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Does TSCA Apply to Me? | How to Comply with TSCA | Section 5 Determinations | Section 13 Certification | Other TSCA Resources
Does TSCA Apply to Me?
The Toxic Substances Control Act (TSCA) applies to you, if you import
TSCA applies to both commercial chemicals and chemical wastes. It is important to ensure that you are in full compliance with all applicable TSCA regulations before you import chemicals/wastes into the U.S. Non-compliance with TSCA can result in detained shipments and/or denied entry as well as civil and/or criminal penalties.
Some chemicals are excluded from TSCA. The materials that are not subject to TSCA include:
There are specific definitions for each of the excluded items. If the material you are importing fits into one of these five categories, check the details of the regulations to be certain that it is exempt from TSCA.
How to Comply with TSCA.
There are various sections of TSCA that apply to importers:
Section 13 requires that importers to "certify" that their imported chemical substances or mixtures are either: (1) in compliance with TSCA Sections 5, 6 and 7 (see requirements below) at the time of import; or (2) not subject to TSCA. Section 13 certification is discussed later in this section in greater detail.
Section 5 requires importers of chemical substances to determine if the chemical substance, mixture, or article (containing a chemical substance or mixture) is a TSCA chemical substance or a "new chemical substance" prior to its importation for a nonexempt commercial purpose. 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. Resources for determining if a material is a TSCA chemical substance are presented later in this section.
Section 6 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.
Section 7 authorizes EPA to commence a judicial action for seizure of a chemical substance, mixture, or article, 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.
Section 8 of TSCA authorizes EPA to require importers and manufactures of TSCA- covered chemical substances and mixtures to keep certain records and report certain information to EPA. Even if you import a substance reportable under the IUR you may be exempt from the reporting requirements for that substance, questions relevant to whether you must report include: (1) Did you import 10,000 pounds (4,540 kilos) or more of a reportable substance at any site during the corporate fiscal year immediately preceding the reporting period? (2) Do you qualify as a small importer? You qualify if you meet one of the following tests. (1) Your total annual sales, combined with those of your parent company, domestic or foreign, do not exceed $40 million and your annual import volume does not exceed 100,000 pounds (45,400 kilos) of a reportable substance at any site. or (2) Your total annual sales, combined with those of your parent company, domestic or foreign, do not exceed $4 million, regardless of annual import volume. The small manufacturer exemption does not apply if the substance being produced is subject to a rule proposed or promulgated, or order under sections 4, 5 or 6 of the Act or is the subject of relief granted under a civil action under sections 5 or 7 of the Act. See "other Resources" at the end of this section for more information on the TSCA Inventory Rule.
Section 5 Determinations - Additional Details
Under Section 5 of TSCA, persons who intend to 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. The only way to determine if the substance you are working with is a new chemical is by consulting EPA's Toxic Substances Control Act Chemical Substance Inventory (commonly referred to as the TSCA Inventory). Any substance that is not on the TSCA Inventory is classified as a new chemical. There are approximately 75,000 chemical substances, as defined in Section 3 of the TSCA, on the Inventory at this time.
There are two parts to the TSCA inventory:
a public portion containing most of the listed chemical substances, and
a business confidential portion.
The public TSCA Inventory of substances can be accessed below on this web site. The identity of an existing chemical that has been claimed, as confidential business information will not be listed on the public portion of the TSCA Inventory. To find out this information, EPA will search the confidential portion of the TSCA Inventory for you if you demonstrate, in writing, a bona fide intent to manufacture or import the chemical substance. For more information, see confidential portion of the TSCA Inventory.
Section 13 Certification - Additional Details
On the invoice used in connection with entry, you must provide a TSCA certification. The certification may be preprinted, typed, or stamped on the invoice. You must use the exact words given below for either a "positive" or "negative" certification.
Specific language you must use for a positive certification:
"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."
Specific language you must use for a negative certification:"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."
Negative Certification Statement: "I certify that all chemicals in this shipment are not subject to TSCA."
Note that certification is not required for tobacco or any tobacco product Also, A negative certification is required for:
Any pesticide (except when accompanied by EPA Form 3540-1)
Any food, food additive, drug, cosmetic or device (except when accompanied by FDA Form FD701)
Source material, special nuclear material, or by-product material
Firearms and ammunitions
Certification for chemical substances/mixtures imported as part of articles is not presently required.
"Blanket" certification may be requested from the Customs District Director on an annual basis to cover several shipments of the same chemical over a one year period.
Other TSCA Resources
TSCA Hotline: (202) 554-1404 or e-mail: email@example.com
Introduction to the Chemical Import Requirements of the Toxic Substance Control Act. EPA Guide to import requirements of TSCA.
Inventory Update Rule. The Environmental Protection Agency (EPA) promulgated a rule in 1986, often referred to as the Inventory Update Rule (IUR), for the partial updating of the Toxic Substances Control Act (TSCA) Chemical Inventory database. The rule requires manufacturers and importers of certain chemical substances included on the TSCA Chemical Substances Inventory to report current data on the production volume, plant site, and site-limited status of these substances. Reporting under the Inventory Update Rule takes place at four-year intervals, which began in 1986.
Importing and Exporting New Chemicals. Explanations of TSCA Sections 12(b) and 13.
EPA's Substance Registry System. The Substance Registry System (SRS) provides information on substances and how they are represented in the Environmental Protection Agency (EPA) regulations and information systems. Using the search below, you can query for substances by common identifiers, names, or alternate identifiers. Additional search capabilities are available on the "Search" page.