Regulatory Developments

EPA Improves Transparency for New Chemicals Review Program under TSCA

August 5, 2019 PRINT

The U.S. Environmental Protection Agency (EPA) announced on August 1, 2019, that it is making additional information about new chemical notices available on its website.  The new web page, “Statistics for the New Chemicals Review Program under TSCA,” allows users to view and search monthly updates for any active Premanufacture Notice (PMN), Significant New Use Notice (SNUN), and Microbial Commercial Activity Notice (MCAN) of interest by case number.  Users can also download a spreadsheet with a list of all active cases and each case’s status. 
 
As reported in our May 16, 2019, TSCA blog item, “EPA Updates Its New Chemical Statistics Web Page to Increase Transparency,” EPA previously presented only the number of cases in each step of the review process without identifying case numbers.  According to EPA, this enhancement supplements the existing status tables describing the received date, the interim status, and final determinations for each case reviewed by EPA since the amendments to the Toxic Substances Control Act (TSCA) were passed in 2016.  The update also supports EPA’s ongoing efforts to review new chemicals submissions more efficiently “by proactively providing status updates to submitters.”  EPA notes that the tool will continue to keep confidential business information confidential.

Commentary

As EPA states, this action is another step toward meeting its transparency goals and other recent actions as reported in the additional resources listed below.  This new tool provides more granular detail about the status of cases.  First, it gives stakeholders richer detail into the steps of PMN review, from presubmission to final determination.  It also gives unprecedented visibility into the number of cases in each stage of review.  Importantly for EPA management and congressional oversight, it differentiates cases waiting for EPA action and those waiting for submitters to provide additional information.  It also helps submitters ensure that they and EPA are in agreement as to which party is responsible for the next step.
 
Probably the most surprising fact is that there are 21 consent orders awaiting signature by the submitter.  In our experience, consent orders do not linger awaiting submitter signature -- the terms are negotiated in advance, so the submitter only needs to review the order to be sure its terms are as expected.  The submitter countersigning and returning the consent order is what ends the review period and allows the submitter to commence manufacture.

Additional Resources

More information on recent EPA actions is provided in the following blog items and memorandum:


 
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