[Code of Federal Regulations]
[Title 40, Volume 28]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR704.3]

[Page 9-12]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 704--REPORTING AND RECORDKEEPING REQUIREMENTS--Table of Contents
 
 Subpart A--General Reporting and Recordkeeping Provisions for Section 
                    8(a) Information-Gathering Rules
 
Sec. 704.3  Definitions.

    All definitions as set forth in section 3 of TSCA apply in this 
part. In addition, the following definitions are provided for the 
purposes of this part.
    Annual means the corporate fiscal year.
    Article means a manufactured item (1) which is formed to a specific 
shape or design during manufacture, (2) which has end use function(s) 
dependent in whole or in part upon its shape or design during end use, 
and (3) which 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 result from a 
chemical reaction that occurs upon end use of other chemical

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substances, mixtures, or articles; except that fluids and particles are 
not considered articles regardless of shape or design.
    Byproduct means a chemical substance produced without a separate 
commercial intent during the manufacture, processing, use, or disposal 
of another chemical substance(s) or mixture(s).
    CAS Number means Chemical Abstracts Service Registry Number.
    Coproduct means a chemical substance produced for a commercial 
purpose during the manufacture, processing, use, or disposal of another 
chemical substance or mixture.
    Customer means any person to whom a manufacturer, importer, or 
processor directly distributes any quantity of a chemical substance, 
mixture, mixture containing the substance or mixture, or article 
containing the substance or mixture, whether or not a sale is involved.
    Domestic means within the geographical boundaries of the 50 United 
States, including the District of Columbia, the Commonwealth of Puerto 
Rico, the Virgin Islands, Guam, American Samoa, the Northern Mariana 
Islands, and any other territory or possession of the United States.
    Enclosed process means a manufacturing or processing operation that 
is designed and operated so that there is no intentional release into 
the environment of any substance present in the operation. An operation 
with fugitive, inadvertent, or emergency pressure relief releases 
remains an enclosed process so long as measures are taken to prevent 
worker exposure to and environmental contamination from the releases.
    EPA means the United States Environmental Protection Agency.
    Import means to import for commercial purposes.
    Import for commercial purposes means to import with the purpose of 
obtaining an immediate or eventual commercial advantage for the 
importer, and includes the importation of any amount of a chemical 
substance or mixture. If a chemical substance or mixture containing 
impurities is imported for commercial purposes, then those impurities 
also are imported for commercial purposes.
    Import in bulk form means to import a chemical substance (other than 
as part of a mixture or article) in any quantity, in cans, bottles, 
drums, barrels, packages, tanks, bags, or other containers, if the 
chemical substance is intended to be removed from the container and the 
substance has an end use or commercial purpose separate from the 
container.
    Importer means (1) any person who imports any chemical substance or 
any chemical substance as part of a mixture or article into the customs 
territory of the United States, and includes:
    (i) The person primarily liable for the payment of any duties on the 
merchandise, or
    (ii) An authorized agent acting on his behalf (as defined in 19 CFR 
1.11).
    (2) Importer also includes, as appropriate:
    (i) The consignee.
    (ii) The importer of record.
    (iii) The actual owner if an actual owner's declaration and 
superseding bond have been filed in accordance with 19 CFR 141.20.
    (iv) The transferee, if the right to draw merchandise in a bonded 
warehouse has been transferred in accordance with subpart C of 19 CFR 
part 144.
    (3) For the purposes of this definition, the customs territory of 
the United States consists of the 50 States, Puerto Rico, and the 
District of Columbia.
    Impurity means a chemical substance which is unintentionally present 
with another chemical substance.
    Intermediate means any chemical substance that is consumed, in whole 
or in part, in chemical reactions used for the intentional manufacture 
of other chemical substances or mixtures, or that is intentionally 
present for the purpose of altering the rates of such chemical 
reactions.
    Known to or reasonably ascertainable by means all information in a 
person's possession or control, plus all information that a reasonable 
person similarly situated might be expected to possess, control, or 
know.
    Manufacture means to manufacture for commercial purposes.

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    Manufacture for commercial purposes means: (1) To import, produce, 
or manufacture with the purpose of obtaining an immediate or eventual 
commercial advantage for the manufacturer, and includes among other 
things, such ``manufacture'' of any amount of a chemical substance or 
mixture:
    (i) For commercial distribution, including for test marketing.
    (ii) For use by the manufacturer, including use for product research 
and development, or as an intermediate.
    (2) Manufacture for commercial purposes also applies to substances 
that are produced coincidentally during the manufacture, processing, 
use, or disposal of another substance or mixture, including both 
byproducts that are separated from that other substance or mixture and 
impurities that remain in that substance or mixture. Such byproducts and 
impurities may, or may not, in themselves have commercial value. They 
are nonetheless produced for the purpose of obtaining a commercial 
advantage since they are part of the manufacture of a chemical product 
for a commercial purpose.
    Manufacturer means a person who imports, produces, or manufactures a 
chemical substance. A person who extracts a component chemical substance 
from a previously existing chemical substance or a complex combination 
of substances is a manufacturer of that component chemical substance.
    Non-isolated intermediate means any intermediate that is not 
intentionally removed from the equipment in which it is manufactured, 
including the reaction vessel in which it is manufactured, equipment 
which is ancillary to the reaction vessel, and any equipment through 
which the substance passes during a continuous flow process, but not 
including tanks or other vessels in which the substance is stored after 
its manufacture. Mechanical or gravity transfer through a closed system 
is not considered to be intentional removal, but storage or transfer to 
shipping containers ``isolates'' the substance by removing it from 
process equipment in which it is manufactured.
    Own or control means ownership of 50 percent or more of a company's 
voting stock or other equity rights, or the power to control the 
management and policies of that company. A company may own or control 
one or more sites. A company may be owned or controlled by a foreign or 
domestic parent company.
    Parent company is a company that owns or controls another company.
    Person includes any individual, firm, company, corporation, joint 
venture, partnership, sole proprietorship, association, or any other 
business entity; any State or political subdivision thereof; any 
municipality; any interstate body; and any department, agency, or 
instrumentality of the Federal Government.
    Possession or control means in the possession or control of any 
person, or of any subsidiary, partnership in which the person is a 
general partner, parent company, or any company or partnership which the 
parent company owns or controls, if the subsidiary, parent company, or 
other company or partnership is associated with the person in the 
research, development, test marketing, or commercial marketing of the 
substance in question. Information is in the possession or control of a 
person if it is:
    (1) In the person's own files including files maintained by 
employees of the person in the course of their employment.
    (2) In commercially available data bases to which the person has 
purchased access.
    (3) Maintained in the files in the course of employment by other 
agents of the person who are associated with research, development, test 
marketing, or commercial marketing of the chemical substance in 
question.
    Process means to process for commercial purposes.
    Process for commercial purposes means the preparation of a chemical 
substance or mixture after its manufacture for distribution in commerce 
with the purpose of obtaining an immediate or eventual commercial 
advantage for the processor. Processing of any amount of a chemical 
substance or mixture is included in this definition. If a chemical 
substance or mixture containing impurities is processed for commercial 
purposes, then the impurities also are processed for commercial 
purposes.

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    Processor means any person who processes a chemical substance or 
mixture.
    Production volume means the quantity of a substance which is 
produced by a manufacturer, as measured in kilograms or pounds.
    Propose to manufacture, import, or process means that a person has 
made a firm management decision to commit financial resources for the 
manufacture, import, or processing of a specified chemical substance or 
mixture.
    Site means a contiguous property unit. Property divided only by a 
public right-of-way shall be considered one site. There may be more than 
one plant on a single site. The site for a person who imports a 
substance is the site of the operating unit within the person's 
organization which is directly responsible for importing the substance 
and which controls the import transaction and may in some cases be the 
organization's headquarters office in the United States.
    Small manufacturer or importer means a manufacturer or importer that 
meets either of the following standards:
    (1) First standard. A manufacturer or importer of a substance is 
small if its total annual sales, when combined with those of its parent 
company (if any), are less than $40 million. However, if the annual 
production or importation volume of a particular substance at any 
individual site owned or controlled by the manufacturer or importer is 
greater than 45,400 kilograms (100,000 pounds), the manufacturer or 
importer shall not qualify as small for purposes of reporting on the 
production or importation of that substance at that site, unless the 
manufacturer or importer qualifies as small under standard (2) of this 
definition.
    (2) Second standard. A manufacturer or importer of a substance is 
small if its total annual sales, when combined with those of its parent 
company (if any), are less than $4 million, regardless of the quantity 
of substances produced or imported by that manufacturer or importer.
    (3) Inflation index. EPA shall make use of the Producer Price Index 
for Chemicals and Allied Products, as compiled by the U.S. Bureau of 
Labor Statistics, for purposes of determining the need to adjust the 
total annual sales values and for determining new sales values when 
adjustments are made. EPA may adjust the total annual sales values 
whenever the Agency deems it necessary to do so, provided that the 
Producer Price Index for Chemicals and Allied Products has changed more 
than 20 percent since either the most recent previous change in sales 
values or the date of promulgation of this rule, whichever is later. EPA 
shall provide Federal Register notification when changing the total 
annual sales values.
    Small quantities solely for research and development (or ``small 
quantities solely for purposes of scientific experimentation or analysis 
or chemical research on, or analysis of, such substance or another 
substance, including such research or analysis for the development of a 
product'') means quantities of a chemical substance manufactured, 
imported, or processed or proposed to be manufactured, imported, or 
processed solely for research and development that are not greater than 
reasonably necessary for such purposes.
    Substance means either a chemical substance or mixture unless 
otherwise indicated.
    Test marketing means the distribution in commerce of no more than a 
predetermined amount of a chemical substance, mixture, article 
containing that chemical substance or mixture, or a mixture containing 
that substance, by a manufacturer or processor, to no more than a 
defined number of potential customers to explore market capability in a 
competitive situation during a predetermined testing period prior to the 
broader distribution of that chemical substance, mixture, or article in 
commerce.
    Total annual sales means the total annual revenue (in dollars) 
generated by the sale of all products of a company. Total annual sales 
must include the total annual sales revenue of all sites owned or 
controlled by that company and the total annual sales revenue of that 
company's subsidiaries and foreign or domestic parent company, if any.
    TSCA means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.

[53 FR 51715, Dec. 22, 1988]

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