United States Office of
Environmental Protection Toxic Substances
Agency Washington, DC 20460
EPA 560/1-91-001
April 1991
Toxic Substances
Control Act
A Guide for
Chemical
Importers/Exporters
An Overview
Printed on Recycled Paper
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This publication summarizes the requirements of sections 12(b), Exports, and 13, Imports, of the Toxic
Substances Control Act (TSCA), and the rules and policies issued under these sections. Each chemical
substance subject to TSCA regulations that is imported into the United States (for other than solely research
and development purposes) must be listed on the TSCA Inventory of Chemical Substances.
The Environmental Protection Agency (EPA) issued a policy statement on December 13, 1983 (48 FR
55462), which explains how the Agency will interpret the chemical substances import rule issued by the U.S.
Customs Service on August 1, 1983 (48 FR 34734), effective January 1,1984, under section 13 of TSCA.
This publication supplements the guidance provided by that policy and is designed as a quick reference
guide for importers, exporters, and Regional EPA and Customs inspectors. Those involved or interested in
chemical imports/exports may find the information useful for other purposes.
Material in this third edition was revised as of January 1990. Future Agency actions may require periodic
updating and republishing of this guide.
Send all questions, comments, or recommendations on the contents to:
Michael Stahl, Director
Environmental Assistance Division (TS-799)
Office of Toxic Substances
Environmental Protection Agency, Room E-545
401 M Street, S.W.
Washington, D.C. 20460
Telephone: 202-554-1404
TD: 202-554-0551
This is an informational publication. Any rules or orders issued by EPA or U.S. Customs take
precedence over the guidance included herein.
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TABLE OF CONTENTS
IMPORTED CHEMICALS 1
Importer Responsibilities 1
Customs Responsibilities 2
Detention at Port of Arrival (Port of Entry if the Same) 2
Detention at Port of Entry 2
Refused Entry 2
EPA Responsibilities 2
Basis For Certification 3
Applicability Of TSCA 3
Applicable Regulations And Chemicals 4
Section 5 Premanufacture Notification and Significant New Use Rules 4
Section 6 Rules 5
Section 7 Judicial Actions 5
Section 12(b) Rules—Export 5
Section 4 and 8 Rules 5
Articles Containing Chemical Substances 5
Chemicals Subject to Specific Rules 5
TSCA INVENTORY OF CHEMICAL SUBSTANCES 7
EPA ENFORCEMENT 9
IMPORTER'S CHECKLIST 11
EXPORTED CHEMICALS 13
Exporter Responsibilities 13
EPA Responsibilities 14
Applicable Chemicals And Regulations .14
U.S. Environmental Protection Agency
Region 5, Library (PL-12J)
77 West Jackson Boulevard, 12th Floor
Chicago, IL 60604-3590
Table of Contents \
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TABLE OF CONTENTS
CHEMICAL IMPORTS — Questions and Answers .15
I. Articles And Mixtures Under TSCA Section 13 .15
II. Certification Format 20
III. Blanket Certification 21
IV. Certification Requirements 25
V. Who Certifies 27
VI. Foods, Drugs, And Cosmetics 28
VII. R&D Use And Samples .30
VIII. In-Transit Through U.S. Export Shipments 32
IX. Special Cases 33
X. Detained Shipments 35
ii Table of Contents
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IMPORTED CHEMICALS
The statutory mandate of section 13 of TSCA requires the Secretary of the Treasury to refuse entry into the
U.S. Customs territory of any chemical substance, mixture, or article 1 if:
• It fails to comply with any rule in effect under TSCA; or
• It is offered for entry in violation of sections 5 or 6, a rule or order under sections 5 or 6, or
an order issued in a civil action brought under sections 5 or 7.
The Secretary of the Treasury, after consultation with the Administrator of the Environmental Protection
Agency (EPA), promulgated a final Customs rule under section 13 on August 1, 1983 (48 Federal Register
(FR) 34734), (19 Code of Federal Regulations (CFR) sections 12.118 through 12.127 and 127.28
(amended)). In order to explain how it will interpret and carry out its responsibilities under this Customs rule,
the EPA issued a policy statement on December 13, 1983 (48 FR 55462), (40 CFR Part 707). This policy
statement is available from the Environmental Assistance Division. (See inside front cover.)
Following are highlights of the rule and policy for guidance to importers and EPA and Customs regional
inspectors.
IMPORTER RESPONSIBILITIES
Under the Customs rule, the importer of a chemical shipment must certify (except as discussed on page 3)
at the port of entry for shipments entering commerce in the U.S. that either:
• The shipment is subject to TSCA and complies with all applicable rules and orders
thereunder; or
• The shipment is not subject to TSCA.
An importer can accomplish the certification and discharge his obligations related to the import by signing, at
the time of Customs clearance, one of the following brief statements to be typed, preprinted on the invoice
or otherwise included in the entry documentation.
Positive certification for shipments subject to TSCA:
"/ 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 for other shipments:
"/ certify that all chemicals in this shipment are not subject to TSCA."
1 See Articles Containing Chemical Substances, page 7
Imported Chemicals 1
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CUSTOMS RESPONSIBILITIES
Customs officers must review the Customs papers for chemical shipments to determine if the certification is
present. The Customs rule defines detention of shipments of chemical substances, mixtures, or articles at
port of arrival and port of entry as follows:
Detention at Port of Arrival (Port of Entry if the Same).
The district director must detain shipments of chemical substances, mixtures, or articles
• That have been banned from the Customs territory of the U.S. by a rule or order issued
under sections 5 or 6 of TSCA (15 USC 2604 or 2605); or
• That have been ordered seized because of imminent hazards as specified under section
7 of TSCA (15 USC 2606).
Detention at Port of Entry.
Detention at port of entry occurs:
• Whenever the EPA Administrator has reasonable grounds to believe that the shipment is
not in compliance with TSCA and notifies the district director to detain the shipment;
• Whenever the district director has reasonable grounds to believe the shipment is not in
compliance with TSCA; or
• Whenever the importer does not certify compliance with TSCA as required.
Refused Entry.
If a shipment is refused entry, the Secretary of the Treasury must:
• Notify the consignee and the EPA Administrator of the entry refusal, including the
reasons for the refusal;
• Not release the shipment, except under bond (when appropriate); and
• Cause its disposal or storage, if the shipment has not been exported by the consignee
within 90 days from date of receipt of the notice of entry refusal.
EPA RESPONSIBILITIES
Under the Customs Rule, the EPA Administrator must:
• Determine whether detained shipments and their entries comply with TSCA
requirements;
• Notify Customs when EPA is aware of shipments that should be detained;
• Identify steps necessary to bring detained shipments into compliance, or that must be
taken when shipments are not brought into compliance; and
2 Imported Chemicals
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• Take action to store or dispose of abandoned noncomplying shipments (importer is liable
for any expenses involved in the storage or disposal).
BASIS FOR CERTIFICATION
Whenever the documents accompanying the imported shipment identify the chemical exactly, the person
who is certifying compliance can check the identity against requirements under TSCA. When the chemical
substance or mixture is imported under a name that does not identify it exactly, and the person certifying
does not otherwise know the identity, he should attempt to discover the chemical constituents of the
shipment by contacting another party to the transaction (e.g., his principal or the foreign manufacturer). This
person may be able to identify the components of the substance or mixture, or at least state that the
substance or mixture complies with TSCA.
The greater the effort an importer makes to learn the identities of the imported substances, the smaller his
chances of committing a violation by importing a noncomplying shipment. If a shipment were ultimately
determined to have violated TSCA, the good faith efforts of the importer to verify compliance, as evidenced
by documents contained in his files, might obviate or mitigate the assessment of a civil penalty under section
16 of TSCA.
APPLICABILITY OF TSCA
TSCA applies to chemical substances and mixtures which are broadly defined in section 3 of TSCA. EPA,
together with other Federal agencies, has issued a policy statement on biotechnology (51 FR 23313, June
26,1986) in which EPA clarified that microorganisms are "chemical substances" under TSCA. Importers of
microorganisms must bear in mind that they are subject to TSCA import certification requirements. In the
remainder of this volume, references to "chemical substances" and "chemicals" include microorganisms.
Section 3 of TSCA specifies that certain chemicals are excluded from the definition of "chemical substance"
based on their use. These chemicals include, but are not limited to, foods, drugs, cosmetics, and active
ingredients in pesticides. Such exempt chemicals, however, still require a certification that they are not
subject to TSCA, except when exempt from negative certification as specified below. Examples of exempted
chemicals for which the importer could sign the negative certification statement shown under Importer
Responsibilities (page 1) include the following:
• Any pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act)
when imported for use as a pesticide;
• Any food, food additive, drug, cosmetic, or device (as such terms are defined in section
201 of the Federal Food, Drug, and Cosmetic Act) when imported for use as a food, food
additive, drug, cosmetic, or device. The term "food" includes poultry and poultry products
(as defined in sections 4(e) and 4(f) of the Poultry Products Inspection Act), meat and
meat food products (as defined in section 1(j) of the Federal Meat Inspection Act), and
eggs and egg products (as defined in section 4 of the Egg Products Inspection Act).
• Source material, special nuclear material, or byproduct material (as such terms are
defined in the Atomic Energy Act of 1954 and regulations issued under such Act);
Imported Chemicals 3
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• Firearms and ammunition, the sale of which is subject to the tax imposed by section 4181
of the Internal Revenue Code of 1954 (determined without regard to any exemptions from
such tax provided by sections 4182 or 4221 or any other provision of such Code).
Tobacco or any tobacco products do not require any certification because there are other controls on the
importation of those items involving other Federal agencies.
APPLICABLE REGULATIONS AND CHEMICALS
The TSCA regulations that apply to importers (who are defined as "manufacturers" under TSCA) include the
following:
Section 5 Premanufacture Notification and Significant New Use Rules
These rules impose notification requirements for chemical manufacturers, importers, and processors. Each
chemical substance (subject to TSCA jurisdiction) that is imported into the United States must be listed on
the TSCA Inventory of Chemical Substances unless it is imported in small quantities solely for research and
development. (See subsequent section entitled TSCA Inventory of Chemical Substances, page 7.) An
importer must verify that all such chemical substances in each of his shipments are listed on this Inventory.
Persons who wish to import chemical substances that do not appear on the Inventory, except for those small
quantities imported solely for research and development purposes, must comply with Premanufacture
Notification (PMN) requirements and review procedures in section 5(a)(1) of TSCA. These are specified in
an EPA final rule issued in the Federal Register on May 13,1983 (48 FR 21722), clarified on September 13,
1983 (48 FR 41132), and amended on April 22, 1986 (51 FR 15096) (40 CFR 720). An importer must
submit a PMN using EPA Form 7710-25 at least 90 days before import begins. Importers are required to
provide information only on exposure that occurs within the United States. The principal importer is the first
importer who selects the new chemical substance and determines the total amount to be imported. The
principal importer must know that the substance will be imported. Only a person incorporated, licensed, or
doing business in the United States may submit the notice. One person may prepare and submit the
Premanufacture notice jointly with another person. A joint submission may be useful where different persons
have information required in the notice. It also may be useful when another person has information
fundamental to the notice but wishes to keep it confidential.
An importer may qualify for one of the exemptions EPA has issued under TSCA section 5(h)(4) which
provides for reduced notification requirements:
• new chemical substances manufactured or imported in quantities of 1,000 kilograms or
less per year (40 CFR 723.50,50 FR 16488, April 26 1985);
• new chemical substances used in or for the manufacturing or processing of instant
photographic or peel-apart film articles (40 CFR 723.175,47 FR 24317, June 4,1982); or
• certain new polymers (40 CFR 723.250,49 FR 46086, November 21,1984).
In addition, chemical substances imported into the United States may be subject to significant new use rules
(SNURs) under section 5(a)(2). Such rules require a notice to EPA at least 90 days before import for a
significant new use.
See Importer's Checklist (page 11) for further clarification of PMN and other requirements in the subsequent
section of this publication entitled TSCA Inventory of Chemical Substances.
4 Imported Chemicals
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Section 6 Rules
These rules cover regulation of selected chemical substances and mixtures. EPA may take certain
regulatory actions (as specified under section 6) to protect against an unreasonable risk of injury to health or
the environment for the manufacture, processing, distribution in commerce, use, or disposal of a chemical
substance or mixture. Certain chemicals imported into the United States may be subject to restrictions under
this section.
Section 7 Judicial Actions
This section authorizes EPA to commence a civil action for seizure of an imminently hazardous chemical; for
relief against any person who manufactures, processes, distributes in commerce, uses, or disposes of an
imminently hazardous chemical; or for both seizure and relief. Chemicals that have been ordered seized by
a court because of imminent hazards may not be imported into the United States.
Section 12(b) Rules—Export
If entry is denied for an intended import, and the importer chooses to export the noncomplying shipments to
a foreign country, rules under this section apply. Such rules may require the exporter to notify EPA of the
intended shipment. EPA, in turn, must notify the foreign government of the intended export to that country.
Section 4 and 8 Rules
Importers may be subject to these rules, since TSCA defines importers as manufacturers. Because these
rules do not apply to individual chemical shipments, however, and because compliance with such rules may
be a lengthy procedure, importation does not depend on importers' satisfying section 4 or 8 requirements at
the time of certification. If, however, a section 8 rulerequires notification to EPA prior to the import of a
specified chemical, any importer of that chemical should ensure that the required notification has been
completed before certifying that a shipment containing the chemical is in compliance with TSCA.
In addition, importers are responsible for submitting to EPA any lists and copies of unpublished health and
safety studies, or references to them, in their possession for the chemicals subject to rules under section
8(d) of TSCA. Importers need only search files located in the United States; they are not required to secure
studies in the possession of a foreign subsidiary or parent. If an importer knows of a study in the possession
of a foreign entity, however, that study must be listed and the list submitted to EPA.
Articles Containing Chemical Substances
The Customs rule does not require certification for chemical substances imported as part of articles. (See
page 17 for definition of article under TSCA.)
Future TSCA rules may require certification of articles containing certain chemical substances, however. In
such cases, the individual rules will specify whether certification is required.
Chemicals Subject to Specific Rules
The Chemicals on Reporting Rules Database (CORR List) gives the chemical substances, chemical
categories, and mixtures that are or have been the subject of proposed or final Office of Toxic Substances
(OTS) regulations. The substances are listed by Chemical Abstract Services (CAS) registry number.
The CORR List is revised quarterly and can be obtained from the TSCA Assistance Information Service by
calling (202) 554-1404. A list of chemical substances subject to TSCA section 12(b) export notification which
includes a list of section 5(e) Consent Orders can also be obtained by calling (202) 554-1404.
Imported Chemicals 5
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To be sure that your import shipment complies with all of the above rules and regulations, refer to Importer's
Checklist (page 11).
Importers may contact the TSCA Assistance Information Service to obtain additional information on
requirements and to get on the mailing list for the Chemicals-ln-Progress Bulletin for information on
current rulemaking actions.
6 Imported Chemicals
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TSCA INVENTORY OF CHEMICAL
SUBSTANCES
Section 8(b) of the Toxic Substances Control Act (TSCA) requires the Administrator of the U.S.
Environmental Protection Agency to identify, compile, keep current, and publish a list of chemical
substances manufactured, imported, or processed for commercial purposes in the United States.
The TSCA Chemical Substance Inventory: 1985 Edition and the 1990 together list nearly 69,000 chemical
substances. Of these some 5,500 have had their identity claimed as confidential and have been assigned
generic names.
Chemical substances that are subject to TSCA but not included on the Inventory are considered "new" and
are therefore subject to premanufacture notification requirements under section 5 of TSCA.
The Inventory does not purport to identify all chemical substances currently in U.S. commerce, because
some substances are specifically excluded by statute or regulation (40 CFR Part 710). Additionally, no
printed version of the Inventory can be completely up-to-date because it is continually subject to change.
New substances for which premanufacture notice (PMN) review under section 5 has been completed and
that are being manufactured or imported will continue to be added to the Inventory upon EPA's receipt of a
Notice of Commencement of Manufacture/Import (NOC). The Agency may propose to delete some
substances from the inventory if, after careful review, it determines that these substances were incorrectly
reported. Furthermore, information regarding chemical identities claimed as confidential is not included in
the published version of the Inventory. Recognizing these limitations, the Agency maintains a Master
Inventory File, which includes all eligible substances that have been reported. The file is updated as new
information becomes available.
The Agency provides a service to assist those who, for various reasons, want to determine whether a
particular substance is on the Inventory. A person who intends to manufacture or import a chemical
substance that does not appear on the published Inventory may ask EPA to determine whether the
substance in question is included in the Agency's Master Inventory File. The Agency will provide an answer
only if the person who submits the inquiry is able to demonstrate a "bona fide intent" to manufacture or
import the substance for a commercial purpose. The exact procedures for establishing and submitting a
bona fide intent are discussed in detail in the Premanufacture Notification Requirements and Review
Procedures (40 CFR 720.25) (48 FR 21722, May 13, 1983). When a bona fide intent has been established
with a formal submission, the Agency will perform a comprehensive search of the entire Master Inventory
File—both confidential and nonconfidential portions—to determine conclusively whether the substance in
question is already included.
All bona fide inquiries must be submitted in writing and accompanied by appropriate documentation.
Incomplete inquiries or submissions will not be processed unless all the requirements of the bona fide intent
are met. Special care should be taken with the submissions that contain TSCA Confidential Business
Information. Bona fide intent submissions should be sent to:
OTS Document Control Officer (TS-790)
U.S. Environmental Protection Agency
Office of Toxic Substances
401 M Street, S.W.
Washington, D.C. 20460
ATTN: Chemical Inventory Section
TSCA Inventory of Chemical Substances 7
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To order the printed public version of the TSCA Inventory, call the U.S. Government Printing Office (202)
783-3238, or write Superintendent of Documents, Washington. D.C. 20402-9325. Visa, MasterCard, and
Choice are accepted. Make checks payable to the Superintendent of Documents.
The five-volume TSCA Chemical Substance Inventory: 1985 Edition costs $161.00 per set shipped to
addresses in the United States and Canada, and $201.25 when shipped to all other countries. The order
number is S/N 055-000-00254-1. The 1990 Supplement costs $15.00 when shipped to addresses in the
U.S., and $18.75 when shipped to all other countries (including Canada). The order number is
055-000-00361-1.
Nonconfidential subsections of the TSCA Inventory are also on computer tape and sold by the National
Technical Information Service (NTIS) of the U.S. Department of Commerce, located at 5285 Port Royal Rd.,
Springfield, VA 22161.
The computer tape includes the TSCA inventory from 1979 to March 30, 1990. It may be obtained by using
the following order numbers.
For Computer Tape:
Order Number: PB90-504226 Cost: 1600 BPI - $560; 6250 BPI - $450
For Tape Documentation:
Order Number: PB90-237447 Cost: Paper Copy - $15; Microfiche - $8
Searches of the NTIS computer tape of the Inventory are available from a number of commercial sources.
The following data bases are maintained by a number of commercial services that have purchased the NTIS
computer tape:
Scientific and Technical Network International maintained by:
Chemical Abstracts Service (CAS)
File: CAS ONLINE
1-800-848-6533
Dialog Information Services maintained by:
Lockheed
File: Number 52
1-800-334-2564
Note that importers and domestic manufacturers of substances on the TSCA Inventory must comply with the
rule on the Partial Updating of TSCA Inventory Data Base; Production and Site Reports (40 CFR Part 710)
(51 FR 21438, June 12,1986) Final Rule—Section 8(a). Recurring reporting is required every four years.
For information, Instruction manual, and reporting forms, contact:
OTS Document Control Officer (TS-790)
U.S. Environmental Protection Agency
Office of Toxic Substances
401 M St. S.W.
Washington, D.C. 20460
Attn: Inventory Update Rule
Telephone: (202) 382-3698 or (202) 755-4880.
8 TSCA Inventory of Chemical Substances
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EPA ENFORCEMENT
EPA and the Customs Service will monitor chemical imports to determine if shipments and their
documentation comply with the certification requirements and the substantive mandates of TSCA. Customs
will refuse entry to any shipment until certification is properly submitted. Customs will also detain a shipment
if there are reasonable grounds to believe that the shipment or its import violates TSCA or regulations or
orders thereunder. Any shipment in violation must either be brought into compliance, exported, destroyed, or
voluntarily abandoned within the time periods prescribed in section 12.124 of the section 13 rule.
When EPA determines that a shipment should be detained, the Agency will identify the reasons for the
detention and the actions the importer must take to bring the shipment into compliance with TSCA. If EPA
has given this information to Customs before the district director issues the detention notice, the information
will become part of the detention notice. The importer should contact one of the following EPA Regional
Offices for guidance as to the proper procedures to correct any deficiencies in the shipment.
EPA REGION I
Pesticides and Toxic Substances Branch
John F. Kennedy Federal Building
Boston, MA 02203
617-223-0585
EPA REGION II
Pesticides and Toxic Substances Branch
Raritan Depot, Building 209
Woodbridge Avenue
Edison, NJ 08837
201-321-6769
EPA REGION III
Toxics and Pesticides Branch
841 Chestnut Street
Philadelphia, PA 19107
215-597-8598
EPA REGION IV
Pesticides and Toxic Substances Branch
345 Courtland Street, N.E.
Atlanta, GA 30365
404-347-3222
EPA REGION V
Pesticides and Toxic Substances Branch
536 South Clark Street
Chicago, IL 60604
312-353-2192
EPA REGION VI
Pesticides and Toxics Branch
Allied Bank Tower
1445 Ross Avenue
Dallas, TX 75270
214-767-2734
EPA REGION VII
Toxics and Pesticides Branch
726 Minnesota Avenue
Kansas City, KS 66101
913-236-2835
EPA REGION VIII
Toxic Substances Branch
One Denver Place
Denver, CO 80202
303-293-1730
EPA REGION IX
Pesticides and Toxic Substances Branch
215 Fremont Street
San Francisco, CA 94105
415-974-8138
EPA REGION X
Pesticides and Toxic Substances Branch
1200 Sixth Avenue
Seattle, WA 98101
206-442-1198
EPA Enforcement 9
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If Customs detains or refuses entry of a shipment (other than for failure to make the general certification) and the
importer takes measures necessary to bring the shipment into conformity with the requirements of TSCA, EPA
officials will reassess the shipment to determine its current compliance status. If the shipment is no longer in violation,
EPA will notify the district director and the importer. The district director will then release the shipment. This notice will
also serve as a determination to permit entry under Section 12.123(c) if a shipment is brought into compliance before
the Section 12.123(C) decision-making process has been completed. If compliance is achieved after a Section
12.123(c) determination (adverse to the importer) has been made, the EPA notice to the district director will serve as a
reversal of the decision to refuse entry.
Assistance in determining whether a chemical shipment is in compliance with TSCA is available from the
Director, Compliance Monitoring Staff, Office of Pesticides and Toxic Substances (EN-342), U.S.
Environmental Protection Agency, 401 M Street, S.W., Washington, D.C. 20460.
Any questions concerning Customs matters should be directed to the District Director of Customs at the port
of entry. Addresses of local Customs Offices can be found in the local telephone directory under United
States Government, Department of the Treasury, United States Customs Service.
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IMPORTER'S CHECKLIST
Step I. Is my substance exempt from TSCA section 13 certification requirements?
• If your substance meets the definition of article or is tobacco or any tobacco product, you
are not required to sign any certification statement.
Step II. Is my substance In the category requiring negative certification?
• Check the categories of materials that require negative certification.
• If your substance falls into any of these categories, you must sign the negative
certification statement that the substance you intend to import is not subject to TSCA
unless your shipment is accompanied by the appropriate form identifying it as a pesticide
or a food, food additive, drug, cosmetic or device.
Step III. Is my substance In the category requiring positive certification?
• If your substance does not fall into any of the categories that require negative certification
or are exempt from certification altogether, it is subject to positive certification.
Step IV. Is my substance being imported solely for research and development purposes?
• If yes, you are exempt from PMN requirements.
Step V. Is my substance a new chemical substance, potentially subject to PMN requirements?
• Prior to import, you must determine whether your chemical substance is actually on the
printed TSCA Inventory or in the Master File. You may ask EPA to search the Inventory,
including the confidential portion, by establishing a "bona fide intent to import" as
discussed in 48 FR 21722,40 CFR 720.25, the PMN rule.
• If your chemical substance is not in the Master Inventory and you wish to import it for
purposes other than research and development, you must file a premanufacture
notification with EPA at least 90 days prior to import. Your chemical substance may
qualify for a polymer exemption or a low-volume exemption, which require notification at
least 21 days prior to import; the notification requirements are reduced as well. You may
call the Environmental Assistance Division for additional information.
Step VI. My chemical substance Is on the Inventory or Imported solely for research and
development. Do I have any further requirements under TSCA section 13?
• You must determine whether there are any specific regulations or actions regarding this
chemical substance under TSCA section 5, 6, or 7.
Importer's Checklist 11
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• Check the lists of chemicals subject to proposed or final regulations under those sections
in the Chemicals on Reporting Rules Database (CORR List), which is available from the
EPA Environmental Assistance Division by calling (202) 554-1404. A list of chemical
substances on which there are section 5(e) consent orders and which require section
12(b) export notices can also be obtained by calling the above number. You must meet
all the requirements outlined for the specified chemicals in order to sign the positive
certification statement.
If the chemical is not listed as subject to any proposed or final rule under TSCA section 5,
6, or 7, you are responsible for verifying that the information has not changed since the
date of the publication. If necessary, call the Environmental Assistance Division to verify
that the information is up-to-date.
Do I have any further obligations under TSCA?
• Since importers are defined under TSCA as manufacturers, they must comply with all
testing, reporting, and recordkeeping requirements imposed on manufacturers under
TSCA sections 4, 8(a), 8(c), 8(d), and 8(e). Some section 8 rules require notification to
EPA prior to the import of a specified chemical. Consult the list of affected chemicals as
explained above. Importers should ensure that the required notification has been
completed before certifying that a shipment containing the chemical is in compliance with
TSCA.
NOTE: It is your responsibility to verify that the information has not changed since the date of
publication of the CORR list or the section 12(b) list of chemicals which includes the Section 5(e)
consent order list.
12 Importer's Checklist
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EXPORTED CHEMICALS
The statutory requirements of section 12(b) of TSCA require that:
• Any person who exports or intends to export a chemical substance or mixture for which
submission of data is required under section 4 or 5(b), for which an order has been
issued under section 5, for which a rule has been proposed or promulgated under section
5 or 6, or with respect to which an action is pending, or relief has been granted under
section 5 or 7, must so notify the EPA Administrator.
• EPA then must notify the importing country's government:
— Of the availability of test data on the chemical submitted to EPA under section 4 or 5(b) of TSCA; and
— Of any rule, order, action, or relief under section 5,6, or 7 of TSCA.
In addition, EPA may regulate a chemical produced for export if it presents an unreasonable risk of injury to
health or the environment of the United States. The Agency may require testing of any such chemical if
necessary to determine whether there is a risk to the United States.
EXPORTER RESPONSIBILITIES
EPA issued a final export reporting rule in the Federal Register on December 16, 1980 (45 FR 82844) (40
CFR 707). Under this rule, an exporter must submit a notice of the first export, within the calendar year, for
the substance or mixture. The notice must be submitted by letter to EPA and include the following
information:
• Name and address of the exporter;
• Name of the chemical substance or mixture;
• Date(s) of export or intended export;
• Country (countries) of import; and
• Section of TSCA (4, 5, 6, or 7) under which EPA has taken action.
Notice is required for the first export or intended export to a particular country in a calendar year. The notice
must be postmarked within seven days after accepting a definite contractual obligation to export or an
equivalent intracompany agreement to export. Where the actual export occurs less than seven days after
the export obligation or agreement has been executed, the notice must be submitted to EPA no later than
the same day as the export.
The country of import to be entered on the section 12(b) notice is defined as:
"... the country where the goods are to be consumed, further processed, or manufactured, as known
to the shipper at the time of exportation. If the exporter does not know the country of ultimate
destination, the shipment is credited to the last country to which the exporter knows that the
merchandise will be shipped."
Exported Chemicals 13
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EPA RESPONSIBILITIES
Under the EPA final export rule, EPA must send a notice to the government of the importing country no later
than five working days after receipt of the first annual notification from the exporter for each regulated
chemical. The EPA notice includes the following information:
• Identification of the regulated chemical;
• Summary of the EPA regulatory action taken, or an indication of the availability of data
under TSCA section 4 or 5(b);
• EPA official to contact for further information; and
• Copy of the pertinent Federal Register notice.
APPLICABLE CHEMICALS AND REGULATIONS
A list of the substances (or classes of substances) subject to export notification requirements can be
obtained from the TSCA Assistance Information Service by calling (202) 554-1404.
NOTE: If the EPA action that prompts the notice is a proposed rule, the section 12(b) notice must be
submitted for exports beginning 30 days after publication of the action in the Federal Register.
14 Exported Chemicals
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CHEMICAL IMPORTS
Questions and Answers about
Requirements under Section 13 of the
Toxic Substances Control Act (TSCA)
I. ARTICLES AND MIXTURES UNDER TSCA SECTION 13
The TSCA Assistance Information Service has received a number of questions concerning classification of
various imported materials as chemical substances (subject to certification) or articles (not subject to
certification). (Refer to Part IV: Certification Requirements for details.) Those listed below were all
determined by EPA to be chemical substances. As such, they require positive certification of compliance
with TSCA.
Aluminum oxide
Bauxite
Bismuth
Coal
Crude oil
Crushed stone
Gasoline
Liquified petroleum gas
Lysine, unless imported for
use as a food additive
Natural gas
Oxalic acid
Peat moss, except as peat
pots, which are articles
Pitch
Potassium sorbates, unless
imported for use as a food
additive
Sorbic acid, unless imported
for use as a food additive
Tetraethyl lead
Chemical Imports/Questions and Answers 15
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Question #1 How Is "chemical substance" defined under TSCA ?
Answer #1 "Chemical substance" is defined in section 3 of TSCA as any organic or inorganic
substance of a particular molecular identity, including:
any combination of such substances occurring in whole or in part as a
result of a chemical reaction or occurring in nature; and
• any element or uncombined radical.
Chemical substance does not include:
• any mixture;
• any pesticide (as defined in the Federal Insecticide, Fungicide, and
Rodenticide Act) when manufactured, processed, or distributed in
commerce for use as a pesticide;
• tobacco or any tobacco product;
• any source material, special nuclear material or by-product material (as
such terms are defined in the Atomic Act of 1954 and regulations issued
under such Act);
• any article (i.e., firearms and ammunition) the sale of which is subject to
the tax imposed by section 4181 of the Internal Revenue Code of 1954
(determined without regard to any exemptions from such tax provided by
section 4182 or 4221 or any other provision of such Code); and
• any food, food additive, drug, cosmetic, or device (as such terms are
defined in section 201 of the Federal Food, Drug, and Cosmetic Act) when
manufactured, processed, or distributed in commerce for use as a food,
food additive, drug, cosmetic, or device.
A chemical substance in bulk form is defined in the Customs rule at 12.120(b) as "a
chemical substance (other than part of a mixture or article) in containers used for
purposes of transportation or containment, provided the chemical substance is intended
to be removed from the container and has an end use or commercial purpose separate
from the container."
16 Chemical Imports/Questions and Answers
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Question #2 How Is "article" defined?
Answer #2 (1) "Article," in the Customs rule at section 12.120(a)(1), is a manufactured item which:
• Is formed to a specific shape, or design during manufacture;
Has end use functions
design during the end use
dependent in whole or in part upon its shape or
and
Has either no change of
those changes of composition
separate from that of the £
12.120(a)(2), below; except
articles regardless of
[shape
chemical composition during its end use or only
which have no commercial purpose
rticle and that may occur as described in section
that fluids and particles are not considered
or design.
(2) The allowable changes of
that result from a chemical
substances, mixtures, or articles
other household products, fuels
photographic films, batteries, mat
manufactured upon end use of
commerce or for use as an intermediate
composition referred to in section 12.120(a)(1) are those
reaction that occurs upon the end use of other chemical
such as adhesives, paints, miscellaneous cleaners or
fuel additives, water softening and treatment agents,
ches, and safety flares in which the chemical substance
he article is not itself manufactured for distribution in
and
Question #3
Answer #3
For which articles Is a certification required pursuant to section 12.121 (b) of the
Customs rule?
Articles require no certification at this time; however, any further regulations on articles
may specify import requirements.i
Question #4
Answer #4
Are metallurgical Intermediates classified as chemical substances or articles?
If an item is manufactured in a
and the shape of the item has nc
Thus, items such as metal ingot
TSCA certification, and are
procedures described in Part III 01
particular shape for the purpose of shipping convenience
function in the end use, it is not considered an article.
, billets, and blooms are chemical substances, require
subject to PMN requirements. (The blanket certification
this section may provide the most convenient option.)
For purposes of compliance with section 5 and section 13, OTS will consider items being
imported as articles if they are manufactured in a specific shape or design for a particular
end use application, and this design is maintained as an essential feature in the finished
product. Thus, materials such as metal or plastic sheets, wire, coated fabric, rolled
carpet, sheets of plywood and otjier similar materials will be viewed as articles by OTS,
even if, for example, subsequentjto import they are rolled or drawn thinner, cut, printed,
laminated, or thermoformed, as long as they meet the above criteria. None of these items
would be subject to TSCA import certification unless they contained a chemical
substance or mixture for which Certification is required by a specific rule under TSCA.
Also, they would not be subject to Premanufacture Notice (PMN) requirements.
Chemical Imports/Questions and Answers 17
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Question #5 We Import small plastic sheets with chemical coatings for analysis In our quality
control laboratories. Do these require certification?
Answer #5 See Answer #4 above.
Question #6 Is waste Imported for disposal In drums and not removed from the drums
considered an article?
Answer #& No, such waste is not an article; it is a bulk chemical and requires a positive certification.
See, however, questions 70 and 71.
Question #7 // an Importer Imports a piece of machinery which contains PCBs, Is a positive
certification necessary?
Answer #7 Because TSCA considers the term "import" to be synonymous with "manufacture", no
PCB equipment can be imported after July 2,1979, unless an exemption is obtained from
EPA. If the exemption has been obtained, no TSCA certification is required for the import
of the machinery, since the PCBs are part of an article (the machinery) and are not
removed from that article. However, the PCBs are subject to the provisions of the TSCA
section 6(e) PCB rules.
Question #8 Can a "new" (not on the Inventory) dielectric fluid (not a PCB) be Imported In a
capacitor or transformer?
Answer #8 As long as it is not removed from the capacitor or transformer, the fluid is considered to
be part of an article and may be imported as such. Import separate from the article would
require a premanufacture notice 90 days before import.
Question #9 A large number of exports, such as argon, hydrogen and oxygen, are shipped In
pressure containers, such as cylinders, tank trucks, and tank cars. Upon return,
the containers and any residuals are released as Instruments of International
Traffic without entry papers. Is a certification required for these residuals?
Answer #9 Containers are considered articles and, as such, do not require certification as long as
residuals therein do not constitute bulk quantities.
18 Chemical Imports/Questions and Answers
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Question #10
Answer # 10
How Is mixture defined under TSCA ?
The term mixture is defined in section 3 of TSCA as follows: "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 a chemical reaction; except that such term does 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 combination is a new chemical substance and if
the combination could have been manufactured for commercial purposes without a
chemical reaction at the time the chemical substances comprising the combination were
combined."
Question #11
Answer #11
How are mixtures to be treated? If each Item Is Identified In the TSCA Inventory,
can certification be made?
Each chemical substance in the mixture (other than impurities) must be identified.
[However, there are certain complex chemicals (e.g., castor oil, barium iron oxide) that
are designated "Class 2" substances on the TSCA Inventory to which this will not apply.]
After identifying each chemical substance, it is necessary to determine whether all the
individual substances are on the Inventory and are in compliance with specific rules
under sections 5,6, and 7 of TSCA before signing the positive certification.
Question #12
Answer #12
Do mixtures such as paints, cleaners, and the like have to be certified?
Yes, the procedure outlined in the answer to the preceding question must be followed
and a positive certification signed.
Question #13
Answer #13
Does the certification requirement apply to shipments of final products that are
chemical mixtures? For example, would the rule apply to a shipment of cartons of
carburetor cleaner?
Yes, certification is required for shipments of final products that are chemical mixtures.
Chemical Imports/Questions and Answers 19
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II. CERTIFICATION FORMAT
Question #14
Answer #14
What Is the acceptable certification language and format and on what document
should the certification be made?
The specific language for a positive certification is:
"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."
Or, for a negative certification:
"I certify that all chemicals in this shipment are not subject to TSCA."
No other language may be substituted. Both positive and negative statements may be
preprinted, typed, or stamped on the invoice used in connection with the entry and entry
summary procedures. The certification statements may be signed by means of an
authorized facsimile signature.
For those entries or entry summaries processed electronically this statement will be in the
form of a Certification Code transmitted as part of the Automated Broker Interface (ABI)
transmission. The entry filer will be obligated by this Certification Code to the same extent
as if these statements were submitted on entry or entry summary documents.
Question #15
Answer #15
Can a single or "blanket" certificate be used to cover several shipments of the
same chemical made over a one-year period?
Yes, if a "blanket" certification (see Part III of this section) has been authorized by the
appropriate District Director of U.S. Customs and a statement to that effect is included on
the commercial invoice or entry document.
Question #16
Answer #16
Is It necessary for the Importer to Include the Chemical Abstracts Service (CAS)
number for each chemical covered by the certification?
No, CAS numbers are not required, but they could be useful in speeding verification of
proper certification. Note that only a few of the existing CAS numbers are actually on the
TSCA Inventory. Importers must not assume that the existence of a CAS number means
that TSCA requirements are met.
20 Chemical Imports/Questions and Answers
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III. BLANKET CERTIFICATION
Question #17
Answer #17
Can you discuss procedures for "blanket" certification?
"Blanket" certification must be made on the letterhead of the certifying firm and signed by
an authorized person. All blanket certifications shall initially be annual on a calendar-year
basis, subject to renewal. Once accepted, a blanket certification may be revoked for
cause by the District Director of the U.S. Customs Service at any time.
Importers authorized to use blanket certifications must also include a statement on the
commercial invoice or entry document referring to the blanket certification and
incorporating it by reference. Such statement need not be signed. Separate blanket
certifications will be required for chemicals subject to TSCA and those not subject to
TSCA.
The format to be used for blanket certifications; and the format for the required statement
referencing the blanket certification, is shown on pages 22,23, and 24.
Question #18
Answer #18
Is It necessary to list tariff Item numbers on blanket certifications?
Yes, blanket certifications will be one of the sources U.S. Customs will use to develop its
TSCA data base, which will ultimately facilitate the clearance of goods subject to TSCA.
Since this data base is Harmonized Tariff Schedule (HTS)-oriented, tariff item numbers
are necessary.
Question #19
Answer #19
Must suppliers' names and addresses be listed?
Yes, names and addresses must be listed to simplify resolution of compliance problems
that may arise.
Question #20
Answer #20
Is It necessary to file blanket certifications at each port of entry?
No, blanket certifications need to be filed with each district where importations are
anticipated, since their acceptance is at the option of each Customs District Director for
his or her district.
Chemical Imports/Questions and Answers 21
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TO: District Director
U.S. Customs Service
(city) (state)
CERTIFICATE
The undersigned, as an authorized officer or agent of
(Importer) , hereby certifies that all
chemical substances in all shipments of product(s)
listed herein and imported from suppliers listed below,
namely:
PRODUCTS
(list name and HTS item number)
SUPPLIERS
(list name and address)
comply with all applicable rules or orders under TSCA,
and (Importer) is not offering a chemical substance
for entry in violation of TSCA or any applicable rule or
order thereunder.
Date this day of , 19 .
(Authorized signature)
(Title)
HTS - Harmonized Tariff Schedule of the U.S.
22 Chemical Imports/Questions and Answers
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TO: District Director
U.S. Customs Service
(city) (state)
CERTIFICATE
The undersigned, as an authorized officer or agent of
(Importer) , hereby certifies that all
chemical substances in all shipments of product(s)
listed herein and imported from suppliers listed below,
namely:
PRODUCTS
(list name and HTS item number)
SUPPLIERS
(list name and address)
are not subject to TSCA.
Date this day of , 19
(Authorized signature)
(Title)
HTS - Harmonized Tariff schedule of the U.S.
Chemical Imports/Questions and Answers 23
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FORM OF STATEMENT
ON COMMERCIAL INVOICE
ON ENTRY DOCUMENT
(COMPLYING PRODUCTS)
"Importation of the products described above are
subject to certificate on file with the District
Director in respect of compliance with TSCA executed by
(Importer) , on , 19 , the terms of
which, including the fact of its execution are incor-
porated herein by this reference".
FORM OF STATEMENT
ON COMMERCIAL INVOICE
ON ENTRY DOCUMENT
(PRODUCTS NOT SUBJECT TO TSCA)
"Importation of the products described above are
subject to certificate on file with the District
Director indicating that they are not subject to TSCA
executed by (Importer) , on , 19 , the
terms of which, including the fact of execution are
incorporated herein by this reference".
24 Chemical Imports/Questions and Answers
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IV. CERTIFICATION REQUIREMENTS
Question #21
Answer #21
What does an Importer need to know to determine the certification requirements
for his Imported chemical?
See the Importer's Checklist on page 18.
Question #22
Answer #22
Which Imported chemicals require TSCA positive certification; which require
negative certification; and which are exempt and require no certification?
A positive certification of compliance with TSCA is required for all chemical substances
under TSCA jurisdiction as discussed in Part I of this section, Articles and Mixtures under
Section 13.
A negative certification is required for chemicals not subject to TSCA jurisdiction. Those
substances which require negative certification are: pesticides (unless accompanied by
EPA Form 3540-1), any food, food additive, drug, drug intermediate, cosmetic, cosmetic
intermediate, or device subject to the Federal Food, Drug, and Cosmetic Act (FFDCA)
(unless accompanied by FDA import Form FD701), nuclear source materials, special
nuclear materials or nuclear by-product materials, and firearms and ammunition.
No certification is required for articles, as defined in section 12.120(a) of the Customs
rule, and any tobacco or tobacco products.
Question #23
Answer #23
Can Harmonized schedules be used to determine the need for certification?
Harmonized schedules alone are insufficient to determine the need for certification. All
chemicals are subject to the TSCA section 13 rule and must have a negative or positive
certification except for pesticides when accompanied by EPA Form 3540-1, tobacco or
tobacco products, articles, and any food, food additive, drug, cosmetic, or device (as such
terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act) when
manufactured, processed, or distributed in commerce for use as a food, food additive,
drug, cosmetic, or device if accompanied by an FDA Form FD701. The term "food"
includes poultry and poultry products (as defined in sections 4(e) and 4(f) of the Poultry
Products Inspection Act), meat and meat food products (as defined in section 1 (j) of the
Federal Meat Inspection Act), and eggs and egg products (as defined in section 4 of the
Egg Products Inspection Act). Customs schedules contain insufficient detailed chemical
identity information to be used for TSCA Inventory purposes.
Chemical Imports/Questions and Answers 25
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Question #24
Answer #24
Is listing of the chemical substance on the TSCA Inventory of Chemical
Substances sufficient basis for certification of compliance with TSCA?
No, you must also check for any rules applicable to the chemical substance under section
5, 6, or 7 of TSCA and meet their requirements. (See Importers Checklist, page 11, Step
VI.)
Question #25
Answer #25
Does positive certification require compliance with sections 4 and 8 of TSCA at
the time of certification?
No. Although testing, reporting, and recordkeeping requirements under sections 4 and
8(a), 8(c), 8(d), and 8(e) apply to specific chemical substances, positive certification of
compliance with TSCA under section 13 does not generally require compliance with
section 4 or 8 at the time of certification.
If, however, a section 8 rule requires notification of EPA prior to the import of a specified
chemical, any importer of that chemical should ensure that the required notification has
been completed before certifying that a shipment containing the chemical is in
compliance with TSCA.
Question #26
Answer #26
Does a chemical subject to TSCA under the statutory definition of "chemical
substance" (section 3(2)(a)), but exempt from section 5 regulations (e.g., R&D
substances), require a negative certification?
No, the chemical substance is subject to TSCA under section 3(2)(a), and this requires
that a positive certification be signed.
Question #27
Answer #27
Does the Importer need to know the Identity of an Imported chemical?
The importer may opt to rely on the warranty or certification from the foreign supplier in
making his TSCA certification. The importer is liable if the certification is not correct,
however. The liability can be reduced if the importer has verifiable evidence that he made
good faith efforts to comply.
Question #28
Answer #28
Can my foreign supplier request a TSCA Inventory search?
No. All bona fide requests must contain a statement of bona fide intent to import, signed
by a U.S. importer. Your foreign supplier, however, may submit technical data in support
of your bona fide submission. Any information submitted by your foreign supplier and
claimed confidential by him will be treated accordingly by EPA.
26 Chemical Imports/Questions and Answers
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Question #29
Answer #29
Is the CO/7/7 List a complete list of chemicals covered by the new certification
requirement?
It is a complete list only of chemicals subject to specific rules and regulations under
sections 4, 5. 6, 8 and 12(b) of TSCA as of its publication date. It is not a list of the TSCA
Inventory of Chemical Substances.
V. WHO CERTIFIES
Question #30
Answer #30
Who must make the TSCA certification to U.S. Customs?
The importer of record or a Customshouse broker with power of attorney acting as the
importer's agent is responsible for TSCA certification.
Question #31
Answer #31
Can the Importer of record be a foreign company?
Yes, provided that in the state or territory where the port of entry is located, there is a
resident who is authorized to accept service of process. Such resident must file a bond
having a resident corporation surety to secure payment of any increased or additional
duties that may be found due.
Question #32
Answer #32
Who can sign the certification for the company?
The certification may be signed by an employee or officer authorized by the company to
do so, or by any agent with power of attorney for the company.
Question #33
Answer #33
Are purchasers of Items from Importers (or customers of Importers) required to
make any certification?
No.
Chemical Imports/Questions and Answers 27
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Question #34
Border Customshouse brokers receive documents back from U.S. Customs for
follow-up entry only after shipments have passed through Customs. How, then,
can an Importer comply with certification requirements?
Answer #34 There are several ways this can be resolved. The broker may:
• Use the bonding provision to secure release of the shipment, with
subsequent certification.
• Give power of attorney to the foreign supplier to put the certification on the
invoice, especially in the case of repeat shipments.
• Use the "blanket" certification.
Question #35
Answer #35
Who Is responsible for TSCA certification If a chemical substance Is purchased
from Canada or Mexico. F.O.B. (freight on board, with freight charges "prepaid")
so that title theoretically passes at point of shipment?
The importer of record with U.S. Customs is responsible for certification. If your customer
is the importer and you are acting as agent of the importer with power of attorney, you
may certify.
Question #36
Answer #36
If a company Imports substances that are TSCA-regulable to be given as gifts to
corporate clients and friends Is a TSCA certification necessary?
Yes, a positive certification is necessary.
VI. FOODS, DRUGS, AND COSMETICS
Question #37
Answer #37
Do Imported foods, food additives, drugs, drug Intermediates, cosmetics,
cosmetic Intermediates, and devices require TSCA certification?
If these substances are imported solely for use as a food, drug, cosmetic, or device or for
use in manufacturing a food, drug, cosmetic, or device and are accompanied by FDA
Form FD701, they do not require TSCA certification.
Question #38
Answer #38
Is TSCA certification required If part of the shipment Is for other than FFDCA
uses?
Identify each chemical for non-FFDCA use and certify accordingly.
28 Chemical Imports/Questions and Answers
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Question #39 What If subsequent to Importation these materials are used by the Importer for
other purposes?
Answer #39 This could constitute a violation of TSCA, and the importer could be subject to penalties.
Question #40
Answer #40
Is TSCA certification required If the chemical Is on the TSCA Inventory of
Chemical Substances?
If the substance is intended solely for FFDCA use, no TSCA certification is required and a
TSCA Inventory listing is irrelevant.
Question #41 Is TSCA certification required If bulk chemicals are Imported for manufacture Into
drug products, such as tablets or capsules?
Answer #41
TSCA certification is not required; however, appropriate FFDCA certification is required.
Question #42
Answer #42
What can be done If Form FDA 701 Is not present with the entry documents fora
substance regulated under FFDCA ?
You could sign the negative TSCA certification to expedite Customs release and
subsequently submit the FDA 701 Form.
Question #43
Answer #43
Are biochemical substances Intended for laboratory testing covered by TSCA—for
example, enzymes, coenzymes, etc., which may be used In FDA products but,
nonetheless, have other uses not related to FDA ?
Yes, if the biochemical substances are for a use governed by TSCA, they require positive
certification.
Question #44
Answer #44
Suppose a cosmetic Ingredient Is Imported without TSCA certification, since only
cosmetic uses are contemplated, but the sale for cosmetic uses falls to
materialize. What should the Importer do to sell It for noncosmetlc use?
If only cosmetic uses were contemplated at the time of import and an FDA 701 Form was
used, the importer may later sell the substance for a noncosmetic use (a use governed by
TSCA) provided it complies with TSCA (i.e., is on the TSCA Inventory, or a PMN has
been filed and cleared) and the substance is not further regulated under section 5, 6 or 7
of TSCA.
Chemical Imports/Questions and Answers 29
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VII. R&D USE AND SAMPLES
Question #45
Answer #45
Do all chemical substances Imported solely for R&D use require TSCA
certification?
Yes, if they are for a use governed by TSCA, they require a positive certification.
Question #46
Answer #46
Is TSCA certification required If the chemicals are samples only?
If they are for a use governed by TSCA, a positive certification is required.
Question #47
Answer #47
Is TSCA certification required If the substances are test-marketing samples?
TSCA certification requirements apply. If the substances are for a use governed by
TSCA, they must be on the Inventory, or the importer must obtain a test-marketing
exemption from EPA. For further details, call the Environmental Assistance Division at
(202)554-1404.
Question #48
Answer #48
Must a chemical substance for R&D use be on the TSCA Inventory of Chemical
Substances?
No, if the R&D activities with the chemical substance comply with the definition of "small
quantities solely for research and development" in Section 720.3(cc) of the
premanufacture notification (PMN) rules and the requirements of section 720.36 and
720.78 are met by the importer, the substance need not be on the TSCA Inventory, a
PMN is not required, and a positive certification should be made.
Question #49
Answer #49
What Is proper procedure If the Imported R&D substances are not covered by
TSCA?
Tobacco and tobacco products do not require any TSCA certification. Negative TSCA
certification is required for other chemical substances unless accompanied by the
appropriate form clearly identifying the substance as one not subject to TSCA.
Also, a pesticide R&D chemical not covered by an experimental use permit under the
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) would need positive TSCA
certification because it is not yet considered to be a pesticide for FIFRA purposes.
30 Chemical Imports/Questions and Answers
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Question #50
Answer #50
How large a quantity can be Imported for R&D purposes?
There is no specific size or weight limitation. Quantities that can be imported for R&D
purposes are defined as those "not greater than reasonably necessary for such
purposes." If a company sends multiple samples to different potential customers, EPA
may question whether the amount imported is legitimately "not greater than reasonably
necessary" for R&D.
Question #51
Answer #51
Under TSCA, can an Imported R&D substance be used to manufacture an article
for a customer?
EPA does not consider the use of a chemical substance in the manufacture of an article
for a customer to be research and development unless the article is itself manufactured
solely for R&D. Therefore, if the substance is not listed on the Inventory, it would be a
violation of TSCA to import the substance into the U.S. for such purposes before a PMN
has been submitted and the PMN review completed.
Question #52
Answer #52
Does sale of an R&D substance remove It from R&D status?
Not necessarily. Companies may purchase R&D substances from an importer without
triggering PMN requirements as long as they use the chemical substance only for R&D.
Question #53
Answer #53
What Is the certification procedure for mailed or parcel post R&D chemicals.
The first receiver of the chemical in the U.S. is considered the importer and is responsible
for the TSCA certification. He should inform his overseas supplier to include the
necessary information or supporting documentation with the shipment mailed to him. The
importer's certification can then be based on the documentation received from his
supplier.
Question #54
Answer #54
In the case of R&D chemicals coming Into the country via parcel post, could the
TSCA certification be placed In an envelope and taped to the package (with proper
postage, of course)? Is that acceptable to U.S. Customs?
Yes, U.S. Customs will accept preprinted or stamped certifications bearing the signature
of the importer and previously forwarded to the supplier to accompany the shipment. The
importer should recognize that he is responsible for this certification, however.
Chemical Imports/Questions and Answers 31
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Question #55
Answer #55
What Is the Importer's responsibility for his own staff's receipt and use of mailed
R&D substances?
Company officials are responsible for the actions of their staff in this case. Company
officials should inform their staff of these TSCA requirements and set up internal
procedures for preparation and submission of TSCA certifications to U.S. EPA, 401 M St.,
S.W., Washington, D.C. 20460, Attn: TSCA Section 13 Coordinator, Chemical
Assessment Rules Section (TS-778) Rm. E 447, until further notice.
Question #56
Answer #56
If an unsolicited shipment of an R&D chemical Is sent by a foreign supplier and
the addressee does not want to sign the certification or accept the shipment, who
Is responsible for Its return or disposal? Suppose the addressee wishes to accept
part of the shipment?
The addressee is responsible for the costs of returning or disposing of the shipment. He
may then request reimbursement from the foreign supplier. It would be to the advantage
of all parties involved for the addressee to inform his foreign suppliers of the TSCA
certification requirements and request that they not send unsolicited samples. If the
addressee wishes to accept part of the shipment, he may separate that part, sign the
certification, and then return or request disposal, at his cost, of the remainder.
VIII. IN-TRANSIT THROUGH U.S. EXPORT SHIPMENTS
Question #57 Is It necessary to certify TSCA compliance for chemicals that are In-transit
through the U.S.?
Answer #57 No, certification is not required for chemicals imported under entry for transportation and
exportation (T & E entry)—e.g., from Mexico to Canada.
Question #58 Do shipments moving via mall between Canada and Mexico require certification?
Answer #58 No.
Question #59
Answer #59
Is TSCA certification required If the chemicals are travelling through the U.S. In
bond for clearance at another port of entry?
The importer need not certify at the first port of arrival but must certify at the subsequent
port of entry.
32 Chemical Imports/Questions and Answers
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Question #60 Which TSCA requirements apply to an Imported chemical that Is:
• used in the U.S. to manufacture a product that will then be exported
In its entirety (for example, used as an Intermediate)?
Answer #60
• processed In the U.S. and then exported In its entirety?
A positive certification would be required in both situations.
Question #61
Answer #61
A chemical Is manufactured In the U.S., sent to Canada for further refining, and
then returned to the U.S. Is TSCA certification required for Importation of the
refined chemical substance from Canada?
If the chemical substance comes under TSCA jurisdiction, a positive certification would
be required for importation into the U.S.
Question #62
Answer #62
Is TSCA certification required for pipeline shipments of crude oil or natural gas?
Pipeline shipments of crude oil or finished products into the U.S. would require a positive
certification. These shipments are candidates for "blanket" certification. (See part III of
this section.)
Question #63
Answer #63
Is certification required for entry Into Foreign Trade Zones for reexport?
Import certification is not necessary for entry into Foreign Trade Zones, but a certification
is required for withdrawal if the chemical is intended for U.S. consumption. Withdrawals
for exportation or transportation need not be certified.
IX. SPECIAL CASES
Question #64
Answer #64
We have been Importing chemicals for the photographic Industry for the past few
years. How does the section 13 rule affect future Imports of these chemicals?
If the chemicals are under TSCA jurisdiction, a positive certification of compliance is
required.
Question #65
Answer #65
As an Importer of hydraulic machinery, I understand that hydraulic fluids
contained Inside the machinery are not covered by these rules. Sometimes,
however my foreign supplier Includes a can of additional fluid with the machinery
shipment. What are my TSCA responsibilities for this can of fluid?
Your responsibility is the same as for any other imported chemical substance governed
by TSCA. A positive certification of compliance with TSCA is required.
Chemical Imports/Questions and Answers 33
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Question #66
Answer #66
Must an Importer determine the possible contaminants and unknown chemicals In
crude oil or gasoline before certification?
No, this is not required as long as the petroleum crude oil or gasoline is on the Inventory,
and the importer is not aware of any unusual contaminant and has no reason to suspect
any. Only intentional additives must be identified, be on the TSCA Inventory, and be in
compliance with any further rules or regulations under section 5,6, or 7 of TSCA.
Question #67
Answer #67
/ Import an alkylatlon waste acid composed of 98 percent sulfurlc acid with 2
percent trace contaminants. Must I determine what the trace contaminants are?
No, as long as you are certain there are no PCBs in the trace contaminants, they are
considered impurities, and you can sign positive certification.
Question #68
Answer #68
Powdered rubber tires are being Imported. The main Ingredients are Isoprene and
carbon black. The other Ingredients are Incidental contaminants with no
commercial value. Do the contaminants need to be determined for positive
certification?
No, the answer to the preceding question also applies in this case.
Question #69
Answer #69
Do wastes Imported Into the United States require TSCA certification?
Yes, wastes imported into the United States are within TSCA jurisdiction, and each import
requires a positive certification.
Question #70
Answer #70
If wastes are Imported solely for disposal or for recycling, what Information do I
need to make a TSCA Import certification?
In general, importers can make a positive certification for wastes imported to be burned
as a fuel, disposed of, or for extraction of component chemical substances. (See 40 CFR
section 720.30(g) of the premanufacture notification regulations.) If the wastes consist of
"by-products" as defined in section 720.3(d) of the premanufacture notification
regulations, i.e., chemical substances produced without a separate commercial intent
during the manufacture, processing, or use of another chemical substance, they are not
subject to premanufacture notification under section 5 of TSCA. It should be noted that
"by-products" include by-products of use as well as of manufacture and processing.
Therefore, spent solvents, spent cleaning agents, and used motor oil are classified as
by-products, in addition to manufacturing waste. Note also, however, that some rules
under section 8 of TSCA may require reporting on a listed substance that is a constituent
of waste burned as a fuel. However, wastes containing greater than 50 ppm PCBs cannot
be imported except in limited situations and importers of wastes imported for disposal
may be subject to applicable testing requirements under section 4.
34 Chemical Imports/Questions and Answers
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Question #71
Answer #71
Is certification required If the wastes are accompanied by a manifest as required
by the Resource Conservation and Recovery Act (RCRA)?
Yes, a positive certification is still required.
Question #72
Answer #72
Is certification required If the wastes are to be used as a feedstock for a
manufacturing process?
A positive certification is required, and the importer must check the TSCA inventory to
determine if the waste is a "new" chemical substance. If the use is solely for extraction of
a commercial chemical substance, however, the waste is not subject to PMN. The
importer must also check rules or orders under sections 5, 6, 7 and 8 of TSCA, though it
is not necessary to be in compliance with all rules under section 8 at the time of import.
Question #73
Answer #73
Are living plants and animals subject to certification?
Living plants and animals, other than microorganisms, are not subject to certification.
Natural products such as lumber, peat, and rubber, though, are subject to certification
unless they are imported in the form of an article.
Question #74
Answer #74
Do seeds sprayed with a pesticide require TSCA certification?
No, as living plant matter, seeds are not subject to certification. The fact that they have
been sprayed with a pesticide does not change their status.
X. DETAINED SHIPMENTS
Question #75
Answer #75
Assume there Is a multiple shipment In which only 2 of 30 chemicals In the
shipment lack a certification. Will the entire shipment be detained, or will Customs
separate out only the noncomplylng Items for detention?
Decisions of this kind will be made on a case-by-case basis, at the discretion of the
Customs Officer, depending upon individual circumstances.
Question #76 We believe that detention most frequently will occur because of a ministerial error
by the broker or Importer or an unforeseen problem In transit. For example, the
certification might be left off the Invoice or become separated from It. A simple
procedure to resolve these minor problems before the shipment leaves the
District Director's custody would be In the best Interests of the Importer, U.S.
Customs, and EPA. Can there be Informal resolution of a problem shipment
Immediately upon notification by the District Director?
Answer #76 To a degree there can, since there is a provision for a bond.
Chemical Imports/Questions and Answers 35
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Question #77 For shipments that have arrived but require additional time for proper certification
to be determined, how and when can a bond be given for production of the
certification?
Answer #77 If a shipment is detained for lack of TSCA certification, its release may be secured by the
importer or his authorized agent upon furnishing a bond on Customs Form 7551,7553, or
7596 for the return of the shipment to Customs custody. The shipment must be held
intact by the importer and not used or disposed of until brought into compliance.
Question #78 Will the notification referred to In the first sentence of section 12.123(c) of the
Importers' rule be made In writing, and will It give the reasons for the
Administrator's decision?
Answer #78 EPA will provide notification in writing that will include the rationale to U.S. Customs and
the importer.
36 Chemical Imports/Questions and Answers
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';'!72 -jgj
"REPORT DOCUMENTATION
PAGE
l._ REPORT NO.
EPA 560/1-91-001
3. Recipient's Accession No.
4. Title and Subtitle
5. Report Date
EPA Toxic Substances Control Act; A Guide for Chemical
Importers/Exporters: An Overview
April 1991
7. Authors)
8. Performing Organization Rept. No.
9. Performing Organization Name and Address
Office of Toxic Substances (TS-799)
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
10. Proiect/Task/Work Unit No.
H. Cootr»ct(C) or Grant(G) No.
(C)
(G)
12. Sponsoring Organization Name and Address
Same as Item 9.
13. Type of Report & Period Covered
14.
IS. Supplementary Notes
16. Abstract (Limit: 200 words)
This publication summarizes the requirements of sections 12(b), Exports, and
13, Imports, of the Toxic Substances Control Act (TSCA), and the rules and policies
issued under these sections.
17. Document Analysis •. Descriptors
b. Identifiers/Open-Ended Terms
C. COSATI Reid/Group
18. Availability Statement
Release Unlimited
19. Security Class (This Report)
Unclassified
20. Security Class (This Page)
Unclassified
21. No. of Pages
37
22. Price
(S«« ANSI-Z39.18)
See Instructions on Reverse
OPTIONAL FORM 272 (4-77)
(Formerly NT1S-3S)
Department of Commerce
37
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