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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.

 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on August 6, 2021, that it will provide $9,272,545 in funding to seven institutions for research to estimate better children’s chemical exposures from soil and dust ingestion. According to EPA, the research will focus on improving estimates of children’s ingestion rates of chemicals such as lead, mercury, polychlorinated biphenyls (PCBs), and asbestos. EPA states that “[a]ccurate, comprehensive measurements of soil and dust ingestion rates are critical for effective risk assessment, reduction, mitigation, and prevention measures.” The following researchers are receiving funding through EPA’s Science to Achieve Results (STAR) program to help improve children’s health:

  • Emory University, Atlanta, Georgia, will conduct a community-based research study to understand and mitigate chemical contaminant exposure among children in neighborhoods with high lead and heavy metal contamination in soils around West Atlanta;
  • Florida International University, Miami, Florida, will estimate soil and dust ingestion rates in children by identifying specific tracers of dust and soil exposure combined with relevant environmental information;
  • Johns Hopkins University, Baltimore, Maryland, will create an integrated and innovative portfolio of tools and approaches to assess dust and soil exposures for children ages six months to six years via activity pattern and tracer studies;
  • New York University, New York, New York, will evaluate specific home environment factors and practices that lead to elevated levels of individual toxic substances ingestible by infants. According to EPA, the researchers hope to evaluate mitigation strategies to reduce infants’ exposure to harmful chemicals in household dust;
  • North Carolina Agricultural and Technical State University, Greensboro, North Carolina, will obtain data on dust loading on various objects and surfaces in children’s homes, foods, and children’s hands. The researchers will also conduct computer-aided investigations about children’s hand contacts and mouthing patterns;
  • University of California Davis, Davis, California, will develop an innovative method for determining children’s dust ingestion rates using unique tracer compounds identified in household dusts; and
  • University of Nevada-Reno, Reno, Nevada, will develop a behavior-driven dust and soil ingestion model to predict the dust and soil ingestion rate from children’s microenvironmental features and behavioral factors.

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on July 27, 2021, that it will provide $3.8 million in funding to create two EPA Science to Achieve Results (STAR) Centers for Early Lifestage Vulnerabilities to Environmental Stressors. The centers will focus on early lifestage exposures to chemicals and non-chemical environmental stressors and how these exposures may impact early childhood developmental health. EPA states that scientific research suggests that exposures to pollutants and non-chemical stressors during early lifestages may be crucial determinants of lifetime health. Exposures to cumulative mixtures of chemicals, along with other stressors, such as poverty, limited access to services, and changing environmental conditions, may pose developmental and lifelong health risks. According to EPA, accurate and comprehensive assessments of cumulative impacts are needed to make sound decisions regarding risk reduction, mitigation, and prevention measures. Each center will focus on two individual research projects:

  • Research Triangle Institute (RTI) International, Research Triangle Park, North Carolina:
    • Evaluating the Causal Impacts of Early Life Chemical Exposures on Neurodevelopmental Functioning in Early Childhood -- Researchers will identify the occurrences and types of chemicals found in toddlers’ caregiving environments and evaluate how these cumulative chemical exposures are associated with neurodevelopmental functioning in early childhood; and
    • Investigating Whether the Caregiving Environment Moderates the Impact of Early Life Chemical Exposures on Neurodevelopmental Functioning in Early Childhood -- Researchers will investigate whether home caregiving environments alter the impacts of early life chemical exposures on neurodevelopmental outcomes in early childhood.
  • University of North Carolina (UNC) at Chapel Hill, Chapel Hill, North Carolina:
    • Early Life Exposure and Neurobehavioral Development -- Researchers will leverage an ongoing, longitudinal study of normative brain development, the UNC Baby Connectome Study, to examine the role that early life exposure to phthalates and other chemicals plays in early childhood behavior, memory, language and motor development, and social cognition; and
    • Neural Substrates of Prenatal and Early Life Neurotoxicity Using Non-Invasive Imaging Methods -- Researchers will work to improve the understanding of the relationships between prenatal and early life exposures and structural and functional brain development, particularly in the third trimester of pregnancy, an important time for brain development.

 

By Lynn L. Bergeson and Carla N. Hutton
 
According to a memorandum posted in Docket ID EPA-HQ-OPPT-2021-0436, the U.S. Environmental Protection Agency (EPA) will not extend the comment period stemming from the July 27, 2021, public webinar on the development of a proposed rule under the Toxic Substances Control Act (TSCA) to implement a tiered data collection strategy intended to inform EPA’s prioritization, risk evaluation, and risk management activities for chemical substances or mixtures. As reported in our July 29, 2021, memorandum, EPA is exploring a data reporting rule that is tiered to specific stages of the TSCA existing chemicals program: identifying a pool of substances as potential candidates for prioritization; selecting candidate chemicals for and completing the prioritization process; and assessing high-priority substances through a robust risk evaluation that may be followed by risk management actions (depending on the outcome of the risk evaluation). According to the memorandum posted in the docket, the August 16, 2021, deadline is for EPA’s use in the current stage of its rulemaking development. While EPA will consider later comments as it continues to develop the proposed rule, EPA states that “comments submitted at this point will be especially useful to EPA and stand a greater chance of influencing the rulemaking.” Because there will be other opportunities to comment on the tiered data reporting rule, including during the public comment period following publication of the proposed rule, EPA “do[es] not believe that an extension of the comment period is necessary.”


 

By Lynn L. Bergeson and Carla N. Hutton
 

On July 27, 2021, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) will hold a public meeting to engage with interested stakeholders on the development of a proposed rule for implementing a tiered data collection strategy to help inform EPA’s prioritization, risk evaluation, and risk management activities for chemical substances or mixtures under the Toxic Substances Control Act (TSCA). According to EPA, it currently primarily collects exposure-related data through the TSCA Chemical Data Reporting (CDR) process. EPA is interested in ensuring that data collection strategies provide information to meet better its basic chemical data needs, such as information related to exposure, health, and ecotoxicity. To this end, EPA states that it is exploring a data reporting rule that is tiered to specific stages of the TSCA existing chemicals program: identifying a pool of substances as potential candidates for prioritization; selecting candidate chemicals for and completing the prioritization process; and assessing high-priority substances through a robust risk evaluation, which may be followed by risk management actions (depending on the outcome of the risk evaluation). According to EPA, feedback from the public meeting and comments received will help inform its development of a proposed rule. The meeting will be held virtually via WebEx on July 27, 2021, from 1:00 to 3:00 p.m. (EDT). Those who would like to make a comment during the meeting must register by 6:00 p.m. EDT on July 22, 2021. Those who would like to participate in listen-only mode must register by 6:00 p.m. EDT on July 26, 2021. Written comments are due August 15, 2021.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On May 18, 2021, the U.S. Environmental Protection Agency (EPA) invited environmental justice communities and stakeholders to participate in environmental justice consultations regarding the development of proposed risk management actions under Section 6(a) of the Toxic Substances Control Act (TSCA) to address unreasonable risks presented by trichloroethylene (TCE) and perchloroethylene (PCE). EPA will hold two identical consultation webinars, one on June 16, 2021, and the other on July 6, 2021. EPA states that both sessions will provide an overview of the TSCA risk management requirements, the findings from the final risk evaluations, the tools available to manage the unreasonable risks from TCE and PCE, and an opportunity for EPA to obtain input on environmental justice concerns. The consultations are open to the public, and EPA invites national, local, and non-governmental organizations, communities, and other interested stakeholders to participate. Comments are due August 20, 2021.
 
In addition to these environmental justice consultations, EPA states that it is executing a “robust outreach effort” that includes consultations with small businesses, state and local governments, and tribes. There will also be an open public comment period on proposed risk management regulations.
 
While outreach and stakeholder engagement on risk management activities for TCE and PCE will continue to move forward, EPA is actively reviewing final risk evaluations to ensure they use the best available science and protect human health and the environment, in accordance with Executive Orders and other direction provided by the Biden-Harris Administration. EPA states that it will keep stakeholders updated as it makes decisions and determines next steps. More information on EPA’s final risk evaluations for TCE is available in our November 24, 2020, memorandum and on EPA’s final risk evaluation for PCE in our December 17, 2020, memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton

On May 12, 2021, the U.S. Environmental Protection Agency (EPA) began environmental justice consultations regarding the development of risk management actions under Section 6(a) of the Toxic Substances Control Act (TSCA) for Asbestos, Part 1: Chrysotile Asbestos and Pigment Violet 29 (PV29). EPA will hold two identical consultation webinars, on June 1, 2021, and June 9, 2021. EPA states that it is offering these repeated sessions to increase opportunities for participation. Both sessions will provide an overview of the TSCA risk management requirements, the findings from the final risk evaluations, the tools available to manage the unreasonable risks from Asbestos, Part 1: Chrysotile Asbestos and PV29, and an opportunity for input on environmental justice concerns. The consultations are open to the public, and EPA is inviting national, local, and non-governmental organizations, communities, and other interested stakeholders to participate. The environmental justice consultation period end August 13, 2021.

EPA states that in addition to these environmental justice consultations, it is implementing a “robust outreach effort” on risk management that includes consultations with small businesses, state and local governments, and tribes. There will also be an open public comment period on proposed risk management actions. More information on EPA’s final risk evaluation for Asbestos, Part 1: Chrysotile Asbestos is available in our January 4, 2021, memorandum and on EPA’s final risk evaluation for PV29 in our January 25, 2021, memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (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 recently completed Toxic Substances Control Act (TSCA) risk evaluation for asbestos, part 1:  chrysotile asbestos.  As reported in our January 4, 2021, memorandum, of the six use categories evaluated (chlor-alkali diaphragms, sheet gaskets, other gaskets, oilfield brake blocks, aftermarket automotive brakes/linings, and other vehicle friction products), EPA states that it found that there is unreasonable risk to workers, occupational non-users (ONU), consumers, and/or bystanders within each of the six chrysotile asbestos use categories.  EPA found no unreasonable risk to the environment.  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.
 
According to EPA, the Regulatory Flexibility Act requires agencies to establish an SBAR Panel for rules that may have a significant economic impact on a substantial number of small entities.  The SBAR Panel will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA.  The SBAR Panel will select SERs to provide comments on behalf of their company, community, or organization and advise the Panel on the potential impacts of the proposed rule on small entities.  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.
 
EPA states that in addition to engaging with small businesses, it “is executing a robust outreach effort on risk management that includes formal consultations with state and local governments, tribes, and environmental justice communities.”  EPA notes that there will also be an open public comment period on any draft risk management regulation.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 9, 2021, that it will host two webinars intended to educate stakeholders on the risk management process under the Toxic Substances Control Act (TSCA) and the findings in the final risk evaluations for pigment violet 29 (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.
 
EPA states that it will also hold formal consultations with state and local governments, tribes, environmental justice communities, and small businesses.  EPA notes that there will also be an open public comment period on any draft risk management regulation.  According to EPA, while outreach and stakeholder engagement on risk management activities for these chemicals will continue to move forward, EPA “is actively reviewing the final risk evaluations to ensure that they use the best available science and protect of human health and the environment, in accordance with the Executive Orders and other direction provided by the Biden-Harris Administration.”  EPA “will keep stakeholders updated as decisions are made, and next steps are determined.”


 
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