Low Volume Exemptions/Modifications
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Low Volume Exemptions
The premanufacture notice (PMN) rule exempts certain categories of new low volume chemical substances from full PMN review under section 5 of the Toxic Substances Control Act (TSCA). This rule provides a limited exemption from PMN requirements for certain low volume substances (i.e., chemicals manufactured at 10,000 kg/year or less). In 1985, the EPA promulgated (50 FR 16477) the first low volume exemption (LVE) for substances produced at 1,000 kilograms per year (kg/year) or less. The 1995 PMN amendments (60 FR 16336-16351) replaced the earlier exemption in full and increased the production volume limit to 10,000 kg/year LVE substances undergo a 30-day review and are not subject to a user fee.
This exemption allows the submitter to designate and be bound to a production volume (PV) smaller than the 10,000 kg/year limit. EPA will perform its risk assessment at the lower PV, if the corresponding binding box has been marked.
More than one manufacturer may hold an Low Volume Exemption (LVE) for the same substance. If the second petition causes EPA to find that the cumulative effects of the substance may present an unreasonable risk, EPA may ask the first submitter to: verify that manufacture has commenced, re-certify intent to manufacture, or withdraw the exemption.
If a submitter holds a previously granted LVE, he/she may either 1) continue activities under the original LVE's terms, or 2) apply for a new LVE. If the second option is chosen, the manufacturer may continue activities under the original LVE until the new exemption is approved and the 30 day review period has expired.
LVE substances are not added to the TSCA (Toxic Substances Control Act) Inventory - a separate list is maintained.
An LVE notice, including a sanitized version, must be submitted at least 30 days prior to manufacture. The notice must be submitted using the PMN Form, EPA Form 7710-25. The following information must be included:
The type of notice, LVE 40 CFR 723.50(c)(1), must be clearly marked.
Certification of the following: 1) intent to manufacture/import the substance for purposes other than research and development, 2) knowledge and willingness to comply with LVE terms, 3) the substance meets all exemption conditions, and 4) intent to manufacture the substance within one year of expiration of the 30-day review period.
Manufacturer identity, a current chemical abstracts (CA) name, impurities, known synonyms or trade names, and byproducts.
The 12-month production volume (the PV period begins the date after the end of the review period). The submitter will be bound to a lesser PV if the corresponding binding box is marked, otherwise a PV of 10,000 kg/year will be assumed.
Description of categories of use.
Readily known or available information on worker exposure and environmental releases. (If not supplied, EPA will develop its own estimate).
Test data (including physical/chemical data) in submitter's possession or control concerning the effect(s) of the substance on health or the environment must be submitted with the exemption.
Certain conditions/controls must be maintained throughout the duration of the exemption: 1) use, 2) site of manufacture (except as described below); 3) exposure and release controls (including physical form, if pertinent to exposure/release levels); 4) importation only, if so specified, and 5) a PV of less than 10,000 kg/year, if so specified.
The site of manufacture may be changed without a new LVE if the magnitude, frequency, and duration of exposure to workers at the new site is equal to, or less than, that which was reported at the site of manufacture in the LVE, and either, 1) at the new site, there are no releases to surface water of the new substance or any waste streams containing the new substance, or (2) surface water concentrations of the new substance resulting from direct or indirect discharges are at, or below, 1 ppb or are at, or below, a concentration pre-approved by EPA or (3) under procedures described in the Low Releases and Low Exposures (LOREX) exemption at 40 CFR 723.50 (c)(2)(iii).
The LVE holder must notify processors and industrial users: 1) that the LVE substance can only be used for uses specified, and 2) of any exposure and environmental release controls identified in the notice (including physical form). Notification may be by label, written communication, or other method that adequately informs of the restrictions and controls.
EPA does not allow simultaneous submissions of a PMN and a LVE for the same substance. With submission of a LVE, the submitter certifies that he/she intends to manufacture a PV at, or less than, 10,000 kg/year.
Manufacturers must submit a new LVE 30 days prior to a change in:
Site of manufacture - includes changes from import to domestic manufacture as well as changes in contract manufacturers - except as provided at 723.506(6);
Use - includes changes in functional application and from one class to another (e.g., industrial use to commercial use);
Physical form - if increases exposure release levels;
Specified worker protection;
Environmental release and human exposure controls; or
Production volume, if the original LVE binds at less than 10,000 kg/year.
The LVE holder should be aware that a change in site or use may result in changes in exposures, releases or stream concentrations. Consequently, exposure and release controls indicated in the original notice may no longer be adequate to mitigate potential risks. Therefore, changes in use or site (except as provided at 723.50(I)(6)) must be approved by the Agency.
If you submit a LVE to EPA, you are required to use the electronic-PMN ("e-PMN") software as discussed in the "e-PMN" final rule (75 FR 773) (PDF) (18 pp, 110K, about PDF). You must use the PMN module within the e-PMN software to submit your LVE. On page 1 of the PMN module, be sure to check the box stating the type of notice you are submitting is a LVE.
During the first year following the effective date of the final rule, LVE submissions will be permitted via Central Data Exchange (CDX), optical disc or paper. One year after the rule's effective date, i.e., as of April 6, 2010, paper submissions will not be accepted. Two years after the final rule's effective date, i.e., as of April 6, 2011, all submissions will be required to be submitted electronically via CDX. Refer to www.epa.gov/cdx, the CDX Registration Guide (PDF) (44 pp, 8.6MB, about PDF), or the CDX Helpful Hints (PDF) (10 pp, 41K, about PDF) for directions on how to register and submit notices via CDX.
Low Volume Exemption Modifications
Modification requests must clearly identify the following information:
The original EPA-assigned LVE number, specific chemical identity, manufacturers name, and name and telephone number of a technical contact,
A statement that the document represents a petition to modify the original LVE,
The nature of the modification (e.g., new site, new use, etc),
Informational data to support the modification request,
Any new exposure and/or release controls due to the modification of site or use, and
New certification statements with original signature by authorized official.
Other information previously reported in the original LVE, unless changed, is not required to be resubmitted.
You must also submit LVE modifications using the PMN module. Mark the modification type on PMN page 1 (continued) and the certification statements on PMN page 2. 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:
- fill in the applicable fields in the PMN pages 4-13;
- enter the modification information in the cover letter; or
- 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.
- The Agency will acknowledge receipt of a modification request by letter. After review of the modification, the Agency will notify the submitter either when the modification request is to be denied, or to address limitation(s)/restriction(s) that may be necessary before the Agency approves a modification request.