[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: 40CFR710.3]

[Page 32-34]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 710--TSCA CHEMICAL INVENTORY REGULATIONS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 710.3   Definitions.

    In addition to the definitions in Sec. 704.3 of this chapter, the 
following definitions apply to this part:
    (a) The following terms will have the meaning contained in the 
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq., and the 
regulations issued under such Act: Cosmetic, device, drug, food, and 
food additive. In addition, the term food includes poultry and poultry 
products, as defined in the Poultry Products Inspection Act, 21 U.S.C. 
453 et seq.; meats and meat food products, as defined in the Federal 
Meat Inspection Act, 21 U.S.C. 60 et seq.; and eggs and egg products, as 
defined in the Egg Products Inspection Act, 21 U.S.C. 1033 et seq.
    (b) The term pesticide will have the meaning contained in the 
Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et 
seq., and the regulations issued thereunder.
    (c) The following terms will have the meaning contained in the 
Atomic Energy Act of 1954, 42 U.S.C. 2014 et seq., and the regulations 
issued thereunder: Byproduct material, source material, and special 
nuclear material.
    (d) The following definitions also apply to this part:
    Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.
    Administrator means the Administrator of the U.S. Environmental 
Protection Agency, any employee or authorized representative of the 
Agency to whom the Administrator may either herein or by order delegate 
his/her authority to carry out his/her functions, or any other person 
who will by operation of law be authorized to carry out such functions.
    An article is 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 may occur as 
described in Sec. 710.4(d)(5); except that fluids and particles are not 
considered articles regardless of shape or design.
    Byproduct means a chemical substance produced without separate 
commercial intent during the manufacture or processing of another 
chemical substance(s) or mixture(s).
    Chemical substance means 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 chemical element or uncombined 
radical; except that ``chemical substance'' does not include:
    (1) Any mixture,
    (2) Any pesticide when manufactured, processed, or distributed in 
commerce for use as a pesticide,
    (3) Tobacco or any tobacco product, but not including any derivative 
products,
    (4) Any source material, special nuclear material, or byproduct 
material,
    (5) Any pistol, firearm, revolver, shells, and cartridges, and
    (6) Any food, food additive, drug, cosmetic, or device, when 
manufactured, processed, or distributed in commerce for use as a food, 
food additive, drug, cosmetic, or device.
    Commerce means trade, traffic, transportation, or other commerce:
    (1) Between a place in a State and any place outside of such State, 
or
    (2) Which affects trade, traffic, transportation, or commerce 
described in paragraph (1) of this definition.
    Distribute in commerce and distribution in commerce, when used to 
describe an action taken with respect to a chemical substance or mixture 
or article containing a substance or mixture, mean to sell or the sale 
of the substance, mixture, or article in commerce; to introduce or 
deliver for introduction into commerce, or the introduction or delivery 
for introduction into commerce of the substance, mixture, or article; or 
to hold or the holding of the substance, mixture, or article after its 
introduction into commerce.
    EPA means the U.S. Environmental Protection Agency.

[[Page 33]]

    Importer means any person who imports any chemical substance or any 
chemical substance as part of a mixture or article into the customs 
territory of the U.S. and includes:
    (1) The person primarily liable for the payment of any duties on the 
merchandise, or
    (2) An authorized agent acting on his/her behalf (as defined in 19 
CFR 1.11).
    Impurity means a chemical substance which is unintentionally present 
with another chemical substance.
    Intermediate means any chemical substance:
    (1) Which is intentionally removed from the equipment in which it is 
manufactured, and
    (2) Which either is consumed in whole or in part in chemical 
reaction(s) used for the intentional manufacture of other chemical 
substance(s) or mixture(s), or is intentionally present for the purpose 
of altering the rate of such chemical reaction(s).
    Note: The equipment in which it was manufactured includes the 
reaction vessel in which the chemical substance was manufactured and 
other equipment which is strictly ancillary to the reaction vessel, and 
any other equipment through which the chemical substance may flow during 
a continuous flow process, but does not include tanks or other vessels 
in which the chemical substance is stored after its manufacture.

    Manufacture means to manufacture, produce, or import for commercial 
purposes.
    Manufacture or import ``for commercial purposes'' means to 
manufacture, produce, or import with the purpose of obtaining an 
immediate or eventual commercial advantage, and includes, for example, 
the manufacture or import of any amount of a chemical substance or 
mixture:
    (1) For commercial distribution, including for test marketing, or
    (2) For use by the manufacturer, including use for product research 
and development, or as an intermediate.
    Mixture means 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 ``mixture'' does 
include:
    (1) Any combination which occurs, in whole or in part, as a result 
of a chemical reaction 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 and if, 
after the effective date or premanufacture notification requirements, 
none of the chemical substances comprising the combination is a new 
chemical substance, and
    (2) Hydrates of a chemical substance or hydrated ions formed by 
association of a chemical substance with water.
    New chemical substance means any chemical substance which is not 
included in the inventory compiled and published under section 8(b) of 
the Act.
    Person means any natural or juridical person including any 
individual, corporation, partnership, or association, any State or 
political subdivision thereof, or any municipality, any interstate body 
and any department, agency, or instrumentality of the Federal 
Government.
    Process means the preparation of a chemical substance or mixture, 
after its manufacture, for distribution in commerce:
    (1) In the same form or physical state as, or in a different form or 
physical state from, that in which it was received by the person so 
preparing such substance or mixture, or
    (2) As part of a mixture or article containing the chemical 
substance or mixture.
    Process ``for commercial purposes'' means to process:
    (1) For distribution in commerce, including for test marketing 
purposes, or
    (2) For use as an intermediate.
    Processor means any person who processes a chemical substance or 
mixture.
    Site means a contiguous property unit. Property divided only by a 
public right-of-way will be considered one site. There may be more than 
one manufacturing plant on a single site. For the purposes of imported 
chemical substances, the site will be the business address of the 
importer.
    Small quantities for purposes of scientific experimentation or 
analysis or chemical research on, or analysis of, such substance or 
another substance, including any such research or analysis for the 
development of a product (hereinafter sometimes shortened to small 
quantities

[[Page 34]]

for research and development) means quantities of a chemical substance 
manufactured, imported, or processed or proposed to be manufactured, 
imported, or processed that:
    (1) Are no greater than reasonably necessary for such purposes, and
    (2) After the publication of the revised inventory, are used by, or 
directly under the supervision of, a technically qualified 
individual(s).

    Note: Any chemical substances manufactured, imported, or processed 
in quantities less than 1,000 lbs. (454 kg) annually will be presumed to 
be manufactured, imported, or processed for research and development 
purposes. No person may report for the inventory any chemical substance 
in such quantities unless that person can certify that the substance was 
not manufactured, imported, or processed solely in small quantities for 
research and development, as defined in this section.

    State means any State of the United States, the District of 
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the 
Canal Zone, American Samoa, the Northern Mariana Islands, or any other 
territory or possession of the United States.
    Technically qualified individual means a person:
    (1) Who because of his/her education, training, or experience, or a 
combination of these factors, is capable of appreciating the health and 
environmental risks associated with the chemical substance which is used 
under his/her supervision,
    (2) Who is responsible for enforcing appropriate methods of 
conducting scientific experimentation, analysis, or chemical research in 
order to minimize such risks, and
    (3) Who is responsible for the safety assessments and clearances 
related to the procurement, storage, use, and disposal of the chemical 
substance as may be appropriate or required within the scope of 
conducting the research and development activity. The responsibilities 
in this paragraph may be delegated to another individual, or other 
individuals, as long as each meets the criteria in paragraph (1) of this 
definition.
    Test marketing means the distribution in commerce of no more than a 
predetermined amount of a chemical substance, mixture, or article 
containing that chemical substance or mixture, 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.
    United States, when used in the geographic sense, means all of the 
States, territories, and possessions of the United States.

[68 FR 888, Jan. 7, 2003]