EPA Effort Announced for Chemical Reviews


The U.S. Environmental Protection Agency has recently announced a new research program under the Toxic Substances Control Act (TSCA) with the goal of modernizing the process and bringing innovative science to the review of new chemicals before they enter the market.

“Science is the backbone of our chemical safety work, and strong science ensures we put measures in place to protect human health and the environment, when necessary,” said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff. “This exciting and collaborative effort announced today will modernize the processes and bring innovative science into the evaluation of new chemicals under TSCA, leading to a more sustainable program.”

According to the EPA, the Office of Chemical Safety and Pollution Prevention (OCSPP) is proposing the development and implementation of a multi-year collaborative research program in partnership with the Agency’s Office of Research and Development (ORD) and other federal entities focused on approaches for performing risk assessments on new chemical substances under TSCA.

Through the partnership, the program aims to bring innovative science to new chemical reviews, modernize the approaches used and increase the transparency of the human health and ecological risk assessment process.

“This collaborative effort between OCSPP and ORD will draw on ORD’s innovative science, expertise, and leadership in relevant areas such as high-throughput testing, computational toxicology and exposure approaches, and development of databases and tools to make data accessible and informative for chemical assessments,” said Deputy Assistant Administrator for Science Policy in the Office of Research and Development Chris Frey.

“Work on this collaborative effort furthers ORD’s commitment to translating research into application and is complementary to efforts on EPA’s New Approach Methods Work Plan.”

The multi-year research program will refine existing approaches and develop and implement new approach methodologies (NAMs) to ensure the best available science is used in TSCA new chemical evaluations.

Key areas proposed in the TSCA New Chemicals Collaborative Research Program include:

  • Updating OCSPP’s approach using data from structurally similar chemicals to determine potential risks from new chemicals, also known as read-across. This will increase the efficiency of new chemical reviews promoting the use of the best available data to protect human health and the environment;
  • Digitizing and consolidating information on chemicals to include data and studies that currently only exist in hard copy or in disparate TSCA databases. The information will be combined with publicly available sources to expand the amount of information available, enhancing chemical reviews and enabling efficient sharing of chemical information across EPA. Safeguards for confidential business information will be maintained as appropriate in this process;
  • Updating and augmenting the models used for predicting a chemical’s physical-chemical properties and environmental fate/transport, hazard, exposure, and toxicokinetics to provide a suite of models to be used for new chemicals assessments. The goal of this effort is to update the models to reflect the best available science, increase transparency, and establish a process for updating these models as science evolves;
  • Exploring ways to integrate and apply NAMs in new chemicals assessments, reducing the use of animal - testing. As this effort evolves, the goal is to develop a suite of accepted, fit-for-purpose NAMs that could be used by external stakeholders for data submissions under TSCA as well as informing and expanding new chemical categories; and
  • Developing a decision support tool that integrates the various information streams specifically used for new chemical risk assessments. The decision support tool will more efficiently integrate all the data streams (e.g., chemistry, fate, exposures, hazards) into a final risk assessment and transparently document the decisions and assumptions made. Simply put, this will facilitate the new chemicals program tracking decisions over time and evaluating consistency within and across chemistries.

The EPA is planning to host a virtual public meeting on April 20 and April 21, from 1-5:00 p.m. (EDT) to provide an overview of the TSCA New Chemicals Collaborative Research Program. The meeting also plans to provide individual stakeholders time to share their input on the program.

Prior to the meeting, the EPA is slated to release a draft document describing the collaborative research program for a 60-day public comment period. After the meeting, the EPA will update the draft and post in the Agency’s docket.

Later this year, the EPA plans to release a revised version of the collaborative research plan for an additional public comment period and peer review by the Board of Scientific Counselors (BOSC).

TSCA Review Background

In February 2021, the EPA received a report evaluating its TSCA chemical risk evaluations system prompting the agency to announce that it will be refining its approach to selecting and reviewing the scientific studies that are used to inform its evaluations.

The peer review was contracted with the National Academies of Science, Engineering, and Medicine in December 2019. The National Academic are private, nonprofit institutions that “provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, technology, and medicine.”

The EPA also noted that this review was being done in accordance with directives from the Biden administration, which it acknowledged previously to this announcement.

The Academies specifically reviewed the EPA’s “2018 Application of Systematic Review in TSCA Risk Evaluations,” and its biggest critique was on the statutory schedule the EPA follows to complete assessments, which is says does not meet state-of-practice standards. The Academies suggested:

  • Staff should engage in ongoing cross-sector efforts to develop and validate new tools and approaches for exposure, environmental health, and other areas where systematic review is applied. TSCA evaluation approaches would benefit from the substantial external expertise available as well as acceptance from outside stakeholders as the approaches are developed.
  • The decision to develop a wholly original approach to hazard assessment, rather than starting with other extant protocols as a foundation, is one source of the process’s problems. The EPA should consider incorporating components of methodologies from the National Institute of Environmental Health Science’s Office of Health Assessment and Translation and EPA’s Integrated Risk Information System and Navigation Guide.
  • Documentation of the process is incomplete and hard to follow. Staff should assemble a handbook for TSCA review and evidence integration methodology to detail steps in the process.
  • The terms “weight of evidence” and “systematic review” are used interchangeably. The report urges EPA to use standard descriptors for the strength of evidence instead.

The EPA noted that it is no longer using the 2018 application and has already begun to review protocol. There is currently to timetable in place for the completion of that review.

Earlier that month, the EPA sent two emailed press releases discussing both a review of its actions of the course of the previous administration, as well as announcing educational webinars that focus on the recent risk evaluations of both pigment violet 29 (PV29) and n-methylpyrrolidone (NMP).

In the general chemical safety action update, the Agency said that it’s reviewing all actions taken under the previous administration and that “this review is being done in accordance with the Administration’s Executive Orders and other directives, including those on environmental justice, scientific integrity and regulatory review.”

The EPA listed three rulings in particular that it will be reviewing, two of which fall under the TSCA. The first, is the expedited action on certain persistent, bioaccumulative and toxic (PBT) chemicals and the final rules that were associated with those actions that went into effect on Feb. 5, 2021.

The EPA was also looking at the risk evaluations for the first 10 chemicals that were introduced under the revamped TSCA. It said that current risk management and stakeholder activities will continue while the process is being reviewed.

Finally, the EPA listed the Dust Lead Post-Abatement Clearance Level Final Rule, which went into effect March 8, 2021.

In March, the EPA released an emailed press release on its evaluation surrounding the policies, guidance, templates and regulations under the TSCA.

At the time, the Agency said that it had identified several instances “where the approach for making determinations and managing risks associated with new chemicals can more closely align with the requirements of TSCA to ensure protections for human health and the environment, including the use of significant new use rules (SNURs) and assumptions related to worker exposures.”

The announcement states that the EPA will stop issuing determinations of “not likely to present an unreasonable risk” based on the existence of proposed SNURs.

EPA intends to continue issuing SNURs following TSCA section 5(e) and 5(f) orders for new chemicals to ensure the requirements imposed on the submitter via an order apply to any person who manufacturers or processes the chemical in the future.

In May, the EPA released a list of 390 chemicals that are expected to lose their confidential status and move to the public portion of the Toxic Substances Control Act inventory. According to the EPA, the identities of these chemicals were reported as non-confidential during Chemical Data Reporting cycles from the 2012, 2016 and/or 2020 reporting periods. In accordance with the CDR rule and with TSCA sections 8 and 14, the EPA intends to update the TSCA Inventory listings for these chemicals to list the specific chemical identities on the public portion of the Inventory. The updates will also involve expanding reporting requirements for certain chemicals and facilities, including PFAS.

That summer, the EPA made several announcements via email regarding the TSCA: namely, that new members have been appointed to the TSCA Science Advisory Committee on Chemicals, and that the EPA would be holding a webinar on the development of the proposed data reporting rule.

The TSCA SACC aims to serve as a peer review mechanism that provides recommendations to the EPA.

In August, two new updates were issued via email regarding per- and polyfluoroalkyl substances, both extending the public comment period for its proposed recordkeeping requirements and releasing data from the 2020 Toxics Release Inventory.

First, the comment period on the proposed reporting and recordkeeping requirements for manufacturers (including importers) of PFAS under section 8(a)(7) of the Toxic Substances Control Act, was extended from an Aug. 27, 2021 closing date to Sept. 27, 2021.

Second, the EPA released data from the TRI about chemical releases, chemical waste management and pollution prevention activities that took place during 2020 at nearly 21,000 federal and industrial facilities across the country. The preliminary data reportedly includes the first-ever reporting on PFAS added to the TRI by the 2020 National Defense Authorization Act.

The EPA noted that the dataset released is raw data and does not contain any summary or trend analysis and the EPA is now conducting additional quality checks on the preliminary data. The 2020 preliminary data will be updated periodically to reflect revisions to previously submitted data and late submissions of TRI reporting forms.

At the time, the data related to the PFAS added by the NDAA and received by the agency include a total of 89 TRI reporting forms for 44 discrete PFAS chemicals filed by 38 individual facilities.

The preliminary data indicate facilities managed over 700,000 pounds of production-related waste of PFAS during 2020.

Most recently, in February, the EPA announced that it was inviting small businesses, governments and not-for-profit organizations to participate as Small Entity Representatives (SERs) for a Small Business Advocacy Review (SBAR) Panel.

The established SBAR is slated to help the agency develop a rule that would require reporting and recordkeeping for per- and polyfluoroalkyl substances (PFAS) from certain persons who have manufactured (including imported) a PFAS in any year since Jan. 1, 2011.

The Panel will include federal representatives from the Small Business Administration, the Office of Management and Budget and EPA. The Panel members ask a selected group of SERs to provide advice and recommendations on behalf of their company, community or organization to inform the Panel members about the potential impacts of the proposed rule on small entities.


Tagged categories: Construction chemicals; Environmental Protection Agency (EPA); EPA; EPA; Good Technical Practice; Government; Health & Safety; Health and safety; NA; North America; Research; Research and development; Safety; Testing + Evaluation

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