Posted on August 10, 2023 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) is launching a webinar series in collaboration with the PETA Science Consortium International (PSCI), Institute for In Vitro Sciences (IIVS), and the California Department of Pesticide Regulation (CDPR). According to EPA, the quarterly series will focus on the use of new approach methodologies (NAM), or alternative methods to reduce vertebrate animal testing, for risk assessment within EPA and CDPR. The first webinar in the series will take place on August 23, 2023, from 11:00 a.m.-12:30 p.m. (EDT). The webinar will cover recent updates from the Organization for Economic Cooperation and Development (OECD), including information about its developmental neurotoxicity in vitro test battery. Registration is open.
EPA notes that the Toxic Substances Control Act (TSCA) directs EPA to reduce and replace the use of vertebrate animals in the testing of chemical substances or mixtures to the extent practicable and scientifically justified. EPA must also promote the development and timely incorporation of alternative test methods or strategies that do not require new vertebrate animal testing. In 2018, EPA published a strategic plan to reduce the use of vertebrate animals in chemical testing.
Posted on August 02, 2023 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
On July 19, 2023, the U.S. Environmental Protection Agency (EPA) extended the comment period on proposed amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 46125. According to EPA, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the [2016] Frank R. Lautenberg Chemical Safety for the 21st Century Act” (Lautenberg Act), improve EPA’s efficiency in the review process, and “update the regulations based on existing policies and experience implementing the New Chemicals Program.” EPA states that the proposed rule includes amendments that would “reduce the need to redo all or part of the risk assessment by improving information initially submitted in new chemicals notices, which should also help reduce the length of time that new chemicals notices are under review.” EPA proposed several amendments to the regulations for low volume exemptions (LVE) and low release and exposure exemptions (LoREX), which include requiring EPA approval of an exemption notice prior to commencement of manufacture, making per- and polyfluoroalkyl substances (PFAS) categorically ineligible for these exemptions, and providing that certain persistent, bioaccumulative, and toxic (PBT) chemical substances are ineligible for these exemptions, consistent with EPA’s 1999 PBT policy. Comments are due August 8, 2023. More information on the proposed rule is available in our May 24, 2023, memorandum.
Posted on July 07, 2023 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) will hold a webinar on July 18, 2023, at 2:00 p.m. (EDT) on its recent final procedural rule for submitting confidential business information (CBI) under the Toxic Substances Control Act (TSCA). The final rule increases transparency, modernizes the reporting and review procedures for CBI, and aligns with the 2016 amendments to TSCA. The rule will become effective on August 7, 2023. EPA states that the webinar will be useful for anyone looking for an overview of the new rule and the new requirements for companies that submit data under TSCA. It will include a demonstration of how and where to locate and open time-sensitive notifications from EPA relating to CBI claims and how to update company contact information, and it will show how CBI claim requirements have been further integrated into TSCA reporting applications. Registration for the webinar is open. More information is available in our June 12, 2023, memorandum.
Posted on May 30, 2023 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
On May 26, 2023, the U.S. Environmental Protection Agency (EPA) proposed amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 34100. According to EPA, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the [2016] Frank R. Lautenberg Chemical Safety for the 21st Century Act” (Lautenberg Act), improve EPA’s efficiency in the review process, and “update the regulations based on existing policies and experience implementing the New Chemicals Program.” EPA states that the proposed rule includes amendments that would “reduce the need to redo all or part of the risk assessment by improving information initially submitted in new chemicals notices, which should also help reduce the length of time that new chemicals notices are under review.” EPA proposed several amendments to the regulations for low volume exemptions (LVE) and low release and exposure exemptions (LoREX), which include requiring EPA approval of an exemption notice prior to commencement of manufacture, making per- and polyfluoroalkyl substances (PFAS) categorically ineligible for these exemptions, and providing that certain persistent, bioaccumulative, and toxic (PBT) chemical substances are ineligible for these exemptions, consistent with EPA’s 1999 PBT policy. Comments are due July 25, 2023. More information on the proposed rule is available in our May 24, 2023, memorandum.
When EPA receives a premanufacture notice (PMN), significant new use notice (SNUN), or microbial commercial activity notice (MCAN), EPA states that it is required to assess the risk associated with the new chemical substance or significant new use that is the subject of the notice under the conditions of use and make a determination for the chemical substance pertaining to the likelihood of such risk. EPA notes that under TSCA, the term “chemical substance” includes microorganisms. To improve the effectiveness and efficiency of these reviews, EPA proposes to amend the procedural regulations at 40 C.F.R. Parts 720, 721, and 725 to align with the requirements in TSCA Section 5, as amended by the Lautenberg Act, and to make additional updates. In particular, EPA proposes to amend the regulations to specify that EPA must make a determination on each PMN, SNUN, and MCAN received before the submitter may commence manufacturing or processing of the chemical substance, and to list the five possible determinations and the actions required in association with those determinations. In addition, EPA proposes to clarify the level of detail expected for the information that a submitter is required to include in a PMN, SNUN, or exemption notice for the notice to be considered complete. EPA also proposes amendments to the procedures for reviewing PMNs and SNUNs; specifically, procedures for addressing PMNs and SNUNs that have errors or are incomplete or that are amended during the applicable review period. Additionally, EPA is proposing to make several amendments to the regulations at 40 C.F.R. Section 723.50 for LVEs and LoREXs. According to EPA, these amendments would require EPA approval of an exemption notice before the submitter may commence manufacture, allow EPA to inform an LVE or LoREX holder when the chemical substance that is the subject of the exemption becomes subject to a significant new use rule (SNUR) and the chemical identity is confidential, make PFAS categorically ineligible for these exemptions, and codify EPA’s use of the 1999 PBT policy for these exemptions by making certain PBTs ineligible for these exemptions. Finally, EPA proposes to amend the regulations pertaining to suspensions for all TSCA Section 5 notices to allow submitters to request suspensions for up to 30 days via oral or e-mail request.
Posted on April 11, 2023 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) will hold training on May 23, 2023, on Generalized Read-Across (GenRA), a publicly available tool that uses an automated approach to make reproducible read-across predictions of toxicity. EPA states that read-across “is a commonly used data gap filling technique whereby endpoint information for one substance is used to predict the same endpoint for another substance, supported by structural or other feature similarities.” According to EPA, while read-across sometimes relies on subjective or expert judgement, use of the GenRA tool could provide more objective and reproducible read-across predictions. Specifically targeted for decision-makers, this training will provide:
- A presentation overview of GenRA’s purpose and scope;
- A demonstration of GenRA’s interface and navigation; and
- Opportunities for participatory learning and engagement.
The virtual training will feature EPA’s Dr. Grace Patlewicz. The training will include a plenary presentation, small group discussions, and a chance to try out GenRA. EPA has divided the training into two parts to accommodate a variety of interests and schedules. Registration for one or both sessions is free but required.
This session will provide an overview of GenRA content and function with opportunities for participation and Q&A.
This session will break participants into breakout rooms to work on exercises in small groups, aided by facilitators.
Posted on February 13, 2023 by Lynn L BergesonBy 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.
Posted on November 30, 2022 by Lynn L BergesonBy 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.
Posted on November 29, 2022 by Lynn L BergesonBy 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).
Posted on November 22, 2022 by Lynn L BergesonBy 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.”
Posted on November 08, 2022 by Lynn L BergesonBy 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.
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