USA Reach Regulation for Various Sectors

The Toxic Substances Control Act (TSCA) regulates the manufacture, import, and use of chemical substances in the US. The Act was originally enacted in 1976. The purpose of TSCA is to regulate the manufacture, importation, processing, distribution, and use of chemicals and chemical substances in order to protect human health and the environment from unreasonable risks. TSCA addresses the production, implementation, use, and disposal of specific chemicals including polychlorinated biphenyls (PCBs), asbestos, radon, and lead-based paint. TSCA applies to all chemical substances produced or imported into the United States.

In June 2016, the Frank R. Lautenberg Chemical Safety for the 21^st Century Act (Lautenberg Chemical Safety Act, LSCA) was signed into law and TSCA was thereby amended. The LSCA is more commonly known as New TSCA. New TSCA include several changes impacting companies that manufacture, import, or process substances in the USA, including review of Pre-Manufacture Notices (PMNs) for new chemicals, review of existing chemicals, testing, confidentiality claims, fees, and relationship between TSCA and other US federal and state law.

New TSCA revised Section 4 to grant additional authority to the EPA to require the development of new information relating to a chemical substance. Additionally, New TSCA expanded the situations under which the EPA is required to take action against chemicals presenting significant risks. Importantly, under New TSCA, the EPA may not consider non-risk factors (such as cost) in determining whether a risk is unreasonable.

Regulation of New Chemicals

New TSCA strengthened the existing Section 5 process. The law now requires manufacturers and processers to submit Pre-Manufacture Notices (PMNs) to EPA at least 90 days before beginning to manufacture or process a new chemical substance.

The following substances are excluded from PMN reporting under certain conditions:

• Naturally occurring materials

• Products of incidental reactions

• Products of end-use reactions

• Mixtures (but not mixture components)

• Impurities

• By-products

• Substances manufactured solely for export

• Non-isolated intermediates

• Substances formed during the manufacture of an article

For chemical substances that have been subject to a PMN Significant New Use Rules (SNURs) are issued by the EPA under TSCA. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is designated as a significant new use by this rule to submit a Significant New Use Notice (SNUN) to the EPA at least 90 days before commencing that activity. The EPA must then review all new chemicals and significant new uses, decide, and take required action during that 90-day window. During its review process, the EPA is prohibited from considering costs or other non-risk factors.

 Flowchart for determining whether a submission is required for a chemical substance.

Confidential Business Information

TSCA has various provisions relating to the submission and protection of Confidential Business Information (CBI). Currently, CBI claims are asserted according to TSCA section 14 and existing TSCA rule requirement for certain reporting requirements. The 2016 amendment to TSCA brought significant changes to Section 14 regarding CBI. The amended TSCA provides new requirements relating to the assertion, substantiation, and review of CBI claims.

In May 2022, the EPA proposed new and amended requirements considering confidential claims. The consultation closed in November. The proposed rule would consolidate all TSCA CBI claim assertations and review procedures in the TSCA rules.

Information Exempt from CBI Reporting

TSCA section 14(c)(2) identifies certain information that is generally not subject to substantiation requirements.  This information includes:

• Specific information describing the processes used in manufacture or processing of a chemical substance, mixture, or article.

• Marketing and sales information

• Information identifying a supplier or customer.

• In the case of a mixture, details of the full composition of the mixture and the respective percentages of constituents.

• Specific information regarding the use, function, or application of a chemical substance or mixture in a process, mixture, or article.

• Specific production or import volumes of the manufacturer or processor.

• Prior to the date on which a chemical substance is first offered for commercial distribution, the specific chemical identity of the chemical substance, including the chemical name, molecular formula, Chemical Abstracts Service number, and other information that would identify the specific chemical substance, if the specific chemical identity was claimed as confidential at the time it was submitted in a notice under TSCA  5.

In the section 14 of TSCA, the EPA requires more substantiation of CBI. Unless otherwise substantiated, CBI claims will sunset after ten years. Section 14 also broadens the categories of who may access TSCA CBI. The EPA has to review the initial CBI claims within 90 days and requests for CBI extensions within 30 days. The EPA also has to provide written statement of reasons if the claim is denied.

TSCA gives the Environmental Protection Agency (EPA) authority to issue regulations designed to gather health/safety and exposure information on, require testing of, and control exposure to individual chemical substances, chemical mixtures, and articles. This may apply to new chemical substances or existing chemical substances for which new uses are being pursued. All manufacturers of chemical substances and mixtures in the United States must comply with the specific requirements of TSCA before the substances can be distributed for research or consumer use.

The EPA is required under TSCA as amended by the LSCA to make information publicly available and to publish information in the Federal Register concerning submissions under TSCA Section 5. This includes notice of receipt of Pre-Manufacture Notices (PMNs), Significant New Use Notices (SNUNs), applications for test marketing exemption (TME) both pending and/or concluded, Notices of Commencement (NOC) of manufacture (including import) for new chemical substances, and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review.

The Toxic Substance Control Act (TSCA) Chemical Substance Inventory contains a list of existing chemical substances that are manufactured or processed in the United States. The Inventory is compiled, kept current and, published by the Environmental Protections Agency (EPA) as required by Section 8 (b) of the TSCA. The Inventory was first published in 1979 and a second version containing approximately 62,000 substances was published in 1982. The Inventory published in 1979 was submitted by manufacturers, processors, and importers between January and May 1978. The current list, updated in February 2023, contains 86,685 chemical substances. There are two sections on the TSCA inventory: a public section and a confidential section. Only the public part is searchable. There are two options to access the TSCA Inventory. One can download the latest TSCA Inventory in a CSV file or search the TSCA Inventory online by using EPA's Substance Registry Services.

The TSCA Regulation defines a chemical substance as any organic or inorganic substance of a particular molecular identity, including any combination of these substances occurring in whole or in part because of a chemical reaction or occurring in nature, and any element or un-combined radical. In other words, the chemical substances on the Inventory include:

• Organic substances

• Inorganic substances

• Polymers

• Chemical substances of unknown origin or variable composition

• Complex reaction products

• Biological materials (UVCBs)

The chemical substances not on the Inventory are those with uses not regulated under TSCA. The use of these chemical substances is governed by other U.S. statutes. Examples of substances not regulated by TSCA are:

• Tobacco and certain tobacco products

• Nuclear materials

• Munitions

• Food and food additives

• Drugs

• Cosmetics

• Pesticides

Substances listed on the Inventory are considered existing chemicals and substances that are not on the Inventory are considered new chemical substances. Furthermore, substance on the Inventory may also have ‘flags’ which indicate that they are subject to manufacturing or use restrictions.

In order for chemicals to be added to the TSCA Inventory, the company must submit a Pre-Manufacture Notice (PMN). After the PMN review has been completed, the company must then provide a Notice of Commencement of Manufacture or Import (NOC) to EPA within 30 calendar days of the date the substance is first manufactured or imported for non-exempt commercial purposes. When the complete NOC is received by the Environmental Protection Agency (EPA) the reported substance enters the Inventory and becomes and ‘existing chemical’. The TSCA Inventory is regularly updated since the EPA receives approximately 400 NOCs yearly.

Substances reported through exemption submissions and exempt uses that are not subject to reporting do not require an NOC and are not added to the Inventory. Examples include:

• Low Volume Exemptions (LVEs): Chemicals manufactured at 10 TPA or less

• Low Release/Low Exposure Exemptions (LoREXs): New chemical substances with low environmental releases and low exposure to humans

• Test Market Exemptions (TMEs)

• Substances used for research and development (R&D)

• Polymers that meet the 1995 Polymer Exemption Rule Amendments

All businesses that are manufacturing, distributing, or importing goods in the US are within the scope of the TSCA Regulation. Additionally, those that sell materials to companies that operate in the US are affected by TSCA.

The first step for a manufacturer/importer is to check if the substance is listed on the TSCA Inventory of Chemical Substances. A substance that is not listed on the TSCA Inventory will be regarded as a new chemical substance and be subject to a Pre-Manufacture Notice (PMN) requirement prior to its import.

The second step is to check if the substance is subject to the Significant New Use Rules (SNURs) requirements under TSCA. Substances that are subject to SNUR requirements are designated as such by an "S" flag in the TSCA Inventory listing. If a chemical substance is subject to a SNUR and the intended manufacture, processing, or use of the substance is a significant new use, the manufacturer will be required to submit a Significant New Use Notice (SNUN) 90 days prior to the manufacture of that substance.

The third step is to check if the products comply with TSCA restriction requirements on Polychlorinated Biphenyls (PCBs) and Asbestos.

New Chemical Substance Requirements

Section 5(a)(1)(A) of TSCA states that no person shall manufacture a new chemical substance (defined as a chemical not on the TSCA Inventory) unless the person submits written notice in the form of a PMN to the EPA at least 90-days in advance or qualifies for one of several exemptions. The data required for the submission of a PMN are as follows:

• Chemical identity, structure, and formula

• Process diagram and description

• Production volume

• Byproducts and impurities

• Intended use

• Environmental release

• Disposal practices 

• Human exposure

The US EPA also requires the following information be submitted with the PMN:

• All existing health and environmental data in the possession of the submitter, parent company, or affiliates

• A description of any existing data known to or reasonably ascertainable by the submitter.

If the identity of some reactants for the synthesis of the substance, or of the substance itself, is unknown to the manufacturer, a letter of support can be used to provide the Agency with full identity information. The PMNs must be submitted to the EPA using the electronic PMN software (e‑PMN).

Import of New Chemicals and New Uses Chemicals

Section 3(9) of the New TSCA Regulation defines the term manufacture as to import, produce, or manufacture. Therefore the requirements described for new chemical substances above (PMN and SNUN) also applies to the import of new chemicals.

TSCA Requirements for Import

The requirements for importing chemical substances, mixtures, or articles that contain a chemical substance are describe in Section 13 of TSCA and in implementing regulations developed by the US Customs and Border Protection (CBP). Importers are required to certify that the chemical substances or mixtures are either subject to TSCA and complies with all applicable rules (positive certification) or is not subject to TSCA (negative certification). No certification is required for chemicals that are a part of articles unless it is required by a specific rule under TSCA or for tobacco and tobacco products. A certification must be signed and filed electronically or in writing with the CBP by the importer or an authorized agent of the importer. A certification must also include the certifier's name, email address, and telephone number. Certification is required for substances that are imported and are received by mail or commercial carrier, including those intended for research and development.

Positive Certification Statement

An example of a positive certification statement could be: “I certify that all chemical substances in this shipment comply with all applicable rules or orders under TSCA and that I am not offering a chemical substance for entry in violation of TSCA or any applicable rule or order under TSCA.” A positive certification means that the chemical substance complies with all applicable TSCA regulations, including:

• Section 5: Pre-Manufacture Notification (PMN) rules

• Section 5: Significant New Use Rules (SNURs)

• Section 5(e): Orders

• Section 5(f): Rules and orders

• Section 6: Rules and orders

• Section 7: Judicial actions

• Title IV: Rules and orders

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Negative Certification Statement

An example of a negative certification statement could be: “I certify that all chemicals in this shipment are not subject to TSCA.” A negative certification statement is relevant for substances that could be found in the list of substances excluded from TCSA or substances that are not in the TSCA Inventory. A negative certification is required for the following products when not clearly identified:

• Any pesticide

• Any food, food additive, drug, cosmetic, or device

• Source material, special nuclear material, or by-product material

• Firearms and ammunitions as defined in Section 3 of TSCA

Note that these products may be considered clearly identified when they are associated with another relevant agency’s entry documentation or electronic entry filing requirements (e.g. Notice of Arrival for pesticides or applicable entry documentation for products regulated by the Food and Drugs Administration (FDA).

The table below provides a list of fees under TSCA adjusted on 1 January 2022. The EPA is providing a reduction of approximately 80% of the TSCA administration fees to submitters who qualify as small businesses. Small business fees are only applicable to qualifying small businesses who are either not associated with a consortium or associated with an all-small business consortium. A company may qualify for a ‘small business concern’ discount if their total number of employees is at or below the maximum allowed in the final rule for that company's North American Industry Classification System (NAICS) code. In order for an entity to qualify as a ‘small business concern’, the company’s revenue or number of employees shall not exceed the size standard for the applicable industry.

Fees under TSCA

Penalties issued by the EPA for violations of the TSCA are summarised in the table below.

Penalties for non-compliance under EPA