New Chemicals Program - Current Status of Section 5 Notices
This web page provides the tentative regulatory status of TSCA section 5 Premanufacture Notices (PMNs), Significant New Use Notices (SNUNs), Low Volume Exemptions (LVEs), Low Volume Exemption Modifications (Ms), Low Exposure/Low Release Exemptions (LoRexes), Low Exposure/Low Release Exemption Modifications (XMs), and Test Marketing Exemption Applications (TMEAs), 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 web page, even though the disposition of some cases may change after the tentative status is posted here. The purpose of this web page 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. The Program Manager's call will take place within two weeks after the Focus meeting. As a reminder, regardless of the Focus decision, notice submitters must wait until day 30 for LVEs, LoRexes, and their modifications, day 45 for TMEAs, and day 90 for PMNs and SNUNs have passed before commencing manufacture/import or new use of the PMN/exemption/SNUN substances undergoing review.
The Status page listing for a specific notice will contain the PMN, SNUN, or exemption number, the Focus date, and the status of the notice. The status will be designated as follows:
For PMNs and SNUNs:
INVALID: For notices that are declared incomplete, for notices with chemicals found on the TSCA Chemical Inventory, for notices of chemicals that are not subject to section 5 of TSCA, and for SNUNs whose uses are not new.
NO ACTION TAKEN (DROP): For notices that have been dropped from further review. The Agency did not make a "may present an unreasonable risk" finding or an exposure-based finding resulting in regulation.
DROP/LETTER: For certain notices that have been dropped from further review. The submitter will receive a letter detailing specific EPA concerns for the PMN substance.
DROP WITH NON-5(E) SNUR: For notices that have been dropped from further review for the 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 website 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 made following this short question review will be posted here.
PENDING STANDARD REVIEW: For notices that are entering the standard or more detailed review process.
For EXEMPTIONS and EXEMPTION MODIFICATIONS:
INVALID: Exemption request was declared incomplete, or the subject chemical was found on the TSCA Chemical Inventory, or the subject chemical is not subject to section 5 of TSCA.
GRANT: Exemption/Modification request is approved and use of the material can begin after day 30 or day 45, subject to the conditions identified in the Exemption/Modification submission.
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/MSDS accordingly.
FINAL CONDITIONAL GRANT: Exemption/Modification request is approved and use of the material can begin after the notice review period is over, subject to the conditions identified in the Exemption/Modification submission (including amendments). Approval is granted because appropriate information such as exposure/release controls/MSDS was included in the Exemption/Modification submission.
CONDITIONAL DENIAL: Exemption/Modification request is denied unless the applicant proposes additional appropriate exposure/release controls and amends application/MSDS accordingly. Agency has not identified what those controls would be.
DENIAL: Exemption/Modification request is denied unless the 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 status of your TSCA section 5(e) Notice or Exemption, i.e., PMNs (P), SNUNs (SN), LVEs (L), LVE Modifications (LM), LoRexes (X), LoRex Modifications (XM), and TMEAs (T) by Case Number, Status, or Date (example 7/8/2011). You can enter all or part of a case number or a status entry using the following structure, e.g., P-11-0001, L-11-0001, Invalid or just the number 0001. To list all entries for a certain fiscal year, you may enter P-[FY] or L-[FY] (e.g., P-11 or L-11 for 2011 cases of that type). This search will return the case status and dates for all PMNs, exemption notices, or SNUNs pertaining to that fiscal year.
For comments or questions, contact Anna Coutlakis at Coutlakis.Anna@epa.gov.