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Tracking Progress: Premanufacture Notices (PMNs)

Last Updated on June 20, 2023

Telly Lovelace

Premanufacture Notices (PMNs)

EPA is mandated under TSCA to conduct a new chemical review within 90 days of a manufacturer or importer submitting a new chemicals application, commonly referred to as Premanufacture Notice (PMN).

PMN Submissions & Determinations

EPA received approximately 28 PMN submissions per month in 2017 and 2018. These submissions were prior to EPA increasing the required PMN fees from $2,500 to $16,000.

After the implementation of the new PMN fees in October 2018, PMN submissions in 2019 decreased to approximately 50% of 2018 submission rates. PMN submission rates have been trending upward since 2019. However, they have yet to reach the submission levels prior to the fees increase.

The number of PMN determinations have fluctuated from a low of 275 in 2018 to 332 in 2019. Between 2018 to 2020, there was an average of approximately 296 determinations.

In 2021, there was a significant decline in PMN determinations with only 140 completed and 110 completed PMNs in 2022.

Type of PMN Determinations

EPA makes a final PMN determination in one of the following notices:

  • Not Likely:  The submitter may begin commercialization when they receive EPA’s confirmation letter that the chemical substance is “not likely to present an unreasonable risk”.
  • Consent Order: Determination request was granted with restrictions requiring the submitter to implement risk management measures to minimize exposure and risks.
  • Withdrawal: The submitter withdrew the submission before the end of the applicable review period.

From 2021 to 2022, there’s been a significant shift in the type of PMN determinations. Since 2017, the number of Consent Orders was on the decline with the exception of 2020 when more than 20 Consent Orders were finalized for photolithography applications and a consolidated submission for 15 chemicals for use in oil and gas wells.

In 2022, Consent Orders accounted for 77% of PMN determinations, 31 of which were Consent Orders for a single submitter for chemicals associated with fuel and fuel components.

PMN Review Backlog since 2021

In 2016, EPA immediately began implementing the “determination requirement” resulting in all new chemicals undergoing review to be “reset” or restarting the review process.

The 2016 determination requirement resulted in the reset of 337 premanufacture notices (PMNs) and significantly increased the number of chemical substances under EPA review for more than the 90-day review period, resulting in a backlog.

EPA’s inability to meet the TSCA-mandated 90-day deadline to conduct new chemical reviews coupled with the drop in the number of completed PMN reviews has led to a significant backlog in the New Chemicals Program.

The PMN submissions under review (PMN backlog) increased approximately 91% from 204 in January 2021 to 361 in June 2023.

Tracking Progress

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