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New Chemicals Program - Current Status of PMNs

This web page provides the regulatory status of TSCA Pre-Manufacture Notices (PMNs) and Low Volume Exemptions (LVE) as determined at EPA's Focus Meeting. This list will be updated weekly to add new cases. Some of these Focus decisions are provisional while others are final pending further risk-related information. Except for PMNs in "short question" review, please note that EPA does not update the status initially posted on this webpage, even though the disposition of some cases may change after the status is posted here. The purpose of this webpage is to allow submitters to determine the initial disposition of their cases as quickly as possible.

In order to make this list timely, there will be times that submitters read about a chemical here before receiving a program manager's call. Program manager's call will take place within 2 weeks after Focus. As a reminder, regardless of the Focus disposition, PMN submitters must wait until day 30 for LVEs and day 90 for PMNs have passed before commencing manufacture and/or import of the PMN/LVE substances undergoing review.

The list will contain the PMN or LVE number, the Focus date, and the status of the notice. The status will be designated as follows:

For PMNs:

INVALID for notices which are declared incomplete, notices with chemicals found on the TSCA (Toxic Substances Control Act) Inventory, and notices of chemicals that are not subject to Section 5 of TSCA.

DROP for notices that have been dropped from further review.

DROP/LETTER for notices that have been dropped from further review. The submitter will receive a letter detailing specific concerns for the PMN substance.

DROP WITH NON-5(E) SNUR for notices that have been dropped from further review for use(s) as submitted in the notice. The chemical substance will have certain restrictions on releases and/or exposures under a non-5(E) SNUR.

PENDING 5(E) REGULATION for notices meeting exposure-based criteria or falling into a category of chemicals for which EPA has risk concerns. Although this status can change based on receipt or development of any new information, the description on this list will not be altered.

PENDING SHORT QUESTION REVIEW for notices that still have outstanding questions following Focus review and whose outcome is contingent upon the answers. The decision pending this review will be posted here.

PENDING STANDARD REVIEW for notices that are entering the standard review process.

For LVEs:

INVALID: LVE request was declared incomplete, or the subject chemical was found on the TSCA Inventory, or the subject chemical is not subject to Section 5 of TSCA.

GRANT: LVE request is approved and use of the material can begin after Day 30, subject to the conditions identified in the LVE submission.

FINAL CONDITIONAL GRANT: LVE request is approved and use of the material can begin after Day 30, subject to the conditions identified in the LVE submission. Exemption approval is granted because appropriate information such as exposure/release controls/MSDS was included in the LVE submission.

CONDITIONAL GRANT: LVE request is expected to be approved, subject to the condition that applicant must suspend the application, propose additional appropriate exposure/release controls and amend application/MSDS accordingly.

CONDITIONAL DENIAL: LVE request is denied unless applicant proposes additional appropriate exposure/release controls and amends application/MSDS accordingly. Agency has not identified what those controls would be.

DENIAL: LVE request is denied unless applicant proposes additional appropriate exposure/release controls and amends application/MSDS accordingly. Agency staff does not expect that adequate controls would be available.

By using the drop-down menus, you can search the PMN or LVE lists by Case Number, Status, or Date. You can enter all or part of a case number, a status entry, or a date, using the following structure, i.e., P99-98 or L99-98, Invalid, 8/15/1999.

To limit the search to a specific case number or item, place a $ immediately after the entry, i.e. P99-1$. To list all entries, place an * immediately after the case type, i.e. L* or P*.














For comments or questions, contact Anna Coutlakis at Coutlakis.Anna@epa.gov

 


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