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.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on July 21, 2022, that the meeting minutes and final report (final report) are now available for the April 19-21, 2022, Science Advisory Committee on Chemicals (SACC) virtual meeting regarding EPA’s proposed Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances Version 1.0 (Draft Protocol). As reported in our December 21, 2021, memorandum, EPA released the Draft Protocol for public comment on December 20, 2021. 86 Fed. Reg. 71891. According to EPA’s December 20, 2021, press release, the Draft Protocol will strengthen EPA’s approach to reviewing and selecting the scientific studies that are used to inform Toxic Substances Control Act (TSCA) chemical risk evaluations and ensure that EPA has the best tools under TSCA to protect human health and the environment. EPA intends to issue its response to the SACC’s recommendations along with any revisions to the approach in 2023.

Charge Question 1: TSCA Systematic Review Protocol Document (Chapters 1-7)

The final report states that the SACC raised some substantive comments that require edits or explanation from EPA. According to the SACC, the Draft Protocol “is closer to a framework to carry out systematic review and other evaluation processes for TSCA risk evaluation.” Multiple SACC members recommended specifying systematic review and non-systematic review processes (e.g., risk assessment) within the Draft Protocol. To increase transparency, the Draft Protocol needs to: (1) start with the problem formulation; (2) describe how Populations, Exposures, Comparators, and Outcomes (PECO) or Receptors, Exposure, Setting or Scenario, and Outcomes (RESO) statements are developed and refined through the process; (3) describe the process of systematic review, evidence synthesis, and integration; and (4) clearly link the steps of the systematic review back to the larger risk evaluation process.

Charge Question 2: Strategies for Literature Search and Screening (Chapter 4)

According to the final report, overall, the SACC found the methods for searching and screening well described in Chapter 4. The general process for searching the peer-reviewed literature was considered robust, but the SACC noted concerns that methods for searching gray literature were neither robust nor complete. The method for searching gray literature does not currently find relevant information from states, non-governmental organizations (NGO), or community groups. The SACC recommends EPA identify authoritative reviews from government agencies and begin with these as a starting point to make more efficient use of time and resources.

Charge Question 3: Method to Assess the Quality of Evidence (Chapter 5)

The final report states that in general, the SACC noted that the Draft Protocol is an improved approach compared with the 2018 method. There was greater transparency and clarity in the data evaluation methods, as EPA’s process for evaluating the data across various evidence streams was well described and explained. The SACC made several recommendations to include more detail regarding the role of certain evidence types, such as biochemical and cellular-level outcomes, and to describe how supplemental data sources will be reviewed, evaluated, and incorporated into the systematic review or what criteria will be used to make the determination to consider/incorporate these data. In addition, EPA should re-evaluate the domain “accessibility” and identify whether an alternative term or phrase would be more appropriate to capture the elements under consideration. The SACC stated that EPA should be specific about the types of quality and validity issues it is considering and maintain appropriate categorizations of each instead of referring to them collectively under a blanket term.

Charge Question 4: Approaches for Integrating Evidence in Exposure and Hazard (Chapter 7)

According to the final report, SACC agreed this is a difficult and multi-faceted task and generally found that several aspects of the chapter were helpful, such as the hierarchies of data and the documentation on integration. As written, the Draft Protocol presents a complicated and potentially inefficient method for integrating data within the various disciplines, however. The final report states that many SACC members were concerned that criteria used to judge quality may exclude useful data that are not of high quality but nevertheless may have specific value for other downstream applications (e.g., corroboration of results or to assist with coherence of a data stream). In addition, the evidence integration process inappropriately introduces criteria for data selection that should be specified earlier in the process.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On May 23, 2022, the Vinyl Institute, Inc. (VI) filed suit in the U.S. Court of Appeals for the District of Columbia against the U.S. Environmental Protection Agency (EPA), seeking review of EPA’s March 2022 test order for 1,1,2-trichloroethane issued under Section 4(a)(2) of the Toxic Substances Control Act (TSCA). As reported in our March 25, 2022, blog item, EPA announced on March 24, 2022, that it issued a second round of test orders under TSCA Section 4 to obtain additional data on eight of the next 20 chemicals undergoing risk evaluation. The VI seeks judicial review of the test order under federal law, including but not limited to the Administrative Procedure Act (APA), TSCA, and EPA’s regulations promulgated thereunder. The VI seeks a determination that, inter alia, the test order violates these authorities; is arbitrary, capricious, an abuse of discretion, and otherwise not in accordance with the law; is in excess of statutory jurisdiction, authority, or limitations, or short of statutory right; is without observance of procedure required by law; is unsupported by substantial evidence; and is otherwise contrary to law. The VI asks that the court hold unlawful, vacate, enjoin, set aside, and remand the test order.


 

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
 
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.


 
 1 2 3 >  Last ›