Regulatory Developments

EPA Holds Kick-Off Meeting for TSCA New Chemical Engineering Outreach Initiative

July 28, 2022 PRINT

The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program held a webinar on July 27, 2022, to provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) of new chemicals. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker exposure) provided for new chemicals submissions under the Toxic Substances Control Act (TSCA) and common issues that cause EPA to have to rework risk assessments for these submissions. EPA has posted the meeting slides online.

According to EPA, when a company amends its submission after EPA’s review process has begun, the additional information may be intended to:

  • Clarify or supplement the original submission; or
     
  • Provide additional information to refute EPA’s initial risk determination.
     

EPA states that for low volume exemptions (LVE), “companies sometimes submit a second or third submission for the same [new chemical substance (NCS)] that was previously denied by EPA.”

To understand the common additionally submitted information causing most of the rework to EPA’s engineering assessment, EPA analyzed 94 unique cases with additional information submissions that were originally submitted from 2019 to 2022. For each case, EPA reviewed the company submissions to identify the type of information submitted. EPA then compared that information to different versions of the engineering assessment to determine whether the additional information resulted in revisions to EPA’s assessment and recorded how many times each case was revised. EPA reviewed, compiled, and catalogued the collected information into major “bins” relevant to environmental release and occupational exposure. EPA then broke each major bin into sub-bins “to develop insight into more specific causes of rework.”

During the webinar, EPA presented an example of a rework case. According to EPA, from its analysis, it observes that:

  • Information on material balance parameters, environmental releases, environmental release media, and engineering controls cause nearly 80 percent of all rework;
     
  • In most cases, companies provide additional information that deviates from EPA model defaults and assumptions; and
     
  • Companies often lack understanding on what information is needed for a Section 5 engineering assessment, including the level of detail needed to support their statements relating to environmental release and worker exposure.
     

As noted in the meeting slides, EPA plans to hold two additional webinars in fall 2022 that will cover:

  • How EPA evaluates quantitative and qualitative information, with examples on the level of detail needed to support the submitted information to be accepted by EPA; and
     
  • The types of information commonly missing in Section 5 submissions, how EPA evaluates environmental release information on sites not controlled by the submitter, and their impact on engineering assessment.
     

The webinar included a question and answer (Q&A) period. EPA stated that it plans to use examples from actual cases in the next webinar. EPA will redact any confidential business information (CBI) and look at how useful the case is after the redaction. EPA may need to edit the case to make it clear to stakeholders. When asked how many of the rework submissions were requested by EPA, EPA responded that it does not request rework. According to EPA, when companies make a submission, it would be helpful to include the number of industrial sites, and even getting a range would be more useful than leaving the information blank. EPA knows that it can be challenging to identify the number of consumer uses, but if companies have that information, it could be beneficial to provide it. EPA understands that it can be difficult to estimate. EPA stated that companies typically change the production volume if they become aware that the initial volume would result in an unreasonable risk determination. EPA is considering revising its directions to ensure better information in initial filings.

Commentary

EPA’s webinar continues its effort to provide submitters with more information to assist in preparing initial submissions. Bergeson & Campbell, P.C. (B&C®) has long been of the view that premanufacture notices (PMN) must be accompanied by robust information. TSCA reform has made it even more important. This webinar extends EPA’s efforts to garner additional information, but other than the breakdown of why cases are reworked, the webinar fell short on providing additional guidance in this regard that was not already available in EPA’s well-written Points to Consider document.

We would welcome EPA providing guidance on what justification or basis is needed to persuade EPA not to use its default assumptions over actual data. One of the EPA presenters suggested that EPA will address this issue in one of the subsequent webinars, which would be useful new information. It is also still not clear what, if any, difference additional information may have on EPA’s regulatory decisions, in particular, what conditions of use are reasonably foreseen. In our experience, information submitted with a PMN or LVE seems primarily to inform EPA’s view on the intended conditions of use, not the known or reasonably foreseen conditions of use. EPA deferred answering questions related to regulatory outcomes during the Q&A period. We look forward to the next webinar in this series.


 
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