All Knowledge & Insights By Date

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...

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...

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...

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...

The U.S. Environmental Protection Agency (EPA) announced on January 13, 2022, that it is accepting public comments on candidates under consideration for selection as ad hoc peer reviewers assisting the Science Advisory Committee on Chemicals (SACC) with its review of the Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances. This comment period follows a previous 30-day call for nominations that ended on November 17, 2021. EPA will use comments on the...

The U.S. Environmental Protection Agency (EPA) has reopened the online dockets for 20 high-priority substances. According to the December 9, 2021, memorandum authorizing the re-opening of the dockets, EPA is re-opening these dockets to receive use, hazard, exposure, and any other information that can help inform their risk evaluations. Information must be submitted by June 9, 2022, when EPA will close the dockets. Information submitted to the docket should be identified by the...

The U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) is accepting public comments on candidates under consideration for selection as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with their review of the draft EPA Toxic Substances Control Act (TSCA) Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities. EPA will use the comments to assist it in selecting approximately...

The U.S. Environmental Protection Agency (EPA) announced the availability of the Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances (Draft Protocol) on December 20, 2021. 86 Fed. Reg. 71891. According to EPA, the Draft Protocol includes a revised generic approach for Toxic Substances Control Act (TSCA)-related approaches accounting for previous peer review comments from the Science Advisory Committee on Chemicals (SACC) reviews of risk...

On December 10, 2021, the Biden Administration released its Fall 2021 Unified Agenda of Regulatory and Deregulatory Actions. According to the U.S. Environmental Protection Agency’s (EPA) rule list, the Office of Chemical Safety and Pollution Prevention (OCSPP) is working on the following rulemakings under the Toxic Substances Control Act (TSCA). Rulemakings at the proposed stage include: Tiered Data Reporting to Inform Prioritization, Risk Evaluation, and Risk Management Under TSCA...

On October 27, 2021, the U.S. Environmental Protection Agency (EPA) requested public nominations of scientific experts to consider for service as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with two peer review topics anticipated for early 2022: the draft EPA Toxic Substances Control Act (TSCA) Systematic Review Protocol and the draft EPA TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities. 86...

As part of a multi-agency effort to address pollution from per- and polyfluoroalkyl substances (PFAS), the U.S. Environmental Protection Agency (EPA) released on October 18, 2021, the PFAS Strategic Roadmap: EPA’s Commitments to Action 2021-2024. The Strategic Roadmap includes: Timelines to set enforceable drinking water limits under the Safe Drinking Water Act (SDWA) to ensure water is safe to drink in every community; A hazardous substance designation under the Comprehensive...

The U.S. Environmental Protection Agency (EPA) announced on September 24, 2021, that it is extending the submission deadline for manufacturers (including importers) of 50 chemicals to report data from certain unpublished health and safety studies. The deadline for the reporting rule was originally September 27, 2021, and EPA has extended the deadline until December 1, 2021, for 20 of the 50 chemicals and to January 25, 2022, for 30 of the 50 chemicals. The 50 chemicals...

On August 31, 2021, the U.S. Environmental Protection Agency (EPA) released the final scope documents for the Toxic Substances Control Act (TSCA) risk evaluations of diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP). 86 Fed. Reg. 48695; 86 Fed. Reg. 48693. In its August 31, 2021, press release, EPA notes that both DIDP and DINP “belong to a family of chemicals called phthalates and are commonly used as plasticizers in the production of plastic and...

The U.S. Environmental Protection Agency (EPA) announced on July 27, 2021, that it will provide $3.8 million in funding to create two EPA Science to Achieve Results (STAR) Centers for Early Lifestage Vulnerabilities to Environmental Stressors. The centers will focus on early lifestage exposures to chemicals and non-chemical environmental stressors and how these exposures may impact early childhood developmental health. EPA states that scientific research suggests that exposures to...

According to a memorandum posted in Docket ID EPA-HQ-OPPT-2021-0436, the U.S. Environmental Protection Agency (EPA) will not extend the comment period stemming from the July 27, 2021, public webinar on the development of a proposed rule under the Toxic Substances Control Act (TSCA) to implement a tiered data collection strategy intended to inform EPA’s prioritization, risk evaluation, and risk management activities for chemical substances or mixtures. As reported in our July 29,...

 On February 16, 2021, the National Academies of Sciences, Engineering, and Medicine (National Academies) announced the availability of a report entitled The Use of Systematic Review in EPA’s Toxic Substances Control Act Risk Evaluations.  The U.S. Environmental Protection Agency (EPA) requested that the National Academies convene a committee to review EPA’s 2018 guidance document on Application of Systematic Review in TSCA Risk Evaluations and associated...

On July 27, 2021, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) will hold a public meeting to engage with interested stakeholders on the development of a proposed rule for implementing a tiered data collection strategy to help inform EPA’s prioritization, risk evaluation, and risk management activities for chemical substances or mixtures under the Toxic Substances Control Act (TSCA). According to EPA, it currently...

The U.S. Environmental Protection Agency (EPA) announced on May 27, 2021, that it has invited environmental justice communities and stakeholders to participate in environmental justice consultations regarding the development of a proposed risk management action under Section 6(a) of the Toxic Substances Control Act (TSCA) to address unreasonable risks presented by N-methylpyrrolidone (NMP). EPA will hold two identical consultation webinars, one on July 7, 2021, and the other on July...

On May 21, 2021, the U.S. Environmental Protection Agency (EPA) published its response to a portion of the petition it received February 8, 2021, from People for Protecting Peace River, Center for Biological Diversity, and 16 other organizations. 86 Fed. Reg. 27546. While the petition requested three actions related to the Toxic Substances Control Act (TSCA), EPA states that it has determined that only one of those actions is an appropriate request: a request to issue a test rule under TSCA...

On May 18, 2021, the U.S. Environmental Protection Agency (EPA) invited environmental justice communities and stakeholders to participate in environmental justice consultations regarding the development of proposed risk management actions under Section 6(a) of the Toxic Substances Control Act (TSCA) to address unreasonable risks presented by trichloroethylene (TCE) and perchloroethylene (PCE). EPA will hold two identical consultation webinars, one on June 16, 2021, and the other on July 6,...

The U.S. Environmental Protection Agency (EPA) announced on May 7, 2021, that it is partnering with the People for the Ethical Treatment of Animals (PETA) Science Consortium International, Unilever, and Syngenta on a three-part virtual workshop series on “Using In Silico and In Vitro Approaches for Next Generation Risk Assessment of Potential Respiratory Toxicants.”  EPA states that this webinar series supports its commitment “to collaborate with partners and stakeholders to reduce,...

The U.S. Environmental Protection Agency (EPA) announced on April 1, 2021, that it is extending the public comment period for a manufacturer-requested risk evaluation of octahydro-tetramethyl-naphthalenyl-ethanone (OTNE), a category of chemical substances consisting of four inseparable individual isomers.  As reported in our February 18, 2021, blog item, EPA notes that two chemicals in the OTNE category are considered persistent, bioaccumulative, and toxic (PBT)...

As reported in our March 9, 2021, blog item, the U.S. Environmental Protection Agency (EPA) announced on March 8, 2021, that “in accordance with Biden-Harris Administration executive orders and directives,” it is asking for additional public input on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, under the Toxic Substances Control Act (TSCA).  On March 16, 2021, EPA announced that comments on the final rules are...

The U.S. Environmental Protection Agency (EPA) announced on February 19, 2021, that it is inviting small businesses, governments, and not-for-profits to participate as Small Entity Representatives (SER) to provide advice and recommendations to a Small Business Advocacy Review (SBAR) Panel for C.I. Pigment Violet 29 (PV29).  The Panel will focus on EPA’s development of a proposed rule to address unreasonable risks identified in EPA’s recently completed Toxic Substances Control Act (TSCA)...

The U.S. Environmental Protection Agency (EPA) announced on February 19, 2021, that it is extending the public comment period on proposed updates to the Toxic Substances Control Act (TSCA) fees rule to give stakeholders more time to review and comment.  The current comment period was set to close on February 25, 2021.  EPA is extending the comment period an additional 30 days.  Information on the proposed updates is available in our December 30, 2020, memorandum, “EPA Intends Proposed...

 The U.S. Environmental Protection Agency (EPA) announced on February 18, 2021, that it is opening a public comment period for a manufacturer-requested risk evaluation of octahydro-tetramethyl-naphthalenyl-ethanone (OTNE), a category of chemical substances consisting of four inseparable individual isomers.  EPA notes that two chemicals in the OTNE category are considered persistent, bioaccumulative, and toxic (PBT) chemicals under TSCA, “meaning they are toxic, can remain in the...

The U.S. Environmental Protection Agency (EPA) published on February 8, 2021, a periodic update of the Toxic Substances Control Act (TSCA) confidential business information (CBI) review statistics.  TSCA Section 14(g)(1) requires that EPA, within 90 days of receipt of a CBI claim: Review and make determinations on CBI claims for chemical identity after the chemical substance has been offered for commercial distribution; and Review and make determinations on a representative subset of...

In the 21st century, we take as given a continuous stream of new and better products. From electronics to building materials to transportation solutions, the flow of new and better products and applications seems unending. New chemical substances play a fundamental role in creating those products and making existing products better. If the pipeline of new chemicals were closed off, the flow of new products and applications would slow to a trickle and eventually dry up. Modern life as we know it...

The U.S. Environmental Protection Agency (EPA) will hold a webinar on February 3, 2021, “to educate stakeholders on the risk management process under the Toxic Substances Control Act (TSCA) and the findings in the final risk evaluation for Asbestos Part 1:  Chrysotile Asbestos.”  EPA states that the webinar will also give the public an opportunity to provide input on considerations the agency should take into account for managing these unreasonable risks.  Stakeholders who wish to...

The U.S. Environmental Protection Agency (EPA) announced on January 15, 2021, that it has issued test orders under Section 4 of the Toxic Substances Control Act (TSCA) to obtain additional data on nine of the next 20 chemicals undergoing risk evaluation.  EPA states that after reviewing the 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 environmental hazard and...

On January 11, 2021, the U.S. Environmental Protection Agency (EPA) published a proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule.  86 Fed. Reg. 1890.  Under TSCA, EPA collects fees from chemical manufacturers and processors to help fund implementation and to ensure that public health and the environment continue to be protected.  TSCA requires EPA to review its fees every three years and, after consulting with parties potentially...

The U.S. Environmental Protection Agency (EPA) will hold webinars on February 2, 2021, and February 18, 2021, to consult with environmental justice communities on risk management for the cyclic aliphatic bromide cluster (HBCD) and carbon tetrachloride.  The webinars will focus on the environmental justice impacts of EPA’s development of proposed rules to address the unreasonable risks identified in the final TSCA risk evaluations for these chemicals.  EPA states that both sessions will...

On December 21, 2020, the U.S. Environmental Protection Agency (EPA) announced that a report compiling the letter peer reviewers’ comments on the revised draft Toxic Substances Control Act (TSCA) risk evaluation of C.I. Pigment Violet 29 (PV29) is now available in Docket EPA-HQ-OPPT-2018-0604.  EPA states that it is in the process of reviewing the letter peer reviewers’ comments and will use the feedback received from the peer review and public comments to inform the final risk...

On December 21, 2020, the U.S. Environmental Protection Agency (EPA) released a proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule.  According to EPA, the proposed rule “reflects real-world situations, narrows the broad scope of current requirements, significantly reduces the burden on American businesses, and increases the flexibility for surrounding TSCA fees requirements.”  Under TSCA, EPA collects fees from chemical...

On December 14, 2020, the U.S. Environmental Protection Agency (EPA) released the final risk evaluation for perchloroethylene.  The final risk evaluation determined that there are unreasonable risks to workers, occupational non-users (ONU), consumers, and bystanders from 59 out of 61 conditions of uses: Consumers and Bystanders:  EPA found unreasonable risks to consumers and bystanders from all consumer uses of perchloroethylene.  Common consumer uses include as a dry...

The U.S. Environmental Protection Agency (EPA) announced on December 8, 2020, that it received a complete manufacturer request to conduct a risk evaluation of octahydro-tetramethyl-naphthalenyl-ethanone (OTNE), a category of chemical substances consisting of four inseparable individual isomers.  International Flavors and Fragrances, Inc., Privi Organics USA Corporation, and DRT America, Inc. formally requested the risk evaluation through the OTNE Consortium managed by B&C® Consortia...

On November 25, 2020, the U.S. Environmental Protection Agency (EPA) released updates to the interim final list of manufacturers and importers subject to fees for the next 20 chemicals undergoing risk evaluation under Section 6(b) of the Toxic Substances Control Act.  According to EPA, “[t]he updated list includes additional manufacturers not identified on the final list of companies and removes manufacturers that self-identified in error or imported the chemical solely for the...

The U.S. Environmental Protection (EPA) will hold a webinar on December 10, 2020, to educate stakeholders on the risk management process under the Toxic Substances Control Act (TSCA) and the findings in the final risk evaluation for carbon tetrachloride.  The webinar will also provide an opportunity for the public to provide input on considerations EPA should take into account for managing these unreasonable risks.  Registration is open.  Stakeholders who would like to provide oral...

The U.S. Environmental Protection Agency (EPA) has extended the comment period for the revised draft risk evaluation for C.I. Pigment Violet 29 (PV29).  85 Fed. Reg. 74718.  As reported in our October 29, 2020, blog item, EPA states that after it issued a draft risk evaluation in November 2018, it received additional data on PV29 in response to test orders, as well as additional information voluntarily submitted by the sole U.S. manufacturer.  EPA’s updated analysis, reflected in the...

The U.S. Environmental Protection Agency (EPA) announced on November 9, 2020, that it is inviting small businesses, governments, and not-for-profits to participate as Small Entity Representatives (SER) to provide advice and recommendations to a Small Business Advocacy Review (SBAR) Panel for the cyclic aliphatic bromide cluster (HBCD).  The Panel will focus on EPA’s development of a proposed rule to address unreasonable risks identified in EPA’s recently completed Toxic Substances Control...

The U.S. Environmental Protection Agency (EPA) announced on November 3, 2020, that it will hold webinars to consult with environmental justice communities on risk management for methylene chloride and 1-bromopropane (1-BP).  EPA states that the webinars are open to the public and will focus on the environmental justice impacts of EPA’s development of proposed rules to address the unreasonable risks identified in the final Toxic Substances Control Act (TSCA) risk evaluations for these...

The U.S. Environmental Protection Agency (EPA) announced on October 29, 2020, that it is releasing a revised draft risk evaluation for C.I. Pigment Violet 29 (PV29) for public comment and peer review under the Toxic Substances Control Act (TSCA).  EPA states that after it issued a draft risk evaluation in November 2018, it received additional data on PV29 in response to test orders, as well as additional information voluntarily submitted by the sole U.S. manufacturer.  According to EPA,...

After reading the article below by Jeffery Morris, former Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT), we were inspired to post it.  We appreciate having the opportunity to share his analysis with our audience. TSCA as a Gap-Filling Statute:  Potentially Exposed and Susceptible Subpopulations By Jeffery Morris, PhD In its response to public comments on the scope documents for its next twenty chemical risk evaluations...

The U.S. Environmental Protection Agency (EPA) granted on October 6, 2020, a manufacturer request for a risk evaluation of octamethylcyclotetra-siloxane (D4), a chemical used to make other silicone chemicals and as an ingredient in some personal care products.  Through the American Chemistry Council’s Silicones Environmental, Health, and Safety Center, Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones...

The U.S. Environmental Protection Agency (EPA) is accepting public comments for all candidates under consideration for membership on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC).  Biographies for all candidates are available in Docket ID EPA-HQ-OPPT-2020-0135.  When providing comments, EPA states that stakeholders should not submit electronically any information considered to be confidential business information (CBI) or other information whose...

On September 24, 2020, the U.S. Environmental Protection Agency (EPA) published the final risk evaluation for cyclic aliphatic bromide cluster (HBCD).  EPA found unreasonable risks to the environment from six out of 12 conditions of use and unreasonable risks to workers and occupational non-users (ONU) from the use and disposal of HBCD in building and construction materials.  EPA found no unreasonable risks to the general population and no unreasonable risks to consumers.  EPA’s next step...

The U.S. Environmental Protection Agency (EPA) posted a September 2, 2020, blog item by Alexandra Dapolito Dunn, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, entitled “Advancing Chemical Safety by Listening to You.”  Dunn describes how EPA will move from risk evaluation to risk management.  As reported in our September 9, 2020, blog item, EPA will hold webinars on September 16 and September 30, 2020, on its final risk...

On August 26, 2020, the U.S. Environmental Protection Agency (EPA) released an interim final list of businesses subject to fees for the 20 chemicals designated as high priority for risk evaluation under the Toxic Substances Control Act (TSCA).  EPA notes that the interim list is an updated version of the preliminary list released in January 2020.  According to EPA, making the interim final list available now gives businesses and other stakeholders an opportunity to review the list for...

Jeff Morris, former Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT), wrote a column published on August 18, 2020, by Chemical Watch.  In the column, “Expert Focus:  Community-based exposures and susceptibilities -- a social justice challenge for TSCA implementation,” Morris discusses how risk evaluations conducted under the Toxic Substances Control Act (TSCA) provide an opportunity to address community exposures and...

On August 17, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) published a report entitled Lack of Planning Risks EPA’s Ability to Meet Toxic Substances Control Act Deadlines.  OIG conducted the audit to determine whether EPA met the deadlines already imposed by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) in 2016, which amended the Toxic Substances Control Act (TSCA), and has the staff, resources, and...