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 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 evaluations on the first ten chemical assessments and more recent recommendations from the National Academies of Sciences, Engineering, and Medicine (NASEM) review of the Application of Systematic Review in TSCA Risk Evaluations. EPA states that in addition to the revised, generic approach, the peer review package will include appendices containing chemical-specific information that is relevant for search strings and screening statements and data evaluation criteria for the next chemical risk evaluations being conducted by the Office of Pollution Prevention and Toxics (OPPT). The Draft Protocol provides specific details of the systematic reviews for the individual chemicals listed below:

o-Dichlorobenzene
p-Dichlorobenzene
1,2-Dichloroethane
trans-1,2- Dichloroethylene
1,1,2-Trichloroethane
1,2-Dichloropropane
1,1-Dichloroethane
Ethylene dibromide
1,3-Butadiene
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB)
4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA)
Tris(2-chloroethyl) phosphate (TCEP)
Phosphoric acid, triphenyl ester (TPP)
Formaldehyde
Phthalic anhydride
Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic acid, 1,2- dibutyl ester)
Butyl benzyl phthalate (BBP) -- 1,2-Benzene-dicarboxylic acid, 1-butyl 2(phenylmethyl) ester
Di-ethylhexyl phthalate (DEHP) -- (1,2-Benzene-dicarboxylic acid, 1,2-bis(2-ethylhexyl) ester)
Di-isobutyl phthalate (DIBP) -- (1,2-Benzene-dicarboxylic acid, 1,2-bis-(2-methylpropyl) ester)
Dicyclohexyl phthalate
Diisodecyl phthalate (DIDP)
Diisononyl phthalate (DINP)
Octamethylcyclotetra-siloxane (Cyclotetrasiloxane, 2,2,4,4,6,6,8,8-octamethyl-) (D4)
Asbestos 2 (including Libby Amphibole Asbestos [LAA] and its tremolite, winchite, and richterite constituents)
1,4-Dioxane supplement
 
EPA invites the public to provide input on the Draft Protocol via Docket No. EPA-HQ-OPPT-2021-0414. Comments are due February 18, 2022.
SACC will hold a virtual three-day peer review public meeting to consider and review the Draft Protocol on April 19-21, 2022. Stakeholders must register online to receive the webcast meeting link and audio teleconference information. Registration instructions will be announced on the SACC website by early March 2022. After the public meeting, SACC will prepare meeting minutes summarizing its recommendations to EPA. The meeting minutes will be posted on the SACC website and in the relevant docket.
 
More information and a detailed commentary will be available in a forthcoming memorandum that will be posted on our website.

 

By Lynn L. Bergeson and Carla N. Hutton

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 (2070-AK62): EPA is developing this rule to obtain information about potential hazards and exposure pathways related to certain chemicals, particularly occupational, environmental, and consumer exposure information. EPA states that this information is needed to inform prioritization, risk evaluation, and risk management of the chemical substances under TSCA Section 6. EPA intends to publish a notice of proposed rulemaking (NPRM) in July 2022 and a final rule in March 2023. More information on the rulemaking is available in our July 29, 2021, memorandum;
     
  • Revisions to the TSCA Fees Rule (2070-AK64): In January 2021, EPA proposed updates and adjustments to the 2018 TSCA Fees Rule. EPA proposed to add three new fee categories: a Bona Fide Intent to Manufacture or Import Notice, a Notice of Commencement of Manufacture or Import, and an additional fee associated with test orders. In addition, EPA proposed exemptions for entities subject to certain fee triggering activities, including: an exemption for research and development activities; an exemption for entities manufacturing less than 2,500 pounds of a chemical subject to an EPA-initiated risk evaluation fee; an exemption for manufacturers of chemical substances produced as a non-isolated intermediate; and exemptions for manufacturers of a chemical substance subject to an EPA-initiated risk evaluation if the chemical substance is imported in an article, produced as a byproduct, or produced or imported as an impurity. EPA proposed a volume-based fee allocation for EPA-initiated risk evaluation fees in any scenario where a consortium is not formed and proposed to require export-only manufacturers to pay fees for EPA-initiated risk evaluations. EPA states that in light of public comments, it has decided to issue a supplemental proposal and seek additional public comment on changes to the January 2021 proposal. EPA intends to issue a supplemental NPRM in February 2022. EPA has not determined when it will issue a final rule. More information on the proposed rule is available in our December 30, 2020, memorandum;
     
  • New Chemicals Procedural Regulations to Reflect Amendments to TSCA (2070-AK65): This rulemaking seeks to revise the new chemicals procedural regulations in 40 C.F.R. Part 720 to improve the efficiency of EPA’s review process and to align its processes and procedures with the new statutory requirements. According to EPA, this rulemaking seeks to increase the quality of information initially submitted in new chemicals notices and improve its processes “to reduce unnecessary rework in the risk assessment and, ultimately, the length of time that new chemicals are under review.” EPA intends to publish an NPRM in September 2022. EPA has not determined when it will issue a final rule;
     
  • Procedures for Submitting Information Subject to Business Confidentiality Claims Under TSCA (2070-AK68): EPA states that it is considering proposing new and amended rules concerning the assertion and maintenance of claims of business confidentiality (i.e., confidential business information (CBI)) under TSCA. The 2016 TSCA amendments included several new provisions concerning the assertion and EPA review and treatment of confidentiality claims. EPA is considering procedures for submitting and supporting such claims in TSCA submissions, including substantiation requirements, exemptions, electronic reporting enhancements, and maintenance or withdrawal of confidentiality claims. EPA is also considering whether the proposed rule should elaborate on EPA’s procedures for reviewing and communicating with TSCA submitters about confidentiality claims. According to EPA, it expects the proposed rule to include new provisions, as well as revisions to existing rules on asserting confidentiality claims to conform to the 2016 amendments. EPA intends to issue an NPRM in April 2022;
     
  • Cyclic Aliphatic Bromide Cluster (HBCD); Rulemaking Under TSCA Section 6(a) (2070-AK71): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for HBCD, EPA initiated rulemaking to address unreasonable risks of injury to health and the environment identified in the final risk evaluation. EPA intends to publish an NPRM by September 2022 and a final rule by April 2024. More information on the final risk evaluation is available in our September 28, 2020, memorandum;
     
  • 1-Bromopropane; Rulemaking Under TSCA Section 6(a) (2070-AK73): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for 1-bromopropane, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM in October 2022 and a final rule in May 2024. More information on the final risk evaluation is available in our August 11, 2020, memorandum;
     
  • Carbon Tetrachloride; Rulemaking Under TSCA Section 6(a) (2070-AK82): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for carbon tetrachloride, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM in October 2022 and a final rule in June 2024. More information on the final risk evaluation is available in our November 4, 2020, memorandum;
     
  • Trichloroethylene (TCE); Rulemaking Under TSCA Section 6(a) (2070-AK83): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for TCE carried out under the authority of TSCA Section 6, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM in October 2022 and a final rule in June 2024. More information on the final risk evaluation is available in our November 24, 2020, memorandum;
     
  • Asbestos (Part 1: Chrysotile Asbestos); Rulemaking under TSCA Section 6(a) (2070-AK86): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for chrysotile asbestos, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM by April 2022 and a final rule by November 2023. More information on the final risk evaluation is available in our January 4, 2021, memorandum;
     
  • Reconsideration of Procedures for Chemical Risk Evaluation Under the Amended TSCA (2070-AK90): EPA published a final rule on July 20, 2017, that established a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. This process incorporates the science requirements of the amended statute, including best available science and weight of the scientific evidence. The final rule established the steps of a risk evaluation process, including: scope, hazard assessment, exposure assessment, risk characterization, and risk determination. EPA states that it is now in the process of reconsidering the final rule in keeping with new executive orders (EO) concerning the advancement of racial equity and support for underserved communities through the federal government (EO 13985), the protection of public health and the environment and restoring science to tackle the climate crisis (EO 13990), tackling the climate crisis at home and abroad (EO 14008), and other Administration priorities (such as the Presidential memorandum on restoring trust in government through scientific integrity and evidence-based policymaking). If EPA determines to amend the 2017 final rule based on its reconsideration, it will solicit public comment through an NPRM. EPA intends to publish an NPRM in September 2022;
     
  • Regulation of Persistent, Bioaccumulative, and Toxic (PBT) Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate (3:1) (PIP (3:1)); Further Compliance Date Extension (2070-AK95): EPA proposed in October 2021 to amend the regulations applicable to PIP (3:1) promulgated under TSCA. Specifically, EPA proposes 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 notes 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 follows a recently-issued 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. Comments on the proposed rule are due December 27, 2021. EPA intends to issue a final rule in March 2022. More information on the proposed rule is available in our October 25, 2021, memorandum; and
     
  • TSCA Section 8(a) Reporting and Recordkeeping Requirements for Asbestos (2070-AK99): This rulemaking, under the authority of TSCA Section 8(a), would require the maintenance of records and submission to EPA of reports by manufacturers, importers, and processors of asbestos and mixtures and articles containing asbestos (including as an impurity). EPA states that the information sought includes data on the quantities of asbestos used in making products, employee exposure data, and waste disposal data. Reported information would be used by EPA and other federal agencies in considering the regulation of asbestos. EPA intends to issue an NPRM in March 2022 and a final rule in November 2022.

The Unified Agenda lists the following TSCA rulemaking at the final stage:

  • Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices (PMN) (2070-AJ94): EPA proposed amending components of the Significant New Uses of Chemical Substances regulations at 40 C.F.R. Part 721, specifically the “Protection in the Workplace” (40 C.F.R. Section 721.63) and “Hazard Communication Program” (40 C.F.R. Section 721.72). 81 Fed. Reg. 49598. The proposed changes are intended to align, where possible, EPA’s regulations with the revised Occupational Safety and Health Administration (OSHA) regulations at 29 C.F.R. Section 1910.1200. OSHA issued a final rule on March 26, 2012, (77 Fed. Reg. 17573) that aligns OSHA’s Hazard Communication Standards with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). EPA states that it is reviewing the comments received and is planning to issue a final rule. EPA intends to issue a final rule in September 2022. More information on EPA’s 2016 proposed rule is available in our July 29, 2016, memorandum.

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 30, 2021, the release of the National Academies of Sciences, Engineering, and Medicine’s (NASEM) external peer review report of the Office of Research and Development (ORD) Staff Handbook for Developing Integrated Risk Information System (IRIS) Assessments (IRIS Handbook). EPA states that the IRIS Handbook provides standard operating procedures for staffers developing IRIS assessments and includes systematic review approaches that promote consistency and ensure that contributors understand how the assessment components are developed.
 
The NASEM committee found that the IRIS Handbook “reflects the significant improvements that EPA has made in its IRIS assessment process.” For instance, according to the report, the IRIS Handbook describes the inclusion of “sophisticated, state-of-the-art methods that use systematic evidence maps to summarize literature characteristics for scoping and systematic review methods for hazard identification.” The committee acknowledges that the IRIS program is “clearly helping” to advance the science of systematic review as applied to hazard identification. The report states that the committee “recognizes that EPA faces challenges in implementing many of the methods for the IRIS assessment process and is impressed and encouraged by the progress that the IRIS program has made to date.” The committee suggests that the methods for developing IRIS assessments can serve as a model for other EPA programs implementing systematic review methods.
 
The committee found that the Handbook does not consistently convey the strengths and advances in methodology for the IRIS assessment process in an even and clear manner, however. The report includes the committee’s recommendations to ensure the IRIS Handbook meets its objectives of providing transparency about the IRIS assessment process and providing operational instructions for those conducting the assessments.


 

By Lynn L. Bergeson and Carla N. Hutton
 
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 Fed. Reg. 59382. EPA states that individuals nominated should have expertise in one or more of the following areas:

  • Systematic review: Individuals nominated for peer review of the draft systematic review protocol should have expertise in one or more of the following areas: systematic review approaches of human health and ecological hazard, exposure topics, and fate. All experts, including those representing other fields of interest, who have experience with engineering, machine learning, artificial intelligence techniques, and natural language processing approaches as applied to systematic review are also needed. EPA states that understanding the TSCA risk evaluation process “is highly desirable for the context of this peer review.”
  • Exposures to fenceline communities: Individuals nominated for peer review of the draft EPA TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities should have expertise in one or more of the following areas: chemical fate and transport via ambient air and water pathways; atmospheric modeling of fate, transport, and human exposures; human health, exposure, and risk assessment for airborne and/or waterborne chemicals; expertise estimating environmental air releases of chemicals from a variety of sources and databases such as Chemical Data Reporting (CDR); experience developing air dispersion methodologies and/or models to estimate ambient air concentrations and impacts to human populations; expertise estimating environmental water releases of chemicals from a variety of sources and databases such as CDR, Toxics Release Inventory (TRI), and Discharge Monitoring Report; experience developing methodologies and/or models to estimate chemical concentrations in ambient/source/drinking water and impacts to human populations; and public health protection for at-risk communities.

EPA states that any interested person or organization may nominate qualified individuals to be considered prospective candidates for these reviews. Individuals may also self-nominate. Nominations are due November 17, 2021.


 

By Lynn L. Bergeson and Carla N. Hutton
 
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 Environmental Response, Compensation, and Liability Act (CERCLA) to strengthen the ability to hold polluters financially accountable;
  • Timelines for action -- whether it is data collection or rulemaking -- on Effluent Guideline Limitations under the Clean Water Act (CWA) for nine industrial categories;
  • A review of past actions on PFAS taken under the Toxic Substances Control Act (TSCA) to address those that are insufficiently protective;
  • Increased monitoring, data collection, and research so that EPA can identify what actions are needed and when to take them;
  • A final toxicity assessment for GenX that can be used to develop health advisories that will help communities make informed decisions the better to protect human health and ecological wellness; and
  • Continued efforts to build the technical foundation needed on PFAS air emissions to inform future actions under the Clean Air Act (CAA).

EPA also released a national PFAS testing strategy that will require PFAS manufacturers to provide toxicity data and information on categories of PFAS chemicals to inform future regulatory efforts. EPA states that it will select the PFAS to be tested “based on an approach that breaks the large number of PFAS into smaller categories based on similar features and considers what existing data are available for each category.” According to EPA, it will “strategically” select the initial set of test orders from more than 20 different categories of PFAS. EPA expects to use its TSCA Section 4 order authority to require PFAS manufacturers to conduct and fund the studies. EPA plans to issue the first round of test orders by the end of 2021 with additional phases thereafter. More information and a detailed commentary will be available in a forthcoming memorandum that will be posted on our website.


 

By Lynn L. Bergeson and Carla N. Hutton
 
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 include:

  • Twenty chemicals designated by EPA as high-priority substances and currently undergoing risk evaluation under the Toxic Substances Control Act (TSCA). The deadline for manufacturers to submit studies on these chemicals will be December 1, 2021. EPA states that this deadline “ensures that health and safety studies will be received in time for use in risk evaluations on these chemical substances.”
     
  • Thirty organohalogen flame retardants being evaluated for health risks by the Consumer Product Safety Commission (CPSC) under the Federal Hazardous Substances Act (FHSA). The deadline for manufacturers to submit studies on these chemicals will be January 25, 2022.

EPA will publish a notice in the Federal Register extending the deadline. A pre-publication version of the notice is available on EPA’s website. EPA has also posted a “historic” question and answer document about reporting under TSCA Section 8(d). Detailed information about the reporting rule is available in our June 29, 2021, memorandum, “Manufacturers and Importers of 20 High-Priority Chemicals and 30 Organohalogen Flame Retardants Must Submit Data to EPA.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 8, 2021, the availability of the draft scope of the risk evaluation to be conducted for octamethylcyclotetra-siloxane (D4). 86 Fed. Reg. 50347. As reported in our October 7, 2020, blog item, 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 of America, Inc., and Wacker Chemical Corporation requested a risk evaluation of D4 pursuant to Section 6 of the Toxic Substances Control Act (TSCA). The draft scope document includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA plans to consider in conducting the risk evaluation for this chemical substance. EPA is also opening a 45-calendar day comment period on the draft scope to allow for the public to provide additional data or information that could be useful in preparing the final scope document. Comments are due October 25, 2021.
 
EPA plans to evaluate manufacturing (including importing); processing; distribution in commerce; industrial, commercial, and consumer uses; and disposal of D4 in the risk evaluation. According to the draft scope document, D4 is manufactured (including imported) in the United States. The chemical is processed as a reactant; incorporated into a formulation, mixture, or reaction product; and incorporated into articles. The draft scope document states that the identified processing activities also include the repackaging and recycling of D4. D4 is primarily used to make other silicone chemicals and as an ingredient in consumer products regulated by the Federal Food, Drug, and Cosmetic Act (FFDCA). Commercial uses include adhesives and sealants, automotive care products, paints and coatings, and other plastic and rubber products. Additional consumer uses include adhesives and sealants, automotive care products, laundry and dishwashing products, paints and coatings, and other plastic and rubber products.
 
EPA notes that some of these conditions of use were identified in the manufacturer request as circumstances on which EPA was requested to conduct a risk evaluation. EPA identified other conditions of use from information reported to EPA through Chemical Data Reporting (CDR), published literature, and consultation with stakeholders for both uses currently in production and uses whose production may have ceased. EPA presented the proposed additions of these EPA-identified conditions of use and the basis for these proposed additions, along with the manufacturer request, for a 45-day comment period in June 2020.


 

By Lynn L. Bergeson and Carla N. Hutton
 
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 plastic coating to increase flexibility.”
 
According to EPA, the final scope documents reflect the policy changes on risk evaluations announced in June 2021. This includes plans to consider exposure pathways that may be regulated outside of TSCA, like air and water, and potential for exposures to fenceline communities (i.e., communities near industrial facilities). EPA states that “[a]ssumptions that personal protective equipment (PPE) in occupational settings will always be properly utilized will not be used as the basis for the risk determination. Use of PPE, and other ways industry protects its workers, will be assessed during the risk evaluation and considered as potential ways to address unreasonable risks during the risk management process.” More information on the policy changes is available in our July 1, 2021, memorandum.
 
The final scope documents explain EPA’s plan for the risk evaluations, including the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA will consider. The documents also include a description of the reasonably available information and the best available science approaches that EPA will use; a conceptual model that outlines the potential hazards and exposures throughout the life cycle of the chemical; an analysis plan to identify the approaches and methods EPA will use to assess health and environmental risks; and a plan for peer review. More information will be available in a forthcoming memorandum that will be posted on our website.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On August 19, 2021, the U.S. Environmental Protection Agency (EPA) announced a collaborative agreement with Unilever to explore better ways to assess chemical risks associated with consumer products. According to EPA, this agreement builds on prior cooperation between EPA and Unilever regarding New Approach Methods (NAM), “which are a promising alternative to conventional toxicity testing that are intended to reduce reliance on the use of animals.” EPA states that the collaboration aims to establish a framework for the Next Generation of Risk Assessments based on NAMs. The collaboration will bring together more than $2 million in both monetary and in-kind contributions, including scientific expertise and equipment, to develop a comprehensive NAMs dataset for a minimum of 40 chemicals. According to EPA, the chemicals will be selected and grouped such that half will be benign and the other half will have known adverse implications for human health. These chemicals will be tested using a wide variety of NAMs, and the results will be compared between the two groups to determine how well particular NAMs can infer differences in risk. EPA states that these data will be used in case studies to evaluate the potential to use NAMs in regulatory decisions. All data generated through the collaboration will be in the public domain, allowing academic, corporate, government, and nonprofit scientists to use the project results in their own research.
 
EPA states that in addition to the data generated through the collaboration, EPA and Unilever will use chemical data from EPA’s high-throughput screening efforts and the federal government’s Tox21 consortium, which is a collaboration among EPA, the National Institutes of Health (NIH), and the U.S. Food and Drug Administration (FDA). According to EPA, “[t]hese automated chemical screening technologies rapidly test thousands of chemicals for their effects on human cells or cellular components that are critical to normal function.” EPA notes that data from these technologies are then incorporated into computational models to predict potential adverse health effects and estimate the amount of chemical that may cause these effects.


 

By Lynn L. Bergeson and Carla N. Hutton
 
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 pollutants and non-chemical stressors during early lifestages may be crucial determinants of lifetime health. Exposures to cumulative mixtures of chemicals, along with other stressors, such as poverty, limited access to services, and changing environmental conditions, may pose developmental and lifelong health risks. According to EPA, accurate and comprehensive assessments of cumulative impacts are needed to make sound decisions regarding risk reduction, mitigation, and prevention measures. Each center will focus on two individual research projects:

  • Research Triangle Institute (RTI) International, Research Triangle Park, North Carolina:
    • Evaluating the Causal Impacts of Early Life Chemical Exposures on Neurodevelopmental Functioning in Early Childhood -- Researchers will identify the occurrences and types of chemicals found in toddlers’ caregiving environments and evaluate how these cumulative chemical exposures are associated with neurodevelopmental functioning in early childhood; and
    • Investigating Whether the Caregiving Environment Moderates the Impact of Early Life Chemical Exposures on Neurodevelopmental Functioning in Early Childhood -- Researchers will investigate whether home caregiving environments alter the impacts of early life chemical exposures on neurodevelopmental outcomes in early childhood.
  • University of North Carolina (UNC) at Chapel Hill, Chapel Hill, North Carolina:
    • Early Life Exposure and Neurobehavioral Development -- Researchers will leverage an ongoing, longitudinal study of normative brain development, the UNC Baby Connectome Study, to examine the role that early life exposure to phthalates and other chemicals plays in early childhood behavior, memory, language and motor development, and social cognition; and
    • Neural Substrates of Prenatal and Early Life Neurotoxicity Using Non-Invasive Imaging Methods -- Researchers will work to improve the understanding of the relationships between prenatal and early life exposures and structural and functional brain development, particularly in the third trimester of pregnancy, an important time for brain development.

 
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