>?xEPA
United States
Environmental Protection
Agency
Office of
Toxic Substances
Washington DC 20460
Revised
August 1986
Toxic Substances
Control Act
A Guide for Chemical
Importers/Exporters
Volume 1: Overview
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Volume 1 of this publication has been compiled to summarize the
requirements of sections 12(b), Exports/ and 13, Imports, of the
Toxic Substances Control Act (TSCA) and of the rules and policies
issued under these sections. Volume 2 provides an alphabetical
listing of chemical-substances that are subject to section 12(b)
export requirements and chemicals which are relevant to section
13, Imports, of TSCA. It also provides excerpts and key points
of each applicable rule, as well as Federal Register citations of
specific rulemaking actions applicable to each of the chemicals
listed. 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 for this second edition was compiled as of August 1986.
Future Agency actions will require periodic updating and
republishing.
Send all questions, comments, or recommendations on the contents
to:
Edward Klein, Director
TSCA Assistance Office (TS-799)
Office of Toxic Substances
Environmental Protection Agency, Room E-543
401 M Street, SW.
Washington, D.C. 20460
Telephone: 202-554-1404
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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CONTENTS
VOLUME 1 Page
IMPORTED CHEMICALS 1
Importer Responsibilities 3
Customs Responsibilities 4
Detention at Port of Arrival 4
(Port of Entry, if the same)
Detention at Port of Entry 4
Refused Entry 4
EPA Responsibilities 5
Basis for Certification 5
Applicable Regulations And Chemicals 6
Section 5 Premanufacture Notification
and Significant New Use Rules 6
Section 6 Rules 7
Section 7 Judicial Actions 8
Section 12(b) Rules 8
Section 4 and 8 Rules 8
Articles Containing Chemical Substances 8
Chemicals Subject to Specific Rules 9
TSCA INVENTORY OF CHEMICAL SUBSTANCES 10
EPA ENFORCEMENT 17
IMPORTER'S CHECKLIST 21
EXPORTED CHEMICALS 29
Exporter Responsibilities 31
EPA Responsibilities 32
Applicable Chemicals and Regulations 32
CHEMICAL IMPORTS QUESTIONS AND ANSWERS 33
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CONTENTS (Cont.)
VOLUME 2
(Bound
separately)
PART I: CHEMICALS SUBJECT TO SPECIFIC FINAL
REGULATIONS UNDER SECTIONS 5 AND 6 OF TSCA
PART II: CHEMICALS SUBJECT TO PROPOSED REGULATIONS
UNDER SECTIONS 5 AND 6 OF TSCA
PART III: CHEMICALS SUBJECT TO PROPOSED AND FINAL
RULES UNDER SECTIONS 4 AND 8 OF TSCA
A. CHEMICALS WITH CURRENT NOTICES
B. CHEMICALS WHICH HAVE IN THE PAST BEEN
SUBJECT TO FINAL 8(a) PRELIMINARY ASSESSMENT
INFORMATION RULES
PART IV: CHEMICALS SUBJECT TO EXPORT
NOTIFICATION TO EPA UNDER SECTION 12(b)
OF TSCA
PART V:
NUMERICAL INDEX OF LISTED CHEMICALS BY
CAS NUMBER
A. CHEMICALS SUBJECT TO SPECIFIC PROPOSED
AND FINAL REGULATIONS UNDER TSCA
B. CHEMICALS SUBJECT TO TSCA SECTION 12(b)
EXPORT REQUIREMENTS
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IMPORTED CHEMICALS
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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* if:
o It fails to comply with any rule in effect under TSCA;
or
o 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 FR 34734), (19 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 TSCA
Assistance Office (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 6) at the port of entry for
shipments entering commerce in the U.S. that either:
o The shipment is subject to TSCA and complies with all
applicable rules and orders thereunder; or
o 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 or preprinted on an entry document or invoice or other
attachment:
For shipments subject to TSCA; "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."
* See Articles Containing Chemical Substances, Page 8,
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IMPORTED CHEMICALS
For other shipments; "I certify that all chemicals in this
shipment are not subject to TSCA."
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:
o That have been banned from 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
o That have been ordered seized because of imminent
hazards as specified under section 7 of TSCA (15 USC
2606).
Detention at Port of Entry
o 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;
o Whenever the district director has reasonable grounds to
believe the shipment is not in compliance with TSCA; or
o Whenever the importer does not certify compliance v/ith
TSCA as required.
Refused Entry - If a shipment is refused entry, the Secretary of
the Treasury must:
o Notify the consignee and the EPA Administrator of the
entry refusal, including the reasons for the detention;
o Not release the shipment, except under bond (when
appropriate); and
o 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.
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IMPORTED CHEMICALS
EPA RESPONSIBILITIES
Under the Customs Rule, the EPA Administrator must:
o Determine whether detained shipments and their entries
comply;
o Notify Customs when EPA is aware of shipments that
should be detained;
o Identify steps necessary to bring detained shipments
into compliance, or that must be taken when shipments
are not brought into compliance; and
o 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 other-
wise 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 sub-
stance 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 covers chemical substances and mixtures which are broadly
defined in section 3 of TSCA. EPA, together with other Federal
agencies, has recently issued a policy statement on biotechnology
(51 FR 23313, June 26, 1986) in which EPA clarified that microor-
ganisms are "chemical substances" under TSCA. Importers of micro-
organisms must bear in mind that they are subject to TSCA import
certification requirements as discussed in this volume. 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,
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IMPORTED CHEMICALS
.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 4) include
the following:
o Any pesticide (as defined in the Federal Insecticide,
Fungicide, and Rodenticide Act) when imported for use as
a pesticide;
o 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);
o 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).
Customs has decided that the following items do not require any
certification because there are other controls on the importation
of those items involving other Federal agencies.
o 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 import 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 l(j)
of the Federal Meat Inspection Act), and eggs and egg
products (as defined in section 4 of the Egg Products
Inspection Act).
o Tobacco or any tobacco product.
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 manu-
facturers 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.
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IMPORTED CHEMICALS
(See subsequent section entitled TSCA Inventory of Chemical Sub-
stances , Page 11.) 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 which 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 pro-
cedures in section 5(a)(l) 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). A principal impor-
ter must submit a PMN using EPA Form 7710-25(4-26-83). Importers
are required to provide information only on exposure which 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. You may prepare and submit the premanufacture notice 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): 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); 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 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 would require a notice to EPA before import
for a significant new use.
See Importer's Checklist (Page 21) for further clarification of
PMN and other requirements in the subsequent section of this
publication entitled TSCA Inventory of Chemical Substances (Page
11).
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
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IMPORTED CHEMICALS
be subject to restrictions under this section. These chemicals
are listed in Volume 2, Part I.
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 non-complying 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. (See Volume 2, Part IV.)
Section 4 and 8 Rules
Importers may be subject to these rules because TSCA defines
importers as manufacturers (see Volume 2, Part III). However,
because these rules do not apply to individual chemical shipments,
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. However/ if 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 certi-
fying 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. However, if an importer knows of a study in the posses-
sion of a foreign entity, then that study must be listed and the
list submitted to EPA.
Articles Containing Chemical Substances
The Customs rule does not require certification for chemical sub-
stances imported as part of articles unless EPA has required
reporting under a specific TSCA rule. At this time, there are no
TSCA rules that require certification for articles. However,
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IMPORTED CHEMICALS
future TSCA rules may require certification of articles containing
certain chemical substances. In such cases, the individual rules
will specify whether certification is required.
Chemicals Subject to Specific Rules
The specific rules issued under these TSCA sections and the chemi-
cal substances to which they apply are indicated on the tabular
lists in Volume 2, Parts I through IV. Each chemical substance is
followed by its appropriate Chemical Abstract Services (CAS)
registry number. This is a unique number assigned to each
chemical substance. Another listing of these chemicals, by CAS
number, appears in Volume 2, Part V.
To be sure that your import shipment complies with all of the
above rules and regulations/ refer to Importer's Checklist (Page
21).
Importers may contact the TSCA Assistance Office to obtain
additional information on requirements and to get on the mailing
list for the Chemicals-In-Progress Bulletin for information
on current ruleraaking actions.
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TSCA INVENTORY OF CHEMICAL SUBSTANCES
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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 lists over
63,000 chemical substances. Of these, some 4,500 have had their
identity claimed as confidential and have been assigned generic
names.
Chemical substances which are 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 specifi-
cally excluded by statute or regulation (40 CFR Part 710). Addi-
tionally, no printed version of the Inventory can be completely
up-to-date because it is continually subject to change. New sub-
stances for which premanufacture review (PMN) under section 5 has
been completed and that are being manufactured or imported will
continue to be added to the Inventory. A few substances that have
been included on the Inventory may be deleted if the Agency, after
a careful review, decides that they should not have been 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 continually updated as new
information becomes available.
The Agency provides a service to assist those who, for various
reasons, wish to query 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 sub-
stance 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 — i.e., both
confidential and non-confidential portions — to determine
conclusively whether the substance in question is already
included.
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TSCA INVENTORY OF CHEMICAL SUBSTANCES
All bona fide inquiries must be submitted in writing and accompa-
nied by appropriate documentation. Incomplete inquiries or sub-
missions will not be processed until all materials have been
received. 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, SW.
Washington, D.C. 20460
ATTN: Chemical Inventory Section
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. Checks should be made out to
the Superintendent of Documents.
The 5-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.
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.
Requestors should ask for the tapes by their PB numbers.
* **
Production Tape (1977 data) PB 86-220803 $275 -$550
Plant Site Tape (1977 data) PB 86-220795 $160 $320
Synonym Tape (1985 data) PB 86-220860 $370 $740
Preferred Name Tape (1985 data) PB 86-220878 $275 $550
* Mailed to addresses in the United States, Canada or Mexico.
Add $3.00 for handling charges.
** Mailed to all other addresses. Add $4.00 for handling charges.
To order any of the tapes from NTIS, call (703) 497-4650. Visa,
MasterCard and American Express are accepted.
The NTIS address is 5285 Port Royal Road, Springfield, VA 22161.
Make checks out to NTIS.
Searches of the NTIS computer tape of the Inventory are available
from a number of commercial sources. Note that importers and
domestic manufacturers of substances on the TSCA Inventory must
comply with the recent rule on the Partial Updating of TSCA Inven-
tory Data Base; Production and Site Reports (40 CFR Part 710) (51
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TSCA INVENTORY OF CHEMICAL SUBSTANCES
FR 21438, June 12, 1986) Final Rule—Section 8(a). Persons
required to report under the rule must submit their reports by
December 23, 1986. 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., SW.
Washington, D.C. 20460
Attn: Inventory Update Rule
Telephone: (202) 382-3698 or (202) 755-4880.
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EPA ENFORCEMENT
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EPA ENFORCEMENT
EPA and the Customs Service will monitor chemical imports to
determine if shipments and their import comply with the
certification requirements and the substantive mandates of TSCA.
Customs will refuse entry to any shipment until such time as the
certification is properly submitted. Customs will also detain a
shipment if there are reasonable grounds to believe that such
shipment or its import violates TSCA or regulations or orders
thereunder. A violative shipment must either be brought into
compliance, exported, destroyed, or voluntarily abandoned within
the time periods prescribed in §12.124 of the section 13 rule.
When EPA determines that a shipment should be detained, EPA will
identify the reasons for the detention and the necessary actions
for an importer 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, NE.
Atlanta, GA 30365
404-347-3222
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EPA ENFORCEMENT
EPA REGION V
Pesticides and Toxic Substances Branch
230 South Dearborn Street
Chicago, IL 60604
312-353-2192
EPA REGION VI
Pesticides and Toxics Branch
1201 Elm Street
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
1860 Lincoln Street
Denver, CO 80295
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
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. Assuming a shipment is
no longer in violation, EPA will notify the district director and
the importer. The district director will then release the ship-
ment. This notice will also serve as a determination to permit
entry under §12.123(c) if a shipment is brought into compliance
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EPA ENFORCEMENT
before the §12.123(c) decision-making process has been completed.
If compliance is achieved after a §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.
You can obtain assistance in determining whether a chemical
shipment is in compliance with TSCA 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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IMPORTERS CHECKLIST
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IMPORTER'S CHECKLIST
Step I Is my chemical substance exempt from positive
certification?
o Check the materials exempted from TSCA. These are
listed on Page 6 of this volume.
o If your chemical substance falls into any of these
categories, follow Steps II and III—otherwise, go
to Step IV.
Step II Is my chemical substance in the category requiring
negative certification?
o Check the list of chemicals on page 6 that do not
require positive certification (pesticides, source
material, special nuclear material, byproduct
material, firearms and ammunition).
o If your chemical substance falls into any of these
categories, you must/sign the negative
certification statement that the chemical you
intend to import is not subject to TSCA.
Step III Is my chemical substance exempt from both positive and
negative certification?
o Check the list of chemicals on Page 6 that do not
require any certification (food, food additive,
drug, cosmetic or device, tobacco or any tobacco
product).
o If your chemical falls into any of these
categories, and if it is accompanied by FDA Import
Form FD701, you are not required to sign any
certification statement.
Step IV Is my chemical substance on the Inventory?
o Verify whether your chemical substance is listed
on the TSCA Chemical Substance Inventory: 1985
Edition.
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IMPORTER'S CHECKLIST
o If your chemical substance is not listed, it may
have been included previously but does not appear
in the printed version because it was added to the
list since the last revision, or because it was
submitted confidentially.
Prior to import, you must determine whether
or not this chemical substance appears on the
Master Inventory File. You must submit a "bona
fide intent to import" so that EPA can review the
Master Inventory File.
o If your chemical substance is not listed on the
Master Inventory, and you wish to import it, you
must file a premanufacture notification with EPA
at least 90 days prior to import. Your chemical
substance may be eligible for a 21-day review
period if it qualifies for EPA's polymer exemption
or low volume exemption. (See p. ) You may call
the TSCA Assistance Office (see inside front
cover) for additional information.
o If you are importing the substance solely in small
quantities for purposes of research and develop-
ment as defined in the PMN rule and in accordance
with the restrictions on such activities, you may
sign the positive certification without further
checking. See 40 CFR 720.3(cc) and 720.36 to
determine if you qualify.
Step V My chemical substance is on the Inventory. Do I have
any further requirements under this rule?
o You must determine whether there are any
regulations or actions regarding this chemical
substance under TSCA sections 5, 6, or 7.
Look in the list of chemicals requiring
certification in Volume 2; List of
Import/Export Chemicals. You must meet all
the requirements outlined for the specified
chemicals.
If the chemical is not listed in the list of
chemicals requiring certification, it is your
responsibility to verify that the information
has not changed since the date of this
publication. If necessary, call the TSCA
Assistance Office to verify that information
is up to date.
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IMPORTER'S CHECKLIST
Step VI Do I have any further obligations under TSCA?
o Since importers are defined under TSCA as
manufacturers, importers must comply with all
testing, reporting, and recordkeeping requirements
under TSCA sections 4, 8(a), 8(c), and 8(d).
o Some section 8 rules require notification to EPA
prior to the import of a specified chemical.
Importers must ensure that the required
notification has been completed before certifying
that a shipment containing the chemical is in
compliance with TSCA. Consult the list of
affected chemicals in this publication.
NOTE; It is your responsibility to verify that the information
has not changed since the date of this publication.
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EXPORTED CHEMICALS
-------
EXPORTED CHEMICALS
The statutory requirements of section 12(b) of TSCA require that:
o 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.
o The 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, of the substance or mixture. Submit
the notice by letter to EPA, and include the following
information:
o Name and address of the exporter;
o Name of the chemical substance or mixture;
o Date(s) of export or intended export;
o Country (countries) of import;
o Section of TSCA (4, 5, 6, or 7) under which EPA has
taken action.
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EXPORTED CHEMICALS
Submit the notice for your 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, submit the notice 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."
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:
o Identification of the regulated chemical;
o Summarization of the EPA regulatory action taken, or an
indication of the availability of data under TSCA
sections 4 or 5(b);
o EPA official to contact for further information;
o Copy of the pertinent Federal Register notice.
APPLICABLE CHEMICALS AND REGULATIONS
A list of the substances (or classes of substances) subject to
the TSCA section 12(b) rule is provided in Volume 2, Part IV. A
second listing of these chemicals, by CAS number, is included in
Volume 2, Part V. Also listed in Part IV is a reference to the
"triggering" action under sections 4, 5, 6, or 7 of TSCA.
NOTE; If the EPA action that prompts the notice is a proposed
rule, the section 12(b) notice must be submitted for exports
beginning thirty days after publication of the action in the
Federal Register.
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CHEMICAL IMPORTS
Questions and Answers
about
Requirements Under Section 13
of the
Toxic Substances Control Act (TSCA)
-------
CHEMICAL IMPORTS
Questions and Answers
CONTENTS
PAGE
I. ARTICLES AND MIXTURES UNDER TSCA SECTION 13 36
II. CERTIFICATION FORMAT 41
III. BLANKET CERTIFICATION 43
IV. CERTIFICATION REQUIREMENTS 44
V. WHO CERTIFIES 50
VI. FOODS, DRUGS, AND COSMETICS 51
VII. R & D USE AND SAMPLES 53
VIII. IN-TRANSIT THROUGH U.S./EXPORT SHIPMENTS 56
IX. SPECIAL CASES 58
X. DETAINED SHIPMENTS 61
-------
I. ARTICLES AND MIXTURES UNDER TSCA SECTION 13
The TSCA Assistance Office 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
Leather hides
Liquified petroleum gas
Lysine, unless used as a
food additive
Natural gas
Oxalic acid
Peat Moss, except as peat
pots, which are articles
Pitch
Potassium sorbates, unless
used as a food additive
Sorbic acid, unless used as
a food additive
Tetraethyl lead
Q. 1. How is "chemical substance" defined under TSCA?
A. 1. "Chemical substance" is defined in section 3 of TSCA as:
any organic or inorganic substance of a particular
molecular identity, including -
(i) any combination of such substances occuring in
whole or in part as a result of a chemical
reaction or occurring in nature; and
(ii) any element or uncombined radical.
Chemical substance does not include -
(i) any mixture;
(ii) any pesticide (as defined in the Federal
Insecticide, Fungicide, and Rodenticide Act)
when manufactured, processed, or distributed
in commerce for use as a pesticide;
(iii) tobacco or any tobacco product;
(iv) 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);
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I. ARTICLES AND MIXTURES UNDER TSCA SECTION 13
(v) 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
(vi) 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."
Q. 2. How is "article" defined?
A. 2. (1) "Article," in the Customs rule at section 12.120(a)(l)
is 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 section 12.120(a)(2);
below; except that fluids and particles are
not considered articles regardless of shape or
design.
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ARTICLES AND MIXTURES UNDER TSCA SECTION 13
(2) The allowable changes of composition referred to in
section 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.
Q. 3. For which articles is a certification required pursuant to
section 12.121(b) of the Customs rule?
A. 3. Articles, as defined by TSCA, require no certification at
this time; however, any future regulations on articles may
specify import requirements.
Q. 4. Are metallurgical intermediates classified as chemical
substances or articles?
A. 4. If an item is manufactured in a particular shape for the
purpose of shipping convenience and the shape of the item
has no function in the end use, it is not considered an
article. Thus, items such as metal ingots, billets, and
blooms are viewed as chemical substances, require TSCA
certification, and are subject to PMN requirements. (The
blanket certification procedures described in Part III of
this document 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 par-
ticular 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 other similar
materials will be viewed as articles by OTS, even if, for
example, subsequent to 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.
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I. ARTICLES AND MIXTURES UNDER TSCA SECTION 13
Q. 5. We import small plastic sheets with chemical coatings for
analysis in our quality control laboratories. Do these
V «•*.,*<» 1 1 1 -W»rt rt«V»#- 1 ft /"* ?* ^ 1 rtV\O
.* .*
require certification?
A. 5. See A.4. above.
Q. 6. Is waste imported for disposal in drums and not removed
from the drums considered an article?
A. 6. No, such waste is not an article, it is a bulk chemical
and requires a positive certification. However, see
questions 70 and 71.
Q. 7. If an importer imports a piece of machinery which contains
PCBs, is a positive certification necessary?
A. 7. Because TSCA considers the term "import" to be synonomous
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.
Q. 8. Can a "new" (not on the Inventory) dielectric fluid (not a
PCB) be imported in a capacitor or transformer?
A. 8. As long as it is not removed from the capacitor or trans-
former, 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.
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I. ARTICLES AND MIXTURES UNDER TSCA SECTION 13
Q. 9. A large number of exports, such as argon, hydrogen and
oxygen, are shipped in pressure containers, such as cylin-
ders, tank trucks, and tank cars. Upon return, the con-
tainers and any residuals are released as Instruments of
International Traffic without entry papers. Is a certifi-
cation required for these residuals?
A. 9. Containers are considered articles and, as such, do not
require certification as long as residuals therein do not
constitute bulk quantities.
Q. 10. How is mixture defined under TSCA?
A. 10. The term mixture is defined in section 3 of TSCA as
follows: "any combination of two or more chemical sub-
stances if the combination does not occur in nature and is
not, in whole or in part, the result of a chemical reac-
tion; except that such term does include any combination
which occurs, in whole or in part, as a result of a chemi-
cal 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."
Q. 11. How are mixtures to be treated? If each item is identi-
fied in the TSCA Inventory, can certification be made?
A. 11. Each chemical substance in the mixture (other than impuri-
ties) must be identified. [However, there are certain
complex chemicals (e.g., Castor oil, Barium iron oxide)
which are designated "Class 2" substances on the TSCA
Inventory to which this will not apply.] After identify-
ing each chemical substance, you must 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.
Q. 12. Do mixtures such as paints, cleaners, and the like have to
be certified?
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I. ARTICLES AND MIXTURES UNDER TSCA SECTION 13
A. 12. Yes, the procedure outlined in the answer to the preceding
question must be followed and a positive certification
signed.
Q. 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?
A. 13. Yes, certification is required for shipments of final
products that are chemical mixtures.
II. CERTIFICATION FORMAT
Q. ,14. What is the acceptable certification language and format
and on what document should the certification be made?
A. 14. 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
thereunder."
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 an
entry document, invoice or other
attachment. The preferred document on
which certification can be made is the
U.S. Customs Form CF 3461 or the entry
summary.
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II. CERTIFICATION FORMAT
Certification on a packing slip or bill of
lading is acceptable if either of these is
included in the entry package. In many
cases, however, the bill of lading is not
part of the entry package. The
certification statements may be signed by
means of an authorized facsimile
signature.
Q. 15. Can a single or "blanket" certificate be
used to cover several shipments of the
same chemical made over a one-year period?
A. 15. Yesf if a "blanket" certification (see
Section III) 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.
Q. 16. Is it necessary for the importer to
include the Chemical Abstracts Service
(CAS) number for each chemical covered by
the certification?
A. 16. 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 actu-
ally on the TSCA Inventory. Importers
must not assume that the existence of a
CAS number means that TSCA requirements
are met.
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III. BLANKET CERTIFICATION
Q. 17. Can you discuss procedures for "blanket" certification?
A. 17. "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 7, 8, and 9, A copy of
every accepted blanket certification will be forwarded by
the District Director, to the Cargo Control Program,
Office of Inspection and Control, Customs Service
Headquarters, Washington/ D.C.
Q. 18. Is it necessary to list tariff item numbers on blanket
certifications?
A. 18. 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 Tariff Schedule of the
U.S.A. (TSUSA)-oriented, tariff item numbers are
necessary.
Q. 19. Must suppliers' names and addresses be listed?
A. 19. Yes, names and addresses must be listed to simplify
resolution of compliance problems which may arise.
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III. BLANKET CERTIFICATION
Q. 20. Is it necessary to file blanket certifications at each
port of entry?
A. 20. 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.
Q. 21. Who is responsible for forwarding a copy of the accepted
blanket certification to Cargo Control?
A. 21. This is the responsibility of the District Director.
IV. CERTIFICATION REQUIREMENTS
Q. 22. What does an importer need to know to determine the
certification requirements for his imported chemical?
A. 22. a) Is my substance exempt from TSCA section 13
certification requirements?
0 Check the categories of materials that do
not require any certification (see
questions 23 and 24).
0 If your substance falls into any of these
categories, you are not required to sign
any certification statement if the ship-
ment is accompanied by the appropriate
forms.
b) Is my substance in the category requiring negative
certification?
o Check the categories of materials that
require negative certification (see
questions 23 and 24).
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IV. CERTIFICATION REQUIREMENTS
o 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.
c) Is my substance in the category requiring positive
certification?
o If your substance does not fall into any
of the categories, either requiring
negative certification, or exempt from
certification altogether, it is subject
to positive certification.
d) Is my substance being imported solely for research
and development purposes?
o If yes, you are exempt from PMN
requirements .-
e) Is my substance a new chemical substance,
potentially subject to PMN requirements?
o Prior to import, you must determine
whether or not your chemical substance is
actually on the printed TSCA Inventory or
Master File. You may ask EPA to search
the Inventory, including the confidential
portion, by establishing a "bona fide
intend to import" as discussed in 48 FR
21722, 40 CFR 720.25, the PMN rule.
o If your chemical substance is not listed
on the Master Inventory, and you wish to
import it, other than for research and
development, you must file a premanufac-
ture notification with EPA at least 90
days prior to import. Your chemical sub-
stance 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 TSCA Assistance Office for
additional information.
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IV. CERTIFICATION REQUIREMENTS
f) My chemical substance is on the Inventory or
imported solely for research and development. Do
I have any further requirements under TSCA section
13?
o You must determine whether there are any
specific regulations or actions regarding
this chemical substance under TSCA
section 5, 6 or 7.
o Check the lists of chemicals subject to
proposed or final regulations under those
sections in A Guide for Chemical Impor-
ters/Exporters , Volume 2: List of
Import/Export Chemicals. You must meet
all the requirements outlined for the
specified chemicals in order to sign the
positive certification statement.
o 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 this
publication. If necessary, call the TSCA
Assistance Office to verify that informa-
tion is up to date.
g) Do I have any further obligations under TSCA?
o Since importers are defined under TSCA as
manufacturers/ they must comply with all
testing, reporting, and recordkeeping
requirements imposed on manufacturers
under TSCA section 4, 8(a), 8(c), 8(d),
and 8(e).
o Some section 8 rules require notification
to EPA prior to the import of a specified
chemical. Importers should ensure that
the required notiication has been com-
pleted before certifying that a shipment
containing the chemical is in compliance
with TSCA. Consult the list of affected
chemicals in Volume 2.
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IV. CERTIFICATION REQUIREMENTS
NOTE; It is your responsibility to verify that the
information has not changed since the date of
publication of A Guide for Chemical
Importers/Exporters.
Q. 23. Which imported chemicals require TSCA positive certifica-
tion, negative certification, and which are exempt and
require no certification?
A. 23. A positive certification of compliance with TSCA is
required for all chemical substances under TSCA
jurisdiction as discussed in PART I: ARTICLES AND
MIXTURES UNDER SECTION 13 in this document.
A negative certification is required for chemicals not
subject to TSCA jurisdiction (except food, drugs, etc.,
as listed directly below under "no certification").
Chemicals which require negative certification are
pesticides, nuclear source materials, special nuclear
materials or nuclear by-product materials, firearms and
ammunition.
No certification is required for articles, as defined in
section 12.120(a) of the rule, and for chemicals not
subject to TSCA because Customs has other controls and
certification requirements involving other federal
statutes. These chemicals are any food, food additive,
drug, drug intermediate, cosmetic, cosmetic intermediate,
or device subject to the Federal Food, Drug and Cosmetic
Act (FFDCA), and any tobacco or tobacco products, when
accompanied by the appropriate forms.
Q. 24. Can Customs schedules be used to determine the need for
certification?
A. 24. Customs 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 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
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IV. CERTIFICATION REQUIREMENTS
by an FDA import 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 l(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.
Q. 25. Is listing of the chemical substance on the TSCA
Inventory of Chemical Substances sufficient basis for
certification of compliance with TSCA?
A. 25. 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 Volume II of the Chemical Importers Guide.]
Q. 26. Does positive certification require compliance with
sections 4 and 8 of TSCA at the time of certification?
A. 26. 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.
However, if 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 notifi-
cation has been completed before certifying that a ship-
ment containing the chemical is in compliance with TSCA.
Q. 27. Does a chemical subject to TSCA under the statutory defi-
nition of "chemical substance" (section 3(2)(a)), but
exempt from section 5 regulations (e.g., R & D sub-
stances), require a negative certification?
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IV. CERTIFICATION REQUIREMENTS
A. 27. No, the chemical substance is subject to TSCA under
section 3(2)(a), and this requires that a positive
certification be signed.
Q. 28. Does the importer need to know the identity of an
imported chemical.
A. 28. The importer may opt to rely on the warranty or certifi-
cation from the foreign supplier in making his TSCA
certification. However, the importer is liable if the
certification is not correct. The liability can be
reduced if the importer has verifiable evidence that he
made good faith efforts to comply.
Q. 29. Can my foreign supplier request an Inventory search?
A. 29. No. All bona fide requests must contain a statement of
bona fide intent to import, signed by a U.S. importer.
However, your foreign supplier may submit technical data
in support of your bona fide submission. Any information
submitted by your foreign supplier and claimed confiden-
tial by him will be treated accordingly by EPA.
Q. 30. Is Volume 2 of A Guide of Chemical Importers/Exporters—
List__gf__jjnp_qrt/_Export Chemicals a complete list of
chemicals covered by the new certification requirement?
A. 30. 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.
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V. WHO CERTIFIES
Q. 31. Who must make the TSCA certification to U.S. Customs?
A. 31. The importer of record (with Customs) or his broker if
acting as his agent with power of attorney is responsible
for TSCA certification.
Q. 32. May the importer of record be a foreign company?
A. 32. 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.
Q. 33. Who may sign the certification for the company?
A. 33. 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.
Q. 34. Are purchasers of items from importers (or customers of
importers) required to make any certification?
A. 34. No.
Q. 35. Border Custom house brokers receive documents from U.S.
Customs for follow-up entry only after shipments have
passed through Customs. How, then, can an importer
comply with certification requirements?
A. 35. There are several ways this can be resolved. The broker
may:
1. Use the bonding provision to secure release
of the shipment, with subsequent
certification.
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V. WHO CERTIFIES
2. Give power of attorney to the foreign
supplier to put the certification on the
invoice, especially in the case of repeat
shipments.
3. Use the "blanket" certification.
Q. 36. Who is responsible for TSCA certification if a chemical
substance is purchased from Canada or Mexico (freight on
board—F.O.B.—shipping point freight allowed—with
freight charges "prepaid"—at the rate from a domestic
point to destination) so title theoretically passes at
point of shipment?
A. 36. Whoever is 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.
VI. FOODS, DRUGS, AND COSMETICS
Q. 37. Are imported foods, food additives, drugs, drug inter-
mediates, cosmetics, cosmetic intermediates, and devices
exempt from TSCA certification?
A. 37. Yes, if these substances are imported solely for use as a
food, drug, cosmetic, device or for use in manufacturing
a food, drug, cosmetic, or device. They do require
separate certification, as specified by U.S. Customs
under the Federal Food, Drug and Cosmetic Act (FFDCA).
Q. 38. What if part of the shipment is for other than FFDCA
uses?
A. 38. Identify each chemical for non-FFDCA use and certify
accordingly.
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VI. FOODS, DRUGS, AND COSMETICS
Q. 39. What if subsequent to importation these materials are
used by the importer for other purposes?
A. 39. This could constitute a violation of TSCA, and the
importer could be subject to penalties.
Q. 40. What if the chemical is on the TSCA Inventory of Chemical
Substances?
A. 40. If the substance is intended solely for FFDCA use, no
TSCA certification is required and a TSCA Inventory
listing is irrelevant.
Q. 41. What if bulk chemicals are imported for manufacture into
drug products, such as tablets or capsules?
A. 41. TSCA certification is not required; however, appropriate
FFDCA certification is required.
Q. 42. What if Form FDA 701 is not present with the .entry docu-
ments though the substance is regulated under FFDCA?
A. 42. You could sign the negative TSCA certification to
expedite Customs release and subsequently submit the FDA
701 form.
Q. 43. Are biochemical substances intended for laboratory
testing covered by TSCA—for example, enzymes, coenzymes,
etc. which may be used in FDS products but, nonetheless,
have other uses not related to FDA?
A. 43. Yes, if the biochemical substances are for a use governed
by TSCA, they require positive certification.
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VI. FOODS, DRUGS, AND COSMETICS
Q. 44. What if a cosmetic ingredient is imported without TSCA
certification, since only cosmetic uses are contemplated/
but the sale for cosmetic uses fails to materialize?
What should the importer do to sell it for non-cosmetic
use?
A. 44. 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 non-cosmetic 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.
VII. R & D USE AND SAMPLES
Q. 45. Do all chemical substances imported solely for R & D use
require TSCA certification?
A. 45. Yes, if they are for a use governed by TSCA, they require
a positive certification.
Q. 46. What if the chemicals are samples only?
A. 46. If they are for a use governed by TSCA, a positive
certification is required.
Q. 47. What if the substances are test marketing samples?
A. 47. TSCA certification requirements apply. If they 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 TSCA Assistance
Office at (202) 554-1404.
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VII. R Si D USE AND SAMPLES
Q. 48. Must the chemical substance for R & D use be on the TSCA
Inventory of Chemical Substances?
A. 48. 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 require-
ments of section 720.36, the substance need not be on the
TSCA Inventory, a PMN is not required, and a positive
certification is correct in this situation.
Q. 49. What if the imported R & D substances are not covered by
TSCA?
A. 49. Negative TSCA certification is required for such substan-
ces, except for certain exempt substances. - _ For those
exempt substances, U.S. Customs requires a separate
certification under another statute. Exempt items
requiring no certification include any food, food
additive, drug, drug intermediate, cosmetic, cosmetic
intermediate, or device under FFDCA, and any tobacco or
tobacco product, when accompanied by the appropriate
form.
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.
Q. 50. How large a quantity can be imported for R & D purposes?
A. 50. There is no specific size or weight limitation. However,
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.
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VII. R & D USE AND SAMPLES
Q. 51. What if the imported R & D substance is used to
manufacture an article for a customer?
A. 51. 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 sub-
stance 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.
0. 52. Does sale of an R & D substance remove it from R & D
status?
A. 52. 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.
0. 53. What is the certification procedure for mailed or parcel
post R & D chemicals.
A. 53. The first receiver of the chemical in the U.S. is
considered the importer and is responsible for the TSCA
certification to U.S. Customs. He should inform his
overseas supplier to include the necessary information or
supporting documentation with the shipment mailed to
him. His certification can then be based on the
documentation received from his supplier.
Q. 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?
A. 54. 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. However, the importer should recognize that he
is responsible for this certification.
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VII. R fit D USE AND SAMPLES
Q. 55. What is the importer's responsibility for his own staff
receiving and using mailed R & D substances?
A. 55. Company officials are responsible for the actions of
their staff in this case. You should inform your staff
of these TSCA requirements and set up internal procedures
for preparation and submission of TSCA certifications to
U.S. Customs.
Q. 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?
A. 56. 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 US/EXPORT SHIPMENTS
Q. 57. Is it necessary to certify TSCA compliance for chemicals
that are in-transit through the U.S.?
A. 57. No, certification is not required for chemicals imported
under entry for transportation and exportation (T & E
entry), e.g., from Mexico to Canada.
Q. 58. Do shipments moving via mail between Canada and Mexico
require certification?
A. 58. No.
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VIII. IN-TRANSIT THROUGH US/EXPORT SHIPMENTS
Q. 59. What if the chemicals are travelling through the U.S. in
bond for clearance at another port of entry?
A. 59. The importer need not certify at the first port of
arrival but must certify at the subsequent port of entry.
Q. 60. What TSCA requirements apply to an imported chemical that
is:
(1) used in the U.S. to manufacture a product
that will then be exported in its entirety
(for example, used as an intermediate)?
(2) processed in the U.S. and then exported in
its entirety?
A. 60. A positive certification would be required in both
situations.
Q. 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?
A. 61. If the chemical substance comes under TSCA jurisdiction,
a positive certification would be required for
importation into the U.S.
Q. 62. What about pipeline shipments of crude oil or natural
gas?
A. 62. 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
section II).
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VIII. IN-TRANSIT THROUGH US/EXPORT SHIPMENTS
Q. 63. What about entry into Foreign Trade Zones for reexport?
A. 63. Import certification is not necessary for entry into
Foreign Trade Zones. However/ 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
Q. 64. We have been importing chemicals for the photographic
industry for the past few years. How does the new rule
impact on future imports of these chemicals?
A. 64. If the chemicals are under TSCA jurisdiction, a positive
certification of compliance is required.
Q. 65. As an importer of hydraulic machinery, I understand that
hydraulic fluids contained inside the machinery are not
covered by these rules. However, sometimes my foreign
supplier includes a can of additional fluid with the
machinery shipment. What are my TSCA responsibilities
for this can of fluid?
A. 65. Your responsibility is the same as for any other imported
chemical substance governed by TSCA. A positive
certification of compliance with TSCA is required.
Q. 66. Must an importer determine the possible contaminants and
unknown chemicals in crude oil or gasoline before
certification?
A. 66. 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 identi-
fied, be on the TSCA Inventory, and be in compliance with
any further rules or regulations under section 5, 6, or 7
of TSCA.
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IX. SPECIAL CASES
Q. 67. I import an alkylation waste acid which is composed of
98% sulfuric acid with 2% trace contaminants. Must I
determine what the trace contaminants are?
A. 67. No, as long as you are certain there are no PCBs in the
trace contaminants, they are considered impurities, and
you can sign the positive certification.
Q. 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?
A. 68. No, the answer to the preceding question also applies in
this case.
Q. 69. Do wastes imported into the United States require TSCA
certification?
A. 69. Yes, wastes imported into the United States are within
TSCA jurisdiction, and each import requires a positive
certification.
Q. 70. If wastes are imported solely for disposal or for
recycling, what information do I need to make a TSCA
import certification?
A. 70. 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 notifica-
tion 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 subs-
tance, they are not subject to premanufacture notifica-
tion under section 5 of TSCA. It should be noted that
"by-products" include by-products of use as well as
manufacture and processing. Therefore, spent solvents,
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IX. SPECIAL CASES
spent cleaning agents, and used motor oil are classified
as by-products, in addition to manufacturing waste.
Q. 71. What if the wastes are accompanied by a manifest as
required by the Resource Conservation and Recovery Act
(RCRA)?
A. 71. A positive certification is still required.
Q. 72. What if the wastes are to be used as a feedstock for a
manufacturing process?
A. 72. A positive certification is required, and the importer
must check the TSCA Inventory to determine if the waste
is a "new" chemical substance. However, if the use is
solely for extraction of a commercial chemical substance,
the waste is not subject to a PMN. The importer must
also check rules or orders under sections 5, 6, and 7 of
TSCA.
Q. 73. Are living plants and animals subject to certification?
A. 73. Living plants and animals, other than microorganisms, are
not subject to certification. However, natural products
such as lumber, peat, or rubber are subject to certifica-
tion unless they are imported in the form of an article.
Q. 74. Do seeds sprayed with a pesticide require TSCA
certification?
A. 74. No, as living plant matter, seeds are not subject to cer-
tification. The fact that they have been sprayed with a
pesticide does not change their status.
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X. DETAINED SHIPMENTS
Q. 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 noncomplying items for detention?
A. 75. Decisions of this kind will be made on a case-by-case
basis, at the discretion of the Customs Officer,
depending upon individual circumstances.
Q. 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?
A. 76. To a degree, since there is a provision for a bond.
Q. 77. Concerning shipments which have arrived, but for which
additional time is necessary to determine proper certifi-
cation, please detail how and when a bond can be given
for production of the certification.
A. 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.
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X. DETAINED SHIPMENTS
Q. 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?
A. 78. EPA will provide notification in writing which will
include the rationale to U.S. Customs and the importer.
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