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
 
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.


 

On May 4-5, 2022, the U.S. Environmental Protection Agency (EPA) Board of Scientific Counselors (BOSC) Executive Committee will meet to review the Office of Research and Development’s (ORD) six Strategic Research Action Plans (StRAP) for fiscal years (FY) 2023-2026. The meetings are open to the public. 87 Fed. Reg. 23861. BOSC will consider comments on the draft StRAPs that are submitted by May 3, 2022. Requests for the draft agenda or making a presentation at the meeting will be accepted until May 3, 2022. The meeting is open to the public. Registration is required.

The draft StRAPs outline the leading-edge research strategies necessary to provide the scientific foundation for EPA to execute its mandate to protect human health and the environment. ORD organized the StRAPs around each of its six National Research Programs and developed them through a series of listening sessions, workshops, and consultations with EPA partners; state, tribal, and local partners; and community groups. EPA plans to release the final StRAPs later this year. The draft StRAPs for ORD’s six National Research Programs include:

According to the draft CSS StRAP, “[a] key issue with current chemical safety assessment is that traditional approaches have been unable to keep pace with innovations in chemical design, synthesis, and use.” The draft StRAP states that CSS will continue to:

  • Develop the science needed to reduce, refine, and replace vertebrate animal testing consistent with EPA policies;
  • Accelerate the pace of chemical assessment to enable its partners to make informed and timely decisions concerning the potential impacts of environmental chemicals on human health and the environment; and
  • Provide leadership to transform chemical testing, screening, prioritization, and risk assessment practices.

While continuing its core research activities, ORD envisions that CSS will further incorporate cross-cutting research priorities. To be effective over the course of the StRAP, CSS will not only develop robust scientific data and innovative tools, but also interpretative frameworks.

According to the draft HERA StRAP, HERA “develops a portfolio of fit-for-purpose human health or environmental assessment products and assessment-related research to meet EPA’s wide-ranging statutory and regulatory needs.” HERA identifies, evaluates, and integrates existing and emerging information from diverse scientific disciplines to characterize human or environmental hazards. The draft StRAP states that HERA advances the science and practice of assessment through methods development, case studies, models, and tools that are tethered to assessment needs.

HERA “will continue as a leader in innovating and applying systematic review methods, including evidence integration and mapping.” According to the draft StRAP, areas of new or increasing emphasis will incorporate research relevant to children’s environmental health, equity and environmental justice, climate change, and cumulative risk. The draft StRAP states that HERA’s strategic direction “culminates in a program structured to facilitate efficient construction and production of high-quality, transparent, state-of-the-science assessment research that maximizes resources to address priority statutory, regulatory, and programmatic needs.”

Tags: ACE, BOSC, CSS, HERA, HS, ORD, SHC, SSWR, StRAP

 
By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 8, 2022, that it is planning to consolidate several Information Collection Requests (ICR) covering reporting and recordkeeping activities under Section 8 of the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 12954. Before submitting the consolidated ICR to the Office of Management and Budget (OMB) for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection. The consolidated ICR is entitled “Reporting and Recordkeeping Under Section 8 of the Toxic Substances Control Act (TSCA)” and is identified under EPA ICR No. 2703.01 and OMB Control No. 2070-[NEW]. According to EPA, it intends to streamline the presentation of the paperwork burden estimates for these various activities and eliminate any duplication, which in turn is expected to reduce the administrative burden for both the public reviewers and EPA. EPA’s Supporting Statement summarizes the currently approved ICRs that would be consolidated in the new ICR:
  • TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR): Under TSCA Section 8(a), persons who manufacture or import chemical substances listed at 40 C.F.R. Section 712.30 are subject to the Section 8(a) PAIR requirements. These manufacturers and importers must submit information about production, use, and/or exposure-related data. Certain specific chemical testing and reporting requirements under 40 C.F.R. Part 766 Subpart B that are very similar to the PAIR requirements are also covered within this information collection activity.
     
  • Chemical-Specific Rules, TSCA Section 8(a): Under TSCA Section 8(a), persons who manufacture, import, or process certain chemical substances or mixtures, or propose to manufacture, import, or process certain chemical substances or mixtures, are subject to chemical-specific rules promulgated under TSCA Section 8(a). A chemical-specific Section 8(a) rule requires more detailed and more types of information than is required by a PAIR rule. Any chemical covered by TSCA for which the Office of Pollution Prevention and Toxics (OPPT), other EPA offices, or another federal agency has a reasonable need for information, and that cannot be satisfied via readily available sources or by use of other rulemakings, is a proper potential subject for a chemical-specific TSCA Section 8(a) rulemaking.
     
  • Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment: Under TSCA Section 8(c), persons who manufacture, import, process, or distribute in commerce any chemical substance or mixture must keep records of significant adverse reactions to health or the environment, as determined by the Administrator by rule, alleged to have been caused by the substance or mixture. TSCA Section 8(c) requires that allegations of adverse reactions to the health of employees be kept for 30 years, and all other allegations be kept for five years. The rule also prescribes the conditions under which a firm must submit or make the records available to a duly designated representative of the Administrator.
     
  • Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies: Under TSCA Section 8(d), certain persons, who manufacture, import, process, or distribute in commerce (or propose to manufacture, import, process, or distribute in commerce) chemical substances and mixtures, are required to submit to EPA lists and copies of health and safety studies in their possession that relate health and/or environmental effects of the chemical substances and mixtures.
Comments are due May 9, 2022.

 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency will hold a virtual public meeting April 20-21, 2022, to seek individual input on the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 10784. In addition, EPA announced the availability of and is soliciting public comment on the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” EPA states that the Office of Chemical Safety and Pollution Prevention (OCSPP) is proposing to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. According to EPA, the effort will be performed in partnership with its Office of Research and Development (ORD) and other federal entities to leverage their expertise and resources. Written comments are due April 26, 2022. Registration for the meeting is now open.

According to EPA, the research program will refine existing approaches and develop and implement new approach methodologies (NAM) to ensure the best available science is used in TSCA new chemical evaluations. Key areas proposed in the TSCA New Chemicals Collaborative Research Program include:

  • Updating OCSPP’s approach to using data from structurally similar chemicals to determine potential risks from new chemicals, also known as read-across. According to EPA, this will increase the efficiency of new chemical reviews, promoting the use of the best available data to protect human health and the environment.
  • Digitizing and consolidating information on chemicals to include data and studies that currently exist only in hard copy or in various disparate TSCA databases. EPA will combine the information with publicly available sources to expand the amount of information available, enhancing chemical reviews and enabling efficient sharing of chemical information across EPA. Safeguards for confidential business information (CBI) will be maintained as appropriate in this process.
  • Updating and augmenting the models used for predicting a chemical’s physical-chemical properties and environmental fate/transport, hazard, exposure, and toxicokinetics to provide a suite of models to be used for new chemicals assessments. The goal of this effort is to update the models to reflect the best available science, increase transparency, and establish a process for updating these models as science evolves.
  • Exploring ways to integrate and apply NAMs in new chemicals assessments, reducing the use of animal testing. EPA states that as this effort evolves, the goal is to develop a suite of accepted, fit-for-purpose NAMs that could be used by external stakeholders for data submissions under TSCA, as well as informing and expanding new chemical categories.
  • Developing a decision support tool that integrates the various information streams specifically used for new chemical risk assessments. The decision support tool will integrate more efficiently all the data streams (e.g., chemistry, fate, exposures, hazards) into a final risk assessment and transparently document the decisions and assumptions made. Simply put, this will facilitate the new chemicals program tracking decisions over time and evaluating consistency within and across chemistries.

EPA states that additional information on each of these areas will be provided in the draft collaborative research plan that will be available in the docket by March 14, 2022. Later in 2022, EPA plans to engage its Board of Scientific Counselors (BOSC), a federal advisory committee, for peer review. EPA also intends to issue a Federal Register notice announcing the BOSC meeting and to open a docket for public comments.

Although the notice states that EPA’s background documents and the related supporting materials to the draft are available in the docket established for this meeting, Docket ID Number EPA-HQ-OPPT-2022-0218, nothing is available at this time. EPA states that it will provide additional background documents as the materials become available. After the virtual public meeting, EPA will prepare meeting minutes summarizing the individual comments received at the meeting. EPA will post the meeting minutes on its website and in the relevant docket.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On February 15, 2022, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget a final rule regarding a further compliance date extension for phenol, isopropylated phosphate (3:1) (PIP (3:1)). EPA proposed in October 2021 to extend the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles and the PIP (3:1) used to make those articles until October 31, 2024, along with the associated recordkeeping requirements for manufacturers, processors, and distributors of PIP (3:1)-containing articles. EPA noted that the articles covered by the proposed rule include a wide range of key consumer and commercial goods such as cellular telephones, laptop computers, and other electronic and electrical devices and industrial and commercial equipment used in various sectors, including transportation, construction, agriculture, forestry, mining, life sciences, and semiconductor production. The proposed rule followed a final rule that extended the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles, from March 8, 2021, to March 8, 2022, along with the associated recordkeeping requirements. More information on the proposed rule is available in our October 25, 2021, memorandum. It is not clear when OMB will complete its review or if the final rule will be published prior to the current March 8 compliance deadline.


 

Bergeson & Campbell, P.C.’s (B&C®) January 26, 2022, webinar “What to Expect in Chemicals in 2022” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/864194569862780944. During the 1-hour webinar, Lynn L. Bergeson, Managing Partner, B&C; Richard E. Engler, Ph.D., Director of Chemistry, B&C; and James V. Aidala, Senior Government Affairs Consultant, B&C offered their best informed judgment as to the trends and key developments chemical industry stakeholders should expect to see from the U.S. Environmental Protection Agency (EPA) in 2022.
 
Momentous changes initiated in 2021 will continue to influence policy development and rulemakings in 2022. For EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), emphasis on science integrity, reviewing decisions made by the Trump Administration in both the pesticide and industrial chemicals programs, meeting statutory deadlines looming over the work of both programs, and dealing with the constant problem of EPA-wide competing priorities will drive the OCSPP program budget and regulatory priorities. We encourage you to view the webinar and read our comprehensive Forecast for U.S. Federal and International Chemical Regulatory Policy 2022 to learn more about these competing priorities for which companies should now prepare.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on December 28, 2021, it is granting a petition from six North Carolina public health and environmental justice organizations filed under Section 21 of the Toxic Substances Control Act (TSCA) to compel companies to conduct testing of certain per- and polyfluoroalkyl substances (PFAS). The previous Administration denied the petition on January 22, 2021. 86 Fed. Reg. 6602. The petition sought issuance of a rule or order under TSCA Section 4 compelling The Chemours Company to fund and carry out this testing under the direction of a panel of independent scientists. The petitioners requested that EPA reconsider its denial in March 2021, which EPA agreed to do in September 2021, in light of the change in Administration and attendant change in policy priorities concerning PFAS. As reported in our October 19, 2021, memorandum, EPA published a National PFAS Testing Strategy (Testing Strategy) that identifies priority substances for the first of several described phases of an iterative testing approach based on grouping of chemicals by chemistry features and available toxicity data. EPA states that these substances include many of the chemicals identified in the petition, as well as additional PFAS that will inform a wider universe of categories of PFAS where key data are lacking. For example, according to EPA, the first phase of testing on 24 PFAS is expected to provide data that can be extrapolated to 2,950 PFAS that belong to the same categories as the 24 individual substances.

EPA states that it has granted the petition and will use its TSCA Section 4 order authority to require PFAS manufacturers to conduct and fund the following studies that will provide toxicity data and information on categories of PFAS:

  • Near-Term Testing Covers 30 of 54 Petition Chemicals -- Under the Testing Strategy, EPA’s first test orders for 24 categories of PFAS about which the least is known will provide human health hazard data that cover 30 of the 54 petition chemicals;
  • Subsequent Testing May Cover Nine of 54 Petition Chemicals -- An additional nine PFAS identified in the petition belong to one other category included in the Testing Strategy. EPA is conducting more in-depth analyses of the sufficiency of the existing data, which will inform later phases of testing;
  • Remaining 15 of 54 Petition Chemicals -- According to EPA, 15 chemicals identified in the petition do not fit the definition of PFAS used in developing the Testing Strategy. EPA has determined that there are robust data on some of them available to it. EPA is conducting more in-depth analyses of the existing data, which will inform later phases of testing;
  • Mixtures Studies -- EPA will address PFAS mixtures by using the toxicity of the individual substances to predict the toxicity of the mixture, an approach which is consistent with the current state-of-science on PFAS. EPA is proceeding with development and peer review of these methods as specifically applied to PFAS;
  • Human Studies -- EPA is contributing to and reviewing numerous existing ongoing human studies, including studies on potentially exposed workers and communities in North Carolina, and is evaluating how to advance and expand on these efforts further. These include studies of health outcomes for people in communities impacted by industrial PFAS releases, as well studies that explore the connection between chronic health outcomes and PFAS exposures in North Carolina; and
  • Analytical Standards -- EPA does not believe it is appropriate to require the development or submission of analytical standards with the initial test orders that will be issued under the Testing Strategy and lacks the ability to order the submission of all analytical standards in the manner requested. Nonetheless, EPA has requested comment on whether to require the submission of existing analytical methods for PFAS under a separate rulemaking that the Agency expects to issue in final next year.

Commentary

EPA’s reversal is hardly surprising. The Biden Administration’s commitment to obtaining information on PFAS is clear and has been reinforced in many contexts. In her remarks before the Committee on Energy and Commerce on October 27, 2021, for example, Assistant Administrator Freedhoff stated that EPA is “scouring all sources of information to identify important gaps in existing data and to select representative chemicals within identified categories or additional testing.” Reconsidering the prior Administration’s denial of the Section 21 petition seems like a no-brainer.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On September 17, 2021, the U.S. Environmental Protection Agency (EPA) published a final rule amending the regulations applicable to phenol, isopropylated phosphate (3:1) (PIP (3:1)) promulgated under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 51823. Specifically, EPA is extending the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles, from March 8, 2021, to March 8, 2022. For such articles, EPA states that it is also extending the compliance date for the recordkeeping requirements applicable to manufacturers, processors, and distributors from March 8, 2021, to March 8, 2022. According to EPA, the articles covered by the amendment “include a wide range of key consumer and commercial goods such as cellular telephones, laptop computers, and other electronic and electrical devices and industrial and commercial equipment used in various sectors including transportation, life sciences, and semiconductor production.” The final rule is effective September 17, 2021. More information on the final PIP (3:1) rule and on EPA’s plan for a new rulemaking on persistent, bioaccumulative, and toxic (PBT) chemicals is available in our September 3, 2021, memorandum, “EPA Plans New Rulemaking for PBTs, Extends Compliance Dates for PIP (3:1) Rule.”


 

By Lynn L. Bergeson
 
On June 10, 2021, the Retail Industry Leaders Association’s (RILA) Retail Compliance Center (RCC) and Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), presented “TSCA - It Is Not What You May Think.” While the Toxic Substances Control Act (TSCA) has long been regarded as a law applying to chemical producers, reforms made in 2016 have drawn many retailers, product manufacturers, and other “article” manufacturers into TSCA’s reach. Nothing illustrates this more clearly than a recent final rule under Section 6(h) limiting or prohibiting the manufacture (including import), processing, and/or distribution in commerce of five persistent, bioaccumulative, and toxic (PBT) chemicals, including phenol, isopropylated phosphate (3:1) (PIP (3:1)). This complimentary webinar, intended for large and small retailers, product stewards, and professionals throughout the product supply chain, covered:

  • What TSCA is and why it matters to retailers;
  • What retailers need to know about their products;
  • What the PIP (3:1) case study signals about the potential reach of TSCA; and
  • What steps to take to prepare for new regulations.

A full recording of this webinar is available now, along with slides and detailed responses to the Q&A portion of the event.


 

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 sat down with Heather J. Blankinship, Senior Manager with B&C® Consortia Management (BCCM), a Bergeson & Campbell (B&C®) affiliate, and Richard E. Engler, Ph.D., B&C’s Director of Chemistry, to discuss chemical testing under the Toxic Substances Control Act (TSCA). Since Congress amended TSCA in 2016, the U.S. Environmental Protection Agency (EPA) has been slowly ratcheting up required chemical testing under TSCA Section 4. Congress gave EPA expanded testing authority under the 2016 Amendments, and EPA is exercising its new authority to compel chemical data production. These test orders authorize EPA to demand the production of new test data by the manufacturers and sometimes processors of the chemical substances at issue. Transactionally, this means that competitors in the marketplace band together to generate the data EPA seeks. We discuss the reality of quickly forming these consortia and the business and scientific challenges consortia managers face in complying with these federally enforceable test orders. It is not as easy as you may think!

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