EPA 305-B-08-001
June 2008
Office of Enforcement and Compliance Assurance
ERA
Compliance Guide For the
Chemical Import Requirements of
the Toxic Substances Control Act
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This guide describes the chemical imports requirements under the Toxic
Substances Control Act (TSCA). It is a compliance assistance tool only
and is not a substitute for applicable laws or regulations.
Fora complete understanding of all legal requirements, the reader must
refer to the applicable federal statutes and regulations. This guide
neither changes nor replaces any applicable legal requirements, nor
does it create any rights or benefits. It includes references to the roles of
the U.S. Environmental Protection Agency (EPA) and U.S. Customs and
Border Protection (CBP) but the information is provided for context only.
Any rules or orders issued by the U.S. Environmental Protection Agency,
U.S. Customs and Border Protection or other agencies take precedence
over this guide.
Compliance Guide For The Chemical Import Requirements of TSCA
TABLE OF CONTENTS
I. INTRODUCTION 1
II. WHAT IS THE TOXIC SUBSTANCES CONTROL ACT (TSCA)?.. 1
AS AN IMPORTER, DOES TSCA APPLY TO ME? 1
IV. WHAT CHEMICAL SUBSTANCES, MIXTURES AND ARTICLES
ARE SUBJECT TO BY TSCA? 2
V. WHAT TSCA PROVISION SPECIFICALLY CONCERNS THE
ENTRY OF CHEMICAL SUBSTANCES, MIXTURES, AND
ARTICLES INTO THE UNITED STATES? 4
V.A. TSCA Section 13 - Entry Into the Customs Territory of the
United States 4
V.B. Abbreviated Overview of TSCA Certification
Requirements 5
V.C. Other Certification Considerations 5
VI. WHAT ARE THE MAJOR SECTIONS OF TSCA FOR WHICH
TSCA IMPORT CERTIFICATION IS REQUIRED, AND WHAT
REQUIREMENTS APPLY? 5
VI.A. TSCA Section 5 New Chemical Substances 6
VI.A.1. TSCA Section 5 - Premanufacture Notification 6
VI.A.2. TSCA Section 5 (e) - Consent Orders 6
VI.A.3 TSCA Section 5 - Significant New Use Rules
(SNURs) 6
VI A.4. Exemptions to Section 5 of TSCA 7
VLB. TSCA Section 6 - Regulation of Hazardous Chemical
Substances and Mixtures 7
VI.C. TSCA Section 7 - Imminent Hazards 7
VI.D. TSCA Section 13 - Import Certification Decision-Making
Process 8
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TABLE OF CONTENTS (CONTINUED)
VII. WHAT OTHER TSCA PROVISIONS APPLY TO THE IMPORTER?
8
VILA. TSCA Section 4 - Testing of Chemical Substances and
Mixtures 8
VII.B. TSCA Section 8 - Reporting and Retention of Information 9
VII.C. TSCA Section 12(b)» "Export Notification" Rule 10
VIM. WHAT PROVISIONS OTHER THAN TSCA APPLY TO THE
IMPORTER? 10
Appendix 11
I. CONTACTS AND RESOURCES FOR TECHNICAL ASSISTANCE.
I.A. TSCA Assistance Information Service (TAIS) / TSCA Hotline ... 11
I.E. EPA Regional Contacts 12
I.C. Internet Sites 13
I.D. Publications and Other Information Sources 16
II TSCA SECTION 13 IMPORT COMPLIANCE CHECKLIST 19
I.
INTRODUCTION
The purpose of this guide is to help people who intend to import chemicals to
better understand the applicable laws and regulations administered by the
Environmental Protection Agency. Although this document briefly discusses
other statues, its primary focus is the Toxic Substances Control Act. This
document does not replace any Federal laws or regulations.
II.
WHAT IS THE TOXIC SUBSTANCES CONTROL ACT?
Congress enacted the Toxic Substances Control Act (TSCA; the Act) in 1976,
[Public Law 94-469, October 11,1976]. Under TSCA, EPA is given broad
authority to issue regulations designed to gather health/safety and exposure
information on, require testing of, and control exposure to individual chemical
substances, chemical mixtures, and articles. This guide is intended to assist
the chemical importer of record (importer, including their agents) to better
understand their responsibilities under TSCA by providing a basic overview of
the Act and its requirements, in particular those that apply to chemical
importation.
Please note that the best authority for information about TSCA is the Act itself
and the regulations that are published by EPA in the Code of Federal
Regulations, Title 40 (40 CFR) Part 700 through Part 799 and by the U.S.
Customs and Border Protection (Customs orCBP) at 19 CFR Sections 12.118
through 12.127 and 127.28 (amended). (Relevant rules can be found at:
http://www.access.qpo.qov/nara/cfr/waisidx 02/40cfrv27 02.html, and,
http://earth1.epa.qov/oppt/chemtest/pubs/policies.htm).
AS AN IMPORTER, DOES TSCA APPLY TO ME?
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. 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."1
It is important that you are in full compliance with all applicable TSCA
regulations and other relevant statutes (e.g., Clean Air Act, Resource
General headnote 2 of the Tariff Schedules of the United States is as follows: Customs
Territory of the United States. The term "customs territory of the United States." as used in the tariff
schedule, includes only the States, the District of Columbia, and Puerto Rico.
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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.
IV. 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.
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."2
"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
2 While it is true that mixtures are not reportable under IUR, the chemical substances comprising
the mixture might be (see 710.4 (c)(2), which identifies the substances excluded from the
inventory). A mixture is defined in §710.3(d);
Note: A chemical substance that is manufactured as part of a mixture is subject to reporting
regulations. This exclusion applies only to the mixture and not to the chemical substances of
which the mixture is comprised. The term "mixture" includes alloys, inorganic glasses, ceramics,
frits, and cements, including Portland cement.
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V.
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.
An Article is also defined under TSCA regulations at 40 CFR Sections
704.3, 710.3(d), and 720.3(c).
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. See Federal Register Notice, number 42, (42 FR), at p.
64583, (December 23, 1977).
WHAT TSCA PROVISION SPECIFICALLY CONCERNS THE ENTRY
OF CHEMICAL SUBSTANCES, MIXTURES, AND ARTICLES INTO
THE UNITED STATES?
V.A. TSCA Section 13 Entry Into the Customs Territory of the United
States
(See 40 CFR Part 707.20 "General Import Requirements and Restrictions"
and 19 CFR Sections 12.118 through 127.128)
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 United States if it fails to comply with any rule in effect under
TSCA or is offered for entry in violation of TSCA Sections 5, 6, or 7. TSCA
Section 13(b) states that the Secretary of Treasury (CBP) after consulting with
the EPA Administrator shall issue rules for the administration of Section13(a).
These rules were issued in August 1983 and are codified at 19 CFR, Sections
12.118 through 12.127 and 127.28(i).
They require that the importer certify that the chemicals either comply with
TSCA, (a "positive certification"), or that the chemicals are not subject to
TSCA, (a "negative certification"). EPA has also issued a 'statement of
policy' for TSCA imports in December 1983 found at 40 CFR Section 707.20.
CBP 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:
+ 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 chemical
substances in this shipment are not subject to TSCA."
V.B. Abbreviated Overview of TSCA Certification Requirements
Item Certification Action
Article
No Certification Required
Tobacco or tobacco product
No Certification Required
Pesticides (but not pesticide
intermediates), nudear materials,
food, food additives, drugs,
cosmetics, or medical devices
Negative Certification
Generally Required
Chemical substances or mixtures
(other than articles) subject to TSCA I
Positive Certification Required
I
V.C. Other Certification Considerations
Certification is also required for substances that are imported and are received
by mail or commercial carrier, including those intended for research and
development. In addition, a "blanket" certification may be requested from the
CBP District Director on an annual basis to cover several shipments of the
same chemical over a one year period.
VI. WHAT ARE THE MAJOR SECTIONS OF TSCA FOR WHICH TSCA
IMPORT CERTIFICATION IS REQUIRED, AND WHAT
REQUIREMENTS APPLY?
Current TSCA import certification requirements apply specifically to compliance
with TSCA Sections 5, 6, and 7. The following briefly describe certain major
requirements under those sections.
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VI.A. TSCA Section 5: New Chemical Substances
VI.A.1. TSCA Section 5: Premanufacture Notification
(See 40 CFR Parts 700, 720, 723, 725 and 747)
If you are importing chemicals or chemical-containing items into the United
States, you must determine whether or not any chemical imported in bulk or as
a part of a mixture, is a TSCA chemical substance and/or a "new chemical
substance" prior to its importation for a nonexempt commercial purpose. Under
TSCA Section 5, persons who intend to manufacture or import a "new chemical
substance" into the United States must submit 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 the 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.
VI.A.2. TSCA Section 5 (e): Consent Orders
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 determine 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.
VI.A.3. TSCA Section 5: Significant New Use Rules (SNURs)
(See 40 CFR Part 721)
Prior to importation of a chemical substance subject to TSCA into the United
States, an importer must determine whether the substance is subject to a
Significant New Use Rule issued under Section 5 of TSCA. Section 5
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.
VI.A.4. Exemptions to Section 5 of TSCA
Section 5 also provides for certain exemptions to the 90-day review of new
chemicals. For specific details, see the regulations cited below and Section 5.
Please note, TSCA compliance certification is still required to import these
chemicals.
Research and Development Exemption - See 40 CFR Section 720.36
Test Marketing Exemption - See 40 CFR Section 720.38
Low volume/low release/low exposure Exemption - See 40
CFR Section 723.50
Polymer Exemption - See 40 CFR Section 723.250.
VLB. TSCA Section 6 Regulation of Hazardous Chemical Substances
and Mixtures
(See also 40 CFR Parts 747, 749, 761, and 763)
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 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, and distribution in commerce,
use, or disposal of a chemical substance or mixture. For example, EPA has
promulgated regulations under Section 6 applicable to polychlorinated
biphenyls (PCBs), asbestos, certain metal working fluids and hexavalent
chromium. The importation of PCBs, or articles containing PCBs, is prohibited
under TSCA with some specific 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.
VI.C. 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. 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.
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VI.D. TSCA Section 13 Import Certification Decision-Making Process
1.
2.
3.
4.
Is the material in the shipment
to be imported an "article," or
tobacco or tobacco product?
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?
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?
Have you complied with TSCA
sections 5, 6, and 7 with respect
to the chemical substances
and/or mixtures in your
shipment?
If Yes - Import certification is not
required (positive or negative).
If No -Continue to #2.
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.
If Yes - Continue to #4.
If No - A positive TSCA import
certification can be made.
ff 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.
[Note that importers'responsibilities under TSCA Sections 4, 8, and 12(b) are
dealt with briefly in the following sections of this document. Because TSCA
Sections 4, 8, and 12(b) regulations/requirements do not affect importers'
responsibilities under TSCA Section 13, they are not reflected in this decision
process. For a more detailed overview of the decision-making process, see
Appendix II- TSCA Section 13 Import compliance Checklist].
VII. WHAT OTHER TSCA PROVISIONS APPLY TO THE IMPORTER?
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.
VILA. TSCA Section 4 Testing of Chemical Substances and Mixtures
(See 40 CFR Parts 790, 791, 792, 799 and 766)
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, 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.
VII.B. TSCA Section 8 Reporting and Retaining Information
Section 8 of TSCA authorizes EPA to require persons that manufacture
(includes import), process, and distribute in commerce 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 Section 8(e)) that apply to importers are:
TSCA Section 8(a) Inventory Update Reporting - see 40 CFR Part 710.
Further information is provided at www.epa.gov/oppt/iur
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 at p. 11110, March 16, 1978) as well as the TSCA
Section 8(e) Reporting Guide (June 1991- available in hard copy from
TSCA Hotline).
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VII.C. TSCA Section 12(b) "Export Notification" Rule
(see 40 CFR Part 707 Subpart D).
Chemical exporters are potentially subject to Section 12(b) of TSCA. ERA'S
TSCA Section 12(b) export notification requirements apply to chemical
substances or mixtures under the following conditions: 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 Sections 5 or 6, or an action is
pending or relief has been granted under Sections 5 or 7. With regard to
Section 4 of TSCA, only those chemical substances or mixtures listed in final
Section 4 test rules and Section 4 Enforceable Consent Agreements (EGAs)
are subject to the export notice requirements under Section 12(b). Notification
of export is generally not required for articles, as provided by 40 CFR Section
707.60(b).
VIM. WHAT PROVISIONS OTHER THAN TSCA APPLY TO ME AS AN
IMPORTER?
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 including, but not limited to: the US
Customs and Border Protection, the Bureau of Alcohol, Tobacco and Firearms,
and the Food and Drug Administration. Additionally, international requirements
such as the Stockholm Convention on Persistent Organic Pollutants (POPs),
the Rotterdam Convention on the Prior Informed Consent, Procedure for
Certain Hazardous Chemicals and Pesticides in International Trade, (PIC), and
the Protocol to the 1979 Convention on Long-Range Trans-boundary Air
Pollution on Persistent Organic Pollutants (LRTAP), as well as regulations
promulgated by the European Union, e.g. EC 304/2003 may apply.
You may wish to visit the Border Compliance Assistance Center at:
http://www.bordercenter.orq/ "Environmental Import-Export Issues" for
additional information regarding the requirements of EPA administered statutes
and international agreements.
Appendix
I. CONTACTS AND RESOURCES FOR TECHNICAL ASSISTANCE
LA. TSCA Assistance Information Service (TAIS)/TSCA Hotline
U.S. Environmental Protection Agency
Office of Pollution Prevention and Toxics
Environmental Assistance Division
1200 Pennsylvania Ave., NW,
Washington, D.C., 20460
Phone: (202) 554-1404, TDD: (202) 554-0551
Fax: (202) 554-5603
E-mail: TSCA-Hotline@epa.gov
Hours of Service: 8:30 a.m. - 5:00 p.m. (EST) M-F
Sponsored by the Office of Pollution Prevention and Toxics, the TSCA Hotline
provides information assistance to chemical manufacturers, processors, users,
storers, disposers, importers and exporters concerning regulations under
TSCA. The Service also operates as an information center for labor
associations, government agencies, domestic and foreign governments,
embassies, attorneys, and private citizens.
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I.B. EPA Regional Contacts
For guidance on the proper procedures to correct any deficiencies in a shipment, contact
the following EPA regional offices:
EPA Region 1 (CT, MA, ME, NH, Rl, VT) EPA Region 6 (AR, LA, NM, OK, TX)
Pesticides, Toxics, and Urban Programs
Mail Code: CPT
One Congress Street, Suite 1100
Boston, MA 02114-2023
Phone: (617)918-1591
Website: vwwv.epa.gov/reqion01/
EPA Region 2 (NJ, NY, PR, VI)
Pesticides and Toxic Substances Branch
Mail Code: 105
2890 Woodbridge Avenue
Edison, NJ 08837-3679
Phone: (732)321-6765
Website: www.epa.qov/reqion02/
EPA Region 3 (DC, DE, MD, PA, VA,
WVA)
Toxics Program and Enforcement Branch
Mail Code: 3WC33
1650 Arch Street
Philadelphia, PA 19103-2029
Phone: (215)814-2080
Website: www.epa.qov/reqion03/
EPA Region 4 (AL, FL, GA, KY, MS, NC,
SC, TN)
Pesticides and Toxic Substances Branch
Mail Code: APTMD/TS
61 Forsyth Street, SW
Atlanta, GA 30303-8960
Phone: (404) 562-8956
Website: www.epa.gov/reqion04/
EPA Region 5 (IL, IN, Ml, MN, OH, Wl)
Pesticides and Toxics Enforcement Section
Mail Code: DT8J
77 West Jackson Boulevard
Chicago, IL 60604-3507
Phone: (312)886-6879
Website: www.epa.gov/region5
Toxics Section
Mail Code: 6PD-T
1445 Ross Avenue, Suite 1200
Dallas, TX 75202-2733
Phone: (214)665-6714
Website: www.epa.qov/reqion06/
EPA Region 7 (IA, KS, MO, NE)
Air, RCRA, and Toxics Division
Mail Code: ARTD/CRIB
726 Minnesota Avenue
Kansas City, MO 66101
Phone: (913)551-1404
Website: www.epa.gov/reqion07/
EPA Region 8 (CO, MT, ND, SD, UT,
WY)
Pollution Prevention and Pesticides and
Toxics Program
Mail Code: 8P-P3T
1595 Wynkoop Street
Denver, CO 80202-1129
Phone: (303)312-6147
Website: www.epa.gov/region08/
EPA Region 9 (AZ, CA, HI, NV, AS Gil)
Toxics Office
Mail Code: CED-4
75 Hawthorne Street
San Francisco, CA 94105
Phone: (415)947-4180
Website: www.epa.gov/region09
EPA Region 10 (AK, ID, OR, WA)
Solid Waste and Toxics Unit
Mail Code: WCM-128
12006th Avenue
Seattle, WA 98101
Phone: (206)553-1716
Website: www.epa.gov/region10/
I.C. Internet Sites
The Border Compliance Assistance Center
Website: www.bordercenter.orq
The Border Compliance Assistance Center offers compliance assistance for
anyone shipping regulated materials across U. S. borders. The Border Center
is conveniently arranged into three main areas of interest: (1) shipments of
hazardous waste from Mexico, (2) shipments of municipal solid waste shipped
from Canada, and (3) Chemical Import-Export Issues site which provides
information on importing and exporting chemicals and includes a new section
on importing a motor vehicle into the United States. In addition, users will find
information on existing international agreements and applicable regulations.
The site includes a 'news section' to keep buyers, sellers, and transporters
informed.
The Border Compliance Assistance Center website is maintained by the
National Center for Manufacturing Sciences (NCMS), and is one of the 14 EPA-
sponsored Centers.
ChemAlliance Regulatory Information for the Chemical Process Industry
Website: www.ChemAlliance.org
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)
Website: www.epa.gov/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.
TSCA Section 13 Requirements Program
Website: http://www.epa.gov/oppt/chemtest/pubs/imex.html
Phone: (202) 564-4780
This site provides information on Section 13 import certification
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Compliance Guide For The Chemical Import Requirements of TSCA
requirements. Additional information may be obtained from the Chemical
Information and Testing Branch.
TSCA Inventory (Public Version)
Website: http://msds.ehs.cornell.edu/tscasrch.asp
Cornell University offers user access to the non-confidential (public)
TSCA Inventory through a searchable database in the Health and
Safety section of their homepage. To conduct a search, the user must
enter a CAS number or a full chemical name. Important Note: For the
most accurate information about the status of a chemical in regard to the
public portion of the TSCA Inventory, contact the Chemical Abstract
Service (CAS) at 800-631-1884
Chemical Abstract Service
Website: www.cas.org/
Phone: (800)631-1884
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 Science
and Technology Network (STN). 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.
TSCA Inventory Update Reporting (IUR)
Website: www.epa.gov/oppt/iur
Phone: (202) 260-2523
This site provides information on Inventory Update Reporting
requirements. Additional information may be obtained from the TSCA
Hotline at (202) 554-1404.
Existing Chemicals Program
Website: http://www.epa.gov/oppt/chemtest/index.htm
Phone: (202) 564-4780
This site provides information on existing chemicals. Additional
information may be obtained from the Chemical Information and
Testing Branch
Bona Fide Searches
Website: www.epa.qov/oppt/newchems/pubs/findsubs.htm
Phone: (202) 564-8963
This site provides information on how to determine if a chemical is on the
confidential portion of the TSCA Inventory. Additional information may
be obtained from the New Chemicals program or the TSCA Hotline.
New Chemicals Program
Website: www.epa.gov/oppt/newchems/
This site describes the procedure forming TSCA Section 5 "Pre-manufacture
Notifications," obtaining forms, and reaching appropriate contacts.
Additional information may be obtained from the New Chemicals program or
the TSCA Hotline at (202) 564-1404.
TSCA Testing Program
Website: www.epa.gov/oppt/chemtest/
Phone: (202) 564-4780
This site describes OPPT's TSCA Testing and Information Gathering
Program and its objectives, and serves as the major link to information
about core TSCA regulations. Additional information can be obtained from
the Chemical Information and Testing Branch.
TSCA, 15 U.S.C. Chapter 53
Website: http://www.access.gpo.gov/uscode/title15/chapter53 .html
The TSCA statute and all of its amendments are available for
downloading through the GPO Access website
TSCA Federal Register Notices
Website: www.epa.gov/fedrgstr/EPA-TOX/
TSCA Federal Register Notices are arranged by date for those issued
since October of 1994. Important Federal Register Notices published
before that date is archived by date and title.
Biotechnology Home Page
Website: www.epa.gov/oppt/biotech/
Phone: (202) 564-8974
Under the scope of TSCA, genetically engineered microorganisms are
reportable under the TSCA Inventory reporting regulations (40 CFR Part
710). At this Internet site, users can download the regulations, guidance
documents for reporting, risk assessments for certain organisms, and status
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Compliance Guide For The Chemical Import Requirements of TSCA
reports. For additional information, contact the New Chemicals Branch.
Toxics & Pesticides Enforcement Division (Need to Change this)
Website: www.epa.gov/compliance/about/offices/division/tped.html
This division of the Office of Enforcement and Compliance Assurance
(OECA) handles enforcement activities for TSCA, FIFRA, and EPCRA.
Users have access to enforcement response policies, enforcement guidance,
civil penalty policies, and information about Supplemental Environmental
Projects (SEPs).
The Right to Know Network
Website: www.rtknet.org
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 toxicological and
ecologic data submitted by industry under Sections 4 test rules, 8(d) health
and safety studies, 8(e) substantial risk notices, and "For Your Information"
FYI submissions.
I.D.
Publications and Other Information Sources
The following publications contain supplementary information on TSCA and
TSCA-related issues:
Toxic Substances Control Act: A Guide for Chemical Importers/Exporters (EPA
560/1-91-001), U.S. EPA, Office of Toxic Substances, April 1991.
TSCA Import Compliance Checklist (EPA 740-B-08-001), U.S. EPA, Office of
Pollution Prevention and Toxics, April 2008.
New Chemicals Program (Brochure) (EPA 743-F-95-001), U.S. EPA, Office of
Pollution Prevention and Toxics (OPPT), May 1995.
Layman's Guide to TSCA (Brochure) (EPA 560/1-87-011), U.S. EPA, Office of
Toxic Substances, June 1987.
TSCA Inventory (Public Version)
Website: www.ntis.gov/
Phone: (800) 553-NTIS
To buy a full copy of the public (i.e., non-confidential) portion of the TSCA
Inventory, users must purchase it on disk or CD ROM from the National
Technical Information Service (NTIS). At this site, the user can get
price information and ordering numbers to get the latest copy.
Master Testing List
Website: http://www.epa.gov/opptintr/chemtest/pubs/mtlintro.htm
The Master Testing List (MTL) is used by OPPT to establish the TSCA
Existing Chemical Testing Program agenda. The MTL presents a
consolidated listing of OPPT's existing chemical testing priorities as well
as those of other EPA program offices, other federal agencies, the
TSCA Interagency Testing Committee, and international organizations
such as OECD.
OPPT Chemical Fact Sheets
Website: www.epa.gov/oppt/chemfact/
To obtain copies of these and other publications, contact the TSCA Assistance
Information Service, or you may contact:
National Service Center for Environmental Publications (NSCEP)
U.S. Environmental Protection Agency
Website: www.epa.gov/ncepihom/index.htm
PO Box 42419
Cincinnati, OH 45242-2419
Phone: (513)489-8190
Toll free: (800)490-9198
Fax: (513)489-8695
NSCEP is the central repository and distribution center for EPA
publications. NSCEP produces the Annual EPA National Publications
Catalog and maintains an in-house inventory of 7,000 current EPA
publications available to the public free of charge.
National Environmental Publications Internet Site (NEPIS)
Website: http://nepis.epa.gov/
NEPI allows users to search, view, and print from a collection of over 20,000
of EPA's technical and public information documents.
OPPT Chemicals Library
Website: http://www.epa.gov/oppt/library/
The library provides the general public, environmental groups,
educational organizers, state and local organizations, and other
interested parties with access to many of OPPT's information products
and services.
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National Technical Information Service (NTIS)
U.S. Department of Commerce Springfield, VA 22161
For subscriptions or ordering options:
Phone: (703) 605-6060 Toll Free: (800) 363-2068
For other items:
Phone: (703) 605-6000
Toll Free: (800) 553-6847 Fax: 703-321-8547
NTIS sells copies of the public portion of the TSCA Inventory on disk and
CD-ROM.
Appendix II TSCA Section 13 Import Compliance Checklist
Disclaimer
This checklist is a compliance assistance tool only and is not a substitute for
applicable laws or regulations. It does not create any legal rights or defenses
to enforcement actions for failure to comply with environmental laws or
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. 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.
PURPOSE - HOW TO COMPLY WITH TSCA IMPORT CERTIFICATION
REQUIREMENTS
This checklist provides a simplified decision tree to help chemical importers
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). The 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 Sections 12.118-12.127 and 127.28(i)) are jointly
administered by the U.S. Department of Homeland Security, 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
Section 707.20.
Under the TSCA Section 13 import requirements, importers (defined at 19
CFR Section 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. According to the CBP
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
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complies with TSCA.
(For rules on one-year port-specific "blanket certifications," see 19 CFR Section
WHERE TO FILE CERTIFICATIONS
According to 19 CFR Section 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 CBP 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 itselfand' 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 accepted only
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, contact the
TSCA Hotline at (202) 554-1404 or tsca-hotline@epa.gov, or visit
www.epa.gov/oppt/ or www.epa.gov/oppt/chemtest/pubs/sect1 3.htm. If not
attached, view "Introduction to the Chemical Import Requirements of the Toxic
Substances Control Act," (EPA 305-B-08-001) US EPA, Office of Enforcement
and Compliance Assurance, March 2008, available at
www.epa.gov/oppt/chemtest/pubs/importguide.pdfand
www.epa.gov/compliance/resources/publications/assistance/sectors/chemimpo
rt.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 1 991 . For questions related specifically to Section
MIA, 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 determine compliance with
the various TSCA requirements and the appropriate certification option.
What is the Chemical Abstracts Index Name and Chemical Abstracts
Service (CAS) Registry Number of the chemical substance being imported?
Specific Chemical Name:
CAS Number (if available):
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 Section 720.25(b); or (3) if the Pre-manufacturing Number (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) (http://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 Section 12.120(a) and thus, per 19 CFR Section 12.121(b),
certification is not required. (Note that Section 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.D., and,
MI.E., below).
D Yes D No
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2. The material being imported is tobacco or a tobacco product per TSCA
Section 3(2)(B)(iii), (see the 1991 and 1999 guidance documents referenced in
the "Further Information" section).
D Yes D 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.
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
Section 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 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 Section 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.
D Yes D 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.
ill. fgCA-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 order there under." 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
III.D.
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 Section III.C.).
Under TSCA Section 5(a)(1)(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
PMN's 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 one 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.
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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 "bona fide" procedure at
40 CFR Section 720.25 to request EPA to search the Confidential Inventory.
For additional guidance, see
http://www.epa.gov/opptintr/newchems/pubs/invntory.htm.').
D Yes D No
2. If the chemical substance is not on the TSCA Inventory, have you submitted
to EPA any of the following TSCA Section 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.)
a. Pre-Manufacture Notice (PMN, 40 CFR Part 720).
PMN#
D Yes D No
b. Low Volume Exemption (LVE, 40 CFR Section 723.50). LVE #
D Yes D No
c. Low Release and Exposure Exemption (LOREX, 40 CFR Section
723.50). LOREX #
D Yes D No
d. Test Market Exemption (TME, 40 CFR Section 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 Section 720.36).
D Yes D No
b. the Polymer Exemption (40 CFR Section 723.250).
D Yes D No
c. any exemption listed in 40 CFR Sections 720.30(a) through (i), for
example, chemicals manufactured solely for export, byproducts,
impurities, non-commercial R&D. Indicate specifically which paragraph
in Section 720.30 applies:
(Note that while "mixtures" as a whole, as defined in 40 CFR Section
720.3(u), are exempt from the TSCA Section 5 PMN requirement, new
chemical substances that are imported as part of a mixture are subject
to the PMN requirement. See 40 CFR Section 720.30(b)(1)).
D Yes D No
d. exempt as part of an article (40 CFR Section 720.3(c) and Section
720.22(b)(1)). (Note: Under 19 CFR Section 12.121 (b), no TSCA
Section 13 import certification is generally required for chemicals
imported as part of an article. See Section I above).
D Yes D No
e. exempt as a Naturally Occurring Chemical Substance (40 CFR
Section 710.4(b); considered automatically included on the Inventory).
D Yes D No
C. New Intergeneric Microorganism Requirements
725)
(under 40 CFR Part
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
Section 725.3 (formed by the deliberate combination of genetic material
originally isolated from organisms of a different genera? Microorganisms that
are not intergeneric are considered implicitly included on the Inventory per 40
CFR Section 725.8(b)).
D Yes D No
2. Does the shipment contain an intergeneric microorganism that is expressly
included on the TSCA Inventory of existing chemical substances? (if importers
do not find the microorganism on the Public Inventory, they should follow the
"bona fide" procedure at 40 CFR Section 725.15 to request EPA to search the
Confidential Inventory. For additional guidance, see
http://www.epa.gov/opptintr/newchems/pubs/invntory.htm).
D Yes D No
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3. If the microorganism is intergeneric and not expressly included on the
Inventory, have you submitted any of the following TSCA Section 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 #
D Yes D No
b. TSCA Experimental Release Application (TERA, 40 CFR Section
725.250). TERA#
D Yes D No
c. Tier I Exemption (Tier I, 40 CFR Section 725.424). TIER l#
D Yes D No
d. Tier II Exemption (Tier II, 40 CFR Section 725.428 ). TIER ll#
D Yes D No
e. Test Market Exemption (TME, 40 CFR Section 725.300 ). TME #
D Yes D No
4. Is the microorganism exempt under any of the R&D Exemptions for
microorganisms (40 CFR Sections 725.200 to 725.239)?
D Yes D No
D. Other Section 5 Requirements
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 Parts 721 or 725
Subparts L and M). TSCA Section 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 Section 5, in which, case it may not be legally imported.
1. This chemical substance is subject to neither a TSCA Section 5(e) Order to
which you are a party nor a Significant New Use Rule.
D Yes D No
2. This chemical substance is subject to a TSCA Section 5(e) Order to which
you are a party or a Significant New Use Rule and you do not qualify for an
exemption there from, 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 Section 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 Parts 721 or 725), what is the CFR citation in 40 CFR
Parts 721 or 725?
3. This chemical substance is subject to a TSCA Section 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
identified below:
D Yes D No
a. If this chemical substance is subject to a TSCA Section 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 Parts 721 or 725), what is the CFR citation in 40 CFR
Parts 721 or 725?
What is the applicable exemption in 40 CFR Sections 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 importer complies with any requirement (e.g.
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Compliance Guide For The Chemical Import Requirements of TSCA
Compliance Guide For The Chemical Import Requirements of TSCA
per a Section 5(e) Order to which the importer is a party) imposed by EPA
pursuant to the review. The SNUN number assigned by EPA is:
D Yes D No
E. Polychlorinated Biphenyls (PCBs) Requirements
The import of polychlorinated biphenyls (PCBs) and articles containing PCBs is
generally prohibited under TSCA Section 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 one 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
Section 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 Section 761.99?
D Yes D No
4. Does this shipment include products that contain PCBs generated
inadvertently through an excluded manufacturing process as defined in 40 CFR
Section 761.3? (Note that there are subsequent associated recordkeeping and
reporting requirements in 40 CFR Sections 761.185 and 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 Part 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 Section 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 Section 763.165(c)(1).
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 Section 763.165(c)(2).
D Yes D No
5. The asbestos-containing product is the subject of a current exemption
approved by EPA per 40 CFR Section 763.173.
D Yes D No
G. Metalworkinq Chemicals Requirements
Certain chemical substances that may be used in metalworking fluids are
regulated under the TSCA Sections 5(f) or 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 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.
D Yes D 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
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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 Section 749.68. In order to certify
that the chemical shipment complies with the water treatment chemicals rules
in 40 CFR Section 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 one 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.
D Yes D 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.
D Yes D No
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 Sections 13 and 19 CFR Sections 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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