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Tracking Progress: TSCA New Chemicals Reviews

Last Updated on May 17, 2024

Telly Lovelace

New Chemicals Analysis

Section 5 of the 2016 TSCA amendments require EPA to determine if a new chemical substance poses an unreasonable risk before the chemical can be manufactured in or imported to the United States.  The statute requires EPA to make this determination within 90 days and allows EPA to extend the review period up to an additional 90 days. 

Of the 407 new chemicals under TSCA review, 76 have been under review for less than 90 days.

The remaining 331 new chemicals have been under TSCA review for more than 90 days, creating a backlog of advanced chemistries ensnared in the EPA’s review pipeline.

As of May 16, 81% of new chemicals have been under EPA review for more than 90 days.  Although it appears that the backlog of new chemical reviews decreased 13% in April there was an increase in the number of PMN submissions, while the number of chemicals under review for greater than 90 days remained essentially the same.

EPA completed 23 PMN submissions in April from the TSCA new chemical review backlog. The average number of PMN submissions per month in 2023 was approximately 11.6, this number increased in the first 3 months of 2024 to an average of 20.  The number of PMNs completed remained essentially the same in 2023 and the first 3 months of 2024 with approximately 12 completions per month.

244 PMNs (74%) of the backlog have been under EPA review for greater than or equal to one year.

EPA’s inability to meet the statutorily mandated 90-day deadline to conduct new chemical reviews coupled with the drop in the number of completed chemical reviews has created a significant backlog in the New Chemicals Program, threatening American innovation and manufacturing. 

In a 2022 survey of ACC member companies, 70 percent of respondents reported that they have decided to introduce new chemicals outside of the U.S. due to uncertainties and challenges with the EPA’s New Chemicals Program. 

Read ACC’s backgrounder on EPA’s TSCA New Chemicals Program

Understanding ACC’s Tracking of EPA’s Progress in TSCA New Chemical Reviews

ACC developed these visualizations to help interpret and track EPA’s performance of the TSCA New Chemicals Program. The data and information were compiled from the following EPA sources: 1) the New Chemicals case tracker and, 2) the Premanufacture Notices (PMNs) and Significant New Use Notices Table

Click on the links below for more visuals and analysis tracking EPA’s progress in determining Premanufacturing Notices (PMN) and Section 5 Exemptions.

Tracking Progress

* The data is from 2017 to the present and is updated monthly. While the data from the two EPA sources has some discrepancies, the information is indicative of the status of the EPA’s New Chemicals program.

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