February 11, 2021, National Climate Advisor Gina McCarthy convened the first meeting of the National Climate Task Force. According to the February 11, 2021, readout of the meeting, during the meeting, representatives from more than 20 federal agencies and offices “underscored the shared commitment of every agency in collaborating and coordinating across the federal government to ensure the United States leads the world in a clean energy revolution that creates American jobs with the chance to join a union and builds back an inclusive, equitable economy.” Agency leadership and senior White House officials also discussed the National Climate Task Force Charter, early actions, near-term priorities and key milestones, and the role of the White House Office of Domestic Climate Policy. Additionally, participants were invited to highlight the ways their agencies and staff are prioritizing climate throughout all of their decision-making and how they plan to collaborate with additional agency partners.

OSHA Proposes To Update HCS To Align It With Seventh Revision Of The GHS: OSHA published a proposed rule in the Federal Register on February 16, 2021, that would update the HCS to align with the seventh revision of the GHS. 86 Fed. Reg. 9576. In its February 5, 2021, announcement, OSHA states that it “expects the HCS update will increase worker protections, and reduce the incidence of chemical-related occupational illnesses and injuries by further improving the information on the labels and Safety Data Sheets for hazardous chemicals.” Proposed modifications will also address issues since implementation of the 2012 standard, and improve alignment with other federal agencies and Canada. Comments are due April 19, 2021. OSHA will schedule an informal public hearing on the NPRM if a request is made during the comment period. If a hearing is requested, OSHA will announce the details in the Federal Register. More information is available in our February 16, 2021, memorandum.

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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