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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) will hold a webinar on December 6, 2022, to provide an overview to stakeholders about its November 16, 2022, supplemental proposed rule modifying and adjusting certain aspects of the fees rule established under the Toxic Substances Control Act (TSCA). EPA states that it is publishing these changes to ensure that collected fees provide it with 25 percent of authorized TSCA costs consistent with direction in the fiscal year 2022 appropriations bill to consider the “full” implementation costs of the law. According to EPA, updating TSCA fees will strengthen its ability to implement successfully TSCA in a way that is both protective and sustainable and significantly improve on-time performance and quality. The webinar will provide stakeholders an opportunity to provide comment to EPA on the supplemental proposed rule. Registration for the webinar is open. Stakeholders who wish to provide oral comments during the webinar are asked to register by December 1, 2022. Comments on the supplemental proposed rule are due January 17, 2023. More information on the supplemental proposed rule is available in our November 18, 2022, memorandum.

Tags: TSCA, Fees

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 10, 2022, that it is requesting nominations of prospective candidates for membership on the Science Advisory Committee on Chemicals (SACC) established under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 67898. Any interested person or organization may nominate qualified persons to be considered for appointment to the SACC. Individuals may also self-nominate. Nominations are due December 12, 2022.
 
SACC serves as a scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). According to EPA, SACC provides independent scientific advice and recommendations to EPA on the scientific basis for risk assessments, methodologies, and pollution prevention measures and approaches for chemicals regulated under TSCA. Currently, there are 17 SACC members, with eight membership terms that will expire over the next year.
 
EPA states that its “rigorous scientific peer review processes ensure all Agency decisions are founded on credible science and data. Science provides the foundation for EPA policies, actions and decisions made on behalf of the American people.”
 
To be considered, all nominations should include the following information:

  • Current contact information for the nominee (including the nominee’s name, organization, current business address, e-mail address, and daytime telephone number);
  • The nominee’s disciplinary and specific areas of expertise;
  • Research activities;
  • Recent service on other federal advisory committees and national or international professional organizations; and
  • When available, a biographical sketch of the nominee, indicating current position and educational background.

EPA states that it is seeking nominations from individuals who have demonstrated high levels of competence, knowledge, and expertise in scientific and other technical fields relevant to chemical safety and risk assessment. EPA seeks nominees with expertise in a variety of disciplines and focus areas, including human health and ecological risk assessment, biostatistics, epidemiology, pediatrics, physiologically based pharmacokinetics (PBPK), toxicology and pathology (including neurotoxicology, developmental/reproductive toxicology, and carcinogenesis), and chemical exposure pathways to susceptible life stages and subpopulations (women, children, and other potentially exposed subpopulations).
 
EPA states that nominees should have backgrounds and experiences that would contribute to the diversity of scientific viewpoints on the committee -- including professional experiences in government, labor, public health, public interest, animal protection, industry, and other groups -- and as the EPA Administrator determines to be advisable (e.g., geographical location; social and cultural backgrounds; and professional affiliations).


 

By Lynn L. Bergeson and Carla N. Hutton
 
On November 21, 2022, the U.S. Environmental Protection Agency (EPA) announced that it has improved public access to certain reports submitted by chemical companies in ChemView, EPA’s web application for public access to non-confidential business information (non-CBI) on chemicals regulated under the Toxic Substances Control Act (TSCA), including new chemical notices and notices of substantial risk. EPA has published previously unpublished new chemical notices received under TSCA Section 5 and notices of substantial risk provided by companies under TSCA Section 8(e). EPA states that going forward, it will continue to identify older, previously submitted unpublished information to make available in ChemView and will publish newly received TSCA Section 5 notices and TSCA Section 8(e) reports on a “near real-time basis.” EPA has also published in ChemView chemical health and safety studies received under TSCA Section 8(d).
 
New Chemical Submissions
 
TSCA Section 5 requires EPA to publish a list of new chemical submissions it has received, including premanufacture notices (PMN), significant new use notices (SNUN), microbial commercial activity notices (MCAN), test market exemption (TME) applications, notices of commencement of manufacture or import (NOC), and test information submitted under Section 5. According to EPA, in 2022 it made available in ChemView more than 25,000 new chemical notice records received under TSCA Section 5, including notices received between 2014 and 2019 that had not been published previously. In 2019, EPA began publishing non-CBI notices on an ongoing basis, and “new records are now generally published within five days of receipt.” EPA states that it will also continue to identify and make public older, previously unpublished new chemicals notices.
 
Notices of Substantial Risk
 
TSCA Section 8(e) requires chemical companies to inform EPA of information that reasonably supports the conclusion that a chemical may present a substantial risk of injury to health or the environment. EPA uses these notices to inform new and existing chemical risk assessment activities. According to EPA, in 2022 it has published 3,900 notices of substantial risk records received under TSCA Section 8(e) in ChemView, including more than 3,300 non-CBI notices submitted between January 1, 2019, and December 20, 2021, that were not previously published due to resource limitations. EPA states that over the next several months, it will publish all non-CBI versions of Section 8(e) notices received from December 20, 2021, to the present. Going forward, “EPA will strive to publish 8(e) notices deemed complete within a week of receiving them from companies.” Additionally, EPA will work to identify and publish Section 8(e) notices received before 2019 as resources allow.
 
Health and Safety Data Reporting
 
Regulations promulgated under TSCA Section 8(d) require chemical companies to submit lists and copies of health and safety studies relating to the health and/or environmental effects of specified chemical substances and mixtures. According to EPA, in 2022 it published more than 1,700 health and safety study records received since September 2021 under TSCA Section 8(d) in ChemView. EPA notes that many of these records were in response to EPA’s 2021 Section 8(d) rulemaking, Health and Safety Data Reporting; Addition of 20 High-Priority Substances and 30 Organohalogen Flame Retardants. EPA states that it expects to publish additional Section 8(d) records “in the future.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On October 18, 2022, the U.S. Environmental Protection Agency’s (EPA) New Chemicals Program held a webinar on EPA’s process for assessing the potential risks of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) and the types of data EPA considers in this assessment. Specifically, the webinar covered examples of data (quantitative and qualitative) that are not likely to be accepted for engineering assessment, considerations EPA makes when evaluating data, and clarifications of common misconceptions in EPA’s new chemical assessments. The webinar was the second in a series of webinars intended to increase the efficiency and transparency of EPA’s new chemical determinations. EPA will hold a third webinar to communicate additional information intended to help submitters of new chemicals supplement complete initial review submissions. EPA will post information on the third webinar as it becomes available. In July 2022, EPA hosted the first webinar, analyzing common issues that cause EPA to have to rework risk assessments. More information on the first webinar is available in our July 28, 2022, memorandum. The slides for the second webinar are available online.
 
The webinar included several case studies from past TSCA Section 5 submissions. The case studies discuss how EPA evaluates submitted information and determines whether it is acceptable for the engineering assessment. According to EPA, worker inhalation exposure from particulates is a frequent area of rework. EPA selected several case studies to cover situations where submitter claims were either accepted or not accepted and provided rationales for each type of determination. EPA expects manufacturing, processing, and use operations involving handling, transferring, unloading, or loading the new chemical substances (NCS) in solid forms to present potential exposure for workers to total and respirable particles. In the absence of specific and substantiated information from the submitter, EPA will assess inhalation exposure to total and respirable particulates using either the applicable Organization for Economic Cooperation and Development (OECD) Emission Scenario Documents (ESD) or the Occupational Safety and Health Administration (OSHA) Particulates Not Otherwise Regulated (PNOR) Total and Respirable Dust, Permissible Exposure Limit (PEL) Model.
 
A more detailed summary of the webinar and an insightful commentary are available in our October 25, 2022, memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will host a webinar on October 18, 2022, on EPA’s process for assessing the potential risks of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) and the types of data EPA considers in this assessment. The webinar will cover examples of quantitative and qualitative data unlikely to be accepted for engineering assessment, considerations EPA makes when evaluating data, and clarifications of common misconceptions in EPA’s new chemical assessments.
 
As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe to stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker exposure) provided for new chemical submissions and common issues that cause EPA to have to reconduct risk assessments (“rework”). The goal of this effort is to prevent delays of EPA’s new chemical reviews caused by rework.
 
This will be the second in a series of webinars intended to increase the efficiency and transparency of EPA’s new chemical determinations. As reported in our July 28, 2022, memorandum, in July 2022, EPA hosted the first webinar, analyzing common issues that cause EPA to have to rework risk assessments. Meeting materials are available for those who missed the first webinar.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On August 25, 2022, the U.S. Environmental Protection Agency (EPA) announced that registration was open for the 2022 Conference on the State of the Science on Development and Use of New Approach Methods (NAM) for Chemical Safety Testing. EPA notes that there will be limited availability in person at EPA headquarters in Washington, DC, on October 12-13, 2022, and a virtual option will also be available. Conference topics include:

  • Variability and Relevance of Traditional Toxicity Tests;
  • Evolution of Validation and Scientific Confidence Frameworks to Incorporate 21st Century Science; and
  • Breakout groups discussing Variability of Traditional Toxicity Tests, Relevance of Traditional Toxicity Tests, and Feedback on EPA Scientific Confidence Framework.

EPA asks that attendees register for the NAMs conference before October 7, 2022.
 
On October 18, 2022, EPA will provide training on the Computational Toxicology (CompTox) Chemicals Dashboard, which is part of a suite of databases and web applications developed by EPA to support the development of innovative methods to evaluate chemicals for potential health risks. The computational toxicology tools and data in the Dashboard help prioritize chemicals based on potential health risks. Specifically targeted for decision-makers, the training will provide:

  • An overview of the Dashboard content and function;
  • Application-oriented use-case demonstrations in the areas of general use, hazard/bioactivity, exposure/absorption, distribution, metabolism, and excretion (ADME)-in vitro to in vivo extrapolation (IVIVE), and chemistry; and
  • Opportunities for participatory learning and engagement.

The training will offer information about the latest release of the Dashboard and how it can be used to gather actionable information about chemical properties and risks through case examples, demonstrations, and hands-on exercises. Registration is now open (attendees must register for the training portions individually):


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on August 22, 2022, that as part of its commitment to re-evaluate policies and practices under the Toxic Substances Control Act (TSCA) New Chemicals Program to ensure they adhere to statutory requirements and the Biden Administration’s executive orders and directives, it has updated its policy to discontinue the use of exposure modeling thresholds when assessing the health and environmental risks of new chemicals under TSCA. According to EPA, due in part to the automation of modeling, it has become less burdensome to complete these calculations. Furthermore, according to EPA, removing the thresholds supports President Biden’s Executive Order 13985, “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government,” which calls on federal agencies to advance equity, including by reviewing and revising as needed government policies and programs impacting underserved communities.
 
The New Chemicals Program will implement this change by making minimal changes to the coding in the New Chemical Review application to remove the thresholds and will update standard operating procedures and training materials for exposure and human health risk assessors. EPA states that it will implement this policy change “as soon as feasible.” According to EPA, despite the resource challenges it is currently facing in the TSCA program, it anticipates that the change “will have minimal impact on the amount of time it takes to complete new chemical reviews and that the benefits gained from a more comprehensive accounting of all potential air and water releases will help ensure any needed protections are in place before a new chemical can come to market.”
 
More information and a detailed commentary that discusses thresholds of toxicological concern (TTC) are available in our August 22, 2022, memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program held a webinar on July 27, 2022, to provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) of new chemicals. In June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker exposure) provided for new chemicals submissions under the Toxic Substances Control Act (TSCA) and common issues that cause EPA to have to rework risk assessments for these submissions. EPA has posted the meeting slides online.
 
During the webinar, EPA presented an example of a rework case. According to EPA, from its analysis, it observes that:

  • Information on material balance parameters, environmental releases, environmental release media, and engineering controls cause nearly 80 percent of all rework;
     
  • In most cases, companies provide additional information that deviates from EPA model defaults and assumptions; and
     
  • Companies often lack understanding on what information is needed for a Section 5 engineering assessment, including the level of detail needed to support their statements relating to environmental release and worker exposure.

As noted in the meeting slides, EPA plans to hold two additional webinars in fall 2022 that will cover:

  • How EPA evaluates quantitative and qualitative information, with examples on the level of detail needed to support the submitted information to be accepted by EPA; and
     
  • The types of information commonly missing in Section 5 submissions, how EPA evaluates environmental release information on sites not controlled by the submitter, and their impact on engineering assessment.

More information is available in our July 28, 2022, memorandum.


 

By Lynn L. Bergeson

The U.S. Environmental Protection Agency (EPA) announced on June 24, 2022, that it is “conducting a broad outreach effort to describe and discuss with stakeholders how the Agency evaluates data provided for new chemicals submissions and common issues that cause EPA to have to reconduct risk assessments (‘rework’) for these submissions.” According to EPA, its goal is to reduce rework of initial risk assessments for new chemicals submissions caused by submitters supplementing incomplete initial new chemicals review submissions, contributing to delays in EPA’s review of these chemicals, and stretching already limited resources. EPA notes that it shares an interest with stakeholders in reducing process inefficiencies while also ensuring a protective review of new chemical risks. EPA states that it anticipates this outreach effort will be “particularly helpful” for Low Volume Exemptions (LVE), which constitute about 60 percent of Toxic Substances Control Act (TSCA) Section 5 submissions annually.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will hold a webinar on Wednesday, July 27, 2022, from 1:00 - 2:00 p.m. (EDT). During the webinar, EPA will provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) before taking questions from the audience. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker exposure) provided for new chemicals submissions under the Toxic Substances Control Act (TSCA) and common issues that cause EPA to have to rework risk assessments for these submissions.
 
Registration for the July 27, 2022, webinar is open. According to EPA, subsequent webinars over the coming months will communicate its considerations in evaluating qualitative claims or quantitative data, especially when they deviate from model defaults such as those used in the Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER) and its considerations for evaluating information about sites not controlled by the submitter. EPA will release information about these webinars, including dates and instructions on how to register, as it becomes available.


 
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