Four Steps to Complete U.S. EPA Chemical Registration

Inquiry

The U.S. Environmental Protection Agency (EPA) manages the registration process for chemicals under the Toxic Substances Control Act (TSCA). The TSCA requires that all chemicals planned for introduction into the U.S. market, as well as new uses for certain existing chemicals, be notified to the EPA prior to production or import. In this article, we overview the EPA chemicals registration process and the required information.

Determine Whether Chemicals are in the TSCA Inventory or Eligible for any Waiver

TSCA inventory query

Only new chemicals or existing chemicals that meet specific new use requirements are submitted to the PMN. You can access the unclassified portion of the TSCA checklist through the relevant guide.

New material does not belong in the TSCA inventory

EPA does not review new substances in the following product categories that are excluded from TSCA authorization under Section 3(2)(B) of the TSCA.

Tobacco and certain tobacco products
Nuclear material
Ammunition
Food, food additives, pharmaceuticals, cosmetics
Substances used only as pesticide

The above new material belongs to the jurisdiction of other federal laws, and to other federal plans for review. Substances used only as pesticides are reviewed by a separate EPA pesticide program.

In addition, in some cases, the PMN report does not include the following:

Natural materials
Accidental reaction products
End-use reaction products
Mixture (but not including ingredients in mixture)
Impurities
By-products
Substances manufactured solely for export
Separation of intermediates
Substances formed during the manufacture of articles

For more information on the TSCA inventory range, please refer to the EPA regulations 40 CFR 710.4 (b) section.

Circumstances of exemption

In the following cases, the EPA reporting requirements for new chemical substances are limited or no requirements:

Prepare a Pre-submission Meeting and PMN

Pre-submission meeting ‍ ‍

EPA encourages companies applying for new chemical substances to contact EPA prior to submitting a PMN to set up a pre-submission meeting. Pre-submission meetings are a chance to discuss the new chemicals to submit and understanding of the screening of new methods of chemical potential risk.

Schedule a pre-submission meeting

PMN preparation ‍

1) Query PMN points

Read the EPA's "Points to Consider When Preparing TSCA New Chemical Notifications" file.

2) Avoid an incomplete PMN

View common causes of incomplete PMN as well as common chemical errors.

3) Prepare relevant information

When submitting a PMN, the following information is usually required:

Identification information of chemical substances: including chemical name, structural formula, CAS number (if any), molecular formula, etc.
Production information: flow chart and description, expected production or imports, by-products and impurities.
Use information: Intended use of the chemical, including a description of the use and type of product.
Exposure information: How and to what extent humans and the environment may be exposed to chemicals.
Disposal and recovery information: expected disposal methods and recovery plans for chemicals.
Environmental and health effects of information: the existing on the effect of chemicals on the environment and human health data and research.
Safety Data Sheet (SDS) : If available, provide a safety data sheet for the chemical.

4) Guidance on PMN filling

Detailed instructions for filling out the content in the PMN

Sample PMN

PMN Submission Methods and Fees

PMN submission method

PMN is submitted online through EPA's Central Data Exchange (CDX) system. And you need to register an account in the CDX system first.

PMN fees

A company may be eligible for a "small business" discount (approximately 80% off) if its total number of employees is equal to or less than the maximum number allowed in the final rule of the company's North American Industry Classification System (NAICS) code. To qualify as a "small business," its revenue or number of employees, including all affiliates, must not exceed the applicable industry size standard.

TSCA Fees and Small Businesses

The standard fee for PMN is $19,020 ($3,330 for small businesses) within 60 days of publication of the 2024 final rule. Sixty days after publication, the standard fee is $37,000 ($6,480 for small businesses).

TSCA Fees Table

EPA Assessment

Upon receipt of the PMN, EPA will conduct an assessment of the potential health and environmental risks of the chemical. The EPA assessment process typically takes up to 90 days, and this time frame includes the following phases:

Receipt day: EPA began timing on the first day after receipt of an intact PMN.

First 30 days: Within the first 30 days after submission, EPA conducts an initial review to determine the potential risk of the chemical and the detailed assessment needed. This stage may include communication with the submitter to clarify information or request additional data.

Intermediate period: If EPA determines that further evaluation is needed, the next 60 days are used for an in-depth analysis of the risks of the chemical, which may include exposure assessment, toxicity assessment, and consideration of risk management measures. During this time, EPA may require additional tests or data.

Final decision: At the end of the evaluation period of 90 days, the EPA will make a decision, which includes unconditional approval, conditional approval or rejecting the production and use of a new chemical substance.

Note that the above periods may be extended if EPA determines that additional time is needed to gather more information or to conduct additional tests to assess the risk of the chemical.

Submitters can voluntarily withdraw their PMN to avoid a negative decision, and reapply at a later date with a more complete dataset. To facilitate effective communication and minimize evaluation time, EPA encourages applicants to conduct pre-submission consultations prior to submitting PMN and to provide as detailed information and data as possible when preparing PMN. ‍

Proregulations provides a variety of chemical registration services in Asia Pacific, Europe and North America. If you are interested in our services or need more details, please contact us.

Related Service:

TSCA Compliance
CAS Number Application