Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson and Carla N. Hutton
 
On March 28, 2022, the Biden Administration submitted to Congress President Biden’s budget for fiscal year (FY) 2023. According to the U.S. Environmental Protection Agency’s (EPA) March 28, 2022, press release, the budget makes critical investments, including:

  • Strengthening EPA’s Commitment and Ability to Implement Toxic Substances Control Act (TSCA) Successfully: The budget provides $124 million and 449 full time equivalents (FTE) for TSCA efforts “to deliver on the promises made to the American people by the bipartisan Lautenberg Act.” According to the budget, “[t]hese resources will support EPA-initiated chemical risk evaluations and protective regulations in accordance with statutory timelines.”
     
  • Tackling Per- and Polyfluoroalkyl Substances (PFAS) Pollution: PFAS are a group of man-made chemicals that threaten the health and safety of communities across the United States. As part of the President’s commitment to tackling PFAS pollution, the budget provides approximately $126 million in FY 2023 for EPA to increase its understanding of human health and ecological effects of PFAS, restrict uses to prevent PFAS from entering the air, land, and water, and remediate PFAS that have been released into the environment. EPA states that it will continue to act on its PFAS Strategic Roadmap to safeguard communities from PFAS contamination.

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Commercial Service, part of the U.S. Department of Commerce’s International Trade Administration, has begun registration for a webinar series designed to inform exporters and manufacturers about potential per- and polyfluoroalkyl substances (PFAS) risks affecting their business:
 
Part I: PFAS Basics: What you need to know
Wednesday, March 9, 2022, 1:00 p.m. (EST)
The first session will cover the PFAS basics, including where they are found, what health, environmental, and legal risks they present, how they are regulated, and how exporters and manufacturers can assess and manage their PFAS risks.
 
Part II: PFAS Technologies: Where are we & where are we going
Wednesday, April 6, 2022, 1:00 p.m. (EDT)
The second session will cover the current and future state of the many technologies needed to handle the increasing attention on PFAS.
 
Panelists will include:

  • Alfredo Fernandez, Partner, Shipman & Goodwin LLP; and
  • Brian Drollette, Managing Scientist, Exponent.

 

By Lynn L. Bergeson and Carla N. Hutton
 
On February 15, 2022, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget a final rule regarding a further compliance date extension for phenol, isopropylated phosphate (3:1) (PIP (3:1)). EPA proposed in October 2021 to extend the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles and the PIP (3:1) used to make those articles until October 31, 2024, along with the associated recordkeeping requirements for manufacturers, processors, and distributors of PIP (3:1)-containing articles. EPA noted that the articles covered by the proposed rule include a wide range of key consumer and commercial goods such as cellular telephones, laptop computers, and other electronic and electrical devices and industrial and commercial equipment used in various sectors, including transportation, construction, agriculture, forestry, mining, life sciences, and semiconductor production. The proposed rule followed a final rule that extended the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles, from March 8, 2021, to March 8, 2022, along with the associated recordkeeping requirements. More information on the proposed rule is available in our October 25, 2021, memorandum. It is not clear when OMB will complete its review or if the final rule will be published prior to the current March 8 compliance deadline.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 4, 2022, the release of a “new and improved” Framework for the Assessment of Environmental Performance Standards and Ecolabels for Federal Purchasing under its Environmentally Preferable Purchasing (EPP) program, as well as a webpage highlighting ecolabel criteria that address per- and polyfluoroalkyl substances (PFAS). EPA states that “[t]hese actions are a key step in implementing President Biden’s Executive Order on Catalyzing Clean Energy Industries and Jobs through Federal Sustainability and the accompanying Federal Sustainability Plan.
 
According to EPA, the EPP program helps federal government purchasers use private sector standards and ecolabels to identify and procure environmentally preferable products and services via the Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing. The updated Framework provides a streamlined, transparent, and consistent approach to assessing marketplace standards and ecolabels for environmental sustainability and for inclusion into the Recommendations.
 
EPA states that the updates to the Framework reflect lessons learned during the last five years of implementation and a desire to address a broader range of purchase categories with a more streamlined set of criteria. In addition, EPA updated the eligibility criteria for standards and ecolabels to support further their implementation across the federal government. EPA will use the Framework to update and expand the Recommendations to support the Biden Administration’s priorities and the Federal Sustainability Plan. The Recommendations currently include more than 40 private sector environmental performance standards and ecolabels in 25 purchase categories.
 
EPA will hold a webinar on March 2, 2022, at 2:00 p.m. (EST) to provide more information on the updated Framework and initial plans to expand the Recommendations. Stakeholders can register for the webinar and provide questions in advance.
 
EPA notes that the webpage highlighting how EPA’s Recommendations of Specifications, Standards, and Ecolabels address PFAS “is an important step toward providing federal purchasers with tools to avoid procurement of products containing PFAS.” The release of the webpage is concurrent with work to identify products and purchase categories that are known to be associated with key PFAS uses, as well as outreach to ecolabel and standard organizations regarding addressing PFAS.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) Office of Enforcement and Compliance Assurance (OECA) issued a January 2022 enforcement alert entitled “Violations May Put Ski Wax Users at Risk from Illegal Perfluoroalkyl Substances.” According to the enforcement alert, EPA has identified several high-performance ski wax consumer products that contain perfluorinated chemicals that were not reviewed by EPA for health risks under the Toxic Substances Control Act (TSCA). EPA notes that these wax products are intended for use on sports equipment to enhance the performance of the equipment’s slick surfaces that are in contact with snow. The alert states that:

  • EPA is concerned that recently identified TSCA violations may be putting skiers and wax applicators at risk for exposure to certain persistent and bioaccumulative chemicals; and
     
  • EPA advises sellers of ski wax to ensure that the products they sell do not contain certain perfluorinated chemicals that are not on the TSCA Inventory or have prohibitions on their use in sporting goods.

The enforcement alert states that EPA identified several manufacturers, importers, and sellers that produced or sold ski wax products that included certain perfluorinated chemicals in violation of TSCA, which prohibits the manufacture, processing, or importation of a chemical that is not on the TSCA Inventory or otherwise exempt. TSCA requires anyone who intends to manufacture (including import) a new chemical substance for a non-exempt commercial purpose to submit a premanufacture notice (PMN) at least 90 days prior to the manufacture, import, or processing of the chemical. According to the alert, review of the risks from per- and polyfluoroalkyl substances (PFAS) in ski waxes “is particularly important in light of the potential for ski wax technicians and recreational skiers who apply waxes to the skis to be exposed to PFAS from handling the waxes and from vapors released when the waxes are melted and applied to skis.” The alert notes that PFAS may enter the environment from the use of waxed skis and from the ski wax shavings scraped off during application.
 
The enforcement alert describes the following best practices for assessing whether a wax product contains a new chemical substance: (1) reviewing the product’s safety data sheet (SDS) and comparing the chemical substances against the TSCA Inventory; (2) contacting manufacturers and suppliers for additional chemical identity information where there is uncertainty regarding whether a chemical is on the TSCA Inventory; and (3) contacting EPA via the TSCA Hotline if it remains unclear whether a chemical substance is on the TSCA Inventory.
 
The enforcement alert provides information on EPA’s Audit Policy, under which regulated entities that voluntarily discover, promptly disclose, expeditiously correct, and take steps to prevent recurrence of potential violations may be eligible for a reduction or elimination of any civil penalties that otherwise might apply. The alert states that most violations can be disclosed and processed via EPA’s automated online “eDisclosure” system. According to the alert, many states also offer incentives for self-policing, and EPA suggests checking with the appropriate state agency for more information.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 2, 2022, that it is inviting small businesses, governments, and not-for-profit organizations to participate as Small Entity Representatives (SER) for a Small Business Advocacy Review (SBAR) Panel. The Panel will focus on EPA’s development of a rule that would require reporting and recordkeeping for per- and polyfluoroalkyl substances (PFAS) from certain persons who have manufactured (including imported) a PFAS in any year since January 1, 2011.
 
As reported in our June 11, 2021, memorandum, the fiscal year 2020 (FY2020) National Defense Authorization Act (NDAA) amended the Toxic Substances Control Act (TSCA) to add Section 8(a)(7), mandating that EPA promulgate a rule “requiring each person who has manufactured a chemical substance that is a [PFAS] in any year since January 1, 2011” to report certain information. EPA’s proposed rule would require all manufacturers (including importers) of PFAS in any year since 2011 to report information related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal. EPA states that the proposed rule will help it better understand the sources and quantities of PFAS manufactured in the United States and support its research, monitoring, and regulatory efforts under the PFAS Strategic Roadmap. Comments on the proposed rule were due September 27, 2021.
 
EPA states that in response to public comments and additional information received during the comment period, it “is interested in convening an SBAR Panel.” The Panel will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA. According to EPA, the Panel members will ask a selected group of SERs to provide advice and recommendations on behalf of their companies, communities, or organizations to inform the Panel about the potential impacts of the proposed rule on small entities.
 
EPA seeks self-nominations directly from the small entities that may be subject to the rule requirements. Other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs. Self-nominations must be received by February 16, 2022.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on January 24, 2022, the automatic addition of four per- and polyfluoroalkyl substances (PFAS) to the Toxics Release Inventory (TRI) list. The Fiscal Year 2020 National Defense Authorization Act (NDAA) provides the framework for adding additional PFAS to the TRI each year. For TRI Reporting Year 2022 (reporting forms due by July 1, 2023), reporting is required for four additional PFAS. NDAA Section 7321(c) identifies certain regulatory activities that automatically add PFAS or classes of PFAS to the TRI beginning January 1 the following year, and EPA states that its development of a final toxicity value is one of the triggering actions. In April 2021, EPA issued a final toxicity value for perfluorobutane sulfonic acid (PFBS) and potassium perfluorobutane sulfonate; therefore, these substances have been added to TRI. According to EPA, PFBS-based compounds are replacement chemicals for perfluorooctane sulfonic acid (PFOS), a chemical that was voluntarily phased out by the primary U.S. manufacturer by 2002. PFBS has been identified in the environment and consumer products, including surface water, wastewater, drinking water, dust, carpeting and carpet cleaners, and floor wax.
 
EPA notes that it previously updated the Code of Federal Regulations with PFAS that were added to the TRI on January 1, 2021, pursuant to NDAA Section 7321(c) and their being regulated by an existing significant new use rule (SNUR) under the Toxic Substances Control Act (see 40 C.F.R. § 721.10536). EPA states that it has since determined that one additional PFAS, Chemical Abstracts Service Registry Number (CAS RN) 65104-45-2, is designated as “active” on the TSCA Inventory and is covered by the SNUR. Therefore, this substance has also been added to the TRI pursuant to the NDAA.
 
Additionally, under NDAA Section 7321(e), EPA must review confidential business information (CBI) claims before adding any PFAS to the TRI list whose identity is subject to a claim of protection from disclosure under 5 U.S.C. Section 552(a). EPA previously identified one PFAS, CAS RN 203743-03-7, for addition to the TRI list based on the NDAA’s provision to include certain PFAS upon the NDAA’s enactment (Section 7321(b)(1)); due to a CBI claim related to its identity, this PFAS was not included on the TRI list until EPA completed its review of the CBI claim. EPA included this PFAS in updates to the confidential status of chemicals on the TSCA Inventory published in October 2021, and thus added it to the TRI list due to the CBI declassification.
 
EPA states that as of January 1, 2022, facilities that are subject to reporting requirements for these chemicals should start tracking their activities involving these PFAS as required by Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA). Reporting forms for these PFAS will be due to EPA by July 1, 2023, for calendar year 2022 data.


 

Bergeson & Campbell, P.C. (B&C®) is pleased to provide our Forecast 2022 to TSCAblog® readers, offering our best informed judgment as to the trends and key developments we expect to see in the new year. In 2022, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) will continue to focus on implementing the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) amendments to the Toxic Substances Control Act (TSCA), including the development of required risk evaluations and risk management actions on certain existing chemicals, review of and determinations on new chemical premanufacture notices (PMN), and issuance of a final rule requiring the reporting of hazard and exposure information on per- and polyfluoroalkyl substances (PFAS). In 2022, OPPT is also expected to initiate the prioritization for risk evaluation of certain chemicals to replace in the TSCA risk evaluation pipeline those “high-priority” chemicals for which risk evaluations may be completed in late 2022 or 2023. More details on this, and expected regulatory changes of all varieties, are available in our Forecast for U.S. Federal and International Chemical Regulatory Policy 2022.

WEBINAR
What to Expect in Chemicals in 2022
January 26, 2022, 12:00 p.m. EST
Register Now

B&C will be presenting a complimentary webinar, “What to Expect in Chemicals in 2022,” focusing on themes outlined in the forecast. Join Lynn L. Bergeson, Managing Partner; Richard E. Engler, Ph.D., Director of Chemistry; and James V. Aidala, Senior Government Affairs Consultant, for this informative and forward-looking webinar.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced the availability of its fiscal year (FY) 2022 oversight plan on December 14, 2021. According to OIG, the plan reflects the priority work that the OIG believes is necessary to keep EPA, the U.S. Chemical Safety and Hazard Investigation Board (CSB), and Congress fully informed about issues relating to the administration of EPA programs and operations. The planned oversight projects concerning Ensuring the Safe Use of Chemicals include:

  • Audit of EPA’s Management of New Chemical Risk Assessments Conducted under the Toxic Substances Control Act (TSCA): Determine the extent to which EPA is using and complying with applicable records-management and quality-assurance requirements and employee performance standards to review and approve new chemicals under TSCA to manage human health and environmental risks;
     
  • Evaluation of EPA Regions’ Oversight Responsibilities for State and Tribal Drinking Water Certification Programs: Determine whether select EPA regions are fulfilling oversight responsibilities for drinking water certification programs in states and tribal nations;
     
  • Evaluation of EPA’s Use of Pesticide Incident-Reporting Data: Determine whether EPA uses pesticide incident-reporting data to prevent unreasonable adverse effects on human health and the environment;
     
  • Evaluation of Implementation of EPA’s Federal Certification for Applicators and Dealers of Restricted-Use Pesticides within Indian Country: Determine how EPA monitors and enforces the requirements for restricted-use pesticide applicators (private and commercial) and restricted-use pesticide dealers in Indian Country;
     
  • Evaluation of EPA’s Progress toward Providing States with Clear Benchmarks to Address Per- and Polyfluoroalkyl Substances (PFAS) in Drinking Water: Determine why EPA has not established a mandatory limit for PFAS in drinking water; what challenges may prevent EPA from setting such a limit; and what EPA’s plan -- if one exists -- is for implementing such a limit; and
     
  • Evaluation of EPA’s Progress to Identify Key Regulatory Stakeholders for TSCA Existing Chemical Risk Management: Determine whether EPA identified and partnered with key regulatory stakeholders and developed a process to coordinate the regulation of occupational exposures from existing chemicals under TSCA.

Ongoing projects concerning Ensuring the Safe Use of Chemicals include:

  • Evaluation of EPA’s Cancer Assessment Review for Pesticide 1,3-Dichloropropene: Evaluate the extent to which EPA followed policies and procedures in developing the cancer assessment for the 1,3-dichloropropene pesticide registration review decision to prevent unreasonable adverse effects on human health; and
     
  • Evaluation of EPA’s Overdue Residual Risk and Technology Reviews: Evaluate whether EPA has conducted residual risk and technology reviews in a timely manner, as required for EPA to revise standards, as needed, to protect the public from air toxics emitted by stationary sources.

Planned and ongoing projects concerning Safeguarding Scientific Integrity Principles include:

  • Congressional Request: Evaluation of EPA’s Changes to Final Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Significant New Use Rule (SNUR): Determine the extent to which EPA followed applicable policies, procedures, and guidance for the changes made to the Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances SNUR between the EPA Administrator’s signing of the final SNUR on June 22, 2020, and the publication of the final SNUR in the Federal Register on July 27, 2020; and
     
  • Evaluation of EPA’s January 2021 Perfluorobutane Sulfonic Acid (PFBS) Toxicity Assessment: Determine whether EPA’s Office of Research and Development (ORD) and Office of Chemical Safety and Pollution Prevention (OCSPP) followed applicable policies and procedures in the development and publication of the January 19, 2021, PFBS toxicity assessment.

OIG states that it is important to note that its planning efforts “are not static and that the projects included herein may be modified throughout the year as challenges and risks for the EPA and the CSB evolve and emerge.”


 

By Lynn L. Bergeson and Carla N. Hutton

On December 10, 2021, the Biden Administration released its Fall 2021 Unified Agenda of Regulatory and Deregulatory Actions. According to the U.S. Environmental Protection Agency’s (EPA) rule list, the Office of Chemical Safety and Pollution Prevention (OCSPP) is working on the following rulemakings under the Toxic Substances Control Act (TSCA). Rulemakings at the proposed stage include:

  • Tiered Data Reporting to Inform Prioritization, Risk Evaluation, and Risk Management Under TSCA (2070-AK62): EPA is developing this rule to obtain information about potential hazards and exposure pathways related to certain chemicals, particularly occupational, environmental, and consumer exposure information. EPA states that this information is needed to inform prioritization, risk evaluation, and risk management of the chemical substances under TSCA Section 6. EPA intends to publish a notice of proposed rulemaking (NPRM) in July 2022 and a final rule in March 2023. More information on the rulemaking is available in our July 29, 2021, memorandum;
     
  • Revisions to the TSCA Fees Rule (2070-AK64): In January 2021, EPA proposed updates and adjustments to the 2018 TSCA Fees Rule. EPA proposed to add three new fee categories: a Bona Fide Intent to Manufacture or Import Notice, a Notice of Commencement of Manufacture or Import, and an additional fee associated with test orders. In addition, EPA proposed exemptions for entities subject to certain fee triggering activities, including: an exemption for research and development activities; an exemption for entities manufacturing less than 2,500 pounds of a chemical subject to an EPA-initiated risk evaluation fee; an exemption for manufacturers of chemical substances produced as a non-isolated intermediate; and exemptions for manufacturers of a chemical substance subject to an EPA-initiated risk evaluation if the chemical substance is imported in an article, produced as a byproduct, or produced or imported as an impurity. EPA proposed a volume-based fee allocation for EPA-initiated risk evaluation fees in any scenario where a consortium is not formed and proposed to require export-only manufacturers to pay fees for EPA-initiated risk evaluations. EPA states that in light of public comments, it has decided to issue a supplemental proposal and seek additional public comment on changes to the January 2021 proposal. EPA intends to issue a supplemental NPRM in February 2022. EPA has not determined when it will issue a final rule. More information on the proposed rule is available in our December 30, 2020, memorandum;
     
  • New Chemicals Procedural Regulations to Reflect Amendments to TSCA (2070-AK65): This rulemaking seeks to revise the new chemicals procedural regulations in 40 C.F.R. Part 720 to improve the efficiency of EPA’s review process and to align its processes and procedures with the new statutory requirements. According to EPA, this rulemaking seeks to increase the quality of information initially submitted in new chemicals notices and improve its processes “to reduce unnecessary rework in the risk assessment and, ultimately, the length of time that new chemicals are under review.” EPA intends to publish an NPRM in September 2022. EPA has not determined when it will issue a final rule;
     
  • Procedures for Submitting Information Subject to Business Confidentiality Claims Under TSCA (2070-AK68): EPA states that it is considering proposing new and amended rules concerning the assertion and maintenance of claims of business confidentiality (i.e., confidential business information (CBI)) under TSCA. The 2016 TSCA amendments included several new provisions concerning the assertion and EPA review and treatment of confidentiality claims. EPA is considering procedures for submitting and supporting such claims in TSCA submissions, including substantiation requirements, exemptions, electronic reporting enhancements, and maintenance or withdrawal of confidentiality claims. EPA is also considering whether the proposed rule should elaborate on EPA’s procedures for reviewing and communicating with TSCA submitters about confidentiality claims. According to EPA, it expects the proposed rule to include new provisions, as well as revisions to existing rules on asserting confidentiality claims to conform to the 2016 amendments. EPA intends to issue an NPRM in April 2022;
     
  • Cyclic Aliphatic Bromide Cluster (HBCD); Rulemaking Under TSCA Section 6(a) (2070-AK71): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for HBCD, EPA initiated rulemaking to address unreasonable risks of injury to health and the environment identified in the final risk evaluation. EPA intends to publish an NPRM by September 2022 and a final rule by April 2024. More information on the final risk evaluation is available in our September 28, 2020, memorandum;
     
  • 1-Bromopropane; Rulemaking Under TSCA Section 6(a) (2070-AK73): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for 1-bromopropane, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM in October 2022 and a final rule in May 2024. More information on the final risk evaluation is available in our August 11, 2020, memorandum;
     
  • Carbon Tetrachloride; Rulemaking Under TSCA Section 6(a) (2070-AK82): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for carbon tetrachloride, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM in October 2022 and a final rule in June 2024. More information on the final risk evaluation is available in our November 4, 2020, memorandum;
     
  • Trichloroethylene (TCE); Rulemaking Under TSCA Section 6(a) (2070-AK83): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for TCE carried out under the authority of TSCA Section 6, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM in October 2022 and a final rule in June 2024. More information on the final risk evaluation is available in our November 24, 2020, memorandum;
     
  • Asbestos (Part 1: Chrysotile Asbestos); Rulemaking under TSCA Section 6(a) (2070-AK86): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for chrysotile asbestos, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM by April 2022 and a final rule by November 2023. More information on the final risk evaluation is available in our January 4, 2021, memorandum;
     
  • Reconsideration of Procedures for Chemical Risk Evaluation Under the Amended TSCA (2070-AK90): EPA published a final rule on July 20, 2017, that established a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. This process incorporates the science requirements of the amended statute, including best available science and weight of the scientific evidence. The final rule established the steps of a risk evaluation process, including: scope, hazard assessment, exposure assessment, risk characterization, and risk determination. EPA states that it is now in the process of reconsidering the final rule in keeping with new executive orders (EO) concerning the advancement of racial equity and support for underserved communities through the federal government (EO 13985), the protection of public health and the environment and restoring science to tackle the climate crisis (EO 13990), tackling the climate crisis at home and abroad (EO 14008), and other Administration priorities (such as the Presidential memorandum on restoring trust in government through scientific integrity and evidence-based policymaking). If EPA determines to amend the 2017 final rule based on its reconsideration, it will solicit public comment through an NPRM. EPA intends to publish an NPRM in September 2022;
     
  • Regulation of Persistent, Bioaccumulative, and Toxic (PBT) Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate (3:1) (PIP (3:1)); Further Compliance Date Extension (2070-AK95): EPA proposed in October 2021 to amend the regulations applicable to PIP (3:1) promulgated under TSCA. Specifically, EPA proposes to extend the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles and the PIP (3:1) used to make those articles until October 31, 2024, along with the associated recordkeeping requirements for manufacturers, processors, and distributors of PIP (3:1)-containing articles. EPA notes that the articles covered by the proposed rule include a wide range of key consumer and commercial goods such as cellular telephones, laptop computers, and other electronic and electrical devices and industrial and commercial equipment used in various sectors, including transportation, construction, agriculture, forestry, mining, life sciences, and semiconductor production. The proposed rule follows a recently-issued final rule that extended the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles, from March 8, 2021, to March 8, 2022, along with the associated recordkeeping requirements. Comments on the proposed rule are due December 27, 2021. EPA intends to issue a final rule in March 2022. More information on the proposed rule is available in our October 25, 2021, memorandum; and
     
  • TSCA Section 8(a) Reporting and Recordkeeping Requirements for Asbestos (2070-AK99): This rulemaking, under the authority of TSCA Section 8(a), would require the maintenance of records and submission to EPA of reports by manufacturers, importers, and processors of asbestos and mixtures and articles containing asbestos (including as an impurity). EPA states that the information sought includes data on the quantities of asbestos used in making products, employee exposure data, and waste disposal data. Reported information would be used by EPA and other federal agencies in considering the regulation of asbestos. EPA intends to issue an NPRM in March 2022 and a final rule in November 2022.

The Unified Agenda lists the following TSCA rulemaking at the final stage:

  • Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices (PMN) (2070-AJ94): EPA proposed amending components of the Significant New Uses of Chemical Substances regulations at 40 C.F.R. Part 721, specifically the “Protection in the Workplace” (40 C.F.R. Section 721.63) and “Hazard Communication Program” (40 C.F.R. Section 721.72). 81 Fed. Reg. 49598. The proposed changes are intended to align, where possible, EPA’s regulations with the revised Occupational Safety and Health Administration (OSHA) regulations at 29 C.F.R. Section 1910.1200. OSHA issued a final rule on March 26, 2012, (77 Fed. Reg. 17573) that aligns OSHA’s Hazard Communication Standards with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). EPA states that it is reviewing the comments received and is planning to issue a final rule. EPA intends to issue a final rule in September 2022. More information on EPA’s 2016 proposed rule is available in our July 29, 2016, memorandum.

 
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