Importers! Use this new Compliance Guide to determine if TSCA applies to your chemical products.
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.
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.
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.
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
- 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).
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:
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."
Major Sections of TSCA Applicable
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
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
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.
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
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
as being a
pesticide or other chemical not subject to TSCA [for example,
the shipment is accompanied by FDA Form FD701 or EPA (FIFRA)
If No -- Continue to #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.
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.
Other Sections of TSCA Applicable
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).
TSCA and Exports
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.
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,
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
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
- the name of an EPA official
for further contact
- a copy of the relevant Federal
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
year to each country. 40
CFR ¤ 707.65(a)(2).
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.
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
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
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