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 that is 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.
Analysis of New Chemicals Rework Issues
EPA’s review of the safety of a new chemical under TSCA Section 5 begins with the submission of information to EPA by chemical companies. EPA then uses this information, along with other data and materials, to assess the risks posed by new chemicals. According to EPA, TSCA Section 5 submitters “sometimes provide additional information after EPA has already begun a risk assessment of the new chemical substance.” EPA states that the additional engineering information is often related to the environmental release and/or occupational exposure assessment of the new chemical substance.
When additional information is submitted, EPA reviews it to determine whether it is relevant, adequately documented, and well-supported and whether EPA needs to revise its risk assessment to incorporate it. EPA states that “[r]evision(s) to risk assessments (known as ‘rework’) take additional time, causing delays in the new chemical review for the submitter as well as other companies whose new chemical reviews are also delayed.”
To identify the most common reasons for rework delays, EPA analyzed which types of data were most often submitted as additional information after the review had commenced, whether this additional information resulted in a revised risk assessment, and the most common data elements and information gaps that resulted in a revision. According to EPA, it found that an individual case may be reworked from one to five times and that the reworks could add at least several months to the notice review. In analyzing 94 unique cases submitted from 2019 to 2022, EPA states that it found that the additional information that most often led it to rework an initial risk assessment included:
- Additional information on engineering controls companies plan to utilize (e.g., local exhaust ventilation to capture and remove airborne emissions, process enclosures). Engineering controls protect workers by removing hazardous conditions or by placing a barrier between the worker and the hazard;
- Additional information on environmental release media (e.g., air, water, land) and waste disposal methods. This includes information on how process equipment and transport containers will be cleaned, and how the associated waste will be disposed (e.g., on-site wastewater treatment, publicly owned treatment works (POTW), incineration, landfill);
- Changes to planned batch parameters (e.g., number of operating days per year, mass of chemical produced per production batch). For the purpose of this analysis, this data element includes parameters that would affect the calculated throughput of the new chemical substance;
- Changes in planned production volume, which directly impact model outputs. For example, an increase in production volume typically increases the potential for environmental release; and
- Additional information on sites not under submitter control (e.g., customers downstream of the manufacturer and/or importer of the new chemical substance).
EPA posted its “Analysis of Engineering Information Submitted for TSCA Section 5 New Chemicals Submissions.”
Outreach and Training
As a part of ongoing efforts to increase the efficiency and transparency of its new chemicals review process, EPA states that it plans to engage in a dialogue with stakeholders through a series of webinars on how it evaluates submitted information, particularly information related to “engineering” information (i.e., occupational exposures and environmental releases).
EPA will “soon announce” the date of a July 2022 kick off meeting that will provide an overview of the webinar series and a more in-depth look at EPA’s analysis, including EPA’s written methodology describing how it conducted the analysis. According to EPA, the webinars will include case studies to help stakeholders understand what data EPA considers acceptable. EPA will provide an opportunity for stakeholders to ask questions during the webinars.
EPA will communicate in subsequent webinars 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 post information on the forthcoming webinars as it becomes available.
Bergeson & Campbell, P.C. (B&C®) applauds and appreciates EPA’s commitment to address the issues that challenge new chemical review. While B&C hopes that this effort will produce more robust submissions, we remain concerned that the “rework problem” is not solely due to a lack of information provided by submitters. In our experience, even when submitters provide detailed release and exposure control information, EPA assessors reject, dismiss, or marginalize data often to mask a fundamental indecision on core science issues, or defer to conservative risk assumptions. In other cases, EPA states the information is insufficient to override its conservative assumptions, but cannot provide a clear or coherent response to the predictable question in response of what exactly EPA would consider sufficient. Even cases with complete Sustainable Futures assessments conducted by expert Sustainable Futures instructors can end up being reworked if EPA departs from its long-standing practices, leading to excessive back-and-forth about the release and exposure controls.
B&C believes all stakeholders, including EPA assessors, would benefit from more training and clearer guidance. We hope this new initiative provides opportunities for submitters to understand better, and for EPA assessors to explain more coherently, when data are needed, why some data are not acceptable, and when default reliance upon EPA model outputs is justified.