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.

In the 21st century, we take as given a continuous stream of new and better products. From electronics to building materials to transportation solutions, the flow of new and better products and applications seems unending. New chemical substances play a fundamental role in creating those products and making existing products better. If the pipeline of new chemicals were closed off, the flow of new products and applications would slow to a trickle and eventually dry up. Modern life as we know it would not exist without the continued invention, production and use of new chemicals.

In the US, all new chemicals must be reviewed by the US EPA before they can enter commerce. The agency looks at new chemicals to determine whether their manufacturing, processing and use would adversely affect people or the environment. If the EPA identifies risks that it determines to be unreasonable, then it either prohibits use of the chemical, or requires restrictions on the chemical to control for risks. Since the 1970s, tens of thousands of chemicals have come through the EPA for review and have been allowed into US commerce.

In this article, Richard E. Engler, Ph.D. and Jeffery T. Morris, Ph.D. write that more robust consideration of a new chemical’s potential to prevent pollution and lower risks could help achieve the right balance between safety and innovation. The full article is available at https://chemicalwatch.com/220164/guest-column-why-the-us-epa-can-and-should-evaluate-the-risk-reducing-role-a-new-chemical-may-play-if-allowed-on-the-market (subscription required).


 

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 19, 2021, that it is extending the public comment period on proposed updates to the Toxic Substances Control Act (TSCA) fees rule to give stakeholders more time to review and comment.  The current comment period was set to close on February 25, 2021.  EPA is extending the comment period an additional 30 days.  Information on the proposed updates is available in our December 30, 2020, memorandum, “EPA Intends Proposed Rule to Increase Flexibility and Reduce Burdens under TSCA Fees Program.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 18, 2021, that it is opening a public comment period for a manufacturer-requested risk evaluation of octahydro-tetramethyl-naphthalenyl-ethanone (OTNE), a category of chemical substances consisting of four inseparable individual isomers.  EPA notes that two chemicals in the OTNE category are considered persistent, bioaccumulative, and toxic (PBT) chemicals under TSCA, “meaning they are toxic, can remain in the environment for long periods of time, and can build up or accumulate in the body.”  Upon publication of the Federal Register notice announcing the public comment period, EPA will accept public comments on the request for 45 days.  EPA states that it “welcomes all public comments,” particularly on the following:

  • Any information not included in the manufacturer request that commenters believe EPA would need to conduct a risk evaluation;
     
  • Additional conditions of use EPA is proposing to include in the risk evaluation; and
     
  • Information on conditions of use not included in the manufacturer request or in the additional conditions of use EPA proposes to include in the risk evaluation, specifically the inclusion of any additional conditions of use and potentially exposed or susceptible subpopulations.  EPA states that it “is in the process of broadly re-examining how it intends to implement these and other provisions of amended TSCA including determining how new executive orders will be addressed.  This process would benefit greatly from stakeholder feedback.”

After the comment period closes, EPA will review the comments and either grant or deny the request to conduct a risk evaluation within 60 days.  If EPA grants the request, the manufacturers would be responsible for half the cost of the risk evaluation.  International Flavors and Fragrances, Inc., Privi Organics USA Corporation, and DRT America, Inc. formally requested the risk evaluation through the OTNE Consortium managed by B&C® Consortia Management, L.L.C. (BCCM).


 

By Lynn L. Bergeson and Carla N. Hutton
 
On February 16, 2021, the National Academies of Sciences, Engineering, and Medicine (National Academies) announced the availability of a report entitled The Use of Systematic Review in EPA’s Toxic Substances Control Act Risk Evaluations.  The U.S. Environmental Protection Agency (EPA) requested that the National Academies convene a committee to review EPA’s 2018 guidance document on Application of Systematic Review in TSCA Risk Evaluations and associated materials.  In its final report, the Committee to Review EPA’s Toxic Substances Control Act (TSCA) Systematic Review Guidance Document states that it “was in strong consensus that the processes used by [the Office of Pollution Prevention and Toxics (OPPT)] do not meet the evaluation criteria specified in the Statement of Task (i.e., comprehensive, workable, objective, and transparent).”  The Committee recognizes the “substantial challenges in implementing review methods on the schedule required by” the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), but concluded that those challenges “have not yet been successfully met.”  The final report includes the following summary of the Committee’s general recommendations:

  • OPPT’s approach to systematic review does not adequately meet the state of the practice.  The Committee suggests that OPPT comprehensively reevaluate its approach to systematic review methods, addressing the comments and recommendations provided in Chapter 2 of the final report.
     
  • With regard to hazard assessment for human and ecological receptors, the Committee comments that “OPPT should step back from the approach that it has taken and consider components” of the Office of Health Assessment and Translation (OHAT) of the National Toxicology Program, EPA’s Integrated Risk Information System (IRIS), and Navigation Guide methods that could be incorporated directly and specifically into hazard assessment.
     
  • The Committee finds that OPPT’s use of systematic review for the evidence streams, for which systematic review has not been previously adapted, “to be particularly unsuccessful.”  The Committee suggests that OPPT elaborate plans for continuing the refinement of methods, ideally in collaboration with internal and external stakeholders.  The Committee also suggests that OPPT evaluate how the existing OHAT, IRIS, and Navigation Guide methods could be modified for the other evidence streams.  In addition, according to the Committee, OPPT should use existing EPA guidance, such as the Guidelines for Human Exposure Assessment, the Guidelines for Ecological Risk Assessment, and the operating procedures for the use of the ECOTOXicology knowledgebase (ECOTOX).  Following these existing guidelines would improve transparency of the assessments.
     
  • The Committee recommends that EPA put together a handbook for TSCA review and evidence integration methodology that details the steps in the process.  Throughout the final report, the Committee points to problems of documentation.  The Committee “believes that the effort of developing and publicly vetting a handbook will pay off in the long run by making the process more straightforward, transparent, and easier to follow.”

The final report states that “[t]here is an ongoing cross-sector effort to develop and validate new tools and approaches for exposure, environmental health, and other new areas of application of systematic review,” and the Committee “strongly recommends that OPPT staff engage in these efforts.”  According to the final report, the approaches used for TSCA evaluation “would benefit from the substantial external expertise available,” as well as additional transparency and acceptance by the different stakeholders as these tools are developed.
 
EPA published a press release on February 16, 2021, in response to the Committee’s report, announcing that it “will refine its approach to selecting and reviewing the scientific studies that are used to inform” TSCA chemical risk evaluations.  According to EPA, its “ongoing effort to update its systematic review approach” is also part of its “broader efforts” to review the first ten TSCA risk evaluations.  EPA states that it “is not using, and will not again use, the systematic review approach that was reviewed by the Academies.”  The 2018 Application of Systematic Review document “represented EPA’s practices at that time.”  According to the press release, EPA has already begun to develop a TSCA systematic review protocol in collaboration with its Office of Research and Development to incorporate approaches from the IRIS Program.  EPA “expects to publish and take public comment on a TSCA systematic review protocol that will adopt many of the recommendations in the Academies’ report later this year.”


 

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

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


 

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).


 

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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