Today, the U.S Environmental Protection Agency (EPA) is announcing 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 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 inefficiencies while also ensuring a protective review of new chemical risks. 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 =E2=80=98rework') 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 =E2=80=98rework' 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 (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 (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 (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).
EPA is releasing a summary of the types of information reviewed, the analysis that was conducted, and next steps. Stakeholder Outreach and Benefits As a part of ongoing efforts to increase the efficiency and transparency of its new chemicals review process, the Agency 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 kick off meeting which 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. The webinars will include case studies to help stakeholders understand what data the Agency considers acceptable and an opportunity for stakeholders to ask questions Subsequent webinars will communicate EPA's 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 anticipates this outreach effort will be particularly helpful in reducing rework on Low Volume Exemptions (LVEs), which constitute about 60% of TSCA section 5 submissions annually. EPA anticipates this effort will also help submitters understand what type of information should be included in the original submission, which can lead to a more robust and accurate risk assessment and reduce the likelihood of the time-consuming process of the same chemical substance being denied by EPA when submitted the first time and then re-submitted under a second or third exemption notice. More information can be found on EPA's website. | 
