On February 28, 2023, the U.S. Environmental Protection Agency (EPA) New Chemicals Program held the third and final webinar in its series on EPA’s process for assessing the potential risks of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) and the types of data EPA considers in this assessment. The webinar covered commonly missed information in Section 5 submissions and how EPA evaluates environmental release information for operations that occur at non-submitter sites. The webinar slides are available on EPA’s website. EPA did not record the webinar.
According to EPA, commonly missed information includes information concerning:
- The physical form of the new chemical substance (NCS) throughout its industrial and commercial lifecycle from manufacturing (including import), processing, and use;
- The number of sites associated with manufacturing (including import), processing, and industrial/commercial use. EPA noted that if the exact number of processing/use sites is not known at the time of application, submitters should provide an estimate or range if reasonably known or ascertainable (e.g., 1-5 sites v. 100-500 sites); and
- The number of workers. Submitters should estimate the number of workers exposed for all sites combined. The estimate should include all employees who are reasonably likely to be exposed to the NCS. This would include both workers who directly handle the NCS and workers who may be exposed as “bystanders.”
EPA suggested for low volume exemption (LVE) cases, submitters should review and consider the binding option for the maximum 12-month production volume (PV) in Part I, Section C. If the PV is not bound, EPA will review the NCS at the maximum PV of 10,000 kilograms per year (kg/yr). If a submitter chooses not to bind this volume, and the stated maximum 12-month production is substantially lower than 10,000 kg/yr, EPA stated that the submitter should indicate how the operation, release, and exposure information is likely to change if the production of the NCS is scaled up.
EPA stated that submitters should clearly describe the intended use, including uses of products containing the NCS at downstream customer sites. If the NCS is a component of coating, paint, or adhesive products, submitters should specify the application method/process (e.g., spray coating, roll coating, roller, syringe, or bead). For coating products with an unknown/unidentified process, EPA typically assumes spray-application unless basis/supporting information is provided to rule out the possibility of spray application. If an engineering control is present, submitters should describe the type of control and control efficiency and provide documentation that supports the control efficiency estimate. EPA recommended that submitters check the entire submission to ensure consistency in all information/narrative/attachments (e.g., information such as physical form, release quantity, NCS concentration, and exposure duration and frequency should be consistent across the premanufacture notice (PMN) submission and attachments).
For sites not under submitter control, EPA assesses environmental releases of new chemicals from manufacturing, processing, and use as part of the engineering assessment. According to EPA, submissions often include statements about the specific operation, process, and waste disposal method, including the environmental media. EPA stated that where the operation is not under submitter control, EPA considers the following when evaluating “media of release”:
- Technical constraint;
- Administrative control; and
- Generic scenario, emission scenario document, or other EPA guidance.
EPA addressed questions from its second webinar, “Information Evaluation Consideration,” that it did not have time to address during that webinar. EPA began with two connected questions: Assuming submitter data are considered reliable, does EPA use data submitted in preference to its models and does the NCD use this [submitted] information to inform what is intended or does it also inform what is reasonably foreseen? EPA responded that if data are submitted as part of new chemical information, EPA would review any human health toxicity studies to determine toxicity, would consider information on environmental release and worker exposure, and since this webinar series is specifically focused on engineering information, it would use the information if it was found to be acceptable after evaluation in terms of commercial and industrial use.
The next question concerned submitters that use third party companies to recycle rinse water and whether EPA assumes the rinse water goes to a publicly owned treatment works (POTW) first. If the recycler collects the rinse water for incineration, what is the best way to document this in a PMN submission? According to EPA, unless specific information is provided in the submission, EPA typically assumes that cleaning could result in releases to water, incineration, or landfill. If waste treatment is handled by a small number of known third party companies, then the submitter should include supporting documentation, such as a written agreement documenting how the waste will be handled.
An attendee suggested that if prescreening is a completeness check, it would be helpful to have something similar to the European Chemicals Agency’s (ECHA) guidance on completeness checks. EPA responded that prescreening is only making sure that the engineering information is available and that the data elements are provided in some way. Prescreening is not a comprehensive completeness check. The process happens quickly. Asked if it provides feedback on data quality to submitters, EPA stated that it does not provide feedback on all submissions, but submitters may request feedback through the assigned program manager.
EPA was asked if the NCS is to be sold to multiple customers, how should the submitter provide exposure information. EPA stated that based on the regulations, information should be provided to the extent that it is known or reasonably ascertainable to the submitter. If not known, it would be helpful to state so explicitly. If a company sells to a small number of customer sites and knows how its customers use the NCS, it would be helpful to provide copies of written agreements. In cases where the NCS is distributed to a large number of customers and information may be hard to provide, EPA will make conservative assumptions.
EPA next addressed questions from the February 28, 2023, webinar. An attendee asked for details on what EPA considers a bystander and how it is defined. EPA stated that the regulations may not specifically define bystander, but that the PMN submission form asks for the number of workers. According to EPA, workers reasonably likely to be exposed would include bystanders. An example would be if a company has a worker performing spray coating activity. Obviously that worker will be exposed, but if the spray coating activity takes place in an open booth or if there are other employees nearby, then it is likely those other workers could also have some exposure. When looking at the exposure model, EPA is trying to assess the concentration of the exposures. An operator may be exposed at one level, but a technician responsible for loading and unloading material may have less exposure.
An attendee asked if EPA asks LVE submitters who do not check the binding option if they wish to do so before EPA spends time developing unrealistic risk assessments. In some cases, EPA does. It does not have the resources to call every submitter, however. EPA stated that it is best if submitters consider the binding option before submitting their applications.
An attendee asked if EPA requests data about engineering controls and if it also asks for worker exposure monitoring data. EPA stated that if companies already have that data, then they should provide them and EPA will evaluate them with the PMN. When asked what default EPA uses for wastewater emissions in absence of data, EPA responded that it does not have a default that applies across the board. An attendee asked if EPA is considering providing training on the Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER) so that submitters can better provide data. EPA stated that training was provided in the past through the Sustainable Futures Program. EPA understands that there is strong interest on both sides to resume training, and it is evaluating its internal resources.
Additional Information
EPA provided links for additional information. Those links, as well as links to our memoranda, are listed below:
- Slides for the webinar series:
- Webinar 1: Kickoff Meeting (July 27, 2022). Bergeson & Campbell, P.C.’s (B&C®) July 28, 2022, memorandum;
- Webinar 2: Information Evaluation Considerations (October 18, 2022). B&C’s October 25, 2022, memorandum; and
- Webinar 3: Commonly Missed Information (February 28, 2023).
- Supporting materials:
- Summary of EPA’s Analysis (supplemental document);
- Analysis Methodology and Results (supplemental document); and
- B&C’s June 27, 2022, memorandum.
- EPA’s web page: TSCA New Chemicals Engineering Initiative to Increase Transparency and Reduce Rework.
Commentary
The third and final webinar on how submitters can improve their PMNs and LVEs provided few novel points for experienced submitters. EPA pointed out common omissions and provided additional details on areas that it frequently sees inadequate data in submissions. EPA reiterated the importance of providing a basis for estimates and reiterated that submitters are required to provide all known or reasonably ascertainable information with the submission. In particular, EPA requested that if a data element is not known or reasonably ascertainable, that submitters make a statement to that effect, so it is clear to EPA that the information was not simply omitted.
As we have long counseled clients, providing robust submissions with well-supported facts (such as how a release quantity was derived, not just providing the final estimate) for all the phases of a chemical’s lifecycle is vital to achieving timely, accurate review. Submitters are advised to re-review EPA’s Points to Consider document for additional information on what to include.
We are also of the view that submitters should request EPA’s new chemicals reports (notably the engineering, exposure, health, and ecotoxicity reports) that form the basis of EPA’s risk conclusion. While it may be difficult for many submitters to understand and interpret those reports until EPA restarts its Sustainable Futures training, those reports do allow experienced reviewers to trace the basis for EPA’s risk assessment, and can form the basis for additional testing, correcting misinterpretations or miscommunications between the submitter and EPA, or identifying errors in EPA’s assessment.
We do appreciate that EPA is engaging in outreach to stakeholders with a wide variety of experience, so providing some basic information is justified. It is in everybody’s interest that initial submissions are robust and as complete as possible to minimize opportunities for rework or resubmission. Submitters should avoid submitting to “start the clock” on the review period with the intention of providing additional information later. EPA has the authority to reset the review period depending on how extensive and material the additional information is. Even if EPA does not reset the review period, EPA is currently putting rework at a lower priority than new submissions. Submitters are much better off waiting until the submission is complete.
We had hoped that EPA would provide additional insight into how and under what circumstances EPA will use submitted, well-supported details to limit the conditions of use that EPA views as reasonably foreseen, but EPA has yet to provide any clarity on how it evaluates reasonably foreseen conditions of use.