Reviewing New Chemicals under the Toxic Substances Control Act (TSCA)

Interim Status of Section 5 Notices reviewed under Toxic Substances Control Act (TSCA)

Please Note

On June 22, 2016, President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which updates the Toxic Substances Control Act. Learn more about the new law, find summary information and read frequently asked questions.

View the final EPA regulatory determinations made under TSCA as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.

Overview

On this page, you can search the interim status of notices received under section 5 of the Toxic Substances Control Act, as amended by the Frank R. Lautenberg Chemical Safety for the 21st  Century Act, and those reviewed under TSCA prior to June 22, 2016, the date of enactment. The tentative regulatory status is determined at EPA's Focus meeting (which is typically held at day 15-20 of the review period). The purpose of this web page is to allow submitters to determine the initial disposition of their cases as quickly as possible.

Cases Reviewed under Amended TSCA

Instructions

By using the drop-down menus, you can search the status of your TSCA section 5 notice or exemption, by case type, by case number, status, or date (example 7/8/2016). You can enter all or part of a case number or a status entry using the following structure, e.g., P-16-0420, L-16-0479, 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-16 or L-16 for 2016 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.









Begin Search:      


 Legend for case types

  • Premanufacture Notices (PMNs): Search P
  • Significant New Use Notices (SNUNs):  Search SN
  • Low Volume Exemptions (LVEs): Search L
  • Low Volume Exemption Modifications (LMs): Search LM
  • Low Exposure/Low Release Exemptions (LoRexes): Search X
  • Low Exposure/Low Release Exemption Modifications (XMs): Search XM
  • Test Marketing Exemption Applications (TMEAs): Search T

Except for exemption applications (i.e., LVEs, LMs, LoRexes, XMs, and TMEAs), please note that EPA does not update the post-Focus Meeting status initially posted on this web page, even though the disposition of some cases may change after the tentative status is posted here.

Note:  In cases where the Agency regulatory determination on a case is “not likely to present an unreasonable risk,” notice submitters may commence manufacture upon notification by EPA'S Chemical Control Division by letter, notwithstanding any remaining portion of the applicable review period, in accordance with section 5(g) of TSCA, as amended.

All other cases must wait until the applicable EPA review period has passed before commencing manufacture (including import) or new use of the PMN/exemption/SNUN substances undergoing review according to the following timeframes:

  • Day 30 for LVEs, LoRexes, and their modifications
  • Day 45 for TMEAs
  • Day 90 for PMNs and SNUNs

The status page listing for a specific notice will contain the PMN, SNUN, or exemption number, the Focus Meeting 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 of chemical substances found on the TSCA Chemical Inventory, for notices of chemical substances that are not subject to section 5 of TSCA, and for SNUNs whose uses are not new.

Recommended “Not likely to present” section 5 (a)(3)(C) determination: For notices of chemical substances expected to be determined to be "not likely to present an unreasonable risk." The submitter may begin commercialization once the official letter confirming the chemical substance is “not likely to present an unreasonable risk” is provided by the EPA.

Recommended section 5(e) regulation - Exposure based: For notices of chemical substances expected to be produced in substantial quantities, and which are expected to either enter or may reasonably be anticipated to enter the environment in substantial quantities or significant or substantial human exposure to the chemical substances is expected. Although this status can change based on receipt or development of any new information, the description on this website will not be altered.

Recommended section 5(e) regulation - Insufficient information: For notices of chemical substances expected to be determined to have “insufficient information available to permit a reasoned evaluation of the health and environmental effects of the chemical substance or significant new use.” Although this status can change based on receipt or development of any new information, the description on this website will not be altered.

Recommended section 5(e) regulation - May present unreasonable risk for intended and reasonably foreseen uses: For notices of chemical substances expected to be determined to “may present an unreasonable risk of injury to health or the environment under the intended conditions of use” described in the PMN or SNUN. Although this status can change based on receipt or development of any new information, the description on this website will not be altered.

Recommended section 5(e) regulation - May present unreasonable risk for reasonably foreseen uses: For notices of chemical substances expected to be determined to “may present an unreasonable risk of injury to health or the environment under reasonably foreseen conditions of use.” Although this status can change based on receipt or development of any new information, the description on this website will not be altered.

Recommended section 5(f) regulation: For notices of chemical substances expected to be determined to present an unreasonable risk of injury to health or environment.

Pending standard review: For notices that are entering the standard or more detailed review process.

Withdrawal: The submitter withdrew the submission before the end of the applicable review period.

For exemptions and exemption modifications:

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 MSDS accordingly.

Conditional denial: Exemption/Modification request is denied unless the applicant proposes additional appropriate exposure/release controls and amends application or Safety Data Sheet accordingly. Agency has not identified what those controls would be.

Denial: Exemption/Modification request is denied. Agency staff does not expect that adequate controls would be available.

Withdrawal: The submitter withdrew the submission before the end of the applicable review period.

Cases Reviewed Prior to June 22, 2016









Begin Search:      

Use this tool to search for cases with completed EPA reviews prior to June 22, 2016.

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.

Note: For companies that submitted premanufacture notices (PMNs) prior to enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act and that were undergoing review on that date, the new law effectively resets the 90-day review period so that the revised review start date is June 22, 2016. EPA will make every effort to complete its review and make a determination as close to the original time period as possible. You can search for the status of these cases under the “Cases Reviewed under Amended TSCA” tab.

Legend for case types

  • Premanufacture Notices (PMNs): Search P
  • Significant New Use Notices (SNUNs):  Search SN
  • Low Volume Exemptions (LVEs)
  • Low Volume Exemption Modifications (LMs)
  • Low Exposure/Low Release Exemptions (LoRexes)
  • Low Exposure/Low Release Exemption Modifications (XMs)
  • Test Marketing Exemption Applications (TMEAs) 

Except for PMNs in "pending short question review" and exemption applications (i.e., LVEs, LMs, LoRexes, XMs, and TMEAs), please note that EPA does not update the post-Focus Meeting status initially posted on this web page, even though the disposition of some cases may change after the tentative status is posted here.

For exemption applications with Focus Meeting decisions made after March 26, 2015, the status codes will be changed to indicate both the initial decision and final decision of “grant,” “denial,” “invalid,” or “withdrawal.”

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 of chemical substances found on the TSCA Chemical Inventory, for notices of chemical substances 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. EPA did not make a "may present an unreasonable risk" finding or an exposure-based finding resulting in regulation.

Drop/Letter: For certain notices of chemical substances that have been dropped from further review. The submitter will receive a letter detailing specific EPA concerns for the PMN substance.

Drop with SNUR following PMN review (i.e., "Non-5(e) SNUR"): For notices of chemical substances 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.

Recommended regulation under section 5(e) Consent Order or SNUR: For notices of chemical substances 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.

Recommended short question review: For notices of chemical substances 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.

Recommended standard review: For notices of chemical substances that are entering the standard or more detailed review process.

Withdrawal: The submitter withdrew the submission.

For exemptions and exemption modifications:

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 MSDS accordingly.

Conditional denial: Exemption/Modification request is denied unless the applicant proposes additional appropriate exposure/release controls and amends application or Safety Data Sheet accordingly. Agency has not identified what those controls would be.

Denial: Exemption/Modification request is denied. Agency staff does not expect that adequate controls would be available.

Withdrawal: The submitter withdrew the submission.

Prior to 2012, EPA also used:

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 or Safety Data Sheet was included in the exemption/modification submission.

For comments or questions, contact Rebecca Edelstein at Edelstein.Rebecca@epa.gov.