• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 23, 2023, that the New Chemicals Program will hold a webinar on February 28, 2023, 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. EPA states that specifically, the upcoming webinar will cover commonly missed information in Section 5 submissions and how EPA evaluates environmental release information for operations that occur at non-submitter sites. Registration is now open.
 
As reported in our June 27, 2022, memorandum, in June 2022, EPA announced outreach to describe how it evaluates engineering (i.e., environmental release and worker exposure) data for new chemical submissions and common causes of EPA having to reconduct risk assessments (i.e., “rework”). The goal of this effort is to prevent delays of EPA’s new chemical reviews caused by rework.
 
The February 28, 2023, webinar is the third and final webinar in a series to increase the efficiency and transparency of EPA’s new chemical determinations. The first two webinars, held in July and October 2022, focused on common issues that cause EPA to rework risk assessments, clarifications of common misconceptions in EPA’s new chemical assessments, and other information related to TSCA Section 5 submissions. More information on these webinars is available on EPA’s website and in our July 28, 2022, and October 25, 2022, memoranda.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
On December 15, 2022, the U.S. Environmental Protection Agency (EPA) announced a redesign and updates to the statistics web page for the New Chemicals Review Program. According to EPA, the update includes additional information and metrics on the Agency’s review of new chemicals under the Toxic Substances Control Act (TSCA), increasing transparency for the public, the regulated community, and other stakeholders.
 
According to EPA, before TSCA was amended in 2016 by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), EPA issued formal risk determinations for approximately 20 percent of new chemical submissions. EPA states that in 80 percent of the cases, EPA dropped the chemical from further review, which under the prior law would allow the manufacturer to take the chemical to market.
 
Under the Lautenberg Act amendments, EPA is required to make an affirmative determination on all new chemical notices submitted under TSCA, “substantially increasing the Agency’s workload.” EPA notes that despite the “dramatic increase in responsibility,” its budget for the TSCA program has remained essentially flat over the past six years.
 
To address resource limitations, EPA has taken several significant steps over the past year to create a sustainable program that follows the science and the law. EPA states that the redesigned and updated web page represents another important step in that process. EPA will update the data displayed on the enhanced web page monthly. According to EPA, the data show that EPA “continues to make positive progress on reviewing new chemicals and managing risks to human health and the environment. With more funding and resources, EPA could further increase the efficiency, effectiveness and transparency of its work.”
 
More Detailed Breakdown of New Chemical Submissions
 
EPA states that the web page now contains month-by-month counts of new chemical submissions, completed risk assessments, and completed risk management actions for all notices and exemptions, allowing users to track monthly progress on EPA’s new chemicals workload.
 
EPA notes that the new monthly statistics table “shows recent improvement in EPA’s ability to conduct risk assessments efficiently -- in October and November, EPA completed 99 risk assessments, more than double from the prior two-month period.” According to EPA this progress “is a result of EPA’s aggressive recruitment and training for scientists with relevant experience and background to conduct risk assessments and efforts to continuously improve the program’s review process and procedures.”
 
Additionally, new tables and graphs on the web page visualize new chemicals submission trends and changes from fiscal years (FY) 2010-2022. Previously, the web page included a count of the total number of completed actions since the 2016 TSCA amendments, but it did not break this information down by FY.
 
Status Tracker for New Chemical Exemptions
 
The revised web page now also includes a tracker for other applications submitted to the New Chemicals Program, including low volume exemptions (LVE), low release and low exposure exemptions (LoREX), test market exemptions (TME), TSCA environmental release applications (TERA), and Tier II exemptions for microorganisms (Tier II). EPA notes that previously, the web page only included this kind of tracking for premanufacture notices (PMN), significant new use notices (SNUN), and microbial commercial activity notices (MCAN).
 
According to EPA, exemptions represent over 50 percent of the new chemical notices submitted to EPA. EPA states that the new tracker “makes it easy for users to monitor the number of active exemption cases currently under review by EPA and their review status, giving stakeholders greater insight into the status of a significant portion of the program’s workload.”
 
Information on the New Chemicals Review Process
 
The new web page provides greater detail about the new chemicals review process, including explanations of each step of the review process for notices and exemptions. Also new to the web page is an explanation of the factors that EPA considers when triaging new chemical submissions for review. EPA states that these factors include the date of receipt of submission, statutory and regulatory deadlines, the level of effort needed to rework potentially some or all of the risk assessment, and the applicability of new approaches that EPA has developed to standardize reviews for certain new chemicals. EPA states that providing this information helps submitters understand how EPA manages its large workload within limited resource constraints and helps them submit complete notices in the order that matters most for their business.
 
Other New Chemicals Improvements
 
EPA states that the New Chemicals Program has taken several steps this year to enhance the review process for new chemicals, resulting in 480 risk assessments completed and 447 risk management actions issued in FY 2022. These efforts include:

• Launching innovative approaches to reviewing new biofuels and mixed metal oxides (MMO) used in new and modified cathode active materials (CAM), which have helped increase the program’s capacity by standardizing the review process for these chemicals;
• Conducting an outreach initiative consisting of several webinars with stakeholders to explain how EPA evaluates engineering data for new chemical submissions, with the goal of preventing common issues that contribute to delays in new chemical reviews and stretch limited resources;
• Developing a multi-year collaborative research program with the Office of Research and Development (ORD) and other federal entities to bring innovate science to new chemical reviews before they can enter the marketplace; and
• Aggressively recruiting, onboarding, and training new staff to conduct risk assessments and developing new policies, guidance, and standard operating procedures.

We applaud EPA’s efforts to improve the efficiency and transparency of its operations. We appreciate that EPA is working hard, with too few resources and staff, and welcome these enhancements to the EPA website.

• Email This
• Print

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.”

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 4, 2022, that it will hold the first of a two-part webinar series on November 17, 2022, on EPA’s new standardized process to assess risk and apply mitigation measures, as appropriate, for mixed metal oxides (MMO), including new and modified cathode active materials (CAM). As reported in our October 11, 2022, memorandum, in October 2022, EPA announced an innovative effort intended to help make its review of new MMOs, including new and modified CAMs, more efficient. According to EPA, MMOs are used in batteries, electric vehicles, semiconductors, and renewable energy generation, making them a vital part of clean energy sectors.
 
EPA states that the kickoff webinar will provide statutory and regulatory background, including the related compliance advisory, a broad overview of the approach for risk assessment and risk management, and information on the Toxic Substances Control Act (TSCA) Inventory, nomenclature, and the bona fide process for those seeking to find out if their MMOs are already on the Inventory.
 
According to EPA, the second webinar, currently targeted for early 2023, will go into greater detail on the standardized risk assessment approach, present various case scenarios and a decision tree for identifying potential hazards and risks, and provide tips on risk calculators, tools, and models that are used for the risk assessment.
 
EPA encourages stakeholders to provide feedback, ideas, and questions at the kickoff webinar. This will help EPA supplement the information that will be shared at the second webinar and any follow-up communication on the new approach.

• Email This
• Print

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.

• Email This
• Print

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.

• Email This
• Print

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.

• Email This
• Print

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.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
On May 27, 2022, the U.S. Environmental Protection Agency (EPA) requested nominations for technical experts to serve as special government employees (SGE) to participate in the review of the New Chemicals Collaborative Research Program with the Board of Scientific Counselors (BOSC), a federal advisory committee to EPA’s Office of Research and Development (ORD). 87 Fed. Reg. 32161. BOSC will be evaluating ORD’s draft Strategic Research Action Plans Fiscal Years 2023-2026 in fall 2022. According to EPA, the fall 2022 meeting will provide a more in-depth evaluation of the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program and associated research plan. EPA states that it will provide an additional draft document that summarizes technical details of the research plan. ORD, in partnership with 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.

EPA will consider nominees from industry, business, public and private research institutes or organizations, academia, government (federal, state, local, and Tribal), non-governmental organizations, and other relevant interest areas. EPA notes that it values and welcomes diversity. EPA encourages all qualified candidates to apply regardless of gender, race, disability, or ethnicity.

EPA invites nominations of individuals to serve as SGEs with expertise or extensive experience in the following scientific disciplines and topic areas as they relate to human health and the environment:

• Using data to develop predictive models and use of predictive models in data-poor environments:
  • Read across and analogue selection;
  • Chemical structures and cheminformatics; and
  • Quantitative structure-activity relationships (QSAR);
• Development, implementation, and validation of new approach methods (NAM). Relevant expertise may include:
  • Veterinary pathology or comparative physiology for perspective on relevance of laboratory animals for predicting human outcomes; and
  • Reference data curation to support validation;
• Computational modeling, bioinformatics, and/or statistics;
• Toxicokinetics, physiologically based pharmacokinetic models (PBPK), and in vitro to in vivo extrapolation (IVIVE);
• Systems biology;
• Human health and ecological risk assessment;
• Exposure modeling and/or assessment, including near-field and far-field sources;
• Knowledge of TSCA; and
• Environmental fate of chemicals.

Nominations are due June 30, 2022. More information on EPA’s Draft Document on “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA” is available in our March 14, 2022, memorandum.

• Email This
• Print