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U.S. EPA: TSCA Compliance

    

Global Regulatory Affairs Consulting Agency, KGMP CORP.

U.S. EPA: TSCA Compliance


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U.S. EPA TSCA (The Toxic Substances Control Act) Compliance: Essential Insights for Your Business

The Toxic Substances Control Act (TSCA) regulates chemical manufacturing, import, and processing in the U.S. to protect health and the environment. Compliance requires substance evaluation, reporting, and adherence to EPA rules. TSCA classifies chemicals as existing or new based on the U.S. TSCA Inventory, with unlisted substances requiring EPA review. Manufacturers and importers must also verify import certification, Chemical Data Reporting (CDR) obligations, and active-inactive status compliance.

Our TSCA specialists provide tailored solutions, ensuring compliance, risk mitigation, and efficient approvals through expert guidance and assessment.


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Role and Significance of the TSCA Inventory

The Toxic Substances Control Act (TSCA) Chemical Substance Inventory classifies chemical substances as either existing or new based on the TSCA Inventory, which lists all chemicals manufactured, processed, or imported in the U.S. that are not subject to exemptions or exclusions.

If a chemical is listed on the Inventory, it is considered an existing chemical substance in U.S. commerce; however, it must be managed in accordance with specific regulations (e.g., CDR reporting, verification of active-inactive status, etc.).

      TSCA Inventory substances are classified into public and confidential lists. Public-listed substances can be manufactured or imported without declassification, while substances on the confidential list are not publicly identifiable. To verify a substance’s inclusion in the confidential list, businesses must submit a Bona Fide Intent request to the EPA for confirmation.

      The TSCA Inventory can determine if a substance is active or inactive. Active substances can be manufactured or imported without notification, while inactive substances require a Notice of Activity (NOA) to reactivate.

      Existing substances must also be evaluated to determine whether they are subject to Chemical Data Reporting (CDR) and Significant New Use Reporting (SNUR) requirements.

Chemicals not listed in the TSCA Inventory are considered new and require a Pre-manufacture Notice (PMN) at least 90 days before production or import.



Obligations of chemical substances

For existing chemical substances listed in the TSCA Inventory, manufacturers and importers must assess compliance with the following obligations:"

      Import Certification (Positive or Negative Certification): Chemical substances, mixtures, or articles containing regulated chemicals must comply with TSCA to enter the U.S. Importers must certify that substances either comply with TSCA (positive certification) or are exempt (negative certification), with some chemicals requiring no certification.

      Significant New Use Rule (SNUR): If the U.S. EPA designates a chemical use as a significant new use, manufacturers and importers must submit a Significant New Use Notice (SNUN) at least 90 days before manufacturing, importing, or processing for that use.

      Chemical Data Reporting (CDR): Manufacturers and importers meeting specified volume thresholds must report production data. The substances subject to certain TSCA actions have a reduced threshold of 2,500 lbs.

For new chemical substances not listed on the U.S. TSCA Inventory, a Pre-manufacture Notice (PMN) at least 90 days before production or import. Certain exemptions may apply instead of a full PMN. Once approved, a Notice of Commencement (NOC) must be submitted within 30 days of first manufacture or import. 

 

Import Certification

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Chemical substances, mixtures, and articles containing them must comply with the Toxic Substances Control Act (TSCA) to enter the U.S. Importers must certify compliance through either:

 

Positive Certification

The substance complies with all applicable TSCA requirements, including:

Section 5 premanufacture notification (PMN) rules

Significant new use rules (SNURs)

Section 5(e) and 5(f) orders

Section 6 and 7 regulations

Title IV rules and orders

 

Negative Certification

The substance is not subject to TSCA. This is required for:

      Pesticides

      Food, food additives, drugs, cosmetics, or medical devices

      Nuclear materials

Firearms and ammunition (as defined in TSCA Section 3)



Significant New Use Notice (SNUN)

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If the EPA issues a Significant New Use Rule (SNUR), manufacturers or processors must submit a Significant New Use Notice (SNUN) at least 90 days before engaging in the designated use.

 

Documents for SNUN Submission

      Cover Letter and SNUN Form (Application)

      Chemical Identity and Characterization

      Intended Use and Exposure Information

      Exposure and Release Assessment

      Confidential Business Information (CBI) Claims (if applicable)

      Certification Statement

 

Additional Considerations

      If the chemical was previously reviewed under a Premanufacture Notice (PMN), include the PMN number.

      If the EPA has issued a Significant New Use Rule (SNUR), demonstrate compliance with its requirements.

If no toxicity data are available, provide a justification or use read-across data from structurally similar substances.



Chemical Data Reporting (CDR)

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The Chemical Data Reporting (CDR) rule under TSCA mandates manufacturers and importers to report production and use data of chemicals to the EPA every four years. This includes exposure-related information such as production volumes and chemical uses for substances at or above 25,000 lbs per year. The CDR database serves as U.S. EPA’s primary screening tool for assessing chemical risks.

 

Who must report?

Manufacturers and importers must report under the CDR rule if they meet the annual production threshold—generally 25,000 lbs per site or 2,500 lbs for substances subject to specific TSCA actions. Reporting is based on production volumes from the four years preceding the submission period (e.g., 2024 submission: FY2020~2023, 2028 submission: FY2024~2027). TSCA actions may lower thresholds, restrict exemptions, or impact reporting requirements.

 

Chemicals exempt from reporting

Certain chemicals are exempt from CDR reporting, including non-TSCA substances (e.g., pesticides, FDA-regulated products), water, naturally occurring substances, polymers, microorganisms, and certain gases unless subject to TSCA actions. Non-isolated intermediates, chemicals in articles, impurities, and certain byproducts are also excluded.

 

Manufacturers exempt from reporting

U.S. EPA has updated the small manufacturer definition under TSCA §8(a)(3)(C). A company qualifies if its 2023 total sales, including any parent company, are below $12 million, or below $120 million with no individual site producing over 100,000 lbs of a reportable substance. Sites exceeding this threshold must report.



Pre-manufacture Notice (PMA)

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PMN Submissions Data

      PMN submissions must include all available data:

      Chemical identity, structure and formula

      Process diagram and description

      Production volume

      Byproducts and impurities

      Intended use

      Environmental release

      Disposal practices

      Human exposure

      Existing available test data on the effect to human health or the environment

 

Excluded Product Categories

      The jurisdiction of other federal laws: Tobacco and certain tobacco products, Nuclear materials, Munitions, Foods, food additives, drugs, cosmetics, and Substances used solely as pesticides

      Others: Naturally-occurring materials, Products of incidental reactions, Products of end-use reactions, Mixtures (but not mixture components), Impurities, Byproducts, Substances manufactured solely for export, Non-isolated intermediates, and Substances formed during the manufacture of an article

 

Limited Exemptions

U.S. EPA has limited or no reporting requirements for new chemical substances in the following cases: Low Volume Exemption, Research and Development Exemption, Low Releases and Low Exposures (LoREX) Exemption, Test Marketing Exemption, Polymer Exemption

 

Notice of Commencement of Manufacture or Import (NOC)

The PMN submitter must submit a Notice of Commencement (NOC) to the EPA within 30 days of the substance's first commercial manufacture or import. Once the EPA receives a complete NOC, the substance is added to the TSCA Inventory, though processing takes about four weeks.



Remember that different regulations apply in each country.

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