Status of Pre-Manufacture Notices reviewed under Section 5 of the Toxic Substances Control Act (TSCA)

Please Note:

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

On this page:

Overview
Case reviewed under amended TSCA
Cases Reviewed Prior to June 22, 2016

Overview

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

View the final EPA regulatory determinations of “not likely to present an unreasonable risk” made under TSCA as amended by the Frank R. Lautenberg Chemical Safety for the 21^st Century Act.

Cases Reviewed under Amended TSCA

Instructions

By using the links to the tables below, you can search the status of your TSCA section 5 notice or exemption, by case type, by case number, status, final determination, or date (example 7/8/2016). You can enter all or part of a case number or a status entry in the search box 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. The status page listing for a specific notice will contain the PMN, SNUN, MCAN, TERA, or exemption number, the Focus Meeting date, the interim status of the notice after the Focus meeting, the final determination of the notice, and the effective date and, if there is a SNUR on the chemical substance, the SNUR effective date. Note that final determinations where Consent Orders are the outcome are not entered into the results column until both EPA and the PMN submitter have signed the Consent Order.

Note: Cases are posted to this page after the Focus meeting; cases that have been received by EPA, but have not yet gone to Focus are not included in this list.

Legend for case types

PMN and SNUN Table

Premanufacture Notices (PMNs): Search P
Significant New Use Notices (SNUNs): Search SN

MCAN Table

Microbial Commercial Activity Notice (MCAN): Search J

Exemptions Table

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
TSCA Environmental Release Application (TERAs): Search R
Tier II Exemption for Microorganisms: Search H

Note on commencing manufacture: 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.

PMN/MCAN/SNUN submitters must wait until EPA has made a determination under section 5(a)(3) and has taken action on their substances. After such determination and action is taken, the submitter may commence manufacture (including import) or new use of the PMN/MCAN/ SNUN substances at the conclusion of the applicable review period. In general, the applicable review period is 90 days for PMNs, MCANs and SNUNs. Learn more about filing a notice of commencement of manufacture or import.

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

Day 30 for LVEs, LoRexes, and their modifications
Day 45 for TMEAs
Day 60 for TERAs

Learn more about exemptions.

For PMNs, MCANs, and SNUNs, common status designations are described as follows:

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.

“Not likely to present an unreasonable risk” section 5 (a)(3)(C) determination: For notices of chemical substances 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. Learn more about filing a notice of commencement of manufacture or import.

Section 5(e) Consent Order - Exposure based section 5(a)(3)(B)(ii)(II) determination: For notices of chemical substances which will be produced in substantial quantities, and which either enter or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the chemical substances.

Section 5(e) Consent Order - Insufficient information section 5(a)(3)(B)(i) determination: For notices of chemical substances 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.” Generally, the status will note whether the determination relates to health effects, environmental effects or both.

Section 5(e) Consent Order - May present unreasonable risk section 5(a)(3)(B)(ii)(I) determination: For notices of chemical substances that in the absence of sufficient information to permit a reasoned evaluation of health and environmental effects, the manufacture, processing, distribution in commerce, use or disposal “may present an unreasonable risk of injury to health or the environment" under the intended conditions of use. Generally, the status will note whether the determination relates to health effects, environmental effects or both.

Note: EPA typically will initiate a Significant New Use Rule (SNUR) following issuance of a Consent Order in accordance with TSCA section 5(f)(4).

Section 5(f) Consent Order – Will present unreasonable risk section 5(a)(3)(A) determination: For notices of chemical substances determined to present an unreasonable risk of injury to health or environment. Generally, the status will note whether the determination relates to health effects, environmental effects or both.

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, common status designations are described as follows:

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.

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.

For TERAs, common status designations are described as follows:

Denial: TSCA Environmental Release request is denied. Agency staff does not expect that adequate controls would be available.

Approval: TSCA Environmental Release request is approved, with or without negotiated conditions.

Cases Reviewed Prior to June 22, 2016

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:

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 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.

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.

Status of Pre-Manufacture Notices reviewed under Section 5 of the Toxic Substances Control Act (TSCA)

Overview

Cases Reviewed under Amended TSCA

Instructions

Legend for case types

For PMNs, MCANs, and SNUNs, common status designations are described as follows:

For exemptions and exemption modifications, common status designations are described as follows:

For TERAs, common status designations are described as follows:

Cases Reviewed Prior to June 22, 2016

For PMNs and SNUNs:

For exemptions and exemption modifications:

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