Updates to New Chemicals Regulations under the Toxic Substances Control Act
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Rule Summary
In December 2024, EPA finalized amendments to the regulations that govern the Agency’s review of new chemicals under the Toxic Substances Control Act (TSCA) to improve efficiency and align with the 2016 bipartisan TSCA amendments under the Frank R. Lautenberg Chemical Safety for the 21st Century Act.
The final rule ensures that new per- and polyfluoroalkyl substances (PFAS) and other persistent, bioaccumulative, and toxic chemicals are always subject to the full, robust safety review process prior to manufacture by eliminating their eligibility for a low volume exemption (LVE) or low release and exposure exemption (LoREX). This rule amends the regulations by specifying that EPA must make one of the five statutory determinations for each premanufacture, significant new use and microbial commercial activity notice before the submitter may commence manufacturing or processing the new chemical substance. The rule updates the regulations to list the actions required in association with each of those determinations. The rule also makes several other changes to add efficiencies to the new chemicals review process, including clarifying the level of detail needed in new chemical notices and amending the procedures for EPA’s review of notices that have errors or are incomplete.
Rule History
In May 2023, EPA issued proposed amendments to the regulations that govern the Agency’s review of new chemicals under TSCA to improve efficiency and consistency and to align with the 2016 bipartisan TSCA amendments under the Frank R. Lautenberg Chemical Safety for the 21st Century Act.
Additional Resources
Technical Support for Submitting New Chemical Data
In the December 2024 final rule, updates were made to the information requirements at 40 CFR 720.45. Specifically, EPA amended the text at 720.45 to clarify the level of detail expected for the information submitters are required to provide in new chemicals notices whenever those data are known to or reasonably ascertainable by the submitter. These notices include Pre-Manufacture Notices (PMNs), Significant New Use Notices (SNUNs), Low Volume Exemptions (LVEs), Low Release and Exposure Exemptions (LoREXs), and Test Marking Exemptions (TMEs).
As noted in the preamble to the final rule, the enhancements to the PMN form in EPA’s electronic reporting site, Central Data Exchange (CDX), were not finalized concurrently with the amendments to 720.45. The enhancements will take time to develop and will be made available as soon as resources allow. The following tables detail approaches to satisfying the amended information requirements at 720.45 pending updates to the PMN form in CDX. For more information on the amendments to EPA’s new chemicals regulations, please see the docket for the final rule on regulations.gov (EPA-HQ-OPPT-2022-0902).
The information below will be updated as changes to the PMN form in CDX are made. If you have issues with CDX, please contact the CDX Help Desk.
- Table 1: Category of Use Reporting Requirements – 40 CFR 720.45(f)
- Table 2: Own Site Identity Reporting Requirements – 40 CFR 720.45(g)(1)-(2)
- Table 3: Own Site Worker Exposure Reporting Requirements – 40 CFR 720.45(g)(3)
- Table 4: Own Site Environmental Release Reporting Requirements – 40 CFR 720.45(g)(4)
- Table 5: Other Site Identity and Process Diagram Reporting Requirements – 40 CFR 720.45(h)(1)-(2)
- Table 6: Other Site Worker Exposure Reporting Requirements – 40 CFR 720.45(h)(3)
- Table 7: Other Site Environmental Release Reporting Requirements 40 CFR 720.45(h)(4)
- Table 8: Physical/Chemical Properties and Environmental Fate Characteristics Reporting Requirements – 40 CFR 720.45(j)
- Table 9: Updates to the CDX Workflow
Table 1. Category of Use Reporting Requirements - 40 CFR 720.45(f)
| Data Element | How to Submit Information Prior to Rollout of CDX Enhancements |
|---|---|
| The estimated percent of production volume devoted to each category of use – 40 CFR 720.45(f)(1)(i) | This information can be provided in the existing CDX environment in the “Use Information” tab of the “Chemicals” section. |
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The percent of the new chemical substance in the formulation for each commercial or consumer use* – 40 CFR 720.45(f)(1)(ii) * Submitters should report the percent of the new chemical substance intended in the final formulation for commercial or consumer end uses of the chemical substance—rather than percentage at upstream manufacturing or processing stages—when designating the percentage intended for commercial or consumer use. |
This information can be provided via the “Attach Document” function in the “Use Information” tab of the “Chemicals” section. Select the attachment type “Other” and provide a short description of the information being uploaded. Please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy. |
| Description of the types of products or articles that would incorporate the new chemical substance (e.g., household cleaners, plastic articles) – 40 CFR 720.45(f)(1)(iii) | |
| Information related to the use of products or articles containing the new chemical substance by potentially exposed or susceptible subpopulations – 40 CFR 720.45(f)(1)(iv) | |
| Description of how and where a potential product or article containing the new chemical substance would be used (e.g., spray applied indoors, brushed on outdoor surfaces) – 40 CFR 720.45(f)(1)(v) | |
| Consumption rates and frequency and duration of use of products or articles containing the new chemical substance – 40 CFR 720.45(f)(1)(vi) | |
| OECD-based functional use codes designating the consumer and commercial product category or categories that best describe the consumer and commercial products in which the new chemical substance is intended or known to be used – 40 CFR 720.45(f)(2) | This information can be provided via the “Attach Document” function in the “Use Information” tab of the “Chemicals” section. Select the attachment type “Other” and provide a short description of the information being uploaded. The list of OECD-based use codes can be found at 40 CFR 720.45(f)(2), Table 1. Please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy. |
Table 2. Own Site Identity Reporting Requirements - 40 CFR 720.45(g)(1)-(2)
| Data Element | How to Submit Information Prior to Rollout of CDX Enhancements |
|---|---|
| Identity and address of each site where the new chemical substance will be manufactured, processed, or used – 40 CFR 720.45(g)(1) | This information can be provided in the existing CDX environment in the “Submitter Operation Information” tab of the “Submitter Controlled Operations” section. |
| A process description of each manufacture, processing, and use operation which includes a diagram of the major unit operations and chemical conversions – 40 CFR 720.45(g)(2) | |
| Whether batch or continuous manufacturing or processing occurs at the site – 40 CFR 720.45(g)(2) | |
| Amount manufactured or processed per batch or per day (if continuous) and per year – 40 CFR 720.45(g)(2) | |
| The identity, approximate weight per batch or per day for continuous production, and entry point of all starting materials and feedstocks (including reactants, solvents, catalysts, etc.) – 40 CFR 720.45(g)(2) | This information can be provided via the “Attach Document” function in the “Submitter Operation Information” tab of the “Submitter Controlled Operations” section. Select the attachment type “Other” and provide a short description of the information being uploaded. Please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy. |
| The identity, approximate weight per batch or per day for continuous production, and entry point of all products, recycle streams, and wastes, including frequency of any equipment cleaning – 40 CFR 720.45(g)(2) | |
| The type of interim storage and transport containers used – 40 CFR 720.45(g)(2) | |
| The points of release of the new chemical substance numbered; if the new chemical substance is released to two media at the same step in the process, assign a second number for the second medium – 40 CFR 720.45(g)(2) | This information can be provided in the existing CDX environment in the “Environmental Releases” tab of the “Submitter Controlled Operations” section. |
Table 3: Own Site Worker Exposure Reporting Requirements – 40 CFR 720.45(g)(3)
| Data Element | How to Submit Information Prior to Rollout of CDX Enhancements |
|---|---|
| Worker exposure information for each worker activity anticipated or known to occur during manufacture, processing, or use of the new chemical substance, including exposure information from exempt manufacture or related use of the new chemical substance under § 720.30 – 40 CFR 720.45(g)(3) | This information includes each data element listed in 40 CFR 720.45(g)(3)(i) through (viii) as described below. |
| A description of each worker activity – 40 CFR 720.45(g)(3)(i) | This information can be provided in the existing CDX environment in the “Occupational Exposures” tab of the “Submitter Controlled Operations” section. |
| Type of potential worker exposure (e.g., dermal, inhalation) – 40 CFR 720.45(g)(3)(ii) | This information can be provided via the “Attach Document” function in the “Submitter Operation Information” tab of the “Submitter Controlled Operations” section. Select the attachment type “Other” and provide a short description of the information being uploaded. Please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy. |
| Protective equipment in place, if any, including a description of the kind of gloves, protective clothing, goggles, or respirator that limit worker exposure – 40 CFR 720.45(g)(3)(iii) | This information can be provided in the existing CDX environment in the “Occupational Exposures” tab of the “Submitter Controlled Operations” section. |
| Engineering controls in place, if any – 40 CFR 720.45(g)(3)(iv) | |
| Physical form of the new chemical substance to which workers can be exposed and moisture content if physical form is solid – 40 CFR 720.45(g)(3)(v) | This information can be provided via the “Attach Document” function in the “Submitter Operation Information” tab of the “Submitter Controlled Operations” section. Select the attachment type “Other” and provide a short description of the information being uploaded. Please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy. |
| The percent of new chemical substance in formulation at the time of worker exposure – 40 CFR 720.45(g)(3)(vi) | This information can be provided in the existing CDX environment in the “Occupational Exposures” tab of the “Submitter Controlled Operations” section. |
| The number of workers likely to be exposed – 40 CFR 720.45(g)(3)(vii) | |
| The duration of activities – 40 CFR 720.45(g)(3)(viii) |
Table 4: Own Site Environmental Release Reporting Requirements – 40 CFR 720.45(g)(4)
| Data Element | How to Submit Information Prior to Rollout of CDX Enhancements |
|---|---|
| Information on known or anticipated release of the new chemical substance to the environment, including releases from the exempt manufacture or related use of the new chemical substance under § 720.30 – 40 CFR 720.45(g)(4) | This information includes each data element listed in 40 CFR 720.45(g)(4) and 720.45(g)(4)(i) through (v) as described below. Information identifying which, if any, releases are from the exempt manufacture or related use of the new chemical substance under § 720.30 can be provided via the “Attach Document” function of the “Submitter Controlled Operations section. Select the attachment type “Other” and provide a short description of the information being uploaded. Please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy. |
| Type of release (e.g., transport, interim storage, disposal, equipment cleaning) – 40 CFR 720.45(g)(4) | This information can be provided via the “Attach Document” function in the “Submitter Operation Information” tab of the “Submitter Controlled Operations section. Select the attachment type “Other” and provide a short description of the information being uploaded. Please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy. |
| The quantity of the new chemical substance released directly to the environment – 40 CFR 720.45(g)(4) | This information can be provided in the existing CDX environment in the “Environmental Releases” tab of the “Submitter Controlled Operations” section. |
| The quantity of the new chemical substance released into control technology – 40 CFR 720.45(g)(4) | |
| The quantity of the new chemical substance released to the environment after control technology – 40 CFR 720.45(g)(4) | |
| The media of release – 40 CFR 720.45(g)(4) | |
| The type of control technology used – 40 CFR 720.45(g)(4) | |
| For equipment cleaning releases, frequency of equipment cleaning and what is used to clean the equipment – 40 CFR 720.45(g)(4)(i) | This information can be provided via the “Attach Document” function in the “Submitter Operation Information” tab of the “Submitter Controlled Operations” section. Select the attachment type “Other” and provide a short description of the information being uploaded. Please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy. |
| For transport and storage releases, how the new chemical substance or product containing the new chemical substance is transported from the site and stored, whether dedicated containers are used, whether the cleaning and disposal of the containers is under the submitter’s control, the container cleaning method, the frequency of container cleaning, and the amount of release per container cleaning – 40 CFR 720.45(g)(4)(ii) | |
| For releases into air, Clean Air Act operating permit numbers, a description of any Leak Detection and Repair program in accordance with 40 CFR parts 60, 61, 63, 65, 264 or 265 (related to the monitoring and management of fugitive releases) the site has implemented, and the type of air pollution control technologies used at these facilities to treat the stack releases that will contain the new chemical substance – 40 CFR 720.45(g)(4)(iii) | |
| For releases into water, the National Pollutant Discharge Elimination System (NPDES) permit number(s), outfall numbers, the name(s) of the waterbody into which the release occurs, and other destination(s) into which the release occurs – 40 CFR 720.45(g)(4)(iv) | NPDES permit numbers and the names of navigable waterways into which releases occur can be provided in the existing CDX environment in the “Environmental Releases” tab of the “Submitter Controlled Operations” section. All other information can be provided via the “Attach Document” function in the “Submitter Operation Information” tab of the “Submitter Controlled Operations” section. Select the attachment type “Other” and provide a short description of the information being uploaded. Please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy. |
| For releases into wastewater treatment plants, the name(s) of the publicly owned treatment works (POTW) or privately owned treatment works into which the release occurs and the corresponding NPDES permit number(s), the type of wastewater treatment technology or technologies employed, and a description of the known or expected treatment efficiency – 40 CFR 720.45(g)(4)(v) | Names of publicly owned treatment works (POTW) can be provided in the existing CDX environment in the “Environmental Releases” tab of the “Submitter Controlled Operations” section. All other information can be provided via the “Attach Document” function in the “Submitter Operation Information” tab of the “Submitter Controlled Operations” section. Select the attachment type “Other” and provide a short description of the information being uploaded. Please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy. |
Table 5: Other Site Identity and Process Diagram Reporting Requirements – 40 CFR 720.45(h)(1)-(2)
| Data Element | How to Submit Information Prior to Rollout of CDX Enhancements |
|---|---|
| Identity and address of each site where the new chemical substance will be manufactured, processed, or used – 40 CFR 720.45(h)(1) | This information can be provided in the existing CDX environment in the “Industrial Sites Controlled by Others” tab of the “Operations Controlled by Others” section. |
| A description of each type of processing and use operation involving the new chemical substance, including identification of the estimated number of processing or use sites – 40 CFR 720.45(h)(2) | This information can be provided via the “Attach Document” function in the “Industrial Sites Controlled by Others” tab of the “Operations Controlled by Others” section. Select the attachment type “Other” and provide a short description of the information being uploaded. Please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy. |
| A process description of each operation which includes a diagram of the major unit operations and chemical conversions – 40 CFR 720.45(h)(2) | |
| The identity, approximate weight per batch or per day for continuous production, and entry point of all starting materials and feedstocks (including reactants, solvents, catalysts, etc.) – 40 CFR 720.45(h)(2) | |
| The identity, approximate weight per batch or per day for continuous production, and entry point of all products, recycle streams, and wastes, including frequency of any equipment cleaning – 40 CFR 720.45(h)(2) | |
| The type of interim storage and transport containers used – 40 CFR 720.45(h)(2) | |
| The points of release of the new chemical substance numbered; if the new chemical substances is released to two media at the same step in the process, assign a second number for the second medium – 40 CFR 720.45(h)(2) |
Table 6: Other Site Worker Exposure Reporting Requirements – 40 CFR 720.45(h)(3)
| Data Element | How to Submit Information Prior to Rollout of CDX Enhancements |
|---|---|
| Worker exposure information for each worker activity anticipated or known to occur during manufacture, processing, or use of the new chemical substance, including exposure information from exempt manufacture or related use of the new chemical substance under § 720.30 – 40 CFR 720.45(h)(3) | This information includes each data element listed in 40 CFR 720.45(h)(3)(i) through (viii) as described below. |
| A description of each worker activity – 40 CFR 720.45(h)(3)(i) | This information can be provided in the existing CDX environment in the “Exposures/Releases” tab of the “Operations Controlled by Others” section. |
| Type of potential worker exposure (e.g., dermal, inhalation) – 40 CFR 720.45(h)(3)(ii) | This information can be provided via the “Attach Document” function in the “Industrial Sites Controlled by Others” tab of the “Operations Controlled by Others” section. Select the attachment type “Other” and provide a short description of the information being uploaded. Please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy. |
| Protective equipment in place, if any, including a description of the kind of gloves, protective clothing, goggles, or respirator that limit worker exposure – 40 CFR 720.45(h)(3)(iii) | This information can be provided in the existing CDX environment in the “Exposures/Releases” tab of the “Operations Controlled by Others” section. |
| Engineering controls in place, if any – 40 CFR 720.45(h)(3)(iv) | |
| Physical form of the new chemical substance to which workers can be exposed and moisture content if physical form is solid – 40 CFR 720.45(h)(3)(v) | This information can be provided via the “Attach Document” function in the “Industrial Sites Controlled by Others” tab of the “Operations Controlled by Others” section. Select the attachment type “Other” and provide a short description of the information being uploaded. Please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy. |
| The percent of new chemical substance in formulation at the time of worker exposure – 40 CFR 720.45(h)(3)(vi) | This information can be provided in the existing CDX environment in the “Exposures/Releases” tab of the “Operations Controlled by Others” section. |
| The number of workers reasonably likely to be exposed – 40 CFR 720.45(h)(3)(vii) | |
| The duration of activities – 40 CFR 720.45(h)(3)(viii) |
Table 7: Other Site Environmental Release Reporting Requirements 40 CFR 720.45(h)(4)
| Data Element | How to Submit Information Prior to Rollout of CDX Enhancements |
|---|---|
| Information on known or anticipated release of the new chemical substance to the environment, including releases from the exempt manufacture or related use of the new chemical substance under § 720.30 – 40 CFR 720.45(h)(4) | This information includes each data element listed in 40 CFR 720.45(h)(4) and 720.45(h)(4)(i) through (v) as described below. Information identifying which, if any, releases are from the exempt manufacture or related use of the new chemical substance under § 720.30 can be provided via the “Attach Document” function of the “Submitter Controlled Operations section. Select the attachment type “Other” and provide a short description of the information being uploaded. Please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy. |
| Type of release (e.g., transport, interim storage, disposal, equipment cleaning) – 40 CFR 720.45(h)(4) | This information can be provided via the “Attach Document” function in the “Industrial Sites Controlled by Others” tab of the “Operations Controlled by Others” section. Select the attachment type “Other” and provide a short description of the information being uploaded. Please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy. |
| The quantity of the new chemical substance released directly to the environment – 40 CFR 720.45(h)(4) | This information can be provided in the existing CDX environment in the “Exposures/Releases” tab of the “Operations Controlled by Others” section. |
| The quantity of the new chemical substance released into control technology – 40 CFR 720.45(h)(4) | |
| The quantity of the new chemical substance released to the environment after control technology – 40 CFR 720.45(h)(4) | This information can be provided via the “Attach Document” function in the “Industrial Sites Controlled by Others” tab of the “Operations Controlled by Others” section. Select the attachment type “Other” and provide a short description of the information being uploaded. Please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy |
| The media of release – 40 CFR 720.45(h)(4) | This information can be provided in the existing CDX environment in the “Exposures/Releases” tab of the “Operations Controlled by Others” section. |
| The type of control technology used – 40 CFR 720.45(h)(4) | |
| For equipment cleaning releases, frequency of equipment cleaning and what is used to clean the equipment – 40 CFR 720.45(h)(4)(i) | This information can be provided via the “Attach Document” function in the “Industrial Sites Controlled by Others” tab of the “Operations Controlled by Others” section. Select the attachment type “Other” and provide a short description of the information being uploaded. Please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy. |
| For transport and storage releases, how the new chemical substance or product containing the new chemical substance is transported from the site and stored, whether dedicated containers are used, whether the cleaning and disposal of the containers is under the submitter’s control, the container cleaning method, the frequency of container cleaning, and the amount of release per container cleaning – 40 CFR 720.45(h)(4)(ii) | |
| For releases into air, Clean Air Act operating permit numbers, a description of any Leak Detection and Repair program in accordance with 40 CFR parts 60, 61, 63, 65, 264 or 265 (related to the monitoring and management of fugitive releases) the site has implemented, and the type of air pollution control technologies used at these facilities to treat the stack releases that will contain the new chemical substance – 40 CFR 720.45(h)(4)(iii) | |
| For releases into water, the National Pollutant Discharge Elimination System (NPDES) permit number(s), outfall numbers, the name(s) of the waterbody into which the release occurs, and other destination(s) into which the release occurs – 40 CFR 720.45(h)(4)(iv) | |
| For releases into wastewater treatment plants, the name(s) of the publicly owned treatment works (POTW) or privately owned treatment works into which the release occurs and the corresponding NPDES permit number(s), the type of wastewater treatment technology or technologies employed, and a description of the known or expected treatment efficiency – 40 CFR 720.45(h)(4)(v) |
Table 8: Physical/Chemical Properties and Environmental Fate Characteristics Reporting Requirements – 40 CFR 720.45(j)
| Data Element | How to Submit Information Prior to Rollout of CDX Enhancements |
|---|---|
| Physical and chemical properties, including boiling point, sublimation, density/relative density, dissociation constant, explodability, flammability, melting temperature, octanol/water partition coefficient, particle size distribution, particle size distribution analysis (i.e., analysis method and data used to develop the particle size distribution value), the physical state of the neat substance, pH, solubility, vapor pressure, volatilization from water, volatilization from soil, spectra, UV-VIS absorption data, and surface tension – 40 CFR 720.45(j)(1) |
Information on surface tension and particle size distribution analysis data can be provided via the dropdown in the “Physical and Chemical Properties Worksheet” section under “Other”; please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy. All other data elements currently have dedicated dropdowns in the “Physical and Chemical Properties Worksheet” tab. |
| Environmental fate characteristics, including hydrolysis, photolysis, aerobic and anaerobic biodegradation, atmospheric oxidation half-lives, Henry’s law constant, adsorption/desorption coefficient, bioaccumulation or bioconcentration factor, Incineration Removal Efficiency (Destruction and Removal Efficiencies or DREs), and Sewage Treatment (WWTP) Removals – 40 CFR 720.45(j)(2) | Information on these environmental fate characteristics can be provided via the dropdown in the “Physical and Chemical Properties Worksheet Continued (Optional)” section under item type “Fate”. Select the appropriate item subtype, and if an item subtype corresponding to the information being provided is not available, select the item type “Other” from the dropdown in the “Physical Chemical Properties Worksheet Continued (Optional)” tab. Please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy. |
Table 9: Updates to the CDX Workflow
| Pending Update | How to Submit Information Prior to Rollout of CDX Enhancements |
|---|---|
| Allow submitters to explain why certain data elements might not be known or reasonably ascertainable at the time of submission of new chemicals notices. | This information can be provided via the “Attach Document” function in the “Additional Attachments” section. Select the attachment type “Other” and provide a short description of the information being uploaded. Please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy. |
| Include dropdown options for “Worker Activity” and “Worker Category” for sites controlled by others. | Worker categories and activities from the drop-down lists in the “Occupational Exposures” tab of the “Submitter Controlled Operations” section can be used to characterize activities at sites controlled by others. This information can be provided via the “Attach Document” function in the “Additional Attachments” section. Select the attachment type “Other” and provide a short description of the information being uploaded. Please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy. |
| Allow submitters to assign a “Letter of Activity” to operations at submitter-controlled sites. | This information can be provided via the “Attach Document” function in the “Submitter Operation Information” section. Select the attachment type “Other” and provide a short description of the information being uploaded. Please use descriptive file names for any attachments to indicate which data element the attachments are intended to satisfy. |
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