The U.S. Environmental Protection Agency (EPA) announced on June 24, 2022 that it was “conducting an extensive outreach effort to describe and discuss with stakeholders how the Agency evaluates data provided for new chemical submissions and common issues that require EPA to re-run risk assessments (“rework”) for those submissions.” According to the EPA, its goal is to reduce the rework of initial risk assessments for new submissions chemicals that is caused by submitters completing incomplete initial review submissions for new chemicals, contributing to delays in EPA’s review of these chemicals, and draining already limited resources. it shares an interest with stakeholders in reducing process inefficiencies while providing protective review of emerging chemical hazards. clarifies that she anticipates this outreach effort will be “particularly helpful” for Low Volume Exemptions (LVEs), which make up about 60% of annual submissions under Section 5 of the Toxic Substances Control Act (TSCA). ).
Analysis of new chemical rework problems
EPA’s review of a new chemical’s safety under TSCA Section 5 begins with chemical companies submitting information to EPA. The EPA then uses this information, along with other data and materials, to assess the risks posed by new chemicals. According to the EPA, TSCA Section 5 submitters “sometimes provide additional information after the EPA has already begun a risk assessment of the new chemical.” The EPA indicates that the additional technical information is often related to the assessment of environmental releases and/or occupational exposure of the new chemical.
When additional information is submitted, EPA reviews it to determine whether it is relevant, adequately documented, and well-supported and whether EPA should revise its risk assessment to incorporate it. The EPA states that “[r]revisions to risk assessments (known as “rework”) take longer, causing delays in re-chemical review for the applicant as well as other companies whose re-chemical reviews are also delayed.
To identify the most common reasons for retake delays, EPA analyzed the types of data most often submitted as additional information after the review began, if that additional information resulted in a revised risk assessment. , as well as the most common data elements and information gaps that resulted in a review. According to the EPA, it found that an individual case could be reworked anywhere from one to five times, and rework could add at least several months to reviewing the notice. In analyzing 94 unique cases submitted from 2019 to 2022, the EPA says 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 use (for example, local exhaust ventilation to capture and eliminate atmospheric emissions, treatment enclosures). Engineering controls protect workers by removing unsafe conditions or placing a barrier between the worker and the hazard;
- Additional information on environmental release media (for example, air, water, land) and waste disposal methods. This includes information on how processing equipment and transport containers will be cleaned and how associated waste will be disposed of (for exampleautonomous wastewater treatment, public treatment plants (POTW), incineration, landfill);
- Scheduled Batch Parameter Changes (for example, number of days of operation per year, mass of chemical produced per production batch). For the purposes of this analysis, this data element includes parameters that would affect the calculated flow rate of the new chemical;
- Changes in the planned production volume, which have a direct impact on model outputs. For example, an increase in production volume generally increases the potential for release to the environment; and
- Additional information on sites not under the control of the author (for exampledownstream customers of the manufacturer and/or importer of the new chemical).
The EPA has released its “Analysis of Technical Information Submitted for TSCA Section 5 New Chemical Submissions”.
Awareness and training
As part of ongoing efforts to increase the efficiency and transparency of its new chemical review process, the EPA says it plans to engage with stakeholders through a series of webinars on how she evaluates submitted information, especially “engineering” related information. information (that’s to sayoccupational exposures and releases to the environment).
The 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 review of EPA’s analysis, including EPA’s written methodology outlining how it conducted the analysis. According to the EPA, the webinars will include case studies to help stakeholders understand what data the EPA considers acceptable. EPA will provide stakeholders with the opportunity to ask questions during the webinars.
EPA will communicate in future webinars its considerations for evaluating qualitative claims or quantitative data, particularly when they deviate from model default values such as those used in the chemical screening tool for exposures and releases to the environment (ChemSTEER) and its considerations for evaluating information on sites not controlled by the depositor.
EPA will post information about upcoming webinars as it becomes available.
Bergeson & Campbell, CP (B&C®) applauds and appreciates EPA’s commitment to addressing issues that challenge the review of new chemicals. While B&C hopes this effort will produce stronger bids, we remain concerned that the “rework problem” is not solely due to a lack of information provided by bidders. In our experience, even when authors provide detailed release and exposure control information, EPA evaluators often reject, dismiss, or marginalize the data to mask fundamental indecision about fundamental scientific questions or rely on conservative risk assumptions. In other cases, the EPA states that the information is insufficient to override its conservative assumptions, but cannot provide a clear or consistent answer to the predictable question in response to what exactly the EPA would have consider sufficient. Even cases with comprehensive sustainable future assessments conducted by expert sustainable future instructors may end up being reworked if the EPA deviates from its long-standing practices, resulting in excessive back-and-forth on controls. release and exposure.
B&C believes that all stakeholders, including EPA assessors, would benefit from more training and clearer guidance. We hope this new initiative will provide an opportunity for bidders to better understand and for EPA evaluators to more consistently explain when data is needed, why some data is not acceptable, and when the default reliance on EPA model is justified.