Toxic Substances Control Act

TSCA Requirements for Importing Chemical Substances

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Toxic Substances Control Act (TSCA)

TSCA (Toxic Substances Control Act) is a United States federal law passed in 1976 that regulates the manufacture, import, and processing of chemicals. The goal of TSCA is to protect human health and the environment from potential hazards posed by these chemicals.

Under TSCA, the Environmental Protection Agency (EPA) has the authority to require companies to report data on the chemicals they produce, as well as to restrict or ban chemicals that are found to pose an unreasonable risk to human health or the environment. TSCA also requires that chemicals be tested before they are introduced into commerce and that certain chemicals be reviewed periodically to determine whether new information about their potential hazards warrants further regulation.

The EPA TSCA plays a crucial role in protecting public health and the environment from the risks posed by chemicals in consumer products, industrial processes, and other areas of modern life.

If you import chemical substances, mixtures or articles into the U.S., you are subject to the Toxic Substances Control Act (TSCA) and generally must meet the same requirements under TSCA as a chemical manufacturer in the United States. The TSCA Section 3 definition of the term “manufacture” includes: “to import into the customs territory of the United States (as defined in general headnote 2 of the Tariff Schedules of the United States), produce or manufacture.”  It is important that you are in full compliance with all applicable TSCA regulations and other relevant statutes (e.g., Clean Air Act, Resource Conservation and Recovery Act, Federal Insecticide, Fungicide and Rodenticide Act) before you import TSCA-covered chemical substances, mixtures, or articles into the United States. Non-compliance with TSCA can result not only in detained shipments and/or denied entry, but can lead to substantial civil and/or criminal penalties.

Importers must certify that imported chemicals either comply with TSCA (positive certification) or, if not otherwise clearly identified as a chemical excluded from TSCA, are not subject to TSCA (negative certification).

The requirements are described in section 13 of the TSCA (15 U.S.C. 2612) and in implementing regulations developed by the U.S. Customs and Border Protection (CBP), in consultation with EPA, at 19 CFR 12.118 through 12.127. In addition, EPA has a companion policy statement on chemical imports at 40 CFR 707.20.

The U.S. Customs and Border Protection (CBP) published a final rule on December 27, 2016 requiring the use of the Automated Commercial Environment (ACE) when filing Toxic Substance Control Act (TSCA) import certification statements electronically. 

  • TSCA import certification requirements
  • Who must certify
  • Certification statements
  • Section 6 TSCA Requirements for specific chemicals
  • Import of new chemicals and new uses of chemicals
  • Import requirements in TSCA section 5(e) orders and section 5(a)(2) Significant New Use Rules

In-Depth Coverage: Country of Origin

What Chemical Substances, Mixtures and Articles are subject to TSCA?

EPA’s authority under TSCA extends to all materials that are “chemical substances,” “mixtures,” or “articles” as defined under TSCA. TSCA regulations currently exempt certain classes of materials (e.g., the TSCA Section 13 Import Certification regulation currently exempts imported articles). The definitions of these terms are provided below:

Chemical Substance:

“. . . any organic or inorganic substance of a particular molecular identity, including — (i) any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature and (ii) any element or uncombined radical.”

It is important to note that the term “chemical substance” also includes microorganisms.

TSCA Section 3 states that the term chemical substance does not include the following, which are regulated by other federal laws:

  • “tobacco or any tobacco product,”
  • a “pesticide” as defined under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) when produced, imported, processed or distributed in commerce for use as a pesticide,
  • a “source material,” “special nuclear material,” or “byproduct material” as defined by the Atomic Energy Act of 1954, (AEA) and regulations issued under that act.

It is important to note that some radioactive materials not defined by the AEA are subject to TSCA, e.g. Technologically Enhanced Naturally Occurring Radioactive Materials (TENORM).

  • an article (i.e., firearms and ammunition) the sale of which is subject to the tax imposed under Section 4181 of the Internal Revenue Service Code of 1954 (determined without regard to the exemptions from such tax provided by Sections 4182 or 4221 or any other provision of such code),
  • a “food,” “food additive,” “drug,” “cosmetic,” or “device” as defined in Section 201 of the Federal Food, Drug, and Cosmetic Act (FFDCA) when produced, imported, processed or distributed in commerce for use as a food, food additive, drug, cosmetic, or device.

In-Depth Coverage: Importing Medical Device 

Mixture:

A “mixture” is defined under Section 3 of TSCA as: “Any combination of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of chemical reaction; except that such term does not include any combination which occurs, in whole or in part, as a result of a chemical reaction if none of the chemical substances comprising the mixture is a new chemical substance and if the combination could have been manufactured (including imported) for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined.”

“Article” is not defined under TSCA itself, but is defined under various TSCA regulations implemented by CBP or EPA. Under the CBP regulations at 19 CFR Section 12.120(a), concerning, among other things, the entry of chemical substances into the Customs territory of the United States under TSCA Section 13, “article” is defined as follows:

Article:

(a) Article — (1) Article means a manufactured item which: (i) is formed to a specific shape or design during manufacture, (ii) has end use functions dependent in whole or in part upon its shape or design during the end use, and (iii) has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article and that may occur as described in 19 CFR Section 12.120(a)(2); except that fluids and particles are not considered articles regardless of shape or design. (2) The allowable changes of composition, referred to in 19 CFR Section 12.120(a)(1), are those which result from a chemical reaction that occurs upon the end use of other chemical substances, mixtures, or articles such as adhesives, paints, miscellaneous cleaners or other household products, fuels and fuel additives, water softening and treatment agents, photographic films, batteries, matches, and safety flares in which the chemical substance manufactured upon end use of the article is not itself manufactured for distribution in commerce or for use as an intermediate.

It is also important to note that chemical substances and mixtures are considered to be imported as part of an article only if the substances or mixtures are not intended to be removed/released from the article and they have no end use or commercial purpose separate from the article of which they are a part.

In-Depth Coverage: Customs Valuation

Who must certify?

A certification must be signed and filed electronically or in writing with 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.

Certifications filed electronically must be filed in the Automated Commercial Environment (ACE).

For paper certification, the statement must be typed, preprinted on the invoice, or otherwise included in the entry documentation and must be filed with the director of the port of entry before release of the shipment.

Certification Statements

An importer's statement must certify either that the chemical shipment is:

  • subject to TSCA and complies with all applicable rules and orders (positive certification)
  • or that the chemical shipment is not subject to TSCA (negative certification)

Positive Certification Statement:

The following is a positive certification statement.

“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 thereunder.”

A positive certification means that the chemical substance complies with all applicable TSCA regulations, including:

  • Section 5 premanufacture notification rules
  • Section 5 significant new use rules
  • Section 5(e) orders
  • Section 5(f) rules and orders
  • Section 6 rules and orders
  • Section 7 judicial actions
  • Title IV rules and orders

Note that sections 4 and 8 rules do not pertain to section 13 import certification requirements. Although importers must satisfy all applicable requirements of sections 4 and 8 rules, compliance with those provisions is not related to individual chemical shipments and therefore does not affect import certification.

Negative Certification Statement

The following is a negative certification statement.

“I certify that all chemicals in this shipment are not subject to TSCA.”

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 FDA regulated products).

No certification is required for the following:

  • Chemicals that are a part of articles, unless required by a specific rule under TSCA
  • Tobacco or tobacco products

In-Depth Coverage: Importing Food Products 

TSCA Section 13 Import Certification Decision-Making Process

1. Is the material in the shipment to be imported as “article,” or tobacco or tobacco product?

     If Yes ― Import certification is not required (positive or negative)

     If No ― Continue #2

2. Is the material in the shipment to be imported (a) a pesticide; (b) a source or special nuclear material or byproduct; (c) a firearm or ammunition; or (d) a food, food additive, drug, cosmetic, or device?

If Yes ― The material is not subject to TSCA, but a “negative” TSCA import certification is required unless the shipment is clearly identified as being a pesticide or other chemical not subject to TSCA [for example, the shipment is accompanied by FDA Form FD701 or EPA (FIFRA) Form 3540-1]

     If No ― Continue to #3

3. Does the shipment contain any chemical substances or mixtures regulated under TSCA Section 5 (including new chemical substances), TSCA Section 6, or TSCA Section 7?

     If Yes ― Continue to #4

     If No ― A positive TSCA import certification can be made.

4. Have you complied with TSCA sections 5, 6, and 7 with respect to the chemical substances and/or mixtures in your shipment?

     If Yes ― A positive TSCA import certification can be made.

If No ― Import certification cannot be provided and the shipment cannot be imported until you have complied with all applicable requirements under TSCA sections 5, 6, and 7.

Section 6 TSCA Requirements for Specific Chemicals

Some chemicals have specific import and export requirements under section 6 of TSCA. These chemicals include, but aren't limited to PCBs, mercury, and, asbestos.

Import of New Chemicals and New Uses of Chemicals

TSCA section 3(7) defines the term “manufacture” to include import. This means that the section 5(a)(1)(B) requirement to submit a pre-manufacture notice (“PMN”) to EPA at least 90-days before commencing non-exempt commercial manufacture of a new chemical substance in the United States applies to the import of new chemicals, as does the section 5(a)(2) significant new use notice (“SNUN”) requirement. Thus, the intended import of chemical substances can trigger the following provisions:

  • remanufacture notice provisions for new chemicals in 40 CFR Part 720
  • Significant new use notice provisions in 40 CFR Part 721
  • Premanufacture notice exemptions for new chemicals in 40 CFR Part 723
  • Reporting requirements for inter-generic microorganisms in 40 CFR Part 725

In-Depth Coverage: Trade Remedies

Import Requirement in TSCA Section 5(e) Orders and Section 5(a)(2) significant New Use Rules

When appropriate, EPA issues section 5 regulatory requirements on new chemicals or significant new uses of chemicals via a TSCA section 5(e) order or section 5(a)(2) significant new use rule (SNUR, 40 CFR Part 721 or 725 Subparts L and M).

TSCA section 5(e) orders may include use prohibitions, labeling and Safety Data Sheet (SDS) requirements, restrictions on the amount of the chemical allowed to be manufactured (including imported), as well as other restrictions. (The import/production limits often serve as triggers for toxicity or related testing requirements.) SNURs require notifying EPA at least 90 days before manufacture (including import), or processing for uses/activities designated by EPA as a significant new use.

To comply with these requirements when applicable, chemical substances must:

  • Not be imported for any prohibited use
  • Satisfy all applicable labeling and MSDS requirements
  • Not exceed any specified restrictions on permissible import volume
  • Not be imported for any designated significant new use
  • Comply with any other applicable requirements

It is important to understand that your product may be subject to other, non-TSCA statutory or regulatory requirements administered by EPA, including: the Clean Air Act, the Solid Waste Disposal Act, the Federal Insecticide, Fungicide and Rodenticide Act, and the Comprehensive Environmental Response, Compensation and Liability Act. In addition, other federal agencies may have requirements that apply to your imports.

In-Depth Coverage: Marketing and Advertising Compliance

Importation of TSCA TitleVI Regulated Articles (Formaldehyde Emission Standards for Composite Wood Products)

The TSCA Title VI import certification requirement applies to composite wood products (i.e., panels of hardwood plywood, particleboard, medium density fiberboard, and thin-medium density fiberboard), component parts containing such composite wood products, and finished goods containing such composite wood products that are imported into the U.S. beginning March 22, 2019.

Under the TSCA Title VI regulation, importers must also: 

Keep Records. Take reasonable precautions by retaining, for three years, bills of lading, invoices, or comparable documents that include a written statement from the supplier that the composite wood products (or component parts/finished goods) are TSCA Title VI compliant.

Provide Records on Request. When EPA requests, make available within 30 days records identifying 1) the panel producer and the date the composite wood products were produced; and 2) records identifying the supplier, if different, and the date the composite wood products (or component parts/finished goods) were purchased. 

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