Tracking Progress: TSCA Section 5 Exemptions

Last Updated on June 20, 2023

Telly Lovelace

LVE, LoREX & Modifications

TSCA Section 5 exempts New Chemical substances from Premanufacture Notice (PMN) requirements if they are manufactured in quantities under 10,000 kilograms per year or have low human exposure and low environmental releases (40 CFR § 723.50).

Chemical substances are not eligible for Low Volume Exemptions (LVE) or Low Environmental Release and Human Exposure (LoREX) Exemptions if they cause serious acute, chronic or environmental effects.

The LoREX exemption requires dermal or inhalation exposures and drinking water exposure to be no greater than 1 milligram per year.

Exemption Submissions & Determinations

The number of Section 5 Exemption determinations (excluding invalids) moderated after an initial spike in 2017, averaging approximately 262 LVE, LoREX and Modifications over the 2018 to 2022 period. In 2023, there were 222 LVE, LoREX and Modifications, a 19% decrease in exemption submissions.

There was an average of 257 Exemption determinations over the 2018 to 2022 period. In 2023, the number of determinations decreased 39% from an average to 257 per year to 157, excluding invalids.

Review Period

The review period for LVE and LoREX notices is 30 days. The submitter can suspend the review period at any time during the review period. If the EPA has not taken any action by the end of the review period, the submitter can commence manufacturing the chemical substance.

As noted in the table below, the number of exemption notices that were completed within the required 30 days dropped significantly in 2021 with only 6 exemptions receiving a determination within 30 days. In 2023, EPA did not complete the review of any exemption notices within the 30-day review period and only 4 were completed within 60 days.

As indicated in the above chart, since 2021, there has been a notable shift in the type of determinations for LVE and LoREX Section 5 Exemptions with significantly more exemption notices receiving denials.

Denial & Grant Exemptions

Before 2021, there was a downward trend in the number of Denials and an increase in the number of grants for Section 5 Exemptions. Denials sharply increased to 21% in 2021, then 35% in 2022, and 18% in 2023.

Withdrawal & Invalid Exemptions

There was a significant increase in the number of Withdrawals, from an approximate average of 5% in over the 2016 to 2020 period to 19% in 2021.

In both 2021 and 2022, approximately 40% of Section 5 Exemptions were either Withdrawn or Denied. This number decreased in 2023 to 21%.

EPA does not publish data on the chemical substances for Exemption notices on the New Chemicals website. Therefore, it is unclear if the increase in Withdrawals and Denials is related to any new EPA policies or initiatives on any particular class of chemical substances.

Exemption Determinations

Final determination may result in one of the following Exemption notices:

Invalid: Exemption request was declared incomplete, or the subject chemical was found on the TSCA Chemical Substance Inventory, or the subject chemical is not subject to section 5 of TSCA.
Grant: Exemption/Modification request is approved, and use of the chemical substance can begin after day 30 or day 45, subject to the conditions identified in the Exemption/Modification submission (including amendments).
Conditional Grant: Exemption/Modification request is expected to be approved, subject to the condition that the applicant must suspend the application, propose additional appropriate exposure/release controls, and amend application and/or the Safety Data Sheet (SDS) accordingly.
Conditional Denial: Exemption/Modification request is denied unless the applicant proposes additional appropriate exposure/release controls and amends application or Safety Data Sheet (SDS) accordingly.
Denial: Exemption/Modification request is denied. EPA staff does not expect that adequate controls would be available.
Withdrawal: The submitter withdrew the submission before the end of the applicable review period.

Tracking Progress

Premanufacture Notices (PMNs) TSCA New Chemicals Review