United States
Environmental
Protection Agency
EPA740-B-08-001
April 2008
vvEPA
Office of Pollution Prevention and Toxics
TSCA Section 13 Import Compliance Checklist
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TSCA Section 13 Import Compliance Checklist
LEGAL DISCLAIMER
This checklist does not create any legal rights or defenses to enforcement actions for failure to
comply with TSCA §13 or its regulations. This checklist is not a substitute for the TSCA statute
and regulations and is not designed to provide importers with sufficient detail to ensure complete
certainty of the compliance status of some chemicals. The information and analysis provided
herein may not be complete. For greater certainty, importers should refer to the TSCA statute,
regulations, interpretive guidance, and personnel at the U.S. Bureau of Customs and Border
Protection and/or U.S. Environmental Protection Agency. Compliance with the TSCA import
certification requirements will be based solely on TSCA and its regulations. Please also note
that, while the current TSCA import rule requires certification of compliance with only sections
5, 6 and 7, other TSCA requirements may apply to imported chemicals, for example, under
sections 4, 8 and 12(b) of TSCA.
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~ TSCA Section 13 Import Compliance Checklist
~ PURPOSE ~
HOW TO COMPLY WITH TSCA IMPORT CERTIFICATION REQUIREMENTS
This checklist provides a simplified roadmap to help chemical importers walk through the logical
analysis needed to determine how to certify their chemical imports in order to comply with the
regulatory requirements under section 13 of the Toxic Substances Control Act (TSCA). This
checklist is not the TSCA certification statement itself. There is no requirement that importers
use this document or submit it to the government.
The import requirements under section 13 of TSCA (15 USC 2612) and related regulations (19
CFR§§ 12.118-12.127 and 127.28(iV) are jointly administered by the U.S. Department of
Homeland Security, Bureau of Customs and Border Protection (CBP), in consultation with the
U.S. Environmental Protection Agency (EPA) which administers all other provisions of TSCA
Title I. EPA's policy statement on imports of chemicals under TSCA appears at 40 CFR 707.20.
Under the TSCA section 13 import requirements, importers (defined at 19 CFR 101.1) must
certify that imported chemical substances (including chemical substances in mixtures and
certain intergeneric microorganisms) either:
• comply with TSCA (positive certification), or
• are not subject to TSCA (negative certification).
However, certain chemicals require no certification, and according to the Customs regulations
and EPA's policy statement, the certification applies only to TSCA sections 5, 6 and 7, but not
sections 4 and 8. (Currently there are no section 7 actions.)
~ INSTRUCTIONS ~
HOW TO USE THIS CHECKLIST
The following analysis should be applied to each chemical you intend to import, including
chemicals in mixtures. Answer the questions below to help determine which certification option
is appropriate for your chemical import. For most chemicals, this entire analysis can be
resolved by a single affirmative response in either Section I, Section II, or one subsection of
Section III. (However for some chemicals, multiple affirmative responses may be necessary in
section III to certify TSCA compliance.) The three main sections below are:
I. No Certification Required —A single "yes" indicates that no certification is required.
II. Non-TSCA/Negative Certification — A single "yes" indicates that the imported material is
not subject to TSCA jurisdiction.
III. TSCA-Compliant/Positive Certification — In general, a single "yes" in a subsection of
Section III indicates that the imported chemical substance complies with TSCA.
(For rules on one-year port-specific "blanket certifications," see 19 CFR 12.121(a)(2)(ii)).
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~ WHERE TO FILE CERTIFICATIONS ~
According to 19 CFR 12.121(a)(2), TSCA import certification statements must be filed with the
director of the port of entry of the shipment. For chemical imports that do not enter through a
customs port, such as import via regular mail or courier, certification statements may be
submitted to the following EPA addresses. (See "Toxic Substances Control Act: A Guide for
Chemical Importers/Exporters" (EPA 5601/1-91-001) US EPA, Office of Toxic Substances,
April 1991, p.32, Q&A#55; "Chemicals in Progress Bulletin," US EPA, Office of Pollution
Prevention and Toxics, April 1992, p.7.) Again, please note that this checklist is not the TSCA
certification statement itself and should not be submitted to the government.
Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics
(OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC
20460-0001 (Attention: TSCA Section 13 Coordinator).
Hand Delivery/Courier: OPPT Document Control Office (DCO), EPA East Bldg., Rm.
6428, 1201 Constitution Ave., NW, Washington, DC. (Attention: TSCA Section 13
Coordinator). Such deliveries are only accepted during the Docket's normal hours of operation.
The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is (202) 564-8930.
~ FOR FURTHER INFORMATION ~
If you have questions about TSCA section 13 import certification, visit
www.epa.gov/oppt/import-export or contact the TSCA Hotline at (202) 554-1404 or tsca-
hotline@epa.gov. If not attached, view "Introduction to the Chemical Import Requirements of
the Toxic Substances Control Act" (EPA 305-B-99-001), US EPA, Office of Enforcement and
Compliance Assurance, June 1999, available at www.epa.gov/oppt/import-
export/pubs/importguide.pdf Another relevant guidance document is "Toxic Substances Control
Act: A Guide for Chemical Importers/Exporters" (EPA 5601/1-91-001),US EPA, Office of
Toxic Substances, April 1991. For questions related specifically to section III.B. on New
Chemical Substances, contact an EPA Pre-Notice Communications Coordinator at (202) 564-
9262.
~ GETTING STARTED ~
CHEMICAL SUBSTANCE IDENTIFICATION
Identifying the chemical substance you are importing, including the individual chemical
constituents within mixtures, is critical to determining compliance with the various TSCA
requirements and the appropriate certification option.
What is the Chemical Abstracts Index Name and Chemical Abstracts Service (CAS) Registry
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Number of the chemical substance being imported?
Specific Chemical Name:
CAS # (if available):
If an intergeneric microorganism, what is the genus/species name of the microorganism?
Microorganism Name:
Generic Identity and Accession Number:
(TSCA Accession Numbers are 5 or 6-digit identifying numbers assigned by EPA to protect the
confidentiality of chemical substances listed in the confidential portion of the TSCA Inventory.
To determine whether a chemical that you wish to import is listed in the confidential portion of
the TSCA Inventory, importers may be able to obtain an Accession Number: (1) from the
supplier of the chemical; (2) from EPA per the "bona fide" procedures in 40 CFR 720.25(b): or
(3) if the PMN number is known, by consulting the CD-ROM product "Toxic Substances
Control Act (TSCA): Searchable Database" sold and distributed by the National Technical
Information Service (NTIS) (www.ntis.gov) or from one of the private databases that carries this
information.)
I. NO CERTIFICATION REQUIRED
No TSCA import certification is currently required if you respond affirmatively to the following:
1. The chemical substance is being imported as part of an "article" as defined at 19 CFR
12.120(a) and thus, per 19 CFR 12.121(b\ certification is not required. (Note that §12.121(b)
states that a specific rule or order can require TSCA import certification for components of
articles; however, none currently exist as of the last revision of this document. Also, although
certification is not required, the import of certain articles is still regulated by TSCA. For
example, for articles containing polychlorinated biphenyls (PCBs) or asbestos, review the
information in Sections III.E. and III.F. below.)
CH Yes CH No
2. The material being imported is tobacco or a tobacco product per TSCA §3(2)(B)(iii).
(See the 1991 and 1999 guidance documents referenced in the "Further Information" section.)
CH Yes CH No
If you answered "yes " to either of the above questions in Section I, no certification is
required. If you answered "no" to both of the above questions, proceed to Section II
below.
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II. NON-TSCA / NEGATIVE CERTIFICATION
Certain materials and/or uses are not subject to TSCA. If you respond affirmatively to any one
of the following specific exclusions under TSCA §3(2), then you may certify as follows: "I
certify that all chemical substances in this shipment are not subject to TSCA."
1. The material being imported will be used only as a pesticide (as defined by the Federal
Insecticide, Fungicide, and Rodenticide Act). Note: Pesticide intermediates are subject to TSCA.
D Yes D No
2. The material being imported is source material, special nuclear material or byproduct
material (as defined by the Atomic Energy Act and related regulations). (Note however
that radioactive materials not defined as above by the Atomic Energy Act are subject to TSCA,
e.g Technologically Enhanced Naturally Occurring Radioactive Materials (TENORM).)
D Yes D No
3. The material being imported will be used only as a firearm, shell or cartridge (taxable under
§4181 of the Internal Revenue Code of 1954).
D Yes D No
4. The material being imported will be used only as a food, food additive, drug, cosmetic, or
device (as defined by the Federal Food Drug and Cosmetic Act), including components thereof.
CH Yes CH No
If you answered "yes" to any of the above questions in Section II, you should certify that
the material being imported is not subject to TSCA. If you answered "no " to all the
above questions, proceed to Section III below.
Note - If, in addition to the types of non-TSCA uses listed above, the material to be imported
will also be used for a use that is subject to TSCA or the use is unknown, then it is ineligible for
the negative certification and must qualify for the positive certification, which is discussed in
Section III below.
III. TSCA-COMPLIANT / POSITIVE CERTIFICATION
This section probes whether the chemical to be imported is subject to various TSCA
requirements and, if so, whether the chemical complies with, and may be legally imported under,
TSCA. If so, the importer may certify as follows: "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
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order thereunder." For many imported chemicals, a single affirmative response in any one of
the following subsections of Section III indicates compliance with TSCA. However, for some
imported chemicals, multiple affirmative responses may be necessary. For example, a new
chemical substance may require an affirmative response in both subsections III.B. and HID.
A. Import for Export Only
Section 12(a) of TSCA states that all TSCA requirements (except those under section 8 of
TSCA) do not apply to any chemical substance that is manufactured, imported, processed or
distributed in commerce solely for export from the United States and labeled as such.
1. Is the chemical substance imported solely for export from the United States, i.e., not for use in
the United States, and is it and any container in which it is enclosed stamped or labeled as
intended for export only?
D Yes D No
B. New Chemical Substance Requirements (under 40 CFR Part 720 or 723; For intergeneric
microorganisms see §111.C.)
Under TSCA §5(a)(l)(A), no person shall import a new chemical substance (defined as a
chemical not on the TSCA Inventory) unless such person submits to EPA 90-days advance
written notice in the form of a pre-manufacture notice (PMN), or qualifies for one of several
exemptions. In order to certify that the chemical substance complies with the "new chemical"
notice requirements under TSCA, you should be able to respond affirmatively to one of the
following specific alternatives (although more detailed analysis is necessary to be certain of full
compliance with all requirements). For those PMNs and exemptions that require submission of
an exemption application to EPA, identifying the case number assigned by EPA should help
those submitters verify the correct response. If you cannot respond affirmatively to any of the
following specific alternatives, your chemical substance may not comply with the "new
chemical" notice requirements under TSCA, in which case it may not be legally imported.
1. Is the chemical substance on the TSCA Inventory of existing chemical substances?
(If importers do not find the chemical substance on the public portion of the TSCA Inventory,
they should follow the "bonafide" procedure at 40 CFR 720.25 to request EPA to search the
Confidential Inventory. For additional guidance, see
www.epa.gov/opptintr/newchems/pubs/invntory.htm.)
CH Yes CH No
2. If the chemical substance is not on the TSCA Inventory, have you submitted to EPA any of
the following TSCA §5 notices for it and are you in full compliance with all the pertinent
requirements? (Note that these notices and exemptions are person-specific. Until a substance is
added to the TSCA Inventory, submission of a notice by one company does not relieve any other
person from the pre-manufacture notice requirement.)
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a Pre-Manufacture Notice (PMN. 40 CFR Part 720). PMN#
CH Yes CH No
b. Low Volume Exemption (LVE. 40 CFR 723.50). LVE #
D Yes D No
c. Low Release and Exposure Exemption (LOREX, 40 CFR 723.50). LOREX #
CH Yes CH No
d. Test Market Exemption (TME. 40 CFR 720.38). TME #
D Yes D No
3. If the chemical substance is not on the TSCA Inventory and you have not submitted one of
the above notices, does the chemical substance comply with all the requirements for any of the
following exemptions for new chemicals?
a. the R&D Exemption (40 CFR 720.36).
D Yes D No
b. the Polymer Exemption (40 CFR 723.250).
CH Yes CH No
c. any exemption listed in 40 CFR 720.30(a) through (i), for example, chemicals
manufactured solely for export, byproducts, impurities, non-commercial R&D. Indicate
specifically which paragraph in §720.30 applies:
(Note that while "mixtures" as a whole, as defined in 40 CFR 720.3 (u), are exempt from
the TSCA §5 PMN requirement, new chemical substances that are imported as part of a
mixture are subject to the PMN requirement. See 40 CFR 720.30(b) fn. 1.)
D Yes D No
d. exempt as part of an article (40 CFR 720.3(c) and 720.22(b)(D). (Note: Under 19
CFR 12.121(b), no TSCA section 13 import certification is generally required for
chemicals imported as part of an article. See Section I above.)
CH Yes CH No
e. exempt as a Naturally Occurring Chemical Substance (40 CFR 710.4(b): considered
automatically included on the Inventory).
D Yes D No
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C. New Intergeneric Microorganism Requirements (under 40 CFR Part 725)
Intergeneric microorganisms are subject to the TSCA section 5 notice requirements per 40 CFR
Part 725. In order to certify that an intergeneric microorganism complies with these
requirements under TSCA, you should be able to respond affirmatively to one of the following
specific alternatives (although more detailed analysis is necessary to be certain of full
compliance with all requirements). For those exemptions requiring submission of an exemption
application to EPA, identifying the case number assigned by EPA should help those submitters
verify the correct response. If you cannot respond affirmatively to any of the following specific
alternatives, your intergeneric microorganism may not currently comply with the "new
chemical" notice requirements under TSCA, in which case it may not be legally imported.
1. The shipment does not contain an "intergeneric microorganism" per 40 CFR 725.3 (formed
by the deliberate combination of genetic material originally isolated from organisms of different
genera)? (Microorganisms that are not intergeneric are considered implicitly included on the
Inventory per 40 CFR 725.8(b).)
D Yes D No
2. Does the shipment contain an intergeneric microorganism that is included on the TSCA
Inventory of existing chemical substances? (If importers do not find the microorganism on the
Public Inventory, they should follow the "bonafide" procedure at 40 CFR 725.15 to request EPA
to search the Confidential Inventory. For additional guidance, see
www.epa.gov/opptintr/newchems/pubs/invntory.htm.
D Yes D No
3. If the microorganism is intergeneric and not expressly included on the Inventory, have you
submitted any of the following TSCA §5 notices for it and are you in full compliance with all
the pertinent requirements?
a. Microbial Commercial Activity Notice (MCAN, 40 CFR Part 725.100).
MCAN #
CH Yes CH No
b. TSCA Experimental Release Application (TERA, 40 CFR 725.250). TERA#
D Yes D No
c. Tier I Exemption (Tier I, 40 CFR 725.424). TIER I#
CH Yes CH No
d. Tier II Exemption (Tier IL 40 CFR 725.428). TIERII#
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CH Yes CH No
e. Test Market Exemption (TME. 40 CFR 725.300). TME #
CH Yes CH No
4. Is the microorganism exempt under any of the R&D Exemptions for microorganisms (40 CFR
725.200 to 725.239)?
D Yes D No
D. Other Section 5 Requirements
When appropriate, EPA issues §5 regulatory requirements on new chemicals or significant new
uses of chemicals via a TSCA §5(e) Order or §5(a)(2) Significant New Use Rule (SNUR, 40
CFR Part 721 or 725 Subparts L and M). TSCA §5(e) Orders may include use prohibitions,
labeling and Material Safety Data Sheet (MSDS) requirements, restrictions on the amount of the
chemical allowed to be manufactured or imported, as well as other restrictions. (The
import/production limits often serve as triggers for toxicity or related testing requirements.) The
SNUR requires notifying EPA at least 90 days before manufacture, import, or processing for
uses/activities designated by EPA as a significant new use. You should be able to respond
affirmatively to one of the following specific alternatives (although more detailed analysis is
necessary to be certain of full compliance with all requirements). If you cannot respond
affirmatively to one of the following specific alternatives, your chemical substance may not
currently comply with the requirements under TSCA §5, in which case it may not be legally
imported.
1. This chemical substance is subject to neither a TSCA §5(e) Order to which you are a party
nor to a Significant New Use Rule.
D Yes D No
2. This chemical substance is subject to a TSCA §5(e) Order to which you are a party or a
Significant New Use Rule and you do not qualify for an exemption therefrom, but this particular
shipment complies with all requirements of the Order or SNUR. The chemical substance is not
being imported for a prohibited use, it satisfies all applicable labeling and MSDS requirements, it
does not exceed any restrictions on permissible import volume, is not being imported for a
designated significant new use, and it complies with any other applicable requirements.
D Yes D No
a. If this chemical substance is subject to a TSCA §5(e) Order to which you are a party,
what is the EPA-designated PMN, MCAN or SNUN case number?
b. If this chemical substance is subject to a Significant New Use Rule (SNUR, 40 CFR
Part 721 or 725). what is the CFR citation in 40 CFR Part 721 or 725?
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3. This chemical substance is subject to a TSCA §5(e) Order to which you are a party or a
Significant New Use Rule, and this particular importation might otherwise exceed a restriction or
constitute a significant new use requiring the submission of a SNUN, but you qualify for the
exemption you have identified below.
D Yes D No
a. If this chemical substance is subject to a TSCA §5(e) Order to which you are a party,
what is the EPA-designated PMN, MCAN or SNUN case number?
What is the applicable exemption (e.g., R&D, byproduct)?
b. If this chemical substance is subject to a Significant New Use Rule (SNUR, 40 CFR
Part 721 or 7251 what is the CFR citation in 40 CFR Part 721 or 725?
What is the applicable exemption in 40 CFR 721.45 or 725.912:
4. This chemical substance is subject to a Significant New Use Rule, but the importer has
submitted a Significant New Use Notice (SNUN) and completed the 90-day review period, and
the import complies with any requirement (e.g., per a §5(e) Order to which the importer is a
party) imposed by EPA pursuant to the review. The SNUN number assigned by EPA is
UYes UNo
E. Polychlorinated Biphenyls (PCBs) Requirements
The import of poly chlorinated biphenyls (PCBs) and articles containing PCBs is generally
prohibited under TSCA §6(e) and 40 CFR Part 761. If your shipment contains PCBs, in order
to certify that the chemical substance complies with the PCB requirements of TSCA, you should
be able to respond affirmatively to one of the following specific alternatives (although more
detailed analysis is necessary to be certain of full compliance with all requirements). If you
cannot respond affirmatively to any of the following specific alternatives, your chemical
substance may not currently comply with the PCB requirements of TSCA, in which case it may
not be legally imported.
1. The shipment being imported does not contain PCBs.
D Yes D No
2. Is this shipment eligible for one of the exemptions identified in 40 CFR 761.80?
Identify specific exemption by CFR citation:
D Yes D No
3. Does this shipment contain PCB waste that qualifies as an "other transboundary shipment"
under 40 CFR 761.99?
CH Yes CH No
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4. Does this shipment include products that contain PCBs generated inadvertently through an
excluded manufacturing process as defined in 40 CFR 761.3? (Note that there are subsequent
associated recordkeeping and reporting requirements in 40 CFR 761.185 and 40 CFR 761.187.)
D Yes D No
F. Asbestos Requirements
Imports of some asbestos-containing products are prohibited by the TSCA section 6(a)
regulations at 40 CFR 763 Subpart I. In order to certify that the chemical import complies with
TSCA, you should be able to respond affirmatively to one of the following specific alternatives
(although more detailed analysis is necessary to be certain of full compliance with all
requirements). If you cannot respond affirmatively to one of the following specific alternatives,
your chemical substance may not currently comply with the asbestos requirements of TSCA, in
which case it may not be legally imported.
1. The shipment being imported does not contain asbestos.
D Yes D No
2. The shipment being imported contains asbestos, but the asbestos-containing product is not
being imported for use in flooring felt, commercial paper, corrugated paper, rollboard, specialty
paper, or new uses of asbestos, as defined in 40 CFR 763.163.
D Yes D No
3. The asbestos-containing product is being imported solely for export from the United States
and will not be further repackaged or processed in the United States, per 40 CFR 763.165(c)(l).
D Yes D No
4. The asbestos-containing product is being imported in small quantities solely for personal use
in the United States, per 40 CFR 763.165(c)(2).
CH Yes CH No
5. The asbestos-containing product is the subject of a current exemption approved by EPA per
40 CFR 763.173. Describe the exemption:
D Yes D No
G. Metalworking Chemicals Requirements
Certain chemical substances that may be used in metalworking fluids are regulated under the
TSCA section 5(f)/6(a) regulations at 40 CFR Part 747. In order to certify that the chemical
shipment complies with the metalworking fluid rules in 40 CFR Part 747, you should be able to
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respond affirmatively to one of the following specific alternatives (although more detailed
analysis is necessary to be certain of full compliance with all requirements). If you cannot
respond affirmatively to one of the following specific alternatives, your chemical substance may
not currently comply with the metalworking fluid requirements of TSCA, in which case it may
not be legally imported.
1. The shipment being imported does not contain any of the chemical substances regulated by 40
CFR Part 747.
CH Yes CH No
2. This shipment contains a chemical substance regulated by 40 CFR Part 747, but not as part of
a metalworking fluid or in any form in which it could be used as a component of a metalworking
fluid.
D Yes D No
3. This shipment contains a chemical substance regulated by 40 CFR Part 747 as part of a
metalworking fluid, but the metalworking fluid contains no nitrosating agents and the warnings
and instructions required by the rule have been provided.
D Yes D No
4. This shipment contains a chemical substance regulated by 40 CFR Part 747, but the material
is exempt from the regulations because it is being imported only in small quantities solely for
research and development in accordance with section 5(h)(3) of TSCA, as an impurity, as part of
an article, or solely for export and is labeled accordingly.
D Yes D No
H. Hexavalent Chromium Requirements
Hexavalent chromium-based water treatment chemicals are regulated under TSCA section 6(a)
regulations at 40 CFR §749.68. In order to certify that the chemical shipment complies with the
water treatment chemicals rules in 40 CFR §749.68, you should be able to respond affirmatively
to one of the following specific alternatives (although more detailed analysis is necessary to be
certain of full compliance with all requirements). If you cannot respond affirmatively to any of
the following specific alternatives, your shipment may not currently comply with the hexavalent
chromium requirements of TSCA, in which case it may not be legally imported.
1. The shipment being imported does not contain any hexavalent chromium-based water
treatment chemicals.
CH Yes CH No
2. This shipment contains hexavalent chromium-based water treatment chemicals, but not for
use in comfort cooling towers and the required warning label is affixed.
CH Yes CH No
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If you answered "yes " to one or more of the above questions in Section III, you can
probably certify that the material being imported complies with TSCA. However, if you
answered "no" to all the above questions, the material may be ineligible for entry into the
customs territory of the United States and may be subject to detention, refusal of
entry/delivery, or a demand for redelivery per TSCA section 13 and 19 CFR 12.122 to
12.127. In that case, you may wish to consult the information sources in the "Further
Information " section above.
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