By Lynn L. Bergeson and Carla N. Hutton

Research in the U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) is organized around six highly integrated and transdisciplinary national research programs that are closely aligned with EPA’s strategic goals and cross-EPA strategies. Each program is guided by a Strategic Research Action Plan (StRAP) developed by EPA with input from its many internal and external partners and stakeholders. In October 2022, EPA published six StRAPs for fiscal years (FY) 2023-2026. EPA states that the StRAP for Chemical Safety for Sustainability (CSS) “is focused on addressing the pressing environmental and health challenge of a lack of sufficient information on chemicals needed to make informed, risk-based decisions.” The StRAP for CSS 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 our 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.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on October 11, 2022, that the Office of Research and Development’s (ORD) Board of Scientific Counselors (BOSC) will review the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 61313. The meeting will be held October 24-25, 2022, via videoconference. Attendees must register by October 23, 2022. Comments must be received by October 23, 2022, to be considered by BOSC. EPA states that requests for the draft agenda or to make a presentation at the meeting will be accepted until October 23, 2022.
 
BOSC is a federal advisory committee that provides advice and recommendations to ORD on technical and management issues of its research programs. The meeting agenda and materials will be posted on BOSC’s website. According to the Federal Register notice, proposed agenda items for the meeting include, but are not limited to, review of the New Chemicals Collaborative Research Program.
 
As reported in our March 14, 2022, memorandum on 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 20-21, 2022, EPA held a virtual public meeting to provide an overview of the program and give stakeholders an opportunity to provide input. EPA has posted the meeting materials in the online docket. A summary of the meeting is available in our April 22, 2022, memorandum.

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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our March 14, 2022, blog item, 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. EPA has since submitted the ICR to the Office of Management and Budget (OMB) for review and approval. EPA published a notice on August 30, 2022, allowing for an additional 30 days for public comment. 87 Fed. Reg. 52967. Comments are due September 29, 2022.
 
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 is consolidating the existing ICRs to streamline the presentation of the paperwork burden estimates, thereby reducing the administrative burden for both the public and EPA and allowing a better assessment of the burden and costs for reporting and recordkeeping activities under TSCA Section 8. 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.

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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) will hold a webinar on August 17, 2022, on the “EPA PFAS Strategic Roadmap: Research Tools and Resources.” EPA states that “[a] growing body of scientific evidence suggests that exposure at certain levels to specific [per- and polyfluoroalkyl substances (PFAS)] can adversely impact human health and other living things.” The webinar will provide a brief overview of EPA’s PFAS Strategic Roadmap and ongoing efforts by EPA’s Office of Research and Development (ORD) to address key PFAS research needs for environmental decision-making. During the webinar, ORD scientists will highlight two recently released data sources: EPA’s PFAS Thermal Treatment Database (PFASTT), which contains information on the treatability of PFAS via various thermal processes, and Systematic Evidence Map for PFAS, which summarizes available toxicity evidence for approximately 150 different PFAS. Recent updates to other PFAS resources will also be shared. Registration is now open.

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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) has posted two new resource documents for recipients of test orders under Section 4 of the Toxic Substances Control Act (TSCA). The August 5, 2022, policy document entitled “Policies Regarding Manufacturers and Processors Subject to TSCA Section 4(a) Testing” provides two policies:

• Policy 1: Companies engaged in manufacturing activities for a chemical substance during the five years prior to the projected signature date or effective date of a Section 4(a) action (i.e., a rule, consent agreement, or order) will generally be included in the scope of the action. EPA may apply a longer or shorter period of time when appropriate in specific cases, however. EPA states that “[w]here (1) a five-year period fails to identify a sufficient number of manufacturers, (2) fairness reasons warrant inclusion of a manufacturer, especially a high-volume manufacturer, of the chemical substance with less recent manufacturing, (3) a chemical substance has persistence and/or bioaccumulative properties that warrant inclusion of companies that contributed to potential exposures associated with such substance, or (4) where warranted for other reasons, which the Agency would explain as part of the Section 4(a) action, EPA will consider a longer manufacturing period than five years for the identification of companies as manufacturers subject to TSCA Section 4 testing obligations for a given chemical substance.” According to EPA, an example of where it may not include a company that has manufactured in the past five years as a manufacturer subject to testing requirements in a specific Section 4(a) action would be a company that “may have gone into bankruptcy and be in the hands of receivers who do not seek to continue the company’s manufacturing activities involving the chemical substance subject to the testing requirements.”
• Policy 2: Section 4 actions will not include an option to cease manufacturing as a means to satisfy the requirements of the action. Test orders issued in January 2021 included this option. EPA removed this response option to ensure that a sufficient number of entities remained subject to an order (e.g., for one 2021 order, no manufacturers identified by the order remained available to conduct the testing due to their use of the cease manufacture response option). According to EPA, were all entities subject to the testing requirements able to exit the market to forgo producing the required data, EPA would be unable to seek and obtain data under Section 4(a) to support better its assessments and action. EPA states that where it is conducting a risk evaluation on chemical substances that have conditions of use that “are not currently ongoing but are reasonably foreseen to reoccur or for which the effects and exposures are ongoing, EPA generally believes it is appropriate to include companies responsible for those activities in testing obligations.”

The August 5, 2022, policy document entitled “Removal of Certain Companies from Seven TSCA Section 4(a)(2) Orders Issued in 2022” states that although EPA’s policy is that it will no longer provide a “cease manufacture” response option for a company to cease its manufacture of a chemical substance to satisfy the requirements of an order, EPA recognizes that a company that ceased its manufacture of a chemical substance in response to a 2021 order “forewent a business opportunity in reliance upon EPA’s representation that testing on the chemical substance would not be required by the company.” EPA will remove from a 2022 order on a chemical substance any company that made successful use of the cease manufacture response option for a 2021 order on that same chemical substance, “provided the company has not, and does not, recommence its manufacture of the chemical substance while testing obligations remain in effect for that chemical substance under the applicable 2021 Order and/or 2022 Order.” According to EPA, removal of such companies due to EPA’s approval of the “cease manufacture” response option provided in the 2021 order applies only to the 2022 orders issued for the eight subject chemical substances. EPA notes that any future Section 4 action involving the applicable chemical substance will include manufacturers and/or processors as EPA deems to be appropriate upon any final future action (e.g., should such companies resume their manufacturing and/or processing of the chemical substance following the completion of the testing requirements in the 2021 and 2022 orders).

EPA states in each document that the policy document is not intended to bind EPA or members of the public. EPA “may revisit and depart from these policies based on reasoned consideration as it deems appropriate in the future.”

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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.

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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.

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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:

• Air, Climate, and Energy (ACE);
• Chemical Safety for Sustainability (CSS);
• Health and Environmental Risk Assessment (HERA);
• Homeland Security (HS);
• Safe and Sustainable Water Resources (SSWR); and
• Sustainable and Healthy Communities (SHC).

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.”

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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.

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