TSCA New Chemical Engineering Initiative to Increase Transparency and Reduce Rework
EPA 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. The goal of this effort is to reduce rework of initial risk assessments for new chemicals submissions that is caused by submitters supplementing incomplete initial new chemicals review submissions, which has contributed to delays in EPA’s review of these chemicals and stretched already limited resources. Both EPA and stakeholders share an interest in reducing process inefficiencies while also ensuring a protective review of new chemical risks. EPA anticipates this outreach effort will be particularly helpful for Low Volume Exemptions (LVEs), which constitute about 60% of TSCA section 5 submissions annually.
On this page:
- Analysis of New Chemicals Rework Issues
- Monthly Statistics on Rework Cases
- Outreach and Training
- Additional Information
Analysis of New Chemicals Rework Issues
EPA’s review of the safety of a new chemical under Section 5 of the Toxic Substances Control Act (TSCA) begins with the submission of information to EPA by chemical companies. This information is then used by EPA along with other data and materials to assess the risks posed by new chemicals. Section 5 submitters sometimes provide additional information after EPA has already begun a risk assessment of the new chemical substance. The additional engineering information is often related to the environmental release and/or occupational exposure assessment of the new chemical substance.
Intake, review, and inclusion of new data and information takes time. When additional information is submitted, EPA reviews it in order to determine whether it is relevant, adequately documented, and well-supported and whether the Agency needs to revise its risk assessment to incorporate it. Revision(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.
In order 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. EPA found that an individual case may be reworked anywhere 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 found that the additional information that most often led the Agency 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 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 of (e.g., on-site wastewater treatment, 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.
- Additional information on sites not under submitter control (e.g., customers downstream of the manufacturer and/or importer of the new chemical substance).
Summary of EPA's Analysis (pdf) .
Analysis Methodology and Results (pdf)
Monthly Statistics on Rework Cases
EPA reports on the number of rework risk assessments completed each month in the Statistics for the New Chemicals Program under TSCA. This webpage provides a general overview of EPA’s new chemicals review work, tracks the status of active cases currently under review and illustrates general statistics for all new chemical submissions received since TSCA was amended on June 22, 2016.
EPA considers a case a “rework assessment” if supplemental work is required after the initial risk assessment has been completed. This supplemental work could include evaluation of new information from the submitter and development of new assessment reports or memos in response to new information or questions.
EPA’s new chemicals program invests significant time to address the rework risk assessments. By adding this data to the statistics that are reported each month, the EPA is increasing the transparency of its workload for the public.
View the Statistics for the New Chemicals Program
Outreach and Training
As a part of ongoing efforts to increase the efficiency and transparency of its new chemicals review process, the Agency has engaged 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).
On July 27, 2022, EPA hosted a webinar to provide an in-depth look at EPA's analysis of common issues that cause EPA to have to rework risk assessments before taking questions from the audience. Read the meeting materials (pdf)
On October 18, 2022, EPA hosted a second webinar to describe EPA’s review process for new chemicals, in particular 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. Read the meeting materials (pdf)
On February 28, 2023, EPA hosted the third and final webinar in the series to explain commonly missed information in section 5 submissions and how EPA evaluates environmental release information for operations that occur at non-submitter sites. Read the meeting materials (pdf) .