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.
KGMP U.S. EPA TSCA Compliance Service
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.).
ㆍ 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.
ㆍ 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.
ㆍ 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:"
ㆍ 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.
ㆍ 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.
ㆍ 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:
ㆍ Pesticides
ㆍ Food,
food additives, drugs, cosmetics, or medical devices
ㆍ 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
ㆍ Cover
Letter and SNUN Form (Application)
ㆍ Chemical
Identity and Characterization
ㆍ Intended
Use and Exposure Information
ㆍ Exposure
and Release Assessment
ㆍ Confidential
Business Information (CBI) Claims (if applicable)
ㆍ Certification
Statement
Additional Considerations
ㆍ If
the chemical was previously reviewed under a Premanufacture Notice (PMN),
include the PMN number.
ㆍ 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
ㆍ PMN
submissions must include all available data:
ㆍ Chemical
identity, structure and formula
ㆍ Process
diagram and description
ㆍ Production
volume
ㆍ Byproducts
and impurities
ㆍ Intended
use
ㆍ Environmental
release
ㆍ Disposal
practices
ㆍ Human
exposure
ㆍ Existing
available test data on the effect to human health or the environment
Excluded Product Categories
ㆍ 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
ㆍ 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.
Contact us today to discover how our drug ingredient and label compliance can benefit your business.
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cosmetic regulations.
K-GMP supports clients in ensuring the quality, safety, and performance of their supply chains while complying with local and global regulations, from ingredients to final cosmetics.
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