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Low-Volume Exemptions/Modifications under TSCA

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Low Volume Exemptions

Overview

Certain categories of new low-volume chemical substances are exempt from full premanufacture notice (PMN) review under section 5 of the Toxic Substances Control Act (TSCA), i.e., chemicals manufactured at 10,000 kg/year or less. LVE substances undergo a 30-day review and are not subject to a user fee.

Contents of the LVE Notice

Conditions of the LVE

Learn about requirements for submitting an LVE

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Low-Volume Exemption Modifications

Contents of the LVE Modification

Modification requests must clearly identify the following information:

  1. The original EPA-assigned LVE number, specific chemical identity, manufacturers name, and name and telephone number of a technical contact,

  2. A statement that the document represents a petition to modify the original LVE,

  3. The nature of the modification (e.g., new site, new use, etc),

  4. Informational data to support the modification request,

  5. Any new exposure and/or release controls due to the modification of site or use, and

  6. New certification statements with original signature by authorized official.

  7. Other information previously reported in the original LVE, unless changed, is not required to be resubmitted.

Learn about requirements for submitting a modification to an LVE

Note: On the opening screen (General Form Information, PMN page 1) of the Premanufacture Notice form, be sure to select from the dropdown list the type of notice you are submitting: LVE Modification. You must also mark the certification statements on PMN page 2 and fill out the contact information on PMN page 3. You can enter the rest of the modification information into the form in one of three ways:

  1. fill in the applicable fields in the PMN pages 4-13;
  2. enter the modification information in the cover letter; or
  3. enter the modification information as an attachment.

It should be noted that for modifications, the e-TSCA/e-PMN software does not validate any data beyond PMN page 3.

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