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.
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 3, 2021, the latest update to the Toxic Substances Control Act (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 significant new use rules (SNUR).


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On February 1, 2021, the U.S. District Court for the District of Montana granted the U.S. Environmental Protection Agency’s (EPA) 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.”  According to EPA, where EPA lacked the authority to promulgate the final rule, “remand without vacatur would serve no useful purpose because EPA would not be able to cure that defect on remand.”  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.”
 
Prior to EPA’s motion to vacate and remand the final rule, on January 20, 2021, President Joe Biden signed an Executive Order (EO) on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis.  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.”  The specified agency actions include EPA’s January 6, 2021, final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.”
 
As reported in our January 11, 2021, memorandum, the origin of EPA’s January 6, 2021, final rule is rooted in legislative proposals more clearly intended to challenge important regulatory requirements, particularly related to EPA’s air program.  We predicted that the final rule would likely be among the first items subject to reversal or “clarifying” guidance making it consistent with previously established science policies (see Bergeson & Campbell, P.C.’s (B&C®) Forecast 2021 memo).  With Democratic control of both houses of Congress, there might also be attempts to repeal the rule via action under the Congressional Review Act (CRA) of recently promulgated regulations.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On February 4, 2021, the ad hoc committee appointed by the National Academies of Sciences, Engineering, and Medicine (the National Academies) to consider current evidence regarding human health effects of the most widely studied per- and polyfluoroalkyl substances (PFAS) will hold its first meeting.  The National Academies will provide the Centers for Disease Control and Prevention (CDC), the Agency for Toxic Substances and Disease Registry (ATSDR), and the National Institutes of Environmental Health Sciences (NIEHS) “an objective and authoritative review of current evidence regarding human health effects of those PFAS being monitored in the CDC’s National Report on Human Exposure to Environmental Chemicals.”  The National Academies will also provide recommendations regarding potential changes to CDC and ATSDR PFAS clinical guidance, including:

  • Options and considerations to guide decision-making for PFAS testing in a patient’s blood or urine;
  • PFAS concentrations that could inform clinical care of exposed patients; and
  • Appropriate patient follow-up and care specific to PFAS-associated health endpoints for those patients known or suspected to be exposed to PFAS.

The committee will host multiple town hall events in the spring and summer 2021 to hear from PFAS-impacted communities.  The National Academies intends to release the final report in 2022.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On January 22, 2021, the U.S. Environmental Protection Agency (EPA) published the reasons for its denial of a petition requesting it to require health and environmental effects testing on 54 per- and polyfluoroalkyl substances (PFAS).  86 Fed. Reg. 6602.  The petition sought issuance of a rule or order under TSCA Section 4 compelling The Chemours Company (Chemours) 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:  According to EPA, the petition does not set forth the facts necessary to demonstrate that there is “insufficient information and experience” for each of the 54 PFAS.  The petitioners state, in part, “[f]or the 54 PFAS, the sufficiency of available information should be determined by comparing available data with the known adverse effects of other PFAS.  The goal should be to conduct a scientifically sound assessment of each of the 54 chemicals for the critical toxic endpoints that have been identified in studies on [perfluorooctane sulfonate (PFOS)], [perfluorooctanoic acid (PFOA)] and other well-characterized studies.”  EPA states that the petitioners do not provide evidence that they conducted an assessment to support a finding of insufficient information and experience, however;
     
  • Testing of Such Substance or Mixture with Respect to Such Effects Is Necessary to Develop Such Information:  According to EPA, the petitioners do not demonstrate “testing of such substance or mixture with respect to such effects is necessary to develop such information.”  EPA finds that the petitioners failed to address ongoing testing and data collections for some of the 54 PFAS, thereby failing to set forth facts that are necessary to establish there is a need for the testing sought in the petition.  According to EPA, this research may provide information that overlaps with testing the petitioners requested, which would render the information unnecessary under TSCA Section 4(a)(1)(A)(i)(III);
     
  • Class-Based Approach to Testing:  TSCA Section 4(h)(1)(B)(ii) “encourage[s]” EPA to consider “the grouping of 2 or more chemical substances into scientifically appropriate categories in cases in which testing of a chemical substance would provide scientifically valid and useful information on other chemical substances in the category.”  EPA states that it “is currently investigating ways to group similar PFAS by likeness into subcategories for purposes of research, data collection, hazard determinations, and other activities.”  EPA notes that it collaborated with the National Toxicology Program (NTP) “to construct a PFAS screening library subset composed of 75 PFAS on a structural category basis and considerations such as structural diversity within a category, data availability, and read-across category-level weight (e.g., value of substance for anchoring read-across trends within a category, serving as an analog); four of the 54 PFAS the petitioners identify are included in this subset.”  While the petitioners mention this effort, they “incorrectly state that just two of the 54 PFAS the petitioners cover are included in the EPA testing.”
     
  • Practicability of National Academy of Sciences Oversight:  The petitioners also request that the National Academy of Sciences (NAS) oversee all aspects of the proposed testing program.  EPA states that it “finds such an oversight arrangement is not within the scope of what a TSCA section 21 petitioner can request when seeking the initiation of a rule or the issuance of an order under TSCA section 4.”  Furthermore, according to EPA, projects and studies must meet certain conditions for the NAS to accept private funding.  EPA concludes that it is not in a position to require NAS to oversee the testing requested by the petitioners, and the petitioners provide no administrative or organizational procedures for implementation.
     
  • Selection of PFAS for Health and Environmental Effects Testing:  The petitioners divide the 54 PFAS at issue into Tier 1 substances “for which there is known human exposure based on detection in blood, food or drinking water,” and Tier 2 substances “for which human exposure is probable based on detection in environmental media.”  According to EPA, the petitioners do not set forth facts showing that for all 40 PFAS it ranks as Tier 2 substances “human exposure is probable based on detection in environmental media” or that “a strong inference of exposure can be drawn from their presence in surface water, stormwater, wastewater, sediment, groundwater, soil, private wells, and/or air emissions,” however.
     
  • Scientific Standards:  EPA states that it “finds the petitioners have not evaluated the quality of the data they have provided or indicated how they conducted their searches, evaluated the quality of the sources, or indicated what gaps were located and then explained why the specific tests requested, as compared to others, would provide the data being sought.”  According to EPA, such an evaluation is necessary for EPA to conduct the considerations under TSCA Section 26(h).
     
  • Vertebrate Testing:  TSCA Section 4(h) requires that EPA reduce and replace the use of vertebrate animals in the testing of chemical substances under TSCA Section 4.  EPA states that it must consider “as appropriate and to the extent practicable and scientifically justified, reasonably available existing information, including (i) Toxicity information; (ii) Computational toxicology and bioinformatics; and (iii) High-throughput screening methods and the prediction models of those methods.”

More information on the TSCA Section 21 petition is available in our October 29, 2020, memorandum, “TSCA Section 21 Petition Seeks Section 4 Test Rule for 54 PFAS.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a webinar on February 3, 2021, “to educate stakeholders on the risk management process under the Toxic Substances Control Act (TSCA) and the findings in the final risk evaluation for Asbestos Part 1:  Chrysotile Asbestos.”  EPA states that the webinar will also give the public an opportunity to provide input on considerations the agency should take into account for managing these unreasonable risks.  Stakeholders who wish to provide oral comments must register by 5:00 p.m. (EST) on January 29, 2021, and those who will only listen may register up to the end of the meeting.  EPA will provide a transcript and recording on EPA’s Asbestos Part 1:  Chrysotile Asbestos web page following the webinar.  According to EPA’s January 19, 2021, announcement, EPA will begin formal consultations with state and local governments, tribes, environmental justice communities, and small businesses.  There will also be an open public comment period on any draft risk management regulation.  More information on EPA’s final risk evaluation is available in our January 4, 2021, memorandum, “EPA Publishes Final Risk Evaluation for Asbestos, Part 1:  Chrysotile Asbestos.”


 
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By Lynn L. Bergeson and Carla N. Hutton

Dan Utech, Incoming Chief of Staff for the U.S. Environmental Protection Agency (EPA), announced to EPA on January 21, 2021, 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 Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis, which states that 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.”  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 Executive Order on Advancing Racial Equity and Support for Underserved Communities through the Federal Government.  In addition to providing a framework for advancing equity, it revokes Executive Order 13950, “Combating Race and Sex Stereotyping.”

Utech’s announcement includes the following updated list of current and acting leaders, as well as a list of the incoming appointees who onboarded this week.

Current and Acting Leadership

  • Acting Administrator:  Jane Nishida
  • Office of the Chief Financial Officer (OCFO):  David Bloom
  • Office of Air and Radiation (OAR):  Joseph Goffman
  • Office of Water (OW):  Radhika Fox
  • Office of Land and Emergency Management (OLEM):  Barry Breen
  • Office of Chemical Safety and Pollution Prevention (OCSPP):  Michal Ilana Freedhoff  (as of January 25, 2021)
  • Office of Research and Development (ORD):  Jennifer Orme-Zavaleta
  • Office of General Counsel (OGC):  Melissa Hoffer
  • Office of Enforcement and Compliance Assurance (OECA):  Larry Starfield
  • Office of International and Tribal Affairs (OITA):  Mark Kasman
  • Office of Mission Support (OMS):  Donna Vizian
  • Office of Policy (OP):  Victoria Arroyo
  • Office of Congressional and Intergovernmental Relations (OCIR):  Robin Richardson
  • Office of Public Engagement and Environmental Education (OPEEE):  Rosemary Enobakhare
  • Office of Public Affairs (OPA):  Lindsay Hamilton
  • Region 1:  Deb Szaro
  • Region 2:  Walter Mugdan
  • Region 3:  Diana Esher
  • Region 4:  John Blevins
  • Region 5:  Cheryl Newton
  • Region 6:  David Gray
  • Region 7:  Ed Chu
  • Region 8:  Deb Thomas
  • Region 9:  Deb Jordan
  • Region 10:  Michelle Pirzadeh

Members of the incoming EPA leadership team who onboarded this week:

  • Radha Adhar, Deputy Associate Administrator for Congressional Affairs;
  • Victoria Arroyo, Associate Administrator for Policy;
  • Tomás Elias Carbonell, Deputy Assistant Administrator for Stationary Sources, OAR;
  • Alison Cassady, Deputy Chief of Staff for Policy;
  • Dimple Chaudhary, Deputy General Counsel for Nationwide Resource Protection Programs;
  • Rosemary Enobakhare, Associate Administrator for Public Engagement and Environmental Education;
  • Philip Fine, Principal Deputy Associate Administrator for Policy;
  • Radhika Fox, Principal Deputy Assistant Administrator, OW;
  • Michal Ilana Freedhoff, Principal Deputy Assistant Administrator for Chemical Safety and Pollution Prevention;
  • Joseph Goffman, Principal Deputy Assistant Administrator, OAR;
  • Lindsay Hamilton, Associate Administrator for Public Affairs;
  • Sinceré Harris, White House Liaison;
  • Melissa Hoffer, Principal Deputy General Counsel;
  • Casey Katims, Deputy Associate Administrator for Intergovernmental Affairs; and
  • John Lucey, Special Assistant to the Administrator.

 
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This week's All Things Chemical™ Podcast will be of interest to readers of the TSCAblog™. A brief description of the episode written by Lynn L. Bergeson is below.

This week I had my final visit with the U.S. Environmental Protection Agency’s (EPA) Assistant Administrator Alexandra Dunn.  As many of our listeners know, Alex Dunn lead the Office of Chemical Safety and Pollution Prevention and was responsible for implementing the nation’s industrial and agricultural chemical laws, the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), respectively.  Alex has done a superb job since taking office in early 2019, and her steady hand in managing TSCA implementation and a wide range of hot button pesticide issues has been effective and comforting.

Prior to Alex’s current role, she served as the Regional Administrator for EPA Region 1, and before Region 1, Alex served as the executive director and general counsel for the Environmental Council of the States.

We focused our discussion on a look back at Alex’s many achievements since taking office, including implementation of the amendments to TSCA, which Congress enacted in 2016.  Alex also addressed some of the most controversial pesticides -- glyphosate, dicamba, and chlorpyrifos, among others -- all the while implementing one of the most consequential pieces of environmental legislation ever passed by Congress.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2021 Bergeson & Campbell, P.C.  All Rights Reserved


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On January 19, 2021, the U.S. Environmental Protection Agency (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.


 
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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on January 15, 2021, that it has issued test orders under Section 4 of the Toxic Substances Control Act (TSCA) to obtain additional data on nine of the next 20 chemicals undergoing risk evaluation.  EPA states that after reviewing the available data on these chemicals, it determined additional data are needed and is using its TSCA test order authority to require companies to develop and submit information on environmental hazard and inhalation and dermal exposures for workers.  According to EPA, companies subject to the test orders may provide EPA with existing data or conduct new tests.  Companies may also form consortia to consolidate costs and burden and to avoid unnecessary duplication of testing.  The nine chemicals subject to the Section 4 test orders are:

  • Chlorinated Solvents:
    • 1,1,2-Trichloroethane;
    • 1,1-Dichloroethane;
    • 1,2-Dichloroethane;
    • 1,2-Dichloropropane;
    • Trans-1,2-Dichloroethylene;
    • o-Dichlorobenzene; and
    • p-Dichlorobenzene;
  • Flame Retardants:
    • 4,4ʹ-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA); and
    • Phosphoric acid, triphenyl ester (TPP).

EPA states that the orders and any data submitted in response to the orders will be made publicly available on EPA’s website and in applicable dockets on www.regulations.gov.  More information will be available in a forthcoming memorandum that will be posted on our website.


 
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By Lynn L. Bergeson and Carla N. Hutton

On January 12, 2021, the U.S. Environmental Protection Agency (EPA) and the Occupational Safety and Health Administration (OSHA) announced a memorandum of understanding (MOU) that advances collaboration and communication on EPA’s review of new chemicals under the Toxic Substances Control Act (TSCA).  EPA states that the MOU provides a framework for coordination and communication between the two agencies on exposure to new chemicals in the workplace and will help achieve the agencies’ shared goal of ensuring workers are protected from potential health and environmental risks.  As required by TSCA, EPA and OSHA are collaborating on workplace exposures as part of EPA’s review of new chemicals.  The MOU formalizes coordination efforts that EPA and OSHA have already implemented and provides a framework for additional opportunities for collaboration.  Highlights of the MOU include:

  • Establishing designated staff and management points of contact from each agency to discuss and resolve workplace exposure issues related to EPA’s review of new chemicals;
  • Providing OSHA with regular updates on EPA’s new chemical determinations, including any necessary worker protection identified during EPA’s review; and
  • Documenting EPA’s role in identifying and notifying OSHA of the need for formal consultation on EPA’s review of new chemicals.

More information will be available in a forthcoming memorandum that will be posted on our website.


 
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By Lynn L. Bergeson and Carla N. Hutton

On January 11, 2021, the U.S. Environmental Protection Agency (EPA) published a proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule.  86 Fed. Reg. 1890.  Under TSCA, EPA collects fees from chemical manufacturers and processors to help fund implementation and to ensure that public health and the environment continue to be protected.  TSCA requires EPA to review its fees every three years and, after consulting with parties potentially subject to the fees, to adjust the fees if necessary.  The proposed rule describes the proposed modifications to the TSCA fees and fee categories for fiscal years 2022, 2023, and 2024 and explains the methodology by which these TSCA fees were determined.  The proposed updates include:

  • Regarding EPA-initiated risk evaluations, narrowing the scope of the TSCA fees rule by exempting from the requirement to pay fees importers of articles containing a chemical substance, companies that produce a chemical as a byproduct or manufacture or import as an impurity, companies that manufacture or import a chemical in de minimis amounts, companies that manufacture or import chemicals solely for research and development (R&D) purposes, and companies that produce a chemical as a non-isolated intermediate;
  • Using cost data gathered over the past two years, instead of estimates, to update the fee calculations;
  • Ensuring fees are fairly and appropriately shared across companies by proposing a production-volume based fee allocation and including export-only manufacturers for EPA-initiated risk evaluations;
  • Allowing for corrections to be made to the list of manufacturers subject to fees for EPA-initiated risk evaluations after the final list is published, ensuring the accuracy of the list;
  • Increasing flexibility for companies by extending the amount of time to form consortia to share in fee payments;
  • Ensuring that EPA can fully collect fees and enabling companies to prepare better for paying fees by allowing payments in installments for EPA-initiated and manufacturer-requested risk evaluations (MRRE); and
  • Adding three new fee categories, two associated with new chemicals activities and one with test orders.

Comments are due February 25, 2021.  More information is available in our December 30, 2020, memorandum, “EPA Intends Proposed Rule to Increase Flexibility and Reduce Burdens under TSCA Fees Program.”


 
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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on January 8, 2021, that it released an updated and improved version of OncoLogic™, a system used to evaluate a chemical’s potential to cause cancer.  EPA states that, in partnership with the Organization for Economic Cooperation and Development (OECD), it developed “a more user-friendly version of the most widely used piece of this system, greatly expanding its usability across the agency and the scientific community.”  According to EPA, the updated module (version 9) is used to analyze organic chemicals, the largest group of chemicals contained in this tool.  It features:

  • A streamlined interface that does not require expert knowledge to navigate;
  • A standardized reporting format that allows users to view and export results quickly; and
  • Increased transparency in the science behind the predictions provided by the model.

EPA notes that OncoLogic™ is one of many publicly available assessment methods, databases, and predictive tools it developed to estimate hazard to humans and the environment, particularly in the absence of test data.  According to EPA, these tools and models support it in implementing programs and regulations, such as the Toxic Substances Control Act (TSCA), and help external users assess and manage chemical risks.  EPA states that version 8.0, which continues to include modules for fibers, metals, and polymers, will remain available to the public.


 
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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on January 5, 2021, that it is inviting small businesses, governments, and not-for-profit organizations to participate as Small Entity Representatives (SER) to provide advice and recommendations to two Small Business Advocacy Review (SBAR) Panels.

One 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 perchloroethylene.  As reported in our December 17, 2020, memorandum, of the 61 conditions of use that EPA reviewed for perchloroethylene, EPA found that 59 present unreasonable risks to workers, occupational non-users (ONU), consumers, and bystanders.  The conditions of use that EPA determined do not present an unreasonable risk are distribution in commerce and industrial and commercial use in lubricants and greases for penetrating lubricants and cutting tool coolants.  EPA found no unreasonable risks to the environment.

The second Panel will focus on a risk management rulemaking for n-methylpyrrolidone (NMP).  As reported in our December 29, 2020, memorandum, of the 37 conditions of use that EPA reviewed for NMP, EPA found that 26 present unreasonable risks to workers and consumers.  These uses include an unreasonable risk to workers when domestically manufacturing or importing NMP, processing NMP for a variety of uses, and when used in a variety of industrial and commercial conditions of use.  These uses also include an unreasonable risk to consumers from one consumer use.  EPA found that NMP does not pose an unreasonable risk when distributed in commerce or in a variety of industrial and commercial and consumer applications.  EPA also determined that NMP does not present an unreasonable risk to the environment and the general population.

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 evaluations.  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 Panels will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA.  The SBAR Panels will select SERs to provide comments on behalf of their companies, communities, or organizations and advise the Panels 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 rules’ 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 January 19, 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 regulations.


 
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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) will hold webinars on February 2, 2021, and February 18, 2021, to consult with environmental justice communities on risk management for the cyclic aliphatic bromide cluster (HBCD) and carbon tetrachloride.  The webinars will focus on the environmental justice impacts of EPA’s development of proposed rules to address the unreasonable risks identified in the final TSCA risk evaluations for these chemicals.  EPA states that both sessions will address HBCD and carbon tetrachloride.  EPA is offering repeated sessions to increase opportunities for participation.  According to EPA, 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 HBCD and carbon tetrachloride, and discussion of environmental justice concerns.  EPA notes that in addition to being open to the public, it is inviting national, local, and non-governmental organizations, communities, and other interested stakeholders to participate.
 
EPA states that in addition to environmental justice consultations, it is executing a “robust outreach effort” on risk management that includes formal consultations with small businesses, state and local governments, and tribes.  There will also be an open public comment period on the proposed risk management regulations.  More information on EPA’s final risk evaluations is available in our September 28, 2020, memorandum, “EPA Publishes Final Risk Evaluation for HBCD,” and in our November 4, 2020, memorandum, “Final Risk Evaluation for Carbon Tetrachloride Finds Unreasonable Risks to Workers and Occupational Non-Users.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On January 6, 2021, the U.S. Environmental Protection Agency (EPA) issued final rules under Section 6(h) of the Toxic Substances Control Act (TSCA) 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).  TSCA required EPA to take expedited action on specific PBT chemicals to address risk and reduce exposures to the extent practicable.  EPA identified these five PBT chemicals for expedited action, following criteria outlined in TSCA.  The final rules limit or prohibit the manufacture (including import), processing, and/or distribution in commerce for the following:

  • DecaBDEA flame retardant in plastic enclosures for televisions, computers, audio and video equipment, textiles and upholstered articles, wire and cables for communication and electronic equipment, and other applications;
     
  • PIP (3:1)A plasticizer, a flame retardant, an anti-wear additive, or an anti-compressibility additive in hydraulic fluid, lubricating oils, lubricants and greases, various industrial coatings, adhesives, sealants, and plastic articles;
     
  • 2,4,6-TTBPAn intermediate/reactant in processing, and it is incorporated into formulations destined for fuel and fuel-related additives;
     
  • HCBDA chemical used as a halogenated aliphatic hydrocarbon that is produced as a byproduct during the manufacture of chlorinated hydrocarbons; and
     
  • PCTP:  A chemical used to make rubber more pliable in industrial uses.

The final rules will be effective February 5, 2021.  More information on the final rules is available in our December 23, 2020, memorandum, “EPA Releases Final TSCA Section 6(h) Rules for Five PBT Chemicals.”


 
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