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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 EPA has published previously unpublished new chemical notices received under TSCA Section 5 and notices of substantial risk provided by companies under TSCA Section 8(e). EPA states that going forward, it will continue to identify older, previously submitted unpublished information to make available in ChemView and will publish newly received TSCA Section 5 notices and TSCA Section 8(e) reports on a “near real-time basis.”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 EPA states that it will also continue to identify and make public older, previously unpublished new chemicals notices.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
 
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.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On October 13, 2022, Earthjustice, on behalf of a coalition of environmental organizations and community advocates, petitioned the U.S. Environmental Protection Agency (EPA) to revoke the approval of approximately 600 per- and polyfluoroalkyl substances (PFAS) that were granted through low volume exemptions (LVE) or low release and low exposure exemptions (LoREX) to the premanufacture notice (PMN) requirements of the Toxic Substances Control Act (TSCA). In its October 13, 2022, press release, Earthjustice states that these exemptions “allow EPA to approve chemicals through lax safety reviews only if it ‘will not present an unreasonable risk’ to humans or the environment.” According to Earthjustice, PFAS do not meet that standard, and EPA must revoke previously granted LVEs and LoREXs for PFAS. The petition follows an April 27, 2021, petition filed by Earthjustice on behalf of many of the same petitioners, and it incorporates the 2021 petition by reference.
 
The petition requests the following actions:

  • For all outstanding LVEs and LoREXs granted for PFAS, EPA must make a preliminary determination that these LVEs and LoREXs do not meet the terms of TSCA Section 5(h)(4) or 40 C.F.R. Section 723.50(d);
  • For all outstanding LVEs and LoREXs granted for PFAS, EPA must notify their manufacturers that it believes their substance does not meet the requirements for a PMN exemption and then proceed to make a final determination based on the current science that no PFAS meets the TSCA Section 5(h)(4) standard for a PMN exemption, taking into account potentially exposed or susceptible subpopulations, in accordance with the protocols set forth in 40 C.F.R. Section 723.50(h);
  • In the alternative, EPA must individually re-assess all PFAS for which there is an outstanding LVE and/or LoREX to determine whether the substance meets the standard set forth in 40 C.F.R. Section 723.50(d) and in TSCA Section 5(h)(4); and
  • Petitioners incorporate by reference all of the requests set forth in the 2021 petition and reiterate the same requests here:
  • EPA must initiate a rulemaking to prohibit: (a) future use of the byproducts exemption for new PFAS; and (b) continued manufacture of any PFAS byproduct under the auspices of the byproducts exemption unless and until such PFAS has undergone a full PMN review and been approved by EPA, with a two-year window for manufacturers to receive such approval; and
  • EPA should immediately stop permitting the use of the LVE, LoREX, and polymer exemption for any new PFAS.

 

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
 
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.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340:

These resources, along with other information on the revised biotechnology regulations, are available on the APHIS website. For additional questions regarding the regulation of modified microorganisms, contact APHIS at .(JavaScript must be enabled to view this email address). For questions regarding confirmation requests, contact APHIS at .(JavaScript must be enabled to view this email address).


 

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 National Academies of Sciences, Engineering, and Medicine (NASEM) announced on July 21, 2022, publication of a new report entitled The Importance of Chemical Research to the U.S. Economy. The National Science Foundation (NSF), the Department of Energy (DOE), the National Institute of Standards and Technology (NIST), and the American Chemical Society (ACS) asked NASEM to convene a committee to consider strategies to sustain and enhance the economic activity driven by fundamental research investments in the chemical sciences. According to NASEM, “a new and evolving chemistry landscape requires changes with regard to funding, training, and a focus on integrating sustainability into manufacturing, product usage, and product disposal.” NASEM states that the report identifies strategies and options for research investments intended to support U.S. leadership “while considering environmental sustainability and developing a diverse chemical economy workforce with equitable opportunities for all chemistry talent.” The report recommends that funding agencies and philanthropic organizations that support the chemical sciences “fund as large a breadth of fundamental research projects as possible.” The chemical industry and their partners at universities, scientific research institutions, and national laboratories “should align the objectives of fundamental research” to assist directly with new practices toward environmental stewardship, sustainability, and clean energy. Additionally, the report recommends that funding agencies “make substantial investment toward education research to enable innovative ways of teaching about emerging concepts, tools and technologies.”

Tags: DOE, NSF, NIST, ACS, NASEM, Research,

 

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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