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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 15, 2021, a settlement requiring Western Reserve Chemical Corp. (WRCC) in Stow, Ohio, to pay a $357,000 civil penalty for violations of chemical data reporting regulations under the Toxic Substances Control Act (TSCA).  EPA claims that from 2012 to 2015, WRCC failed to submit data reports for 18 chemical substances as required by TSCA.  According to EPA, WRCC imports various chemicals for businesses that formulate rubber, plastics, adhesives, sealants, and coatings.  EPA states that the alleged violations “presented a potential harm to the Agency’s ability to maintain accurate and updated information regarding commercially-produced chemicals.”  EPA’s consent agreement and final order with WRCC resolves the alleged violations and requires the payment of a $357,000 civil penalty in installments within 18 months.
 
Information about chemical reporting is available on the TSCA Chemical Data Reporting web page.  EPA notes that the chemical data reports for 2016 to 2019 were due from industry manufacturers by January 29, 2021.  The Substance Registry Services web page offers a search function to find out if a specific chemical is on the TSCA Inventory.


 

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our March 9, 2021, blog item, the U.S. Environmental Protection Agency (EPA) announced on March 8, 2021, that “in accordance with Biden-Harris Administration executive orders and directives,” it is asking for additional public input on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, under the Toxic Substances Control Act (TSCA).  On March 16, 2021, EPA announced that comments on the final rules are due May 17, 202186 Fed. Reg. 14398.  EPA seeks comment on:

  • Whether the rules sufficiently reduce exposure to these chemicals, including exposures to potentially exposed or susceptible subpopulations and the environment;
  • Newly raised compliance issues associated with the final rule on phenol, isopropylated phosphate (3:1) (PIP (3:1)), including the compliance dates for certain regulated articles; and
  • Whether to consider additional or alternative measures or approaches.

EPA will use the feedback received during the comment period to determine the best path forward, which could include amending the final rules to include additional or alternative exposure reduction measures or extending compliance dates for certain regulated products and articles.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 8, 2021, that “in accordance with Biden-Harris Administration executive orders and directives,” it is asking for additional public input on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, under the Toxic Substances Control Act (TSCA).  EPA states that as a first step in its efforts to review these rules immediately, EPA is opening a 60-day comment period for the public to provide new input on:

  • Whether the rules sufficiently reduce exposure to these chemicals, including exposures to potentially exposed or susceptible subpopulations and the environment;
  • Newly raised compliance issues associated with the final rule on phenol, isopropylated phosphate (3:1) (PIP (3:1)), including the compliance dates for certain regulated articles; and
  • Whether to consider additional or alternative measures or approaches.

EPA states that it will use the feedback received during the comment period to determine the best path forward, which could include amending the final rules to include additional or alternative exposure reduction measures or extending compliance dates for certain regulated products and articles.  Upon publication of the Federal Register notice, EPA will accept public comments for 60 days.
 
Stakeholders recently informed EPA that the prohibition on processing and distribution of PIP (3:1) could impact articles used in a wide variety of electronics, from cell phones, to robotics used to manufacture semiconductors, to equipment used to move COVID-19 vaccines and keep them at the appropriate temperature.  EPA states that stakeholders “note that the complexity of international supply chains makes locating the presence of, and finding alternatives to, PIP (3:1) in components challenging.”  According to EPA, stakeholders assert that an extension to the compliance deadline is necessary to avoid significant disruption to the supply chain for a wide variety of articles.  EPA states that it was not its intent during the development of the final rule to have such a broad disruptive impact.  Thus, EPA “is also announcing its expectation that this specific issue will be addressed as part of the broader re-examination of these rules.”  EPA “intends to extend compliance dates as necessary for the prohibitions on processing and distribution of PIP (3:1) for use in some articles, and some of the articles to which PIP (3:1) has been added.”
 
EPA states that for these same reasons, it is issuing a temporary 180-day “No Action Assurance” indicating that the agency will exercise its enforcement discretion regarding the prohibitions on processing and distribution of PIP (3:1) for use in articles, and the articles to which PIP (3:1) has been added.  EPA “is taking this action to ensure that the supply chain of these important articles is not interrupted while EPA continues to collect the information needed to best inform subsequent regulatory efforts and allow for the issuance of a final agency action to extend the March 8, 2021, compliance date as necessary.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 19, 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 C.I. Pigment Violet 29 (PV29).  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 PV29.  As reported in our January 25, 2021, memorandum, EPA reviewed 14 conditions of use for PV29, including as an intermediate for other perylene pigments, as well as a component of paints, coatings, industrial carpeting, and plastic and rubber products used primarily in the automobile industry, in ink used for commercial printing, and in consumer watercolors and artistic paints.  EPA determined that there are unreasonable risks to workers and occupational non-users (ONU) from ten out of 14 conditions of use.  EPA found no unreasonable risks to the environment, consumers, or the general public.  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 March 5, 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 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.”


 

By Lynn L. Bergeson and Carla N. Hutton

On February 5, 2021, the U.S. Environmental Protection Agency (EPA) announced that it is reviewing actions issued under the previous Administration and will take any needed steps to ensure that they protect human health and the environment.  The announcement included an update on the following chemical safety actions that have immediate or near-term effective dates or other steps associated with them.  According to the announcement, these actions, along with other chemical safety actions identified by the Biden-Harris Administration, “will undergo review (and, as necessary, revisions) to ensure they are protective of human health and the environment.”

PBT Final Rules

Under the Toxic Substances Control Act (TSCA), EPA was required to take expedited action on certain persistent, bioaccumulative, and toxic (PBT) chemicals and promulgate final risk management actions no later than the statutory deadline of December 2020.  As reported in our December 23, 2020, memorandum, EPA released on December 22, 2020, final rules under TSCA Section 6(h) for five PBT chemicals -- 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP) (86 Fed. Reg. 866); decabromodiphenyl ether (decaBDE) (86 Fed. Reg. 880); hexachlorobutadiene (HCBD) (86 Fed. Reg. 922); pentachlorothiophenol (PCTP) (86 Fed. Reg. 911); and phenol, isopropylated phosphate (3:1) (PIP (3:1)) (86 Fed. Reg. 894).  The final rules took effect February 5, 2021.  EPA states that it “is aware of concerns about these rules, including implementation issues, that have been raised by a range of stakeholders and may consider additional measures, approaches, or revisions that build upon the steps taken thus far.”

Dust Lead Post-Abatement Clearance Level (DLCL) Final Rule

In January 2021, EPA issued a final rule establishing lower clearance levels for the amount of lead that can remain in dust on floors and window sills after lead removal activities (abatement), strengthening lead regulations to protect children’s health.  86 Fed. Reg. 983.  The DLCL final rule goes into effect on March 8, 2021.  EPA states that it will continue to consider the DLCL final rule and the related final rule for Dust-Lead Hazard Standards, which was revised in 2019, as a part of its broader review of actions, in accordance with the Executive Orders and other direction provided by the Biden-Harris Administration.

TSCA Risk Evaluations and Risk Management for First Ten Chemicals

EPA issued final TSCA risk evaluations for the first ten chemicals starting in June 2020 and immediately began the risk management process for each of these chemicals.  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 in light of statutory obligations and policy objectives related to use of the best available science and protection of human health and the environment, in accordance with the Executive Orders and other direction provided by the Biden-Harris Administration.”  More information on the final risk evaluations is available in our memoranda available at https://www.lawbc.com/regulatory-developments/tsca.


 

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.


 

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.”


 

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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