Import

Toxic Substances Control Act

New Information:

Importers! Use this new Compliance Guide to determine if TSCA applies to your chemical products.

 

Overview

The Toxic Substances Control Act (TSCA) of 1976 was enacted to provide information about all chemicals and to control the production and of new chemicals that might present an unreasonable risk of injury to health or the environment. TSCA defines manufacture to include importation. Therefore, importers of chemical substances must meet all TSCA requirements that are relevant to manufacturers. (Customs regulations define "importer" as the person liable for the payment of duties, and note that the responsible party may be a consignee, importer of record, the actual owner, or the transferee of the merchandise.) This may include submitting to a testing and registration process intended to assess the substance’s potential impacts on health or the environment. TSCA exempts chemicals intended solely for export from the U.S. from many provisions of the act (except recordkeeping and reporting requirements) unless the U.S. Environmental Protection Agency (EPA) finds they present an unreasonable risk to health or the environment in the U.S. These exempted substances must be labeled "for export only" (or similar language).

Under TSCA EPA has the authority to track the 75,000 industrial chemicals currently produced or imported into the US. EPA repeatedly screens these chemicals and can require reporting or testing of those that may pose an environmental or human-health hazard. EPA can ban the manufacture and import of those chemicals that pose an unreasonable risk.

Also, EPA has mechanisms in place to track the thousands of new chemicals that industry develops each year with either unknown or dangerous characteristics. EPA then can control these chemicals as necessary to protect human health and the environment.

TSCA is a federal program that is not delegated to the states. No one federal agency has sole responsibility for enforcing chemical import and export rules. EPA, DOT, and the U.S. Customs Service have enforcement authority, but their enforcement authority varies depending on the chemical being imported or exported.

The remainder of this section of the website explains how imports and exports of toxic chemicals are regulated under TSCA.

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Applicability to Importers

If you import chemical substances, mixtures or articles, you are subject to TSCA and generally must meet the same requirements under TSCA as a chemical manufacturer in the United States.

It is important to ensure 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) 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.

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Chemical Substances, Mixtures and Articles Covered by TSCA

TSCA covers any new or existing commercial chemical substances, mixtures, and articles unless they are specifically exempted by the Act. Existing materials include more than 75,000 chemicals that are listed in EPA’s TSCA Chemical Substance Inventory (TSCA Inventory). New materials are added to the list as a result of "premanufacture notice" (PMN) reporting, which is a requirement that must be met by manufacturers or importers prior to producing or importing a new chemical substance.

It is important to know the definitions of three types of materials regulated under TSCA:

  • chemical substance "any organic or inorganic substance of a particular molecular identity, including any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature and any element or uncombined radical." It is important to note that the term "chemical substance" also includes microorganisms, however, it does not include pesticides, regulated nuclear materials, firearms/ammunition, food, drugs or cosmetics (see TSCA section 3 for details).
  • mixture - "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 - a manufactured item (see 12.120(a)(1) and 12.120(a)(2) for specific details).

Importation Rules

TSCA Section 13 requires that any chemical substance, mixture, or article containing a chemical substance or mixture be refused entry into the customs territory of the U.S. if it fails to comply with any rule in effect under TSCA or is offered for entry in violation of section 5, 6, or 7 of TSCA (these are explained below). EPA’s Policy Statement, 40 CFR 707.20, requires that importers "certify" their imported chemical substances or mixtures are either: (1) in compliance with TSCA Sections 5, 6 and 7 at the time of import; or (2) not subject to TSCA. The current TSCA Import Rule does not pertain to importation of articles.

In addition, Section 13 provides that the Treasury Department (U.S. Customs), in conjunction with EPA, implement these requirements. For that reason, Customs can refuse entry of any shipment that does not have a TSCA certification. An importer of record provides the certification by signing one of the following statements to be typed, preprinted on the invoice, or otherwise included in the entry documentation:

Item

Certification Action

Article

No certification required

Tobacco or tobacco product

No certification required

Pesticides (but not pesticide intermediates), nuclear materials, food, food additives, drugs, cosmetics, or medical devices.

Negative certification generally required*

Chemical substances or mixtures (other than articles) subject to TSCA

Positive certification required**

*Negative Certification Statement: "I certify that all chemicals in this shipment are not subject to TSCA."

**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 under TSCA."

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Major Sections of TSCA Applicable to Importers

TSCA Section 5 - New Chemical Substances. Under Section 5 of TSCA, persons who intend to manufacture or import a "new chemical substance" into the United States must seek EPA approval by submitting a pre-manufacture notice (PMN) to EPA at least 90 days prior to importation to enable EPA to determine whether the new chemical may present an unreasonable risk to human health or the environment. A new chemical substance is one that is not already in commerce in the United States, as determined by inclusion in the TSCA Inventory of Chemical Substances maintained by EPA. New chemical substances include certain genetically modified microorganisms (also known as intergeneric microorganisms). When the PMN is approved and the substance is imported, a "Notice of Commencement" (NOC) is required to be submitted to EPA within 30 days of first importation. Following receipt of this NOC, the subject chemical substance will be added to EPA’s TSCA Inventory of existing chemical substances for the purposes of future importation and/or domestic production.

If you are a manufacturer or importer who has signed a consent order issued by EPA under section 5(e) of TSCA, you must also ascertain whether a chemical substance intended to be imported into the United States is subject to that order. If so, the chemical substance must be in compliance with the provisions of the consent order before it may be imported into the United States.

In addition, prior to importation of a chemical substance subject to TSCA into the U.S., an importer of record must determine whether the substance is subject to a Significant New Use Rule issued under Section 5 of TSCA. Section 5 of TSCA authorizes EPA to designate use of a chemical substance as a "significant new use," and require the submission of information to EPA prior to the chemical substance being manufactured (including imported) or processed for that use.

Section 5 of TSCA also provides for certain exemptions to the 90-day review of new chemicals. For specific details, see the regulations cited below and section 5 of TSCA. Please note, TSCA compliance certification is still required to import these chemicals.

Section 6 - Regulation of Hazardous Chemical Substances and Mixtures. An importer must also determine whether a chemical substance it intends to import into the United States is subject to a rule issued under Section 6 of TSCA. Section 6 of TSCA authorizes EPA to take regulatory action to protect against unreasonable risk of injury to human health or the environment due to the manufacture (including importation), processing, distribution in commerce, use, or disposal of a chemical substance or mixture. For example, EPA has promulgated regulations under Section 6 of TSCA applicable to polychlorinated biphenyls (PCBs) and asbestos. The importation of PCBs, or articles containing PCBs, is banned under TSCA with a few minor exemptions. In addition, the importation of certain asbestos-containing products, such as flooring felt, commercial paper, corrugated paper, rollboard, and specialty paper is banned under TSCA.

TSCA Section 7 - Imminent Hazards. Because imports are required to comply with any judicial orders that may be issued under Section 7 of TSCA, importers need to be aware of Section 7 requirements. TSCA Section 7 authorizes EPA to commence a judicial action for seizure of a chemical substance, mixture, or article containing such a chemical substance or mixture, which EPA has determined is imminently hazardous, and/or for other relief against any person who manufactures (imports), processes, distributes in commerce, uses, or disposes of an imminently hazardous chemical substance or mixture or any article containing such a substance or mixture.

TSCA Section 13 Import Certification Decision-Making Process. Use the following table to determine the import certification requirements for a given material.

Issue

Issue

Import Requirement

1.

Is the material in the shipment to be imported an "article," or tobacco or tobacco product?

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

If No -- Continue to #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; as those terms are described in Part III of this guide?

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.

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.

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Other Sections of TSCA Applicable to Importers

Importers need to be aware that imports must also be in compliance with certain other sections of TSCA, although current regulations require certification at the time of import only for compliance with TSCA sections 5, 6, and 7.

Section 4 - Testing of Chemical Substances and Mixtures. Under Section 4 of TSCA, EPA has the authority to require manufacturers (including importers) and processors of chemical substances and mixtures to conduct testing on the health and environmental effects of chemical substances and mixtures. A person who imports or intends to import a chemical substance or mixture subject to a test rule under Section 4 must comply with Section 4 requirements unless the importation qualifies for an exemption included in the regulations at 40 CFR Section 790.42, or under a specific test rule listed under Parts 766 or 799. Following promulgation of a test rule under Section 4 of TSCA, the responsibility to comply with the rule continues for a period of five years from the date the data from all required tests have been submitted or an amount of time equal to that which was required to develop the test data, whichever is longer. Importers therefore have a continuing responsibility to determine whether a chemical substance or mixture which they import or intend to import is subject to a test rule.

Section 8 - Reporting and Retention of Information. Section 8 of TSCA authorizes EPA to require persons engaged in the manufacture (includes import), processing, and distribution in commerce of TSCA-covered chemical substances and mixtures to keep certain records and report certain information to EPA. Specific TSCA Section 8 rules (and implementing policy documents in the case of TSCA Section 8(e)) that apply to importers are:

  • TSCA Section 8(a)Inventory Update Rule see 40 CFR Part 710
  • TSCA Section 8(a)Preliminary Assessment Information Reporting (PAIR) Rule see 40 CFR Part 712
  • TSCA Section 8(a)Chemical Specific Recordkeeping and Reporting Rules see 40 CFR Part 704 Subpart B
  • TSCA Section 8(c)Allegations of Significant Adverse Reactions Recordkeeping and Reporting Rule see 40 CFR Part 717
  • TSCA Section 8(d)Unpublished Health and Safety Data Reporting Rule see 40 CFR Part 716
  • TSCA Section 8(e) Substantial Risk Information Reporting Requirement (Statutory Provision) see implementing Policy Statement (43 FR 11110, March 16, 1978) as well as the TSCA Section 8(e) Reporting Guide.

Section 12(b) - "Export Notification" Rule. Chemical importers, if also exporters, are potentially subject to Section 12(b) of TSCA. EPA’s TSCA Section 12(b) export notification requirements apply to chemical substances or mixtures for which data are required under TSCA Section 5(b), an order has been issued under TSCA Section 5, a proposed or final rule has been issued under TSCA Sections 5 or 6, or an action is pending or relief has been granted under TSCA Sections 5 or 7. With regard to Section 4 of TSCA, only those chemical substances or mixtures listed in final TSCA Section 4 test rules and TSCA Section 4 Enforceable Consent Agreements (ECAs) are subject to the export notice requirements under TSCA Section 12(b). Notification of export is generally not required for articles, as provided by 40 CFR section 707.60(b).

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TSCA and Exports of Chemicals

The Toxic Substances Control Act 12(b) and 40 CFR Part 707 requires EPA to notify importing countries of the export of chemicals or mixtures that are subject to certain rules and orders. Approximately 1,100 chemicals come under this requirement. These notices also satisfy the information exchange provisions of the Prior Informed Consent (PIC) procedures under the United Nations Environment Program. For chemicals banned or severely restricted in the U.S. and subject to the PIC procedures, EPA forwards to the designated national authority of the importing country information on the chemicals regulatory controls.

TSCA 12(a) exempts chemicals intended solely for export from the U.S. from provisions of the Act, unless EPA finds they present an unreasonable risk to health or the environment in the U.S. Exempted substances must be labeled "for export only" (or similar language) and the recordkeeping and reporting requirements of TSCA 8 still apply.

Chemical substances are subject to export notification only if:

  • subject to a 4 test rule (i.e., if large quantities may be released to the environment, insufficient data exists, or the substance may present an unreasonable risk to health or the environment)
  • included on the 5(b)(4) "risk list" (of substances determined to present possible unreasonable risks to health or the environment)
  • subject to an order under 5(e) or 5(f) (preliminary limitations, where "unreasonable risk" is at issue, prior to promulgation of a formal rule under 6)
  • subject to a proposed or final significant new use rule.

Export notice is specifically required for PCBs. 40 CFR 707.60(c)

Upon receipt of export notification, where required, EPA must transmit to the importing country

  • the name of the regulated chemical
  • a summary of EPA’s regulatory action
  • the name of an EPA official for further contact
  • a copy of the relevant Federal Register notice

For most chemicals, one time notice is sufficient. For substances registered under TSCA 4, EPA requires export notice for the first shipment to each country, then notice of the first shipment each year to each country. 40 CFR 707.65(a)(2).

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Related Websites

ChemAlliance is a source of up-to-date information concerning the environmental regulations affecting the chemical industry. ChemAlliance is operated by a partnership of environmental professionals in academia, government and industry. The site offers access to feature articles, regulatory information, regulatory and compliance tools, and pollution prevention information.

U.S. EPA Office of Pollution Prevention and Toxics (OPPT). OPPT is responsible for implementing TSCA and certain other U.S. environmental rules and legislation. The OPPT website contains information about and links to: OPPT projects and programs (e.g., New Chemicals Program); other information resources (e.g., dockets, clearinghouses, libraries, and hotlines); OPPT publications; and chemical and regulatory information databases and software.

Introduction to the Chemical Import Requirements of TSCA. TSCA Federal Register Notices are arranged by date for those issued since October of 1994. Important Federal Register Notices published before that date are archived by date and title.

Biotechnology Home Page. Under the scope of TSCA, genetically engineered microorganisms are reportable under the TSCA Inventory reporting regulations (40 CFR 710). At this Internet site, users can download the regulations, guidance documents for reporting, risk assessments for certain organisms, and status reports. For additional information, contact the New Chemicals Branch. Phone: (202) 260-3725.

Chemical Abstract Service. Chemical Abstract Service, a division of the American Chemical Society, is the producer of the world’s largest and most comprehensive databases of chemical information. The public (i.e., non-confidential) portion of the TSCA Inventory is available online for members for searches through the Scientific and Technical Information Network (STIN). CAS also provides information regarding chemical lists of other countries. Please see, "Bona Fide Searches" for information about the confidential portion of the TSCA Inventory. Phone: (800) 631-1884, Select option #2.

Toxics & Pesticides Enforcement Division. This division of the Office of Enforcement and Compliance Assurance (OECA) handles enforcement activities for TSCA, FIFRA, and EPRCA. Users have 15 June 1999 Introduction to the Chemical Import Requirements of TSCA access to enforcement response policies, enforcement guidance, civil penalty policies, and information about Supplemental Environmental Projects (SEPs).

The Right to Know Network. RTK Net was started in 1989 in support of the Emergency Planning and Community Right to Know Act (EPCRA), which requires that information be made available via the TRI. TSCA information is available through chemical fact sheets, IRIS, and other databases such as the TSCA Test Submissions (TSCATS) database. TSCATS contains unpublished toxicologic and ecologic data submitted by industry under Section 4 test rules, 8(d) health and safety studies, 8(e) substantial risk notices, and "For Your Information" FYI submissions.

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