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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our March 25, 2022, blog item, the U.S. Environmental Protection Agency (EPA) announced on March 24, 2022, that it issued a second round of test orders under Section 4 of the Toxic Substances Control Act (TSCA) to obtain additional data on eight of the next 20 chemicals undergoing risk evaluation. In April 2022, EPA issued corrections to the following test orders:

  • 1,1,2-Trichloroethane: EPA amended Appendix D -- Order Recipient Selection. According to EPA, Appendix D referred to p-dichlorobenzene, although it should have referred to 1,1,2-trichloroethane. Appendix D only explains the process for identifying order recipients. EPA states that this correction does not change the obligations that apply to manufacturers and processors of 1,1,2-trichloroethane, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of 1,1,2-trichloroethane.
     
  • 1,2-Dichloroethane: EPA amended Appendix D -- Order Recipient Selection. According to EPA, Appendix D referred to p-dichlorobenzene, although it should have referred to 1,2-dichloroethane. Appendix D only explains the process for identifying order recipients. EPA states that the correction does not change the obligations that apply to manufacturers and processors of 1,2-dichloroethane, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of 1,2-dichloroethane.
     
  • 1,2-Dichloropropane: EPA amended Appendix D -- Order Recipient Selection. Appendix D referred to p-dichlorobenzene, although it should have referred to 1,2-dichloropropane. Appendix D only explains the process for identifying order recipients. The correction does not change the obligations that apply to manufacturers and processors of 1,2-dichloropropane, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of 1,2-dichloropropane.
     
  • 4,4'-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA): EPA states that it amended the list of recipients to replace INEOS USA LLC with INEOS Enterprises US Holdco LLC. The effective date for INEOS Enterprises US Holdco LLC is five days after April 20, 2022, the date the memorandum was signed. The effective date for the companies listed in the original order issued on March 24, 2022, will remain March 29, 2022. EPA amended Appendix D -- Order Recipient Selection. Appendix D referred to p-dichlorobenzene, although it should have referred to TBBPA. Appendix D only explains the process for identifying order recipients. The correction does not change the obligations that apply to manufacturers and processors of TBBPA, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of TBBPA.
     
  • o-Dichlorobenzene: EPA amended Appendix D -- Order Recipient Selection. EPA states that Appendix D referred to p-dichlorobenzene, although it should have referred to o-dichlorobenzene. Appendix D only explains the process for identifying order recipients. The correction does not change the obligations that apply to manufacturers and processors of o-dichlorobenzene, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of o-dichlorobenzene.
     
  • Phosphoric acid, triphenyl ester (TPP): EPA amended the list of recipients to replace Axalta Coating Systems LLC with ChemSpec Ltd. The effective date for ChemSpec Ltd is five days after April 20, 2022, the date the memorandum was signed. The effective date for the companies listed in the original order issued on March 24, 2022, will remain as March 29, 2022. EPA also amended Appendix D -- Order Recipient Selection. According to EPA, Appendix D referred to p-dichlorobenzene, although it should have referred to TPP. Appendix D only explains the process for identifying order recipients. The correction does not change the obligations that apply to manufacturers and processors of TPP, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of TPP.
     
  • Trans-1,2-dichloroethylene: EPA amended the list of recipients to add the companies listed below. The effective date for the order for these companies will be five days after April 20, 2022, when the modification was signed. The effective date of the order for the companies listed in the March 24, 2022, order will also have the effective date of five days from April 20, 2022, when the modification was signed (i.e., both the companies listed below and the companies in the order signed on March 24, 2022, for trans-1,2-dichloroethylene will have an effective date five days after April 20, 2022, the date the memorandum was signed):
    • Chemical Compounding Co;
    • Dow Inc;
    • MicroCare LLC;
    • Occidental Chemical Holding Corp;
    • Olin Corp; and
    • Versum Materials Inc.

EPA amended Appendix D -- Order Recipient Selection. Appendix D referred to p-dichlorobenzene, although it should have referred to trans-1,2-dichloroethylene. Appendix D only explains the process for identifying order recipients. EPA states that the correction does not change the obligations that apply to manufacturers and processors of trans-1,2- dichloroethylene, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of trans-1,2-dichloroethylene.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 25, 2022, the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 10784. On March 10, 2022, EPA posted the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” The Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. On April 26, 2022, the TSCA New Chemicals Coalition (NCC) submitted comments to EPA expressing strong support for EPA’s proposed update to its approach to review and evaluate new chemicals under TSCA Section 5:

  • Research Area 1 -- Update and Refine Chemical Categories: The NCC suggests that EPA develop an Integrated Approach to Testing and Assessment (IATA) for each category, and that the IATA include New Approach Methodologies (NAM) both to set boundaries and to provide a tiered approach for testing;
     
  • Research Area 2 -- Develop and Expand Databases Containing TSCA Chemical Information: The NCC suggests that EPA include robust chemical structure information that is searchable by substructure and Markush representations, as appropriate, in the database. The NCC agrees that using IUCLID and the Organization for Economic Cooperation and Development (OECD) harmonized templates would be an efficient way to curate the data and would contribute to interoperability with other data systems (especially as data are transported from other regions that rely upon IUCLID);
     
  • Research Area 3 -- Develop and Refine Quantitative Structure-Activity Relationship and Predictive Models: The NCC suggests that EPA evaluate whether other existing models may serve EPA’s needs. The NCC also suggests that EPA update E-FAST with additional site-specific stream flows;
     
  • Research Area 4 -- Explore New Ways to Integrate and Apply NAMs: The NCC strongly supports expanding the use of NAMs in the assessment of new chemicals. The NCC also strongly suggests that EPA develop and enforce internal policies about in vivo testing of irritating and corrosive substances;
     
  • Research Area 5 -- Develop a TSCA New Chemicals Decision Support Tool: The NCC supports developing such a decision support tool, but refers EPA to this function within IUCLID. The NCC supports improved transparency on risk assessments and suggests that EPA separate boilerplate explanations of hazard, exposure, and risk from the unique assessment results.

More information on EPA’s draft document is available in our March 14, 2022, memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) held a virtual public meeting on April 20-21, 2022, to provide an overview of the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program and give stakeholders an opportunity to provide input. As described in EPA’s draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA,” the Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. EPA has posted the following presentations from the April 20-21, 2022, meeting:

More information on the meeting is available in our April 22, 2022, memorandum, and more information on EPA’s draft document is available in our March 14, 2022, memorandum. Written comments on the draft document are due May 10, 2022.


 

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

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

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 24, 2022, that it has issued a second round of test orders under Section 4 of the Toxic Substances Control Act (TSCA) to obtain additional data on eight of the next 20 chemicals undergoing risk evaluation. EPA states that after reviewing reasonably 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 avian and aquatic environmental hazard and consumer exposure. The chemicals are:

  • Chlorinated Solvents:
    • 1,1,2-Trichloroethane;
    • 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).

According to EPA, this is the third time it has used its new authority to issue test orders under Section 4 of amended TSCA. As reported in our January 15, 2021, blog item, in January 2021, EPA issued test orders for nine chemicals -- the eight chemicals above plus 1,1-dichloroethane -- requiring testing on aquatic environmental hazard and inhalation and dermal exposures for workers. EPA states that the information obtained through the orders will help ensure that its risk evaluations are “robust, credible, and use the best available data.”
 
EPA has posted a document describing the process of developing, drafting, and issuing Section 4 test orders. Companies subject to test orders may provide EPA with existing data, if available, or may conduct new tests. EPA states that companies are “encouraged to form consortia to consolidate costs and burden and avoid unnecessary duplication of testing.”


 

By Lynn L. Bergeson and Carla N. Hutton

On March 23, 2022, the U.S. Environmental Protection Agency (EPA) held a webinar on “Biofuel Premanufacture Notices: New Chemical Risk Assessment and Applications of Tools and Models.” As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. EPA states that to support this effort, it is offering outreach and training to stakeholders interested in biofuels. According to EPA, the bi-weekly webinar series includes reviewing requirements under the Toxic Substances Control Act (TSCA), outlining the streamlined approaches for risk assessments and risk management actions, and providing information on how to navigate the new chemicals premanufacture notice (PMN) process. EPA provided background and outlined the following challenges for each risk assessment conducted:

  • Chemistry Assessment:
    • Fuel stream and related substances are broad in number and scope, especially with the addition of current biobased and waste feedstock blends; they can be class 1, class 2, or chemical substances of unknown or variable composition, complex reaction products, and biological materials (UVCB) substances;
    • Many petroleum-derived fuel streams are on the original TSCA Inventory and there are very little data associated with them; and
    • Complete characterization of the new chemical substance is often unavailable;
  • Environmental Fate and Transport Assessment:
    • Analysis of constituents may not represent the properties of the new chemical substance;
  • Engineering Assessment: Environmental Releases:
    • EPA’s release assessment analyzes each manufacturing, processing, and use operation and determines the sources/activities that can result in releases to the environment. These release estimates are used to estimate exposure estimates for ecological and human receptors;
    • Examples of release data: (1) Measured release data; (2) Measured release data for a “surrogate” chemical; (3) Modeled release estimates; and
    • Release estimates have limitations -- examples:
      • Lack of appropriate model/method to estimate releases from specific industrial activities (e.g., storage tank emissions); and
      • Limitation in certain release models (e.g., limited to a vapor pressure threshold of 35 torr);
  • Engineering Assessment: Occupational Exposures:
    • The occupational exposure assessment estimates the magnitude, frequency, and duration of exposures to the new chemical substance at the workplace;
    • Worker inhalation and dermal exposures are expected throughout the lifecycle of the new chemical substance (e.g., manufacturing, processing, use); and
    • Exposure models do not account for some engineering controls (vapor capture/reduction);
  • Exposure Assessment: General Population and Consumer Exposures:
    • The occupational exposure assessment estimates the magnitude, frequency, and duration of exposures to the new chemical substance for the general population and consumers via inhalation and drinking water pathways; and
    • The confidence of the exposure estimates are affected by:
      • Assumptions, limitations, and areas of uncertainty in the fate and engineering analyses; and
      • Inherent uncertainties of the exposure parameters and assumptions for the estimation of the general population and consumer exposures;
  • Hazard Assessment:
    • Data on the new chemical substance or an analogous biofuel are preferred, but few submissions include toxicological or composition data;
    • EPA often lacks acute/chronic environmental test data on the new chemical substance and the analogous substances; and
    • There are challenges in performing read-across approaches and route-to-route extrapolations with analogous substances of variable composition.

For biofuel PMNs, EPA has started generating one report that combines the results of each of the above assessments. The final webinar in the series will be held April 6, 2022, on new chemicals risk management actions, including TSCA Section 5 orders and significant new use rules (SNUR).


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will hold a webinar on Wednesday, February 23, 2022, from 2:00 to 3:00 p.m. (EST) to learn about requirements under the Toxic Substances Control Act (TSCA) and the premanufacture notice (PMN) process for biofuels. As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. EPA states that to support this effort, it is offering outreach and training to stakeholders interested in biofuels. According to EPA, the bi-weekly webinar series includes reviewing TSCA requirements, outlining the streamlined approaches for risk assessments and risk management actions, and providing information on how to navigate the new chemicals PMN process. Future webinars will include:

Registration is required for the February 23, 2022, webinar.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 14, 2022, that it will reopen the comment period for its draft revision to the risk determination for the cyclic aliphatic bromide cluster (HBCD) risk evaluation issued under the Toxic Substances Control Act (TSCA). As reported in our December 29, 2021, memorandum, EPA is reconsidering two key aspects of the risk determinations for HBCD. First, EPA proposes that the appropriate approach to these determinations under TSCA and implementing regulations is to make an unreasonable risk determination for HBCD as a whole chemical substance, rather than making unreasonable risk determinations separately on each individual condition of use (COU) evaluated in the risk evaluation. Second, EPA proposes that the risk determination should be explicit that it does not rely on assumptions regarding the use of personal protective equipment (PPE) in making the unreasonable risk determination under TSCA Section 6; rather, the use of PPE would be considered during risk management. EPA “finds that HBCD, as a whole chemical substance, presents an unreasonable risk of injury to health and the environment when evaluated under its conditions of use.” EPA will publish a Federal Register notice on February 17, 2022, to reopen the comment period for 15 days. Comments will be due March 3, 2022.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On February 10, 2022, the U.S. Environmental Protection Agency (EPA) extended the comment period on the draft scope of a risk evaluation under the Toxic Substances Control Act (TSCA) for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos. 87 Fed. Reg. 7833. As reported in our December 30, 2021, memorandum, in the Part 2 risk evaluation, EPA will evaluate the conditions of use of asbestos (including other types of asbestos fibers in addition to chrysotile) that EPA had excluded from Part 1 as legacy uses and associated disposals, as well as any conditions of use of asbestos in talc and talc-containing products. The draft scope includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations (PESS) that EPA plans to consider in conducting the risk evaluation for this chemical substance. EPA seeks additional data or information that could be useful to EPA in preparing the final scope of the risk evaluation. Comments are now due March 1, 2022.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 7, 2022, that registration is now open for the March 15-17. 2022, meeting of the Science Advisory Committee on Chemicals (SACC) to peer review EPA’s “Draft TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0” (screening level methodology). As reported in our January 24, 2022, memorandum, EPA will use the screening level methodology to evaluate potential chemical exposures and associated potential risks to fenceline communities in its Toxic Substances Control Act (TSCA) risk evaluations. EPA has extended the comment period to March 22, 2022, to give stakeholders additional time to provide input. EPA “encourages” written comments for consideration by SACC during its peer review be submitted by the original deadline of February 22, 2022. EPA states that it will provide comments submitted after this date to the SACC members, but notes that members “may not have adequate time to consider those comments prior to the meeting’s discussions.” While SACC is unable to consider comments submitted after the March 15-17, 2022, meeting, EPA will consider all comments submitted by March 22, 2022.
 
To provide oral comments during the virtual peer review meeting, registration must be received by 12:00 p.m. (EST) on February 25, 2022. Stakeholders may register as a listen-only attendee at any time until the end of the meeting on March 17, 2022.


 
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